Friday, December 23, 2011
Wednesday, December 21, 2011
Tuesday, December 06, 2011
Tuesday, November 22, 2011
10,000 Signatures in 10 Days; We Can Do It!
By James J. Gormley
With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.
To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!
Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!
With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.
To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!
Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!
Friday, November 18, 2011
Petition to Demand that the FDA Withdraws the NDI Draft Guidance!
By James J. Gormley
Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.
That's why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:
Thanks!
That's why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:
"I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."Will you sign this petition? Please click here.
Thanks!
Friday, November 11, 2011
A Defining Moment for the Dietary Supplement Industry
By James J. Gormley
The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”
Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).
And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah), is alarmed by the Guidance.
Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.
Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.
War seldom is.
In 1966, the FDA announced plans that it was going to ban nutrient potencies over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.
When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender! No retreat!”
The battle cry was not “Let’s play nice,” of that I can assure you.
In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, and aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
And we won.
Offering an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.
So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome.Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”
Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.
“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”
Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?
Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?
They should.
When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.
We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.
For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833), and circulate these links via all of your lists.
Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.
Because that plate in front of them might well be empty.
The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”
Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).
And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah), is alarmed by the Guidance.
Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.
Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.
War seldom is.
In 1966, the FDA announced plans that it was going to ban nutrient potencies over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.
When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender! No retreat!”
The battle cry was not “Let’s play nice,” of that I can assure you.
In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, and aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
And we won.
Offering an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.
So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome.Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”
Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.
“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”
Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?
Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?
They should.
When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.
We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.
For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833), and circulate these links via all of your lists.
Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.
Because that plate in front of them might well be empty.
Wednesday, November 09, 2011
Senate Vote Puts Net Neutrality Rules in Jeopardy
Consumers Union Urges Senators to Support an Open Internet
WASHINGTON, D.C. - As the Senate gears up to vote on a proposal to repeal the Federal Communication Commission’s (FCC) Open Internet rules, Consumers Union, the policy and advocacy division of Consumer Reports, sent a letter to Capitol Hill yesterday urging lawmakers to reject the proposal and keep the Internet open for consumers.
“The FCC’s Open Internet rules simply make it harder for internet providers to play favorites by speeding up or slowing down content over their networks. Consumers expect and deserve to be able to freely surf the internet. To do away with these rules goes against the very nature of the Internet’s open marketplace,” said Parul P. Desai, policy counsel for Consumers Union.
The Congressional Review Act before the Senate (S.J. Res. 6) would eliminate the current FCC rules and hobble the FCC when it comes to keeping the Internet open. President Obama yesterday announced that he would veto the Senate legislation, saying an open Internet is critical to job creation, economic growth, and global competitiveness.
Desai said, “The overwhelming majority of stakeholders -- consumers, small businesses, unions, religious organizations and minority groups -- agree that the Open Internet rules are needed and that the FCC has the authority to implement and enforce these rules. We urge the Senate to vote no on this proposal. Rejecting this measure would ensure consumers could continue to use the Internet equally.”
For a full copy of the letter, please contact David Butler or Kara Kelber of Consumers Union.
### Contact:
David Butler or Kara Kelber, 202-462-6262
WASHINGTON, D.C. - As the Senate gears up to vote on a proposal to repeal the Federal Communication Commission’s (FCC) Open Internet rules, Consumers Union, the policy and advocacy division of Consumer Reports, sent a letter to Capitol Hill yesterday urging lawmakers to reject the proposal and keep the Internet open for consumers.
“The FCC’s Open Internet rules simply make it harder for internet providers to play favorites by speeding up or slowing down content over their networks. Consumers expect and deserve to be able to freely surf the internet. To do away with these rules goes against the very nature of the Internet’s open marketplace,” said Parul P. Desai, policy counsel for Consumers Union.
The Congressional Review Act before the Senate (S.J. Res. 6) would eliminate the current FCC rules and hobble the FCC when it comes to keeping the Internet open. President Obama yesterday announced that he would veto the Senate legislation, saying an open Internet is critical to job creation, economic growth, and global competitiveness.
Desai said, “The overwhelming majority of stakeholders -- consumers, small businesses, unions, religious organizations and minority groups -- agree that the Open Internet rules are needed and that the FCC has the authority to implement and enforce these rules. We urge the Senate to vote no on this proposal. Rejecting this measure would ensure consumers could continue to use the Internet equally.”
For a full copy of the letter, please contact David Butler or Kara Kelber of Consumers Union.
David Butler or Kara Kelber, 202-462-6262
Tuesday, November 01, 2011
NHRI Symposium Heralds A New Era for Dietary Supplements
By James J. Gormley
The ballroom was packed at the Natural Health Research Institute (NHRI) 6th Annual Scientific Symposium in Schaumburg, Illinois on October 28th, as well it should have been not only considering the event title, which was “Cutting Healthcare Costs Through Prevention: Measuring the Efficacy, Safety, and Cost Savings of Dietary Supplements,” but also given the stellar lineup of world-class experts.The speakers were:
- Meg Jordan, PhD, RN, Department Chair and Professor of Integrative Health Studies at the California Institute of Integral Studies, and Director of Integrative Practice at the Health Medicine Institute;
- Mark Blumenthal, Founder and Executive Director of the American Botanical Council (ABC) and Founding Member of the American Herbal Products Association (AHPA)
- Allen Dobson, PhD, Health Economist and President of Dobson DaVanzo and Associates;
- Artemis Simopoulos, MD, Founder and President of the Center for Genetics, Nutrition and Health; and
- Russell Jaffe, MD, PhD, Fellow of the Health Studies Collegium and Founder of PERQUE.
 |
| Meg Jordan |
Dr. Jordan, whose presentation was entitled “Let Sanity Reign: The Undeniable Health-Wealth Connection for a Happier, Healthier Society,” electrified the audience with what could have been an indictment of how unhealthy the U.S. is but, instead, pointed the ways we can build a well-being society that takes into account: spirituality, nutrition-food, physical health, social belonging, intimacy and love, financial well-being and occupation-livelihood.
 |
| Mark Blumenthal |
Mark Blumenthal’s talk was entitled: “Review of Safety and Benefits of Numerous Herbs and Phytomedicinal Dietary Supplements as Demonstrated by Systematic Reviews and Meta-Analyses of Controlled Clinical Trials.” Mr. Blumenthal stunned many attendees with the statement that over a 3-year period, the annual number of herbal medicine papers rose from 739 in 1977 to 6,364 in 2007, most of which were scientific reviews and randomized controlled trials.
He compared thenumber of studies with the imbalanced, typicaly negative coverage of herbal studies by the mainstream press, especially noticeable in journals that have the highest ratio of pharmaceutical ads, and reviewed the worldwide research on a wide range of medicinal plants.
 |
| Allen Dobson |
Dr. Dobson’s presentation, “Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements,” reviewed the billions of dollars in healthcare savings that could be achieved by widespread public-health promotion of a number of nutrients (including: calcium with vitamin D; folic acid; omega-3 fats; and lutein with zeaxanthin). Of great interest to many in attendance, he punched a number of holes in the recent multivitamin and vitamin E studies that have achieved such infamy.
 |
| Artemis Simopoulos |
Dr. Simopoulos’ talk was entitled: “Economic and Health Implications of Changing America’s Oil: The Omega-3 Opportunity.” She outlines the many downsides of the dramatic decrease in omega-3 fat consumption over the past 150 years due to agribusiness and food processing and the reasons why it is utterly imperative that we, as a society, significantly increase our consumption of omega-3 fats and decrease our intake of omega-6 fats.
Dr. Jaffe closed out the presentations with a talk entitled, “Evidence of Savings Through Application of Supplements to Treat Dietary Deficiencies.” He explained how by our correcting essential nutrient deficits relating to diabetes alone could save $135 billion each year, and that supplements for other health areas can save America an additional $50-100 billion annually, all while improving quality of life.
 |
| Russ Jaffe |
With the event having been organized by the NHRI and the American Nutrition Association, the NHRI is an independent, non-profit organization that supports science-based research on natural health and wellness. It is “committed to informing consumers, scientists, the media, policymakers and legislators about scientific evidence on the efficacy and cost-effectiveness of diet, supplements and a healthy lifestyle in order to improve health and wellness, and reduce disease, around the world.”
Wednesday, October 26, 2011
Thursday, October 20, 2011
The Next Ephedra is Ephedra?
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
It would seem so based on recent ads in the musclehead magazines.
In a recent issue of one mag, there are double-page ad spreads from a company that one would think has had enough enforcement actions against it to last several lifetimes. The ads feature images and cartoons of women who look either like Vegas strippers or hookers along with ad language screaming that these products have 25 mg of ephedra extract, but with caveats that say "we're not breaking the law, folks; these things are perfectly legal."
The only way these products could not be in direct and flagrant violation of the law is if: 1.) they are not dietary supplements but are instead special classes of OTC remedies (which they are not); or 2.) the so-called ephedra is not really ephedra but some other botanical.
Well, there are a few big problems here. If the main active is not ephedra, then the FTC could slam the company for false and deceptive advertising and for claiming their products have a banned ingredient. If the flagship ingredient is ephedra, well the enforcement pathway on that is pretty clear!
If, however, the so-called ephedra extract is actually derived from the Acacia rigidula plant (as one of the ads suggests), it may not contain ephedra alkaloids but it may well contain methamphetamine, mescaline and nicotine, not the safest profile, to say the very least.
Seeing these ads really got me mad, and I wound up calling Marc Ullman, who was equally incensed. I sent these ads to the FTC, FDA and the USDA import-export officials, in addition to copying the trade associations.
Precisely because the vast majority of supplement manufacturers are responsible and ethical, it behooves us as an industry to do everything we can to not only protect consumers from misinformation and harm but to also shine a light on gray-market profiteers who are taking advantage of the DSHEA regulatory pathway yet whose products are merely masquerading as nutritional supplements.
It’s hard for us to stand tall when these bottom-feeders are muddying the waters for all of us.
There have been astounding advances in athletic-performance-related nutritional research along with the introduction of powerful, science-based sports supplements, but until we call out, shame and shun these jokers, we will have our treadmill set to “uphill” for a long time.
Saturday, October 08, 2011
Saturday, September 24, 2011
Wednesday, September 21, 2011
Friday, September 16, 2011
Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Information Request
By Stephen Daniells
From Nutraingredients-USA.
California-based Jarrow Formulas has submitted a 128-item Freedom of Information [Act] Request to the U.S. FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.
The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.
Read More
From Nutraingredients-USA.
California-based Jarrow Formulas has submitted a 128-item Freedom of Information [Act] Request to the U.S. FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.
The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.
Read More
Saturday, September 10, 2011
Busting the Anti-Supplement Myth Machine
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
Pick up any newspaper, scan your daily news feed, glance at the TV --- and you’re sure to be hit by the latest “news” about dietary supplements: how they don’t work, how they’re all tainted with contaminants and laced with pharmaceuticals; and how their manufacturers are out to get us!
The truth, however, is far more reassuring than the headlines make out. Go ahead, Google “dietary supplements” with the name of any of the big networks or newspapers, anything from ABC News to the Chicago Sun-Times or CNN, you name it.
I did: and in top search listings for seven of the country’s leading newspapers and five of its major networks, nearly 70 percent of the coverage is skeptical and cautionary about dietary supplements.
In fact, our self-appointed guardians of public health (whether wielding Senatorial powers or using a journalist’s pen) almost always forget to discuss those tablets and capsules that are profoundly dangerous and largely toxic: prescription drugs. Each year, prescription drugs injure approximately 2.2 million and kill at least 100,000 Americans.
With today’s nutritionally bankrupt diet over 52 percent of Americans take dietary supplements, a rate that is expected to keep growing. So, if supplements are so popular, and good for us, why, we ask, are they getting such a bum rap? Good question.
Feeding the undeservedly bad reputation is a confluence of several factors, including: historically poor government enforcement against a small number of fringe operators; general misunderstanding of how well-regulated the dietary supplement industry actually is; and media feeding frenzies related to high-profile cases that have little, or nothing, to do with the dietary supplement industry, aside from actually showing the regulations effectively working.
Therefore, it’s up to all of us to be myth-busters on a daily, or weekly or monthly basis — so that one day our guardians of public health will have no choice but to acknowledge what we already know: the power and promise of safe dietary supplements that are produced by a responsible, well-regulated dietary supplement industry: in other words, the facts.
It’s time that conventional researchers begin to design studies that build on vitamin research of the last 50 years rather than attempt to poke holes in what we already all know: vitamins promote health, reduce disease, and help people live longer … and better.
And it’s high time that the media write a new story about dietary supplements, one based on science and facts not on cynicism and misreporting, because the story they have been writing of late is getting old fast.
Friday, September 09, 2011
The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun
By James J. Gormley
According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.
I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone --- calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) --- could reduce healthcare costs by over $24 billion.
These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements --- such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on ---- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.
Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.
It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.
Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.
Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.
The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.
Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.
In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:
While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.
While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.
Our defining health-freedom battle of the first century of this new millennium has begun.
U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.
I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone --- calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) --- could reduce healthcare costs by over $24 billion.
These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements --- such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on ---- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.
Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.
It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.
Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.
Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.
The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.
Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.
In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:
- Citizens for Health (http://www.citizens.org/);
- Alliance for Natural Health (http://www.anh-usa.org/);
- Your Voice for Health (http://www.yvfh.org/about/);
- Operation Pushback (http://operationpushback.com/); and others.
While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.
While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.
Our defining health-freedom battle of the first century of this new millennium has begun.
Thursday, September 08, 2011
Emord on NDI Guidance
From Nutraingredients-USA
By Elaine Watson
If sufficient pressure is exerted by key members of Congress, it is not beyond the realm of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan Emord.
Read More
By Elaine Watson
If sufficient pressure is exerted by key members of Congress, it is not beyond the realm of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan Emord.
Read More
Monday, September 05, 2011
Monday, July 18, 2011
What’s old is new again? The FDA takes aim at modern science and innovation
By James J. Gormley
On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.
What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ─ herbal extracts and nutrients ─ that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.
NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.
So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.
Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.
The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.
“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.
![]()
As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!
This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!
As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”
![]()
The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!
Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”
In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.
According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”
What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.
If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.
![]()
Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.
On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.
What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ─ herbal extracts and nutrients ─ that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.
NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.
So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.
Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.
The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.
“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.
As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!
This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!
As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”
The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!
Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”
In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.
According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”
What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.
If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.
Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.
Monday, June 27, 2011
E.F.S.A. ? N.O.P.E.!
Courtesy of the SupplySide Community
By James J. Gormley
Let me start off by saying that EFSA (the European Food Safety Authority) and I go way back, as it were.
As a natural products industry regulatory officer, while I found having to not only go through individual European Union (EU) member states (countries) but also specifically through each country’s version of the U.S. Food and Drug Administration (FDA) to be maddening and frustrating, I happened to ultimately achieve success with the EFSD (European Food Supplements Directive) derogation requests that I submitted in over 20 EU countries. The ingredient form for which I submitted dossiers was, in fact, eventually added to Annex II of the EFSD and ultimately received a Positive Opinion from EFSA, meaning that that particular ingredient form is good to go in the 27 countries of the European Union.
However, as a health freedom advocate and industry association member, I---along with the U.K.’s Health Food Manufacturers Association (HFMA), Citizens for Health (CFH) and others---agreed with the European Court of Justice (ECJ) which, in an April 2005 ruling, said that EFSA’s procedures "had the transparency of a black box" and recommended that the EFSD be invalidated.
On top of that, recent research by the watchdog, Corporate Europe Observatory (CEO), found that 11 of the 20 experts on EFSA’s food additives panel (ANS), for example, have a conflict of interest as defined by the Organization for Economic Co-operation and Development (OECD).
CEO is calling for stricter rules on the way conflicts of interest are handled at EFSA, and in the report compares EFSA's approach to conflicts of interest with the new rules at EFSA’s sister agency, the European Medicines Agency. “If these new rules, although far from perfect, were applied at EFSA,” said CEO, “four of the experts on the ANS panel would be disqualified from sitting on the [EFSA] panel.”
Into this maelstrom comes the regulation on nutrition and health claims made on foods, which went live on January 19, 2007. The regulation, EC No. 1924/2006, has 37 clauses, 29 articles and an annex for nutrition claims and related conditions. The three main types of health claims are referenced in Articles 13 and 14.
The focus of industry angst over this regulatory Cirque du Soleil is that 80 to 95 percent of health claims submitted have received a negative opinion from EFSA, a fact which has angered a number of Members of European Parliament (MEPs), who voiced their criticisms of EFSA’s approach to health claims at an April 20th workshop in Brussels, noting that EFSA’s evaluation of health claims endangers consumer choice and hurts small- and medium-sized supplement and ingredient businesses.
According to Dr. Joerg Gruenwald, head of the German consultancy, analyze & realize (http://www.analyze-realize.com/en/contact/): “The evaluations by EFSA are not yet legally binding. The positive list of generic claims has to be enforced by the EU Commission, which is expected to occur by the end of 2011; the transitional period for negatively evaluated claims will therefore end by mid-2012.”
In the spirit of “You gotta be in it to win it,” there is now (until August 31st) an open period for industry comments to EFSA on three separate “draft guidances”:
- health claims related to antioxidants, oxidative damage and cardiovascular health (http://www.efsa.europa.eu/en/consultations/call/nda110426a.htm);
- health claims related to bone, joints and oral health (http://www.efsa.europa.eu/en/consultations/call/nda110426b.htm); and
- health claims related to appetite ratings, weight management and blood glucose concentrations (http://www.efsa.europa.eu/en/consultations/call/nda110426.htm).
Upshot? For companies selling in Europe, make sure to submit comments on the three open EFSA draft guidances above. That being said, EFSA’s approach to nutritional supplements, botanicals and health claims is deeply compromised and broken, not a system we in the U.S. would ever want to emulate, especially considering the U.S. FDA’s own historical and deep-seated animus towards dietary supplements and its apparent inability to regulate fairly and rationally.
Thursday, June 16, 2011
The FDA Needs A Warning Letter of Its Own
By James J. Gormley
In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”
Vasilos Frankos, Ph.D, former director of the FDA’s Division of Dietary Supplement Programs, told health-food industry magazine, Nutritional Outlook, that the FDA is looking to greatly increase the number of inspections it performs.
If companies are inspected by FDA and receive a Form 483 letter (List of Inspectional Observations) noting noncompliance, Frankos said that they should respond to FDA quickly, preferably within 15 days. Form 483 letters are used by the FDA to document and communicate concerns discovered during these inspections. According to the FDA, these letters:
“...list observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”
As of April 29th, reported Nutritional Outlook, FDA had performed 66 dietary supplement GMP inspections. “Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year [2011],” the trade publication noted. “By contrast, FDA performed 84 total inspections in 2010.”
With reports noting that 25 percent of supplement companies did not pass their FDA GMP inspections, the “FDA is due to assist industry overcome these and other issues by producing a compliance program for dietary supplements that is in the clearance phase and is due to be published imminently,” FDA senior advisor, Carl Reynolds, told attendees at a recent industry conference.
But will it assist companies? And, more importantly, what’s really at stake here?
It’s hard to comply with every requirement when the FDA holds all of the cards and provides guidance that is either surfacey in many cases or nearly impossible to carry out in others. With the agency’s surfeit of discretionary authority, the FDA can decide what is adequate documentation and what constitutes satisfactory compliance—and what is or does not—with many well-meaning companies left bewitched and bewildered by the unexpected 483 letter or warning letter they receive.
According to Jonathan Emord, one of the lead architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA admits that cGMPs:
• may result in the elimination of over 100 dietary supplement companies;
• will likely increase the cost of dietary supplements;
• will likely decrease demand for dietary supplements;
“These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes,” noted Emord.
Knowing this, Emord and his colleagues commissioned Dr. Steve Hanke, former senior economist on President Reagan's Council of Economic Advisers, to evaluate the economic impact of the cGMP regulations and he predicts the burden will be approximately 10 times higher than the FDA has predicted.
What if the FDA says a company’s paperwork is not in compliance? Failure to comply with the regulations is considered "adulteration," and the agency does not need any proof that products produced by the company “present an actual risk of illness or injury to the public.”
Emord and the consumer health group, ANH-USA, and others challenged this in federal court and sued the FDA over GMPs. “Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling ‘adulterated’ products, with the same jail sentence,” noted ANH-USA.
“We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.” The judge in this case ultimately sided with the FDA.
Gormley Take-Away: The way the FDA is going about implementing the cGMPs is misguided, at best, and malign, at worst. No consumer, health food store or legitimate manufacturer has a problem with the concept and practice of Good Manufacturing Practices. However, we all should have a problem with supplement companies being set up for failure by a combination of flimsy guidance and cut-throat enforcement tactics. Companies deserve to have clear guidance and to not be buried in administrative recordkeeping and paperwork requirements. These same companies also deserve to be treated fairly and respectfully, for example to be given a heads up about something that needs correction instead of immediately being slapped with an FDA Warning Letter. While the FDA will be gunning for supplement companies in the second half of 2011, all of us need to be closely watching how our tax dollars-funded agency is conducting itself as well. Because it is high time that the agency receive a warning notice of its own from the American people that we will not tolerate continued tax dollars being spent on malicious witch hunts against companies that produce wholesome food products that help us live better and healthier.
In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”
Vasilos Frankos, Ph.D, former director of the FDA’s Division of Dietary Supplement Programs, told health-food industry magazine, Nutritional Outlook, that the FDA is looking to greatly increase the number of inspections it performs.
If companies are inspected by FDA and receive a Form 483 letter (List of Inspectional Observations) noting noncompliance, Frankos said that they should respond to FDA quickly, preferably within 15 days. Form 483 letters are used by the FDA to document and communicate concerns discovered during these inspections. According to the FDA, these letters:
“...list observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”
As of April 29th, reported Nutritional Outlook, FDA had performed 66 dietary supplement GMP inspections. “Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year [2011],” the trade publication noted. “By contrast, FDA performed 84 total inspections in 2010.”
With reports noting that 25 percent of supplement companies did not pass their FDA GMP inspections, the “FDA is due to assist industry overcome these and other issues by producing a compliance program for dietary supplements that is in the clearance phase and is due to be published imminently,” FDA senior advisor, Carl Reynolds, told attendees at a recent industry conference.
But will it assist companies? And, more importantly, what’s really at stake here?
It’s hard to comply with every requirement when the FDA holds all of the cards and provides guidance that is either surfacey in many cases or nearly impossible to carry out in others. With the agency’s surfeit of discretionary authority, the FDA can decide what is adequate documentation and what constitutes satisfactory compliance—and what is or does not—with many well-meaning companies left bewitched and bewildered by the unexpected 483 letter or warning letter they receive.
According to Jonathan Emord, one of the lead architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA admits that cGMPs:
• may result in the elimination of over 100 dietary supplement companies;
• will likely increase the cost of dietary supplements;
• will likely decrease demand for dietary supplements;
“These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes,” noted Emord.
Knowing this, Emord and his colleagues commissioned Dr. Steve Hanke, former senior economist on President Reagan's Council of Economic Advisers, to evaluate the economic impact of the cGMP regulations and he predicts the burden will be approximately 10 times higher than the FDA has predicted.
What if the FDA says a company’s paperwork is not in compliance? Failure to comply with the regulations is considered "adulteration," and the agency does not need any proof that products produced by the company “present an actual risk of illness or injury to the public.”
Emord and the consumer health group, ANH-USA, and others challenged this in federal court and sued the FDA over GMPs. “Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling ‘adulterated’ products, with the same jail sentence,” noted ANH-USA.
“We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.” The judge in this case ultimately sided with the FDA.
Gormley Take-Away: The way the FDA is going about implementing the cGMPs is misguided, at best, and malign, at worst. No consumer, health food store or legitimate manufacturer has a problem with the concept and practice of Good Manufacturing Practices. However, we all should have a problem with supplement companies being set up for failure by a combination of flimsy guidance and cut-throat enforcement tactics. Companies deserve to have clear guidance and to not be buried in administrative recordkeeping and paperwork requirements. These same companies also deserve to be treated fairly and respectfully, for example to be given a heads up about something that needs correction instead of immediately being slapped with an FDA Warning Letter. While the FDA will be gunning for supplement companies in the second half of 2011, all of us need to be closely watching how our tax dollars-funded agency is conducting itself as well. Because it is high time that the agency receive a warning notice of its own from the American people that we will not tolerate continued tax dollars being spent on malicious witch hunts against companies that produce wholesome food products that help us live better and healthier.
Wednesday, June 15, 2011
The (FDA's) Claim Game
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
On May 26, the FDA announced the first in a series of proposals to “increase public understanding of the public health impact of FDA’s enforcement efforts,” etc., all part of the FDA Transparency Initiative that was launched in 2009.
Hate to say it, but the FDA has been the model of opacity, not transparency, in regards to dietary supplements, a perfect example of which is the mystical structure-function claim process for dietary supplements.
Section 403 [ r] (6) of the Federal Food, Drug and Cosmetic Act (21 USC 343 [r] [6]) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. The manufacturer “shall notify the Secretary [of Health and Human Services, the FDA] no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.”
The funny thing is that the FDA does not actually approve 403[r] [6] post-market structure-function claim submissions; it merely objects to certain ones and provides no comment on others, so companies are put in a position of using structure-function claims that were not objected to under the assumption that by not objecting the FDA is providing implicit approval.
Therefore, companies that want to know what specific structure-function claims are allowable have two choices: (1) to submit several claims, one of which is at least likely to receive an objection note from the FDA; or (2) to not submit any claims, provided they are confident that they have a robust level of substantiation.
If a manufacturer submits several claims, one of which is known to be objectionable, whatever claims are not objected to are generally considered by industry to be implicitly, although not explicitly, approved or allowed by the FDA.
The downside of including an egregious claim, says DSHEA architect and guru, Jonathan Emord, Esq.: “If you submit an egregious claim you will be scrutinized more closely by the FDA.
“The window in which FDA considers to be acceptable structure-function claims is getting narrower and narrower, yet what it considers prohibited speech or a drug claim is getting wider and wider.”
Adds Emord: “Overall, today there is no tolerance and more hostility in this current regulatory climate.”
Tuesday, May 17, 2011
Quality: Giving It A Chance
By James J. Gormley
Courtesy of the SupplySide Community
FDA defines economic adulteration as: “The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” Suppliers and manufacturers guilty of this are what I would call cheap jacks, somewhat like the itinerant vendors of old who sold shoddy goods and then moved their wagon on.
Unfortunately, the dietary supplement version of this crime has many causes, and we are going to have to attack all of the main drivers if we are going to effectively, or largely, eliminate this practice.
It’s a chicken or egg argument as to whether unethical manufacturers are encouraged by consumers to provide the nutritional versions of the El Dorado or marketers are duping unwitting customers. Added to this mix are ingredient suppliers who are dumbing down products with cheap or dangerous fillers and spiking with either legal actives to cloud results or illegal adulterants to please avid end users.
Just as there is no easy and safe path to weight loss, fitness or any other health goal, there is no legitimate excuse for manufacturers to continue to cut corners or to bottle those illusory magic bullets nor for retailers to stock them nor for consumers to ask for them.
While there are excellent industry programs that can be game-changers if adopted widely, and they should be---such as the NPA’s TruLabel program, the Natural Product Foundation’s Truth in Advertising program, the CRN/NAD advertising monitoring program---where the rubber hits the road is at the city gates, pardon the mixed metaphor.
As an industry, we need to expand our self-enforcement activities and messages to include retailer-specific training materials and consumer-specific public service ads that make it clear that what we gain in price we generally lose in quality, trust and reputation, and that what we surrender in common sense we generally lose with ineffective and dangerous products.
If a U.S. finished product manufacturer vigilantly quarantines ingredient shipments and vigorously tests everything that comes in (from qualified suppliers), if retailers stop stocking those “sexy” but probably spiked products, and if consumers are educated as to how dangerous (and dumb) it is to seek out “too good to be true” products……then we have a chance.
Courtesy of the SupplySide Community
FDA defines economic adulteration as: “The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” Suppliers and manufacturers guilty of this are what I would call cheap jacks, somewhat like the itinerant vendors of old who sold shoddy goods and then moved their wagon on.
Unfortunately, the dietary supplement version of this crime has many causes, and we are going to have to attack all of the main drivers if we are going to effectively, or largely, eliminate this practice.
It’s a chicken or egg argument as to whether unethical manufacturers are encouraged by consumers to provide the nutritional versions of the El Dorado or marketers are duping unwitting customers. Added to this mix are ingredient suppliers who are dumbing down products with cheap or dangerous fillers and spiking with either legal actives to cloud results or illegal adulterants to please avid end users.
Just as there is no easy and safe path to weight loss, fitness or any other health goal, there is no legitimate excuse for manufacturers to continue to cut corners or to bottle those illusory magic bullets nor for retailers to stock them nor for consumers to ask for them.
While there are excellent industry programs that can be game-changers if adopted widely, and they should be---such as the NPA’s TruLabel program, the Natural Product Foundation’s Truth in Advertising program, the CRN/NAD advertising monitoring program---where the rubber hits the road is at the city gates, pardon the mixed metaphor.
As an industry, we need to expand our self-enforcement activities and messages to include retailer-specific training materials and consumer-specific public service ads that make it clear that what we gain in price we generally lose in quality, trust and reputation, and that what we surrender in common sense we generally lose with ineffective and dangerous products.
If a U.S. finished product manufacturer vigilantly quarantines ingredient shipments and vigorously tests everything that comes in (from qualified suppliers), if retailers stop stocking those “sexy” but probably spiked products, and if consumers are educated as to how dangerous (and dumb) it is to seek out “too good to be true” products……then we have a chance.
Sunday, March 20, 2011
Un-Health and the Crisis of Modern Civilization
By James J. Gormley
The modern healthcare crisis is a modern crisis in health, first and foremost, before we even get to access to the question of “care.”
To put this point in perspective, let’s take a step back to late 2010, when British researchers published their examination of nearly 1,000 mummies from ancient Egypt and South America. They found that only a few of these ancients suffered from cancer before they died.
The findings suggest that cancer is not a naturally occurring condition and that modern lifestyles and industrial pollution are the main cause of the 33 percent cancer rate seen in the industrialized world today.
In an October 2010 article in England’s The Telegraph, Dr. Rosalie David, a biomedical Egyptologist said that in ancient times, cancer was extremely rare. “There is nothing in the natural environment that can cause cancer, “ said David. “So it has to be a man-made disease, down to pollution and changes to our diet and lifestyle—cancer appears to be a modern disease created by modern life.”
Since the life expectancy of people in the ancient world was between 25 and 40, we might attribute the low incidence of cancer to the abbreviated lifespan — for example, if certain cancers take 25 to 30 years to develop then it would be expected that the incidence of cancer would be low. That might have held water except for the fact that the main reason the life expectancy estimates were so low was because the infant mortality rates were so high: as high as 30 to 40 percent.
The Discouraging News in 2011
It is known that breast, prostate and colorectal cancers are increased in certain societies, such as the U.S., and it is believed that this is partly due to the fast food consumption in this country in comparison with diets rich in fiber, seafood, lean meat, vegetables and fruit.
In the U.S., breast cancer hit about 208,000 women last year, and it was estimated that 39,840 women would die from it. Colorectal cancer, which is perhaps the type of disease most closely linked to dietary choices, killed 51,370 people in 2010. In terms of incidence, there were 101,700 new cases of colon cancer last year and 39,510 new cases of rectal cancer.
Smoking is linked to cancers of the lung, bladder, mouth, colon, kidney, throat, voice box, esophagus, lip, stomach, cervix, liver and pancreas.
In terms of lung cancer, there were 222,520 new cases in 2010 and approximately 157,300 deaths, making lung cancer the leading cause of cancer death by far, accounting for nearly 30 percent of all deaths from cancer.
In terms of cancers with a strong environmental/industrial exposure component, while asbestos is linked primarily to lung cancer, exposure to benzidine (a chemical found in certain dyes) is mainly associated with bladder cancer.
Diabetes, Heart Disease and the Quality of Life Killers
Moving outside the realm of cancer, type 2 diabetes, of course, is largely caused by lifestyle choices, such as diet and physical activity. Type 2 diabetes, in which the body gradually loses its ability to use and produce insulin, accounts for 90 to 95 percent of cases.
Although diabetes kills less people, nearly 26 million Americans (or nearly 8 percent of the population) have diabetes and 79 million people have pre-diabetes. People with diabetes can experience numerous serious and deadly complications, including heart disease and stroke, blindness, chronic kidney disease, and amputations.
The no. 1 killer, of course, is heart disease. Clocking in at 26.8 million non-institutionalized people with diagnosed heart disease, heart disease kills 616,067 people each year.
What makes matters even worse, 33 percent of adults have hypertension and 15 percent have high cholesterol. Nearly 70 percent of Americans are overweight or obese. Add these factors together, and stroke may be in the picture, which by itself strikes down 135,952 people a year.
Quality of Life Indicators
And the discouraging news is not only about killer diseases; it’s also about conditions that impact our quality of life, that hobble us with all of the pains and aches that can make living feel like a torture.
Arthritis is one such quality-of-life killer, one which is diagnosed in 52.1 million people. Other critical, life-impacting conditions and areas for concern are: osteoporosis (including hip fractures); osteoarthritis and joint pain; and cognitive decline (including memory loss).
The Encouraging News in 2011
According to the U.S. National Institute of Environmental Health Sciences (NIEHS), as many as two-thirds of all cancer cases are linked to environmental causes and have some (or many) risk factors or exposures that can be modified or prevented, respectively.
Environmental factors include: radiation and industrial exposure (e.g., asbestos and pesticides). Lifestyle factors include: cigarette smoking, excessive alcohol consumption, poor diet, lack of exercise, excessive sunlight exposure, and social behaviors that increase exposure to certain viruses (e.g., HPV).
Research bears out the fact that nutritional supplements can provide powerful support in any effort to address the lifestyle part of the risk factors for the diseases of aging.
B Vitamins
In April 2010, Japanese researchers published a landmark study in the journal, Stroke, which examined data from 23,119 men and 35,611 women between the ages of 40 and 79.
After 14 years of follow up, it was found that men who had higher consumption of folic acid and vitamin B-6 experienced significantly fewer deaths from heart failure. Women who consumed higher levels of B vitamins experienced fewer deaths from stroke, heart disease and total cardiovascular death.
Calcium and Vitamin D
A wide body of scientific research supports the use of supplements to prevent fractures, especially hip fractures, in older people. A 2011 review in the journal, Metabolism, confirmed this: “Combined therapy, with calcium and vitamin D, has been shown to reduce hip fracture risk,” especially in frail elderly patients.
Glucosamine and Chondroitin
A two-year follow-up on the GAIT study of glucosamine, chrondroitin sulfate, their combination and the arthritis drug, Celebrex, published in 2010, carried forward the 2008 findings that showed glucosamine provided beneficial effects in knee pain and mobility.
Memory and Cognitive Function
Anyone who has a family member who seems to be overly forgetful, or who may be struggling with signs of age-related cognitive decline, should be familiar with a recent study published in the journal, Alzheimer’s and Dementia, which provides yet additional evidence that older adults who took 900 mg supplements of purified DHA (an omega-3 marine oil) for six months experienced improved memory and overall brain health.
Gormley Take-Away? While politicians and healthcare policy experts debate how best to fix our nation’s healthcare mess, if we focus on health, including responsible self-care using diet, exercise and judicious nutritional supplementation, the mammoth healthcare structure that is built may very well wind up with a significant number of empty beds that were supposed to have patients on them. This is something to work towards, to be sure: a medical complex in search of patients!
The modern healthcare crisis is a modern crisis in health, first and foremost, before we even get to access to the question of “care.”
To put this point in perspective, let’s take a step back to late 2010, when British researchers published their examination of nearly 1,000 mummies from ancient Egypt and South America. They found that only a few of these ancients suffered from cancer before they died.
The findings suggest that cancer is not a naturally occurring condition and that modern lifestyles and industrial pollution are the main cause of the 33 percent cancer rate seen in the industrialized world today.
In an October 2010 article in England’s The Telegraph, Dr. Rosalie David, a biomedical Egyptologist said that in ancient times, cancer was extremely rare. “There is nothing in the natural environment that can cause cancer, “ said David. “So it has to be a man-made disease, down to pollution and changes to our diet and lifestyle—cancer appears to be a modern disease created by modern life.”
Since the life expectancy of people in the ancient world was between 25 and 40, we might attribute the low incidence of cancer to the abbreviated lifespan — for example, if certain cancers take 25 to 30 years to develop then it would be expected that the incidence of cancer would be low. That might have held water except for the fact that the main reason the life expectancy estimates were so low was because the infant mortality rates were so high: as high as 30 to 40 percent.
The Discouraging News in 2011
It is known that breast, prostate and colorectal cancers are increased in certain societies, such as the U.S., and it is believed that this is partly due to the fast food consumption in this country in comparison with diets rich in fiber, seafood, lean meat, vegetables and fruit.
In the U.S., breast cancer hit about 208,000 women last year, and it was estimated that 39,840 women would die from it. Colorectal cancer, which is perhaps the type of disease most closely linked to dietary choices, killed 51,370 people in 2010. In terms of incidence, there were 101,700 new cases of colon cancer last year and 39,510 new cases of rectal cancer.
Smoking is linked to cancers of the lung, bladder, mouth, colon, kidney, throat, voice box, esophagus, lip, stomach, cervix, liver and pancreas.
In terms of lung cancer, there were 222,520 new cases in 2010 and approximately 157,300 deaths, making lung cancer the leading cause of cancer death by far, accounting for nearly 30 percent of all deaths from cancer.
In terms of cancers with a strong environmental/industrial exposure component, while asbestos is linked primarily to lung cancer, exposure to benzidine (a chemical found in certain dyes) is mainly associated with bladder cancer.
Moving outside the realm of cancer, type 2 diabetes, of course, is largely caused by lifestyle choices, such as diet and physical activity. Type 2 diabetes, in which the body gradually loses its ability to use and produce insulin, accounts for 90 to 95 percent of cases.
Although diabetes kills less people, nearly 26 million Americans (or nearly 8 percent of the population) have diabetes and 79 million people have pre-diabetes. People with diabetes can experience numerous serious and deadly complications, including heart disease and stroke, blindness, chronic kidney disease, and amputations.
The no. 1 killer, of course, is heart disease. Clocking in at 26.8 million non-institutionalized people with diagnosed heart disease, heart disease kills 616,067 people each year.
What makes matters even worse, 33 percent of adults have hypertension and 15 percent have high cholesterol. Nearly 70 percent of Americans are overweight or obese. Add these factors together, and stroke may be in the picture, which by itself strikes down 135,952 people a year.
Quality of Life Indicators
And the discouraging news is not only about killer diseases; it’s also about conditions that impact our quality of life, that hobble us with all of the pains and aches that can make living feel like a torture.
Arthritis is one such quality-of-life killer, one which is diagnosed in 52.1 million people. Other critical, life-impacting conditions and areas for concern are: osteoporosis (including hip fractures); osteoarthritis and joint pain; and cognitive decline (including memory loss).
The Encouraging News in 2011
According to the U.S. National Institute of Environmental Health Sciences (NIEHS), as many as two-thirds of all cancer cases are linked to environmental causes and have some (or many) risk factors or exposures that can be modified or prevented, respectively.
Environmental factors include: radiation and industrial exposure (e.g., asbestos and pesticides). Lifestyle factors include: cigarette smoking, excessive alcohol consumption, poor diet, lack of exercise, excessive sunlight exposure, and social behaviors that increase exposure to certain viruses (e.g., HPV).
Research bears out the fact that nutritional supplements can provide powerful support in any effort to address the lifestyle part of the risk factors for the diseases of aging.
B Vitamins
In April 2010, Japanese researchers published a landmark study in the journal, Stroke, which examined data from 23,119 men and 35,611 women between the ages of 40 and 79.
After 14 years of follow up, it was found that men who had higher consumption of folic acid and vitamin B-6 experienced significantly fewer deaths from heart failure. Women who consumed higher levels of B vitamins experienced fewer deaths from stroke, heart disease and total cardiovascular death.
Calcium and Vitamin D
A wide body of scientific research supports the use of supplements to prevent fractures, especially hip fractures, in older people. A 2011 review in the journal, Metabolism, confirmed this: “Combined therapy, with calcium and vitamin D, has been shown to reduce hip fracture risk,” especially in frail elderly patients.
Glucosamine and Chondroitin
A two-year follow-up on the GAIT study of glucosamine, chrondroitin sulfate, their combination and the arthritis drug, Celebrex, published in 2010, carried forward the 2008 findings that showed glucosamine provided beneficial effects in knee pain and mobility.
Memory and Cognitive Function
Anyone who has a family member who seems to be overly forgetful, or who may be struggling with signs of age-related cognitive decline, should be familiar with a recent study published in the journal, Alzheimer’s and Dementia, which provides yet additional evidence that older adults who took 900 mg supplements of purified DHA (an omega-3 marine oil) for six months experienced improved memory and overall brain health.
Gormley Take-Away? While politicians and healthcare policy experts debate how best to fix our nation’s healthcare mess, if we focus on health, including responsible self-care using diet, exercise and judicious nutritional supplementation, the mammoth healthcare structure that is built may very well wind up with a significant number of empty beds that were supposed to have patients on them. This is something to work towards, to be sure: a medical complex in search of patients!
Saturday, January 29, 2011
The Food Safety Law: The Way Forward
By James J. Gormley
The biggest food-industry-related issue of the 2009-2010 Congress was S. 510/HR 2751, the Food Safety Modernization Act (FSMA or Public Law 111-353).
Advocacy and political positioning on the FSMA exemplified both successes that can be achieved via industry-consumer collaboration and yet, ultimately, likewise the failure of such a collaboration to achieve more than the political version of NIMBY (not in my back yard) accomplishments.
What trade groups failed to realize:
Reasonable probability and reasonable belief: According to Section 423, if there is a “reasonable probability” that an article of food is adulterated under section 402 or misbranded under section 403, the U.S. Food and Drug Administration will offer the manufacturer an “opportunity to cease distribution and recall such article.”
Section 113 (new dietary ingredients) re anabolic steroids: One example of where dietary supplements were not totally excluded from HR 2751 is Section 113, wherein there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids, which could be excellent if judiciously applied — this was something I am pleased to note that I personally created a campaign on via Citizens for Health and various calls to action.
POTENTIAL DANGER: Nevertheless, the FDA merely needs to suspect that a supplement “may contain” an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement, which does open the door to potential targeting of legitimate manufacturers along with the fly-by-night operators.
Section 207. Administrative detention of food. In the final version of HR 2751, “credible evidence” was changed to “reason to believe” for suspected adulterated or contaminated food to be quarantined.
Section 404. Compliance with International Agreements. Nothing in this act (or an amendment made by this act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g., General Agreement on Tariffs and Trade [GATT], NAFTA, the Uruguay Rounds, Codex).
Section 420. Limited distribution. “In the interest of national security, the Secretary of HHS, in consultation with the Secretary of Homeland Security, may determine the time, manner and form in which the guidance documents […] are made public, including by releasing such documents to targeted audiences.”
The FSMA’s fate
Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.
The way forward
One thing to keep in mind: Many old-school, good government Democrats vote anti-supplement because they honestly believe that, in so doing, they are protecting consumers. Some of the anti-supplement co-sponsors are also anti-GMO.
Therefore, approaches to the good-government Dems (called goo-goos) should not attack them as being anti-supplement but should, instead, make it clear that most measures which hurt consumer access to supplements and supplement information also hurts consumers themselves. We must drive home one of Benjamin Franklin’s many truths:
“The man who trades freedom for security does not deserve nor will he ever receive either.”
The biggest food-industry-related issue of the 2009-2010 Congress was S. 510/HR 2751, the Food Safety Modernization Act (FSMA or Public Law 111-353).
Advocacy and political positioning on the FSMA exemplified both successes that can be achieved via industry-consumer collaboration and yet, ultimately, likewise the failure of such a collaboration to achieve more than the political version of NIMBY (not in my back yard) accomplishments.
What trade groups failed to realize:
- While the FSMA does provide some improved food-safety system measures, its over-reliance on recordkeeping and documentation that features a Hazard Analysis and Critical Control Point (HACCP) algorithmic/risk-based approach to food safety, and an under-reliance on on-site physical inspections, does nothing to address the core problems in this country’s food-safety system: filthy factory farms and disgusting slaughterhouses.
- While these groups are patting each other on the back for being representatives of the regulated industry that have a “seat at the table,” their members’ raw material suppliers are being saddled with a dizzyingly complex and expensive system of paperwork and systems, onerous requirements whose impact is already being felt by companies that are attempting to be forward-compliant.
- If the FDA abuses its now expanded powers, legitimate manufacturers (and classes of products) will be swept up in its allegations of adulteration, contamination and misbranding.
- The organic trade groups will regret their effusive praise if raw milk and raw milk cheeses (a cottage industry and gourmet food segment) are taken off the market.
- Although all trade groups claim that consumer benefit and consumer safety are at the very core of everything they support, including this law, they disregarded the fact that consumer health freedom organizations — groups which truly represent consumer interests — were completely opposed to S. 510 and HR 2751 and that tens of thousands of letters were sent to Congress demanding that this bill not pass in its current form (this is on top of over 20,000 letters to the White House calling for its veto).
Regardless, once trade groups and some conservative consumer groups saw that farms and dietary supplement finished products were ostensibly excluded from HR 2751, most parties claimed victory and applauded the bill’s passage despite the fact that very troubling provisions remain in the law, such as:
Reasonable probability and reasonable belief: According to Section 423, if there is a “reasonable probability” that an article of food is adulterated under section 402 or misbranded under section 403, the U.S. Food and Drug Administration will offer the manufacturer an “opportunity to cease distribution and recall such article.”
DANGER: The FDA has often called products misbranded based on the flimsiest of bases; it has also challenged the GRAS status of certain ingredients (or the data behind NDI filings) as a back-door attempt to go after certain combination supplements. The FDA has also made clear its regulatory animus regarding raw milk products (milk, cheeses). The FDA could very well attempt to use its expanded recall authority to effectively go on a “witch hunt” against certain products or classes or products that it cannot hurt through existing law.
Section 113 (new dietary ingredients) re anabolic steroids: One example of where dietary supplements were not totally excluded from HR 2751 is Section 113, wherein there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids, which could be excellent if judiciously applied — this was something I am pleased to note that I personally created a campaign on via Citizens for Health and various calls to action.
POTENTIAL DANGER: Nevertheless, the FDA merely needs to suspect that a supplement “may contain” an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement, which does open the door to potential targeting of legitimate manufacturers along with the fly-by-night operators.
Section 207. Administrative detention of food. In the final version of HR 2751, “credible evidence” was changed to “reason to believe” for suspected adulterated or contaminated food to be quarantined.
DANGER: Now the FDA does not even need credible evidence in order to impound food; all the agency needs to have is a gut feeling that food is dangerous, and it can be quarantined. While this might help in cases of intentional poisoning of the food supply, it does provide the FDA a great deal of additional discretionary authority.
Section 404. Compliance with International Agreements. Nothing in this act (or an amendment made by this act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g., General Agreement on Tariffs and Trade [GATT], NAFTA, the Uruguay Rounds, Codex).
DANGER: This is dangerous ground even if it was intended as a pro forma thruway. As an example of unintended, sovereignty-endangering consequences of nations including such language, one commentator claims that in Canada’s new Bill C-36, Health Canada has proposed that the powers provided to Parliament should be forfeited so that Canada can “honor its international agreements and commitments”! The FDA has not provided any explanation, much less a good reason, as to why sovereign U.S. domestic laws and regulations would need to be consistent, or not inconsistent, with international treaties and agreements.
Section 420. Limited distribution. “In the interest of national security, the Secretary of HHS, in consultation with the Secretary of Homeland Security, may determine the time, manner and form in which the guidance documents […] are made public, including by releasing such documents to targeted audiences.”
DANGER: If the U.S. government does not care to release the very instructions and guidance needed by suppliers and producers in order to properly comply with the requirements, the government does not have to, if cloaked under the usual catch-all blanket of “national security.” Obviously, in this way many food producers would likely fail if the requirements (and related compliance guidance) are a secret until inspection. This is similar to a teacher handing you a graded final exam despite the fact that you were denied the course, the textbook, the studying and the very exam questions themselves. Talk about setting food producer and ingredient suppliers up for failure!
The FSMA’s fate
Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.
The way forward
Effective health-freedom advocacy in 112th Congress. On the good side, the Republican-controlled House bodes well for anti-big-government, anti-big-spending, fiscally conservative efforts, including efforts to de-fund “Obamacare” (which will encounter stiff opposition in the Senate) and the FSMA (which is winnable).
One thing to keep in mind: Many old-school, good government Democrats vote anti-supplement because they honestly believe that, in so doing, they are protecting consumers. Some of the anti-supplement co-sponsors are also anti-GMO.
Therefore, approaches to the good-government Dems (called goo-goos) should not attack them as being anti-supplement but should, instead, make it clear that most measures which hurt consumer access to supplements and supplement information also hurts consumers themselves. We must drive home one of Benjamin Franklin’s many truths:
“The man who trades freedom for security does not deserve nor will he ever receive either.”
Thursday, January 20, 2011
In the land of real women
By James J. Gormley
Although winter has much of the U.S. in its icy grip, many Americans like going to Florida or other sunny climes in February and especially in March, when Spring Break is upon us. With sun-kissed beaches come the tiny, itsy bitsy polka dot bikinis with which sandy diversions are often associated. Many young women (not to mention, lots of men) are alternately looking at the calendar and peeking at the mirror, worried that they will not be able to fit into that swimsuit that’s two sizes too small that was bought as an “incentive” after New Year’s Eve.
What’s with all of this bikini anxiety? As I pointed out in 1999, in an article called “Giving Barbie the ‘Boot”: (1) real women have different body types than do most fashion models, who are often emaciated and (2) typical diets don’t work. In addition, the Barbie body-myth acculturation is now beginning in very young girls who should, arguably, be excited about many things -- such as science, math, sports, and jump-rope -- but not about losing weight!
Rachel Caplin, author of I’m Beautiful, Dammit! Waging Your Own Curvolution and co-founder of Curvolution, a Calif.-based entertainment company that’s working to put real women, of all sizes, into the media, said in a 2006 interview with the Pittsburgh Tribune-Review: “The fact that it’s bathing suit season doesn’t mean that this is the moment in time where you have to be what the season is telling you to be.”
Our society’s bathing suit obsession becomes even clearer when we look at a few stats on women, girls, and weight extracted from the book, The 7 Secrets of Slim People, by Vikki Hansen, M.S.W., and Shawn Goodman:
• The average American woman is 5'4", weighs 140 lbs., and wears a size 14 dress.
• 33% of American women wear a size 16 or larger.
• 50% of American women are on a diet at any one time.
• 90 to 99% of diets fail to achieve permanent weight loss.
• 50% of 9-year-old girls and 80% of 10-year-old girls have dieted.
• 90% of high-school junior and senior girls diet regularly, even though only between 10-15% are over the "recommended" weight.
And when I learned from authors Hansen and Goodman, that “young girls are more afraid of becoming fat than they are of nuclear war, cancer, and losing their parents,” then it makes me more determined than ever to try to encourage my (trim) teenaged daughter to enjoy her summer and not get sucked into the dysfunctional body-type vortex that surrounds us.
Adding to bikini anxiety is its kissing cousin, fitness anxiety: Are we buff enough? Although we can sometimes feel stress as we unfairly judge ourselves by looking at the aerobics instructor next to us on the StairMaster®, we might not be aware that many everyday activities --- including shopping at the mall! --- really help us to be more fit and burn more calories each day.
For example, did you know that 25 minutes of brisk walking at the mall (the best way to avoid buying too much!) or 30 minutes of washing windows burn the same amount of calories as 20 minutes of medium aerobics or 20 minutes of tennis? Better yet: did you know that 30 minutes of mowing the lawn (although be careful in the heat) or 45 minutes of washing dishes offer the same calorie-burning as the aerobics? All true. That’s what I call putting things in perspective.
So what if it gives us another excuse to go to the mall!
Although winter has much of the U.S. in its icy grip, many Americans like going to Florida or other sunny climes in February and especially in March, when Spring Break is upon us. With sun-kissed beaches come the tiny, itsy bitsy polka dot bikinis with which sandy diversions are often associated. Many young women (not to mention, lots of men) are alternately looking at the calendar and peeking at the mirror, worried that they will not be able to fit into that swimsuit that’s two sizes too small that was bought as an “incentive” after New Year’s Eve.
What’s with all of this bikini anxiety? As I pointed out in 1999, in an article called “Giving Barbie the ‘Boot”: (1) real women have different body types than do most fashion models, who are often emaciated and (2) typical diets don’t work. In addition, the Barbie body-myth acculturation is now beginning in very young girls who should, arguably, be excited about many things -- such as science, math, sports, and jump-rope -- but not about losing weight!
Our society’s bathing suit obsession becomes even clearer when we look at a few stats on women, girls, and weight extracted from the book, The 7 Secrets of Slim People, by Vikki Hansen, M.S.W., and Shawn Goodman:
• The average American woman is 5'4", weighs 140 lbs., and wears a size 14 dress.
• 33% of American women wear a size 16 or larger.
• 50% of American women are on a diet at any one time.
• 90 to 99% of diets fail to achieve permanent weight loss.
• 50% of 9-year-old girls and 80% of 10-year-old girls have dieted.
• 90% of high-school junior and senior girls diet regularly, even though only between 10-15% are over the "recommended" weight.
And when I learned from authors Hansen and Goodman, that “young girls are more afraid of becoming fat than they are of nuclear war, cancer, and losing their parents,” then it makes me more determined than ever to try to encourage my (trim) teenaged daughter to enjoy her summer and not get sucked into the dysfunctional body-type vortex that surrounds us.
For example, did you know that 25 minutes of brisk walking at the mall (the best way to avoid buying too much!) or 30 minutes of washing windows burn the same amount of calories as 20 minutes of medium aerobics or 20 minutes of tennis? Better yet: did you know that 30 minutes of mowing the lawn (although be careful in the heat) or 45 minutes of washing dishes offer the same calorie-burning as the aerobics? All true. That’s what I call putting things in perspective.
So what if it gives us another excuse to go to the mall!
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