Guest post by Kathleen Barnes
As I prepare to put in my garden this year, I feel a little like some whacko-zombie apocalypse fanatic. I am on a fervent mission to find non-GMO seeds and plants.
It’s not as easy as you might think since Monsanto, the father of Frankenfoods and RoundUp (what a pair!) has not only managed to protect itself against lawsuits from consumers whose health is damaged by its GMO products, it has also managed to buy up most of the seed companies and insert genetically modified organisms (GMOs) into their products.
The day is not far off when it will be impossible to buy seeds that have not been modified.
Until very recently, Monsanto had targeted corn, canola, soy and cotton, but now its gobbled up the market for the seeds you and I plant in our backyard gardens. Monsanto now owns 90 to 95 of all seed companies in the U.S. While Monsanto says it has no intention of making all seeds GMO, I can only say: If you believe that, I’ve got a bridge I’d like to sell you.
Let’s back up a few weeks to March 29 when President Obama signed into law, which has been dubbed the Monsanto Protection Act. The bill allows Monsanto to promote and plant genetically modified organisms (GMOs) and genetically engineered (GE) seeds and precludes the courts for litigating any cases contending the products are unsafe.
This unprecedented legal protection also gives Monsanto a green light to continue producing and expanding its market for GMO crops and seeds.
The danger now is that according to US laws, Monsanto always wins, even if its experimental crops are proven to be hazardous to human health and even if they cause a runaway crop plague. Now, the American government has given away the judicial power to prohibit the planting and harvesting GMO crops in almost any case.
Zombie apocalypse, indeed!
GMO foods have been scientifically linked to obesity, diabetes, immune system alterations and impaired ability to digest protein. malfunction. The Bt-toxin introduced by Monsanto in the 1990s to kill insects has now been found in the blood of 67 percent of all women, 93 percent of all pregnant women and 80 percent of umbilical cord blood in their babies.
That’s just the tip of the iceberg. At least we, as consumers, have the right to know what we’re eating. Well-financed corporate interests helped defeat the GMO labeling amendment in California. Washington state has a labeling initiative pending. More than 60 countries now requires GMO labeling, but not the U.S. This is everyone’s fight, so I encourage you to get involved.
Back home, I’m seeking out heirloom seeds and plants for my garden. I found a good list at Garden of Eatin’that not only give us a very short list of seed companies that have signed a non-GMO statement for their products and a much longer list of those that are either owned by Monsanto or have at least some GMO seeds.
Today’s revolution is with our pocketbooks. Don’t buy products from companies that have bought into the Monsanto lie.
This is a complex issue that I’ll be visiting and re-visiting frequently in the future. Stay tuned. Your health and mine and the health of the planet for the next seven generations depends on it.
All content is written by Kathleen Barnes and may be used freely if unedited and attributed.
Friday, May 17, 2013
Sunday, April 28, 2013
James Gormley's "Health at Gunpoint"; First Video Narration from OneNinth Media
OneNinth Media has just released the first in a series of video narrations of select snippets from my new book, Health at Gunpoint: The FDA's Silent War Against Health Freedom.
You can find the book here:
Tuesday, March 12, 2013
Publishers Weekly Announces Gormley Segment on The Brett Winterble Show!
My thanks to Publishers Weekly for announcing my appearance on tonight's The Brett Winterble Show on SiriusXM's America's Talk Channel 166 between 9:00 pm and 12:00 am EST.
And my thanks to host Brett Winterble for asking some great questions!!
And my thanks to host Brett Winterble for asking some great questions!!
Saturday, February 16, 2013
Sustainability = The New Green
Green, or ecologically conscious, politics have been around, in one shape or form, since 1892, when the Sierra Club was founded. Other verdant-hued milestones include, but are not limited to: the 1912 founding of the National Audubon Society, the establishment of the World Wildlife Fund in 1961, the publication of a book that launched a movement, Rachel Carson’s Silent Spring in 1962, and the release of Davis Guggenheim’s documentary starring Al Gore, An Inconvenient Truth, in 2006.
While the green movement has been, and still represents, a path humanity must consider in order to preserve our planet and its people from total ecological collapse, global economic meltdown and social catastrophe, the recent eco-based climate push was considered by some to be “a total flop,” wrote New Republic’s Bradford Plumer in 2011.
“By late 2010, the main cap-and-trade bill had fizzled in the Senate [. . .] Greens ended up winning zilch from Congress, not even minor legislation to boost renewable electricity or energy efficiency,” added Plumer. “All those flashy eco-ads and all that tireless eco-lobbying only got us even further from solving climate change than we were in 2008.”
Plumer cites the 2011 publication of an 84-page report, Climate Shift, by American University’s Matthew Nisbet, which aimed to dope out why climate activism has flopped so badly in the past several years. Nisbet argued that greens were not badly outspent by industry and that media coverage was not the problem. He believes that greens used a much too simplistic approach, treating the complex macro issue of global warming as a simple, easily defined problem such as “acid rain,” and that they did not focus enough on boosting innovation and helping to make clean energy cheaper.
Aside from not engaging with voters and legislators in a powerful enough way regarding climate change, according to a Roper Green Gauge study released by GfK Research on September 24, 2012, “While 93% of consumers say they have personally changed their behavior to conserve energy in their household, they’re becoming less willing to pay more for green products,” wrote Advertising Age about the report.
Diane Crispell, GfK’s director, told the Examiner that the green-pushback from consumers appears to stem from several factors, including: cost; efficacy (that they don’t work well); and message fatigue due to years of “overpromise and hype.”
So if eco messaging doesn’t get us to where we want to go, what does? What if we took over from within? Enter: corporate social responsibility, which is sustainability put into practice in how businesses operate and engage in the world.
What is “sustainability”? According to the U.S. EPA, “Sustainability is based on a simple principle: Everything that we need for our survival and well-being depends, either directly or indirectly, on our natural environment. Sustainability creates and maintains the conditions under which humans and nature can exist in productive harmony, that permit fulfilling the social, economic and other requirements of present and future generations.”
Tim Mohin, author of Changing Business from the Inside Out: A Treehugger’s Guide to Working in Corporations (2012), wrote in Forbes that the unstoppable corporate (and political) march toward globalization will “continue to stretch the scope of corporate responsibility,” referring to the recent conflict minerals tracking rules created by the Dodd-Frank Financial Reform Act, as one example.
Mohin predicts ever-increasing “levels of transparency and disclosure” will become the norm, noting that, in 2011, over 5,500 companies across the globe issued sustainability reports, reports which don’t just note how many rolls of recycled toilet paper were purchased but describe the many ways companies are being good global citizens and investing in: education, human rights, health care, communities, social justice and a whole range of sustainable activities.
In addition, noted Mohin, not only are people who work for socially responsible companies 43% more efficient than their counterparts who work for non-CSR-focused companies, they are also 38% more loyal and enjoy a 55% higher level of morale.
And as far as the concern goes over green-bored customers, Mohin wrote that “Consumers are increasingly tuned in to sustainability when making their buying decisions.” He cites the Cone Communications 2010 Cause Evolution Study which notes that “even as cause marketing continues to grow, consumers are eager for more. In fact, 83 percent of Americans want more of the products, services, and retailers they use to support causes.”
With a world population that exceeded 7 billion in 2011, Mohin observes that, “The imperative to stretch resources even further will make sustainability a central design principle for the winning corporations of the future.”
While green labeling and marketing will continue to have a place, just as the meaning of “sustainable” means “to endure,” sustainability as an over-arching principle and governing force is not a fad or short-lived trend, but our last best chance to save lives, provide hope, ensure opportunity, grow responsibly, and, oh yeah by the way, also save the planet and all its inhabitants.
Sustainability truly is the new green.
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
Saturday, February 02, 2013
Health at Gunpoint: Expo West Book Signing Coming Up!
By James J. Gormley
What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?
These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.
The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.
Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregnancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?
Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.
Far from being a “conspiracy theory” book, Health at Gunpoint looks at how Americans made up their minds to develop a more food-secure, cleaner, and healthier world and how they had to fight vested interests and the FDA to create that world for themselves---and for us.
It informs, blows holes in myths, and hopefully will also inspire a brand new generation of health-freedom advocates to fight for their rights!
Note: If you are attending the 2013 Natural Products Expo West trade show in Anaheim, California, please stop by the Health at Gunpoint book signing at the Square One Publishers' Booth No. 804 on Saturday, March 9th, at 12:00 pm!
These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.
The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.
In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.
Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregnancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?
Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.
Far from being a “conspiracy theory” book, Health at Gunpoint looks at how Americans made up their minds to develop a more food-secure, cleaner, and healthier world and how they had to fight vested interests and the FDA to create that world for themselves---and for us.
It informs, blows holes in myths, and hopefully will also inspire a brand new generation of health-freedom advocates to fight for their rights!
Note: If you are attending the 2013 Natural Products Expo West trade show in Anaheim, California, please stop by the Health at Gunpoint book signing at the Square One Publishers' Booth No. 804 on Saturday, March 9th, at 12:00 pm!
Wednesday, November 28, 2012
Dieticians and Efforts to Monopolize Nutrition
By James J. Gormley
There are many healthcare professionals who provide dietary advice. One subset is “Registered Dietitians” or RDs, a private credential offered by the private trade association, the Academy of Nutrition and Dietetics (AND), formerly known as the American Dietetic Association, or ADA.
RDs typically provide government-sanctioned dietary advice, such as the USDA dietary guidelines. There is a large other set of professionals – fully 2/3 of the nutrition community!– more commonly referred to as “nutritionists” who typically take a very different approach to dietary advice (not constrained by government-imposed guidelines), and there are many other professionals who use nutrition as part of their practice.
It does not involve substances that the law otherwise forbids the public to use (such as a medical license permitting the prescription of pharmaceuticals). This is the purveying of advice with regard to a substance freely available to all and consumed every day: food.
The dietician lobby seeks to not just prevent laypeople from providing dietary advice, but non-RD health professionals as well! The crux of the problem is this:
Unlike many health professions, “nutrition advice” is not a single profession, but is a tool-set legitimately used by many professionals (and the public). Those professionals include dietitians, nutritionists, medical doctors, chiropractors, naturopaths, acupuncturists, health coaches, and many more. Thus, it is much more difficult to reduce nutrition to a uniform regulatory scheme than it is for a discrete profession, such as nursing, for instance. It is like trying to license “exercise advice” – which is a tool used by many professions, not the domain of a single profession.
The dietician licensing bills make it a crime for those who give nutrition advice without a license. These laws prevent the vast majority of non-RDs from providing nutrition advice and artificially constrain the number of nutrition advisers and practitioners. In over half of states in the U.S. these one-sided licensure laws have passed, and entire segments of nutrition practitioners – such as naturopaths, nutritionists, herbalists and many others – are often barred from providing advice.
The sole beneficiaries of the dieticians’ drive for monopoly are its Registered Dietitians. And they are by no means the most highly qualified. The RD credential requires a bachelor’s degree, while several other nutrition credentials require a Masters or Doctoral level. What the dietician lobby does have is far greater financial resources.
According to the American Nutrition Association (ANA), the dietician lobby is acting as legislator, executive, judge, and jury:
While Current Illinois law has been a near-monopoly for dietitians, I am pleased to announce that the American Nutrition Association’s bill to open up access to nutrition practitioners is up for a vote, likely by tomorrow morning, November 29th. If you are in Illinois or have a family member, friend or colleague in the state, I urge you to pass along the this link asap!
The ANA has approval of the bill sponsor, Sen. Iris Martinez, many other legislators, and the Illinois Department of Professional Regulation, on an amended bill that would:
According to the ANA, “This bill doesn’t correct every provision of current law we sought to change. However, the significance of rolling back a monopolistic RD practice law to one which includes other nutritionists and exemptions, is immense.”
Ending a dietetics monopoly and ensuring protection for a diverse range of nutrition care providers for Americans is underway. This is a huge step in the process, and I look forward to, along with Citizens for Health, working with all of you to roll back these nutrition monopolies in other states!
There are many healthcare professionals who provide dietary advice. One subset is “Registered Dietitians” or RDs, a private credential offered by the private trade association, the Academy of Nutrition and Dietetics (AND), formerly known as the American Dietetic Association, or ADA.
RDs typically provide government-sanctioned dietary advice, such as the USDA dietary guidelines. There is a large other set of professionals – fully 2/3 of the nutrition community!– more commonly referred to as “nutritionists” who typically take a very different approach to dietary advice (not constrained by government-imposed guidelines), and there are many other professionals who use nutrition as part of their practice.
Despite an urgent need for more nutrition therapy and advice (not less), nutritionists claim that the dietician lobby has engaged in a campaign to monopolize nutrition advice through regulatory capture, specifically state nutrition licensing laws and federal regulations.Regulatory capture of health professions is nothing new. But this attempt is said by nutritionists to be particularly egregious, because the ‘scope’ of the so-called ‘dietetics and nutrition’ profession is not a set of competencies unique to a particular health care provider (like an MD or a nurse).
It does not involve substances that the law otherwise forbids the public to use (such as a medical license permitting the prescription of pharmaceuticals). This is the purveying of advice with regard to a substance freely available to all and consumed every day: food.
The dietician lobby seeks to not just prevent laypeople from providing dietary advice, but non-RD health professionals as well! The crux of the problem is this:
Unlike many health professions, “nutrition advice” is not a single profession, but is a tool-set legitimately used by many professionals (and the public). Those professionals include dietitians, nutritionists, medical doctors, chiropractors, naturopaths, acupuncturists, health coaches, and many more. Thus, it is much more difficult to reduce nutrition to a uniform regulatory scheme than it is for a discrete profession, such as nursing, for instance. It is like trying to license “exercise advice” – which is a tool used by many professions, not the domain of a single profession.
The dietician licensing bills make it a crime for those who give nutrition advice without a license. These laws prevent the vast majority of non-RDs from providing nutrition advice and artificially constrain the number of nutrition advisers and practitioners. In over half of states in the U.S. these one-sided licensure laws have passed, and entire segments of nutrition practitioners – such as naturopaths, nutritionists, herbalists and many others – are often barred from providing advice.
The sole beneficiaries of the dieticians’ drive for monopoly are its Registered Dietitians. And they are by no means the most highly qualified. The RD credential requires a bachelor’s degree, while several other nutrition credentials require a Masters or Doctoral level. What the dietician lobby does have is far greater financial resources.
According to the American Nutrition Association (ANA), the dietician lobby is acting as legislator, executive, judge, and jury:
- It has attempted to insinuate itself into federal regulations, so that only members of its professional trade group are permitted to be reimbursed for nutrition counseling.
- It has been fairly successful at getting state laws passed, substantially similar to North Carolina’s, that criminalize the provision of nutrition advice. This at a time when their own data show a shortage of nutrition professionals relative to the demand
- Those dietician-friendly state laws enshrine Registered Dietitians as the dominant force on each of these state licensing boards.
- The state licensing boards play a large role in determining who can and cannot obtain a license, first by drafting ‘rules’ that spell out the details of licensure requirements (which mimic the dietician group’s requirements), and second by being the gatekeeper for applicants for licensure.
- The association then encourages its members to file complaints with the state licensing boards
- Then the Registered Dietitians in the state, encouraged explicitly by the dietician lobby to police the field, report unlicensed practitioners to the state’s licensing board, which are referred for prosecution.
- Hearings and settlements during the course of such prosecutions are conducted by or in close contact with the particular licensing board.
While Current Illinois law has been a near-monopoly for dietitians, I am pleased to announce that the American Nutrition Association’s bill to open up access to nutrition practitioners is up for a vote, likely by tomorrow morning, November 29th. If you are in Illinois or have a family member, friend or colleague in the state, I urge you to pass along the this link asap!
The ANA has approval of the bill sponsor, Sen. Iris Martinez, many other legislators, and the Illinois Department of Professional Regulation, on an amended bill that would:
- Change current law from an RD-only law, to one that permits a wider variety of nutrition education and allows other nutrition exams and credentials (the CNS, CCN, and DACBN).
- Strengthen exemptions protecting acupuncturists, health food stores and other businesses and employees who respond to consumer questions regarding nutrition and dietary supplement information.
According to the ANA, “This bill doesn’t correct every provision of current law we sought to change. However, the significance of rolling back a monopolistic RD practice law to one which includes other nutritionists and exemptions, is immense.”
Ending a dietetics monopoly and ensuring protection for a diverse range of nutrition care providers for Americans is underway. This is a huge step in the process, and I look forward to, along with Citizens for Health, working with all of you to roll back these nutrition monopolies in other states!
Thursday, November 01, 2012
What's the real take-home message of a new, negative Department of Health and Human Services report regarding dietary supplements?
By James J. Gormley
On October 2nd, 2012, Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS), issued two reports regarding dietary supplements.
The first report, regarded as the more serious of the two, entitled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” captured immediate public attention and could have, say some, lasting negative impact on the dietary supplement industry. But are the report’s allegations true ... or fair?
The Report: What Does It Say Its Says?
With its first report on structure-function claims, HHS purported to assess industry compliance with structure-function claim requirements. As such, HHS’s Office of the Inspector General (OIG) purchased 127 dietary supplement products—specifically, immune support and weight-loss supplements—on the open market to examine their structure-function claims.
In total, OIG purchased 67 immune support supplements and 60 weight-loss supplements, 67 of which were from Internet sites and 60 of which were from retail stores. Aside from other alleged problems, the HHS report said that 20 percent of the products displayed prohibited disease claims.
As to what stimulated the HHS OIG to conduct the review, the structure-function report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”
A Cherry-Picked Sample?
A number of industry organizations and consumer advocates challenged whether such a small sampling of products could be regarded as representative of the dietary supplement industry at large, including the industry’s many responsible companies.
As Washington, D.C.-based Natural Products Association (NPA) executive director and CEO John Shaw, said in an an interview with me for Nutritional Outlook magazine, “The OIG only checked 127 supplements out of more than 29,000 on the market. The report itself says that the results cannot be generalized across the entire industry. Therefore, a small sampling of supplements should not be used as a smear against a legitimate industry that cares about the safety and health of consumers.”
Others expressed concern regarding the OIG’s sampling methods, expressing doubt that 20 percent of randomly chosen products would have had disease claims.
Justin J. Prochnow, a Denver-based attorney with Greenberg Traurig, discussed the sampling question. “My inclination would be to believe that the majority of the products cited in the report said to be marketed with alleged disease claims were being marketed online from websites without an established reputation. It has been my experience that ‘brick and mortar’ stores, as well as reputable online stores, are putting products through a pretty comprehensive label and claims review process before allowing them to be sold.”
“I would be very surprised if many of the products used as the basis for the report were purchased at well-known stores or from reputable online retailers,” he noted. In addition, industry members criticized the HHS report for intentionally not identifying the questionable products.
"They don’t identify the companies, so you don’t know which ones were in the 20 percent [of questionable products],” said Steve Mister, president and CEO of the Washington, DC-based Council for Responsible Nutrition in an interview with me for Nutritional Outlook. “You don’t know if they were all fringe companies on the edges of the internet that maybe collectively had sales of a million dollars, and whether everybody else, the ones that got it right, were the NBTYs and the Pharmavites.”
In an attempt to tackle this question, on behalf of Nutritional Outlook magazine I submitted a Freedom of Information Act (FOIA) request to the IG’s office asking them to reveal the names and manufacturers of the products with questionable claims, in addition to information on what websites the products were purchased from.
In addition, some take issue with the fact that the OIG’s office asked companies to voluntarily send substantiation data, but then in the reports criticized the submissions for not also containing negative data—a criticism that Mister dismisses.
“If the OIG wrote to me in a voluntary survey and asked for my substantiation, why would I ever send them anything that was negative?” Mister said. “Even if I had [negative substantiation] and I gave it to FDA, why would I send it to the OIG? I wouldn’t. However, the OIG says, ‘Well, you didn’t meet all of [our] criteria because you didn’t disclose studies that went the other way.’ But did OIG ask those companies to do so? No. Instead, OIG said, ‘Send us your substantiation for your product,’ so naturally a company is only going to send OIG the substantiation that’s supportive.”
What Does It Really Say
Since Inspectors General (regardless of department of agency) are almost always charged with primarily investigating internal fraud, waste, abuse and mis-management, what did the IG find regarding how the FDA manages dietary supplements?
When the FDA was asked by the IG to produce substantiation documents that had been previously submitted by companies, the FDA had no idea where to find them and, indeed, had no system in place to record, archive, track and retrieve submission documents that its own regulations require!
Here’s what the IG wrote:
Future Effects?
Despite the serious flaws in the report, to the average consumer the HHS reports have the potential to paint the broad supplements industry in a bad light, indeed. The media was quick to gravitate to this. Among the alarmist headlines following the reports’ release: Huffington Post’s “Dietary supplements illegally labeled: Dozens make false claims, report says;” CBS News’ “Study: Some dietary supplement labels illegal;” and from that most balanced of news sources, the American Medical Association (AMedNews.com), “Dietary supplements often lack reliable evidence to support health claims.”
As largely unimportant as the report might seem since it is a small study with limited applicability and potentially flawed, both industry and consumer groups view it as likely ammo the dietary supplement industry’s foes in Congress could try to use in support of efforts to expand FDA’s authority over dietary supplements, which we’ve shown would be disastrous for several reasons.
“I’m particularly concerned about [one] recommendation [in particular], because I think this is the most damning line in the report, which says, ‘FDA could seek legislation requiring approval for all structure-function claims in the labeling of dietary supplements,’” added Mister. He noted, “I don’t think FDA has a right to do that under the law, and certainly even if it had a right to do that under the Constitution, obviously [the dietary supplements industry] would fight that tooth and nail in Congress.”
Mister speculated how the FDA might use the first report for a longer-term plan that might include the revocation of some, or many, structure-function claims, with the agency reasoning, “Well, you know what? These have really become de facto disease claims,” he said.
“This dubious document, which we believe will serve as an advocacy [tool] for greater FDA regulation of free speech, is a far cry from the OIG’s stated mission, which is to audit and investigate HHS programs to prevent and detect fraud and abuse,” added Gretchen DuBeau from the Washington, DC-based Alliance for Natural Health.
Editor's note: The Gormley Files is very grateful to Nutritional Outlook magazine for permitting some text from the upcoming November 2012 "Global Regulations" story to be adapted for use here.
On October 2nd, 2012, Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS), issued two reports regarding dietary supplements.
The first report, regarded as the more serious of the two, entitled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” captured immediate public attention and could have, say some, lasting negative impact on the dietary supplement industry. But are the report’s allegations true ... or fair?
The Report: What Does It Say Its Says?
With its first report on structure-function claims, HHS purported to assess industry compliance with structure-function claim requirements. As such, HHS’s Office of the Inspector General (OIG) purchased 127 dietary supplement products—specifically, immune support and weight-loss supplements—on the open market to examine their structure-function claims.
In total, OIG purchased 67 immune support supplements and 60 weight-loss supplements, 67 of which were from Internet sites and 60 of which were from retail stores. Aside from other alleged problems, the HHS report said that 20 percent of the products displayed prohibited disease claims.
As to what stimulated the HHS OIG to conduct the review, the structure-function report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”
A Cherry-Picked Sample?
A number of industry organizations and consumer advocates challenged whether such a small sampling of products could be regarded as representative of the dietary supplement industry at large, including the industry’s many responsible companies.
As Washington, D.C.-based Natural Products Association (NPA) executive director and CEO John Shaw, said in an an interview with me for Nutritional Outlook magazine, “The OIG only checked 127 supplements out of more than 29,000 on the market. The report itself says that the results cannot be generalized across the entire industry. Therefore, a small sampling of supplements should not be used as a smear against a legitimate industry that cares about the safety and health of consumers.”
Others expressed concern regarding the OIG’s sampling methods, expressing doubt that 20 percent of randomly chosen products would have had disease claims.
Justin J. Prochnow, a Denver-based attorney with Greenberg Traurig, discussed the sampling question. “My inclination would be to believe that the majority of the products cited in the report said to be marketed with alleged disease claims were being marketed online from websites without an established reputation. It has been my experience that ‘brick and mortar’ stores, as well as reputable online stores, are putting products through a pretty comprehensive label and claims review process before allowing them to be sold.”
“I would be very surprised if many of the products used as the basis for the report were purchased at well-known stores or from reputable online retailers,” he noted. In addition, industry members criticized the HHS report for intentionally not identifying the questionable products.
"They don’t identify the companies, so you don’t know which ones were in the 20 percent [of questionable products],” said Steve Mister, president and CEO of the Washington, DC-based Council for Responsible Nutrition in an interview with me for Nutritional Outlook. “You don’t know if they were all fringe companies on the edges of the internet that maybe collectively had sales of a million dollars, and whether everybody else, the ones that got it right, were the NBTYs and the Pharmavites.”
In an attempt to tackle this question, on behalf of Nutritional Outlook magazine I submitted a Freedom of Information Act (FOIA) request to the IG’s office asking them to reveal the names and manufacturers of the products with questionable claims, in addition to information on what websites the products were purchased from.
In addition, some take issue with the fact that the OIG’s office asked companies to voluntarily send substantiation data, but then in the reports criticized the submissions for not also containing negative data—a criticism that Mister dismisses.
“If the OIG wrote to me in a voluntary survey and asked for my substantiation, why would I ever send them anything that was negative?” Mister said. “Even if I had [negative substantiation] and I gave it to FDA, why would I send it to the OIG? I wouldn’t. However, the OIG says, ‘Well, you didn’t meet all of [our] criteria because you didn’t disclose studies that went the other way.’ But did OIG ask those companies to do so? No. Instead, OIG said, ‘Send us your substantiation for your product,’ so naturally a company is only going to send OIG the substantiation that’s supportive.”
What Does It Really Say
Since Inspectors General (regardless of department of agency) are almost always charged with primarily investigating internal fraud, waste, abuse and mis-management, what did the IG find regarding how the FDA manages dietary supplements?
When the FDA was asked by the IG to produce substantiation documents that had been previously submitted by companies, the FDA had no idea where to find them and, indeed, had no system in place to record, archive, track and retrieve submission documents that its own regulations require!
Here’s what the IG wrote:
“FDA could retrieve notification letters for only 21 of 127 supplements in our sample. FDA’s failure to locate notification letters raises questions about its ability to adequately monitor and enforce manufacturers’ compliance with structure/function claim requirements” [emphasis mine].In addition, as mentioned above, the IG wrote that the FDA “lacks a reliable tracking system for notification letters.” The report said:
“FDA saves letters in a PDF format that cannot be searched by keyword. As a result, FDA could not locate letters for our sampled supplements using the product name or the manufacturer’s name. As of December 2011, FDA staff told us the agency had letters waiting to be scanned that dated back almost a year. FDA files the paper copies of notification letters chronologically. Therefore, FDA would have had to search thousands of files by hand to locate letters for our sample of supplements” [emphasis mine].So, as the saying goes, the elephant in the room was the obviously horrible mismanagement and disorganization (perhaps incompetence) of an agency, in this case the FDA, an agency that the IG is suggesting be given even more power and responsibility over supplements despite the fact that the agency has proven that it cannot even handle the most basic of its existing responsibilities. This serious indictment of the FDA was half-buried in the report itself and completely ignored by the mainstream media.
Future Effects?
Despite the serious flaws in the report, to the average consumer the HHS reports have the potential to paint the broad supplements industry in a bad light, indeed. The media was quick to gravitate to this. Among the alarmist headlines following the reports’ release: Huffington Post’s “Dietary supplements illegally labeled: Dozens make false claims, report says;” CBS News’ “Study: Some dietary supplement labels illegal;” and from that most balanced of news sources, the American Medical Association (AMedNews.com), “Dietary supplements often lack reliable evidence to support health claims.”
As largely unimportant as the report might seem since it is a small study with limited applicability and potentially flawed, both industry and consumer groups view it as likely ammo the dietary supplement industry’s foes in Congress could try to use in support of efforts to expand FDA’s authority over dietary supplements, which we’ve shown would be disastrous for several reasons.
“I’m particularly concerned about [one] recommendation [in particular], because I think this is the most damning line in the report, which says, ‘FDA could seek legislation requiring approval for all structure-function claims in the labeling of dietary supplements,’” added Mister. He noted, “I don’t think FDA has a right to do that under the law, and certainly even if it had a right to do that under the Constitution, obviously [the dietary supplements industry] would fight that tooth and nail in Congress.”
Mister speculated how the FDA might use the first report for a longer-term plan that might include the revocation of some, or many, structure-function claims, with the agency reasoning, “Well, you know what? These have really become de facto disease claims,” he said.
“This dubious document, which we believe will serve as an advocacy [tool] for greater FDA regulation of free speech, is a far cry from the OIG’s stated mission, which is to audit and investigate HHS programs to prevent and detect fraud and abuse,” added Gretchen DuBeau from the Washington, DC-based Alliance for Natural Health.
DuBeau summed it up in this way: “FDA chooses not to provide or improve guidance for the industry. [When] a few bad apples exploit the regulatory uncertainty, those bad apples are then used by advocacy groups and members of Congress to reduce our access to all supplements.”
Editor's note: The Gormley Files is very grateful to Nutritional Outlook magazine for permitting some text from the upcoming November 2012 "Global Regulations" story to be adapted for use here.
Wednesday, October 10, 2012
The FDA's Record on Slimming Products: Weighing In
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
Considering the U.S. Food and Drug Administration’s (FDA) record
as a flibbertigibbet on weight-loss product enforcement (dragging its feet on
ephedrine for years while green-lighting dangerous weight-loss drugs on a
dime) — and in light of the FTC’s record of multimillion dollar fines and orders
against makers of supplement weight-loss products — for any company to enter
this arena, either with a proprietary slimming ingredient or with a finished
product, it is a minefield out there. Witness warning letters sent by the FDA to makers of HCG diet products.
Despite (or due to) the
aforementioned spotty record, it is hard to fathom an FDA agency advisory
committee’s recent green light for a combo of phentermine and topiramate
(Qnexa), a diet pill that has, according to the Alliance for Natural Health,
“documented risks of causing birth defects and heart problems.”
Abdominal
Cramps Anyone?
On January 24, 1996, the FDA
approved the synthetic fat-substitute, olestra, for use in snacks. But would
you want a product with this warning? “This Product Contains Olestra. Olestra
may cause abdominal cramping and loose stools. Olestra inhibits the absorption
of some vitamins and other nutrients.”
Anal leakage is most certainly
not on my “hit parade” of things I am looking for in a snack beverage, or any
product for that matter!
According to an update by
Center for Science in the Public Interest (CSPI), “Olestra is a moribund, if
not totally dead, product.” No surprise there.
A few years later, in March
1999, consumer and industry advocates successfully testified on Capitol Hill to
oppose the FDA’s proposal to redefine disease to include life stages and normal
discomforts, such as pregnancy, aging, menopause and headache.
The FTC
Steps Into the Breach
On November 9, 2004, the
Federal Trade Commission (FTC) launched “Operation Big Fat Lie,” what it billed
as “a nation-wide law enforcement sweep against […] companies making false
weight-loss claims in national advertisements.”
According to the FTC at the
time: “Operation Big Fat Lie is the latest in the Commission’s efforts to: stop
deceptive advertising and provide refunds to consumers harmed by unscrupulous
weight-loss advertisers; encourage media outlets not to carry advertisements
containing bogus weight-loss claims; and educate consumers to be on their guard
against companies promising miraculous weight loss without diet or exercise.”
Agreed, although the FDA’s
track record on weight-loss products in all categories has not helped American
consumers very much, either.
Alley-oop!
In 2006, GSK applied to get its
drug (orlistat) — which was said, at the time, by the group Public Citizen, to
have a history of side effects and gastrointestinal problems — re-classified as
an OTC weight loss drug called alli™.
Shades of olestra, Public
Citizen’s objections cited such embarrassing product usage problems as anal
leakage and such serious problems as pre-cancerous lesions. On February 7,
2007, the FDA dismissed the group’s well -argued petition, saying that the
product label already warns people about the messy bowel problems.
As to those pesky pre-cancerous
cellular changes allegedly caused by the drug (called “aberrant crypt foci”),
the FDA said they aren’t of “clinical significance.”
Interesting, because according
to the NIH National Cancer Institute, aberrant crypt foci represent “one of the
earliest changes that can be seen in the colon that may lead to cancer.”
But, then again, FDA’s
approvals were being called into question — institutional arrogance can’t allow
that — and a powerful drug maker’s products were also being questioned.
Still dead set on the
weight-loss market, on April 17, 2008, GSK and groups it funds submitted a
Citizen Petition (FDA-2008-P-0248-0001) calling for the FDA to reclassify all
weight loss support claims for dietary supplements as disease claims.
GSK was joined in this petition
by the American Dietetic Association, the Obesity Society, and Shaping
America’s Health. The organizations’ signatories included a lobbyist, a person
who helped get obesity classified as a disease and a fundraising guru.
In the petition’s summary, GSK
and its co-petitioners stated: “Moreover, the actions requested in this
petition would help address concerns about the safety of weight loss
supplements” and “By requiring weight-loss supplements to undergo pre-market
review, FDA would shift the burden to manufacturers to show that their products
are safe.”
What about the potential safety
problems related to GSK’s alli? This product went through both a prescription
drug and (an albeit cursory) OTC safety review process and it still has a
number of reported concerns associated with it.
Takeaway: Allowing questionable
weight-loss drugs and prohibiting legitimate claims for dietary supplements
that assist people in achieving body composition and weight-loss goals provides
Big Pharma an El Dorado, like the legendary lost city of gold, and cheats
consumers out of safe, effective products while exposing them to unwarranted
risk.
Thursday, September 20, 2012
Where Supplement Ingredients Go to Play When We're Not Looking
By James
J. Gormley
OK, so we all know about the gut-friendly benefits of beneficial bacteria, those good “bugs” which wage a neverending battle for Truth, Justice and the American Way! Sorry, that was George Reeves as TV’s Superman in the 1950s, but you get the picture.
Consumers get them in yogurt and in high-potency probiotic supplements with billions and billions of colony forming units (CFUs).
Interestingly enough, there are other applications for friendly bacteria, including products that help plants grow better with less reliance on fertilizers and pesticides. One product with soil probiotics (Trident Products’ Growtastic) is said to stimulate root and plant growth, increase the bad-bug-killing benefits of pesticides and help defend plants from disease. Other products (e.g., Green Earth Agriculture’s Quantum Growth, John & Bob’s Grow Green, and Custom Biologicals’ Biota Max) are combined with other inputs, such as nutrient-rich organic matter and beneficial fungi.
Ever wonder if there are eco-friendly approaches to tackling wastewater, sewage and environmental bio-remediation? Probiotics to the rescue again, as Kansas City, MO-based SCD Probiotics has a range of industrial solutions using good bacteria. This company also offers probiotics for aquaculture.
If we are surprised at these industrial uses for supplement ingredients, we shouldn’t be, especially if we consider the wide range of uses for plants and botanicals in food products and non-food products.
Example: corn starch. Although we may know it as a processing aid in tableting or as a thickening agent in gravies, corn starch was originally only used industrially for starching laundry and for adhesives and coatings.
Natural preservatives for foods and supplements are another example of non-nutritional uses of nutrients: antioxidant vitamins and BI Nutraceuticals’ RoseOx® are very well known to food technologists.
Algal-based products and technologies have also stimulated a great deal of industrial interest, witness the 2009 overture of BP to Martek/DSM for the development of algae-based fuels.
So it's not surprising that plant-based ingredients are also used in cleaning products. Wonder why that all-purpose cleaner is so versatile? Look no further than the plant-derived alkyl polyglucoside in the ingredients list. Why does the cleaner lather so well even though I use hard water? Citric acid and lactic acid from corn reduce minerals to soften hard water and increase cleaning power. We already know about enzymes fighting blood and other stubborn stains, but did we know plant-based lauramine oxide and sodium lauryl sulfate help remove dirt to give us sparkling dishes?
OK, so we all know about the gut-friendly benefits of beneficial bacteria, those good “bugs” which wage a neverending battle for Truth, Justice and the American Way! Sorry, that was George Reeves as TV’s Superman in the 1950s, but you get the picture.
Consumers get them in yogurt and in high-potency probiotic supplements with billions and billions of colony forming units (CFUs).
Interestingly enough, there are other applications for friendly bacteria, including products that help plants grow better with less reliance on fertilizers and pesticides. One product with soil probiotics (Trident Products’ Growtastic) is said to stimulate root and plant growth, increase the bad-bug-killing benefits of pesticides and help defend plants from disease. Other products (e.g., Green Earth Agriculture’s Quantum Growth, John & Bob’s Grow Green, and Custom Biologicals’ Biota Max) are combined with other inputs, such as nutrient-rich organic matter and beneficial fungi.
Ever wonder if there are eco-friendly approaches to tackling wastewater, sewage and environmental bio-remediation? Probiotics to the rescue again, as Kansas City, MO-based SCD Probiotics has a range of industrial solutions using good bacteria. This company also offers probiotics for aquaculture.
If we are surprised at these industrial uses for supplement ingredients, we shouldn’t be, especially if we consider the wide range of uses for plants and botanicals in food products and non-food products.
Example: corn starch. Although we may know it as a processing aid in tableting or as a thickening agent in gravies, corn starch was originally only used industrially for starching laundry and for adhesives and coatings.
Natural preservatives for foods and supplements are another example of non-nutritional uses of nutrients: antioxidant vitamins and BI Nutraceuticals’ RoseOx® are very well known to food technologists.
Algal-based products and technologies have also stimulated a great deal of industrial interest, witness the 2009 overture of BP to Martek/DSM for the development of algae-based fuels.
So it's not surprising that plant-based ingredients are also used in cleaning products. Wonder why that all-purpose cleaner is so versatile? Look no further than the plant-derived alkyl polyglucoside in the ingredients list. Why does the cleaner lather so well even though I use hard water? Citric acid and lactic acid from corn reduce minerals to soften hard water and increase cleaning power. We already know about enzymes fighting blood and other stubborn stains, but did we know plant-based lauramine oxide and sodium lauryl sulfate help remove dirt to give us sparkling dishes?
Don’t even get me started on plant-based nano-materials: can you say nanocrystalline cellulose (NCC) from Alberta, Canada 10 times fast?
All in all, I think it’s fascinating (and cool) that there are so many known, not well known, and emerging applications for plant- and organism-based ingredients. Provided the beneficial exploitation of these opportunities doesn’t imbalance agriculture by siphoning off production that could be used for better purposes, such as feeding the world, we have a fascinating road ahead.
Courtesy of the SupplySide Community
Courtesy of the SupplySide Community
Monday, August 13, 2012
An Open Letter to Consumer Reports: 10 Misinformation Hazards in Your “10 Surprising Dangers of Vitamins and Supplements” Article
By James J. Gormley
It is personally disappointing for me that Consumer Reports, the flagship of the respected marketplace-empowerment organization, Consumers Union, has once again seen fit to arm the American consumer with detrimental misinformation regarding safe, beneficial food supplements.
In the alarmist piece which appears in the September 2012 issue, the anti-supplement subtitle reads: “Don’t assume they’re safe because they’re all natural.”
Here are the “10 Surprising Dangers” along with some accurate information and perspective:
“1. Supplements are not risk free.”
With 3,000 deaths and 128,000 hospitalizations a year from food poisoning, it is clear that nothing in life is risk-free, but we already knew this. It would be of better service to do an expose on the dangers of properly prescribed pharmaceuticals, which injure over 1 million and kill over 100,00 Americans each year in hospitals alone. The subtitle on a prescription drugs-focused article could read: “Don’t assume they’re safe because they’re FDA-approved.”
The fact of the matter is that food supplements are inherently benign and pharmaceuticals are inherently dangerous; they are part of a completely different risk paradigm. With the millions of supplements sold and safely used every year, dietary supplements have an enviable consumer safety record.
Since the 1994 enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has had the authority to remove any dietary supplement from the market if FDA shows that it presents "a significant or unreasonable risk of illness or injury" or that it contains "a poisonous or deleterious substance which may render it injurious to health." In fact, the FDA can act immediately against any product that poses an "imminent hazard to public health or safety." With the passage of the Food Safety Modernization Act (FSMA) in 2011, the FDA’s mandatory recall authority was affirmed and expanded.
Recently released data from risk-management expert Ron Law confirmed that food supplements are by far the safest substances that people are exposed to daily (http://tinyurl.com/ron-law-data).
“2. Some supplements are really prescription drugs.”
Supplements are a class of food, not drugs, so drugs masquerading as supplements is a drug adulteration problem best handled by the Drug Enforcement Administration (DEA), something which I and Citizens for Health have been calling for since early 2010 (http://tinyurl.com/dea-should-take-over), which is now being supported by industry as well (http://tinyurl.com/dea-and-steroids).
“3. You can overdose on vitamins and minerals.”
With only a few exceptions (e.g., iron, selenium, zinc, vitamin A), even with the dosages found in high-potency supplements there is a window of safety on supplements of several hundred percent; in fact, most supplements are so safe that no upper limit can even be determined. What we really have to worry about are the over 13,000 truly dangerous prescription drugs on the market with known side effects.
“4. You can’t depend on warning labels.”
True, but since dietary supplements are inherently benign with a margin of safety a mile wide, there is virtually nothing to warn consumers about. To be conservative, many products carry cautions relating to consumption by children and pregnant/breastfeeding women, but this is more to protect companies from actions stemming from gross misuse.
“5. None are proven to cure major diseases.”
The same can be said for prescription drugs. And even if they did, supplement manufacturers would not be allowed to tell consumers about it. Regardless, supplements are complements to the diet not substitutes for healthy food and physical activity.
“6. Buy with caution from botanicas.”
I would venture to say that apart from cities bordering Mexico, over 99.999% of herbal products are sold through mainstream channels of trade. We could also say “don’t buy prescription pain killers” on the black market or from peddlers in back alleys, but some level of common sense usually prevails.
“7. Heart and cancer protection: not proven.”
The American Heart Association recommends a diet rich in marine-based omega-3s, and the U.S. government has approved health claims for vitamin D and calcium supplementation. In 2005, Harvard researchers estimated that low intake of omega-3s in the U.S. diet accounted for 72,000 to 96,000 deaths from cardiovascular disease. There have been numerous animal studies showing direct cancer prevention with omega-3s and epidemiological studies associating high levels of dietary omega-3s with reduced rates of cancer.
“8. Choking.”
Now Consumer Reports is really reaching. Anybody who tries to dry-swallow any pill can experience a gag reflex, which is not a problem unique to any one class of products.
“9. Some natural products are anything but.”
Most dietary ingredients are analogues of natural extracts; technologists are not standing around with wooden mallets, mortars and pestles. There are only one or two cases where a true synthetic is not as efficacious as a natural source nutrient, and that is with vitamin E.
“10. You may not need supplements at all.”
But we need drugs? For decades the USDA has shown that most of us do not get anywhere near a basic level of vitamins and minerals from the standard American diet, so it would be a rare person indeed who would not stand to benefit from a multivitamin/multimineral supplement at the very least.
Although Consumers Union has a long, and illustrious, track record in advocating for consumers, Consumer Reports appears to have a bug in its bonnet regarding dietary supplements, either that or single-copy newsstand sales soar when “supplements are bad” stories are run.
This is unfortunate, since scare-mongering re safe, well-regulated and effective dietary supplements will, at best, only serve to unfairly cause consumers to wrongly distrust a beneficial class of products and, at worst, drive even more Americans away from responsible self-care into the welcoming arms of drug-happy conventional medicine.
That’s not what I call consumer advocacy.
It is personally disappointing for me that Consumer Reports, the flagship of the respected marketplace-empowerment organization, Consumers Union, has once again seen fit to arm the American consumer with detrimental misinformation regarding safe, beneficial food supplements.
In the alarmist piece which appears in the September 2012 issue, the anti-supplement subtitle reads: “Don’t assume they’re safe because they’re all natural.”
Here are the “10 Surprising Dangers” along with some accurate information and perspective:
“1. Supplements are not risk free.”
With 3,000 deaths and 128,000 hospitalizations a year from food poisoning, it is clear that nothing in life is risk-free, but we already knew this. It would be of better service to do an expose on the dangers of properly prescribed pharmaceuticals, which injure over 1 million and kill over 100,00 Americans each year in hospitals alone. The subtitle on a prescription drugs-focused article could read: “Don’t assume they’re safe because they’re FDA-approved.”
The fact of the matter is that food supplements are inherently benign and pharmaceuticals are inherently dangerous; they are part of a completely different risk paradigm. With the millions of supplements sold and safely used every year, dietary supplements have an enviable consumer safety record.
Since the 1994 enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has had the authority to remove any dietary supplement from the market if FDA shows that it presents "a significant or unreasonable risk of illness or injury" or that it contains "a poisonous or deleterious substance which may render it injurious to health." In fact, the FDA can act immediately against any product that poses an "imminent hazard to public health or safety." With the passage of the Food Safety Modernization Act (FSMA) in 2011, the FDA’s mandatory recall authority was affirmed and expanded.
Recently released data from risk-management expert Ron Law confirmed that food supplements are by far the safest substances that people are exposed to daily (http://tinyurl.com/ron-law-data).
“2. Some supplements are really prescription drugs.”
Supplements are a class of food, not drugs, so drugs masquerading as supplements is a drug adulteration problem best handled by the Drug Enforcement Administration (DEA), something which I and Citizens for Health have been calling for since early 2010 (http://tinyurl.com/dea-should-take-over), which is now being supported by industry as well (http://tinyurl.com/dea-and-steroids).
“3. You can overdose on vitamins and minerals.”
With only a few exceptions (e.g., iron, selenium, zinc, vitamin A), even with the dosages found in high-potency supplements there is a window of safety on supplements of several hundred percent; in fact, most supplements are so safe that no upper limit can even be determined. What we really have to worry about are the over 13,000 truly dangerous prescription drugs on the market with known side effects.
“4. You can’t depend on warning labels.”
True, but since dietary supplements are inherently benign with a margin of safety a mile wide, there is virtually nothing to warn consumers about. To be conservative, many products carry cautions relating to consumption by children and pregnant/breastfeeding women, but this is more to protect companies from actions stemming from gross misuse.
“5. None are proven to cure major diseases.”
The same can be said for prescription drugs. And even if they did, supplement manufacturers would not be allowed to tell consumers about it. Regardless, supplements are complements to the diet not substitutes for healthy food and physical activity.
“6. Buy with caution from botanicas.”
I would venture to say that apart from cities bordering Mexico, over 99.999% of herbal products are sold through mainstream channels of trade. We could also say “don’t buy prescription pain killers” on the black market or from peddlers in back alleys, but some level of common sense usually prevails.
“7. Heart and cancer protection: not proven.”
The American Heart Association recommends a diet rich in marine-based omega-3s, and the U.S. government has approved health claims for vitamin D and calcium supplementation. In 2005, Harvard researchers estimated that low intake of omega-3s in the U.S. diet accounted for 72,000 to 96,000 deaths from cardiovascular disease. There have been numerous animal studies showing direct cancer prevention with omega-3s and epidemiological studies associating high levels of dietary omega-3s with reduced rates of cancer.
“8. Choking.”
Now Consumer Reports is really reaching. Anybody who tries to dry-swallow any pill can experience a gag reflex, which is not a problem unique to any one class of products.
“9. Some natural products are anything but.”
Most dietary ingredients are analogues of natural extracts; technologists are not standing around with wooden mallets, mortars and pestles. There are only one or two cases where a true synthetic is not as efficacious as a natural source nutrient, and that is with vitamin E.
“10. You may not need supplements at all.”
But we need drugs? For decades the USDA has shown that most of us do not get anywhere near a basic level of vitamins and minerals from the standard American diet, so it would be a rare person indeed who would not stand to benefit from a multivitamin/multimineral supplement at the very least.
Although Consumers Union has a long, and illustrious, track record in advocating for consumers, Consumer Reports appears to have a bug in its bonnet regarding dietary supplements, either that or single-copy newsstand sales soar when “supplements are bad” stories are run.
This is unfortunate, since scare-mongering re safe, well-regulated and effective dietary supplements will, at best, only serve to unfairly cause consumers to wrongly distrust a beneficial class of products and, at worst, drive even more Americans away from responsible self-care into the welcoming arms of drug-happy conventional medicine.
That’s not what I call consumer advocacy.
Sunday, July 29, 2012
Friday, July 27, 2012
Health at Gunpoint: The FDA's Silent War Against Health-Freedom
By James J. Gormley
What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?
These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.
The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.
In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.
Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?
Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.
In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.
Health at Gunpoint will help prepare you for the coming fight.
These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.
The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.
In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.
Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?
Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.
In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.
Health at Gunpoint will help prepare you for the coming fight.
Labels:
FDA,
health at gunpoint,
health freedom,
health-freedom,
james gormley
Friday, July 20, 2012
Maybe Food: Why What We're Feeding Babies Is Iffy at Best
About 60 percent of the brain/neurologic-boosting effects of breast milk are due to the concentration of omega-3 DHA (docosahexaenoic acid) and arachidonic acid (AA).
Despite the demonstrated advantages of breastfeeding vs. standard-formula-feeding, James W. Anderson, M.D., told me way back in 1999 that, in the U.S., "The DHA content in breast milk has gone down 67 percent in the last 60 years. The DHA levels in the breast milk of American women is 50 percent less than those of European women, and about 66 percent less than those of Japanese women."
Studies have also shown that infants fed formula supplemented with DHA and AA exhibited: improved mental development; better visual acuity; and significantly lower blood pressure at age six (which may reduce the risk of cardiovascular disease later in life).”
Although the United Nations' World Health Organization (WHO) issued a report in 1994 calling for the inclusion of DHA in all infant formulas, it took seven years for the U.S. FDA to allow DHA and arcahidonic acid. And the situation was not much better internationally.
On September 2004, I testified before Codex’ Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) at the FDA headquarters, during which I argued that while DHA was listed as an “optional component” for infant formula it should be a required ingredient. I, and others, also pointed to other problems with what was allowed in infant formula around the world, such as high-fructose corn syrup (HFCS) and very low-quality fats.
As to why HFCS would have ever been allowed in baby formula, as usual follow the money. In 2008, the Corn Growers Association was said to have spent $20 to 30 million on an 18-month public (dis)service ad campaign targeting mothers with the message that high-fructose corn syrup is just fine for toddlers and children.
While it appears that some headway has been made on infant formula, both here in the U.S. and internationally (e.g., high-fructose corn syrup and partially hydrogenated fats are no longer commonly found, or at least not labeled as such), serious problems still exist.
My recent trip to the infant-formula aisle was somewhat of an eye-opener for me. Apparently, “corn syrup solids” is the first or second ingredient in most infant formula and saturated-fat-packed palm oil (50% saturated fat) and coconut oil (90% saturated fat) are still major ingredients.
Unfortunately, challenges to babies’ health are not limited to infant formula, since sweetened juices are widely used in place of, or in alternation with, formula. Not a good thing.
According to the American Academy of Pediatrics’ Nutrition Committee on Nutrition (1999-2000), “Historically, fruit juice was recommended by pediatricians as a source of vitamin C and an extra source of water for healthy infants.” According to the Academy, the facts however are these:
- Fruit juice offers no nutritional benefit for infants younger than 6 months.
- Fruit juice offers no nutritional benefits over whole fruit for infants older than 6 months and children.
- Fruit drinks are not nutritionally equivalent to fruit juice.
- Excessive juice consumption may be associated with diarrhea, flatulence, abdominal distention, and tooth decay.
As daunting as are the problems associated with the ubiquity of unhealthful choices for infants, toddlers and very young children, we have a backdrop of global obesity that has more than doubled since 1980, according to the WHO, which also notes that over 40 million children under age 5 were overweight in 2010, a number which I think is extremely conservative.
As a global natural products industry, we can feel just pride in having steered over 54 of the world’s governments to require folic acid fortification, which has contributed to thousands fewer babies being born with devastating neural tube defects. We can also point to the inclusion of DHA and AA in many infant formulas around the world, which has helped the cognitive and visual development of so many children.
But there is much work to do on behalf of the babies of future generations. Natural ingredient makers can make higher quality ingredients a more attractive option for makers of formula and all of the various fortified foods and beverages for the little ones.
One approach to making natural-source ingredients more desirable is to work with existing finished product partners in developing and engaging a committed customer base of consumer activists, potentially via organizations that focus on infant and toddler development, such as (but not limited to) ZERO TO THREE, which can spearhead petition drives and letter-writing campaigns directed to the big formula and baby-food manufacturers (perhaps through such platforms as Change.org).
Because once the “bad stuff” becomes a public relations’ liability and a market negative, formula makers may well be poised to rapidly reformulate the offending products and to avidly consider the advantages of your premium, optimal nutritional ingredient or pre-mix.
Look what happened to non-recycled paper and BPA---they’re heading the way of the Dodo bird.
Looks like it’s time for the infant food giants to evolve.
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
Saturday, July 14, 2012
"Rules for a Young Lady" from The Journal of Health, 1829
Compiled by James J. Gormley
Let her to go to bed at ten o’clock---nine, if she pleases. She must not grumble, or be disheartened […]
Her breakfast should be something more substantial than a cup of slops, whether denominated tea or coffee, and a thin slice of bread and butter. She should take a soft boiled egg or two, a little cold meat, a draught of milk or a cup or two of pure chocolate.
She should not lounge all day by the fire, reading novels, nor indulge herself in thinking of the perfidy of false swains or the despair of a pining damsel; but bustle about---walk or ride in the open air, rub the furniture, or make puddings---and when she feels hungry eat a custard in place of the fashionable morning treat of a slice of pound cake and a glass of wine or cordial.
In place of three of four cups of strong tea for supper she may eat a custard---a bowl or bread of milk---or similar articles, and in a few hours afterwards let her retire to bed.
At other periods of the day which are not occupied by business or exercise, let her read---no sickly love tales---but good humoured and instructive works---calculated, while they keep the mind unincumbered with heavy thoughts, to augment its store of ideas, and to guard it against the injury which will ever result from false perceptions of mankind and of the concerns of life.”
The Journal of Health, 1829
In the research for my health freedom book, I came upon these pearls of what would have passed for wisdom in the politically incorrect, feminism-deficient year of 1829. It totally cracked me up, political incorrectness by today's standards aside!
What's with the obsession with custard? And wine or a cordial for breakfast? Huh?
“Rules for a Young Lady.
What's with the obsession with custard? And wine or a cordial for breakfast? Huh?
“Rules for a Young Lady.
Let her to go to bed at ten o’clock---nine, if she pleases. She must not grumble, or be disheartened […]
Her breakfast should be something more substantial than a cup of slops, whether denominated tea or coffee, and a thin slice of bread and butter. She should take a soft boiled egg or two, a little cold meat, a draught of milk or a cup or two of pure chocolate.
She should not lounge all day by the fire, reading novels, nor indulge herself in thinking of the perfidy of false swains or the despair of a pining damsel; but bustle about---walk or ride in the open air, rub the furniture, or make puddings---and when she feels hungry eat a custard in place of the fashionable morning treat of a slice of pound cake and a glass of wine or cordial.
In place of three of four cups of strong tea for supper she may eat a custard---a bowl or bread of milk---or similar articles, and in a few hours afterwards let her retire to bed.
At other periods of the day which are not occupied by business or exercise, let her read---no sickly love tales---but good humoured and instructive works---calculated, while they keep the mind unincumbered with heavy thoughts, to augment its store of ideas, and to guard it against the injury which will ever result from false perceptions of mankind and of the concerns of life.”
The Journal of Health, 1829
Tuesday, July 10, 2012
The Right to No --- GMOs Must Go
By James J. Gormley
Her chariot is an empty hazelnut [ . . .]
And in this state she gallops night by night [ . . .]
o'er lawyers' fingers, who straight dream on fees
--- Mercutio, Shakespeare's Romeo and Juliet, Act 1, Scene 4
Not that lawyers only think of (or dream about) fees, however it is worth noting that when Californians vote this November 6th on the Right to Know Genetically Engineered Foods Act (aka the GE Foods Mandatory Labeling Initiative), they will not only, fortunately, be taking an historic stand for consumer rights but also, unfortunately, throwing down a wild card on the table, one that could potentially open up the floodgates to private actions (lawsuits) against makers of all manner of raw and processed foods, food supplements and packaged goods, in short: 60 to 80 percent of products on store shelves in The Golden State.
Her chariot is an empty hazelnut [ . . .]
And in this state she gallops night by night [ . . .]
o'er lawyers' fingers, who straight dream on fees
--- Mercutio, Shakespeare's Romeo and Juliet, Act 1, Scene 4
Not that lawyers only think of (or dream about) fees, however it is worth noting that when Californians vote this November 6th on the Right to Know Genetically Engineered Foods Act (aka the GE Foods Mandatory Labeling Initiative), they will not only, fortunately, be taking an historic stand for consumer rights but also, unfortunately, throwing down a wild card on the table, one that could potentially open up the floodgates to private actions (lawsuits) against makers of all manner of raw and processed foods, food supplements and packaged goods, in short: 60 to 80 percent of products on store shelves in The Golden State.
In the case of non-processed foods, the words ‘Genetically Engineered” will appear on the front of the package; in the case of processed foods with a variety of ingredients, the words “Partially Produced with Genetic Engineering” or “May be Partially Produced with Genetic Engineering” will appear on the front or back of the package. I wish the term “Produced with Genetically Modified Organism [GMO] Ingredient Technology,” or something similar, had been chosen instead.
Natural Genetic “Engineering” … and Frankenfoods
Why? Because as early as 8,000 B.C. farmers had already domesticated many wild food-plant species, with growers having selectively bred thousands of different strains, each with its own hereditary genetic material, or “germ plasm.”
While our ancestral farmers did not understand hybridization, and could not engage in mutation breeding (exposing plants to chemicals or radiation to create beneficial mutations) or utilize genetically modified organism (GMO) technology, clearly plant husbandry was an early version of genetic engineering: farmers using what they knew about a plant to select for specific desirable traits to develop improved varieties.
Examples of crops that are the product of traditional hybridization techniques include grapefruit (which was a cross of two different citrus fruits) and maize (a plant that was domesticated in Mexico 10,000 years ago that produced very tiny cobs).
Animals have not been immune to human-made genetic crossing as well, and centuries of domestication and breeding for specific traits. In this example, we of course have mules (a horse and donkey cross) and anywhere from 150 to 600 breeds of domesticated dogs all bred to bring out certain characteristics.
This is of course far different from producing a hybrid plant that could never have existed in nature, especially using genes from one species (even an alien species, like fish) to create changes in another species.
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| Courtesy azrainman.com |
While the fish tomato thankfully never made it to the produce aisle, other cross-species combos have. A gene from the Bacillus thuringiensis bacteria was inserted into corn to combat a corn-eating worm; today, 63 percent of the U.S. corn crop uses this Franken-seed.
The use of genetically engineered bacteria to create nutraceutical compounds has had a disastrous track record. Case in point: in 1989 over 1,500 people became very sick and nearly 40 died as a result of ingesting contaminated L-tryptophan that had been made by a foreign pharmaceutical company using genetically engineered bacteria.
This is a perfect example of the grave concerns over 90 percent of Americans have regarding GMOs and why they want products with GMOs to be labeled as such.
Europe Has Taken A Hard Line Against GMOs; the U.S. Government Is a Huge GMO Advocate
The European Union (EU) took a more aggressive approach, at least initially, with a six-year moratorium on gene-altered products than ran from 1998 to 2004. Sadly, the U.S., Canada and Argentina challenged it in court and, in 2006, the World Trade Organization (WTO) ruled that the EU ban was illegal.
At the time, Eric Gall of Greenpeace told EurActiv.com that "All this verdict proves is that the WTO is unqualified to deal with complex scientific and environmental issues, as it puts trade interests above all others. Its only effect has been to reinforce the determination of EU countries to resist bullying by pro-GE governments and to say no to GE crops and food."
Case in point: After the May 2006 WTO ruling, American exports of rice to Europe were stopped when a majority of the U.S. crop was confirmed to be contaminated with unapproved engineered genes.
In the interim, in April 2004 Hugo Chavez had announced a total ban on genetically modified (GM) seeds in Venezuela and, in January 2005, the Hungarian government had issued a ban on the importation and planting of GM maize seeds, which was subsequently upheld by the EU .
Which brings us back to December 18 of 2006, when the EU’s environment ministers officially rejected the WTO’s ruling, specifically the proposal to force Austria to lift its bans on GM foods and crops. National bans have also been issued in Bulgaria, France, Germany and Ireland.
All in all, according to journalist Jeremy Stahl in the June 14, 2012 edition of Slate.com, public opinion in the EU has for years been adamantly against GMOs. “European policymakers have responded to their constituents rather than their scientists, and only two GM crops have been approved for farming in EU states, while 90 have been permitted by the FDA for use in the United States.”
That being said, the tide may be turning in the other direction in Europe just as the U.S. (California most prominently) is shifting back to where the EU was. The European Food Safety Authority (EFSA) rejected the French ban on GM corn. While the EU Commission is deciding how to enforce the ruling, EU’s health commission has said that it “could now ask France to lift the ban,” wrote Stahl.
Will GMO Labeling Help or Confuse Consumers?
Peggy Lemaux, Ph.D., a cooperative extension specialist at the University of California, Berkeley who manages a website on biotechnology told Eliza Barclay of National Public Radio (NPR) in a May 14, 2012, interview, that the GE label may “scare less savvy consumers away from affordable, healthful foods.”
The July 5th issue of trade magazine, Retail Leader, noted the concerns of opponents to the California initiative who ask readers to “consider how costs could increase and small businesses could be hurt if the mandate encouraged frivolous lawsuits against companies that didn’t carry a GMO label but were sued nonetheless.”
As I noted in my April 3rd, 2012 commentary, the last time there was a mandatory labeling initiative in California was 1986, when “The Safe Drinking Water and Toxic Enforcement Act” (aka Proposition 65, or Prop 65) was passed into law via a direct voter initiative.
Another Gravy Train for Lawyers and Their Straw Man Plaintiffs?
Prop 65, a well-intended yet disastrously misguided law that should instead be called the “Private Attorney Enrichment Via Straw Man Plaintiffs Act,” has done little to protect consumers but has done much to hurt businesses operating in or selling into California, including dietary supplement companies.
![]() |
| Courtesy Robert Huffstutter |
And lawsuits for GMO labeling are a very real prospect, indeed.
While the organizers of the California initiative point to the fact that the lawsuit will not authorize the awarding of Prop 65-like “bounty hunter fees” to lawyers who bring suits, which is true, what is not brought out is that (1) anyone can sue to enforce the new statute, (2) they can be awarded their attorney fees and costs of bringing suit, and (3) they don’t have to prove anything---such as facts, damage or loss---or to even win the case as such for the Court to award them fees.
In a legal analysis of the initiative by James C. Cooper, JD, Ph.D., entitled “Proposition 65 and the Proposed California Right to Know Genetically Engineered Foods Act: A Comparison of Litigation Incentives,” Cooper wrote: “The adoption of Label GMO likely would result in private lawsuits to enforce its provisions.”
In an interview with The Gormley Files, when asked as to how widespread the “private lawsuit business will be,” Cooper said: “As I note in my paper, because there is a private right of action, we can expect private suits, however there are reasons to believe that the GMO ballot initiative will not yield the levels of abusive litigation associated with Prop 65.” We shall see.
Will Labeling Stop the Virulent Spread of GMOs?
And while it is hoped that GMO labeling will allow consumers to vote with their pocketbooks and that they will choose the few remaining products over the 70 to 95 percent of products contaminated with GMOs, we don’t know this for certain, regardless of whatever poll numbers suggest.
As California consumers make those choices over the coming years, growers and countries will continue to abandon old, land-race crops in favor of GE, single-variety monocultures, thus setting the stage for the entire world’s complete, and utter, destruction, as a single disease, or only a few of them, could then wipe out the planet’s food supply before we could stop it.
![]() |
| Deforestation in the Pacific Northwest |
It is predicted that by the year 2050, 25 percent of the world’s 250,000 plant species will disappear due to deforestation, the shift to genetically uniform crops, over-grazing, water control projects and urbanization.
In April 1991, plant geneticist Jack Harlan (1917-1998) warned: “The diversity of our genetic resources stands between us and starvation on a scale we cannot imagine.”
To prevent worldwide disaster scenarios such as this, groups are tracking down the wild relatives of modern crops in habitats believed to favor their survival, then preserving their germ plasm in a global network of seed banks (or gene banks)---such as the Svalbard Global Seed Vault---and protected natural sites.
However, better oversight and controls need to be devoted to these efforts, as not only have many seed banks fallen into decay but the funding for these efforts appears to have been, thus far, subverted by the same company that rules the GMO roost.
The Way Forward?
Assuming the ballot initiative passes, only time will tell as to who will truly benefit and who will truly lose, especially as similar initiatives are on the hopper in several other states and the Federal government.
But the bigger question is this: Why don’t we push for a full ban of GMOs?
It’s no accident that only 5 percent of food in Europe contains GM traces, which is thanks to a “zero tolerance” policy that the EU has had.
For Europe, moving to zero would be a lot easier than for us, however a staged approach to eliminating GMOs for U.S. agriculture and the food industry might just work, similar to the milestones associated with vehicle emission requirements (e.g., hydrocarbons, carbon monoxide and nitrogen oxide) staged for five milestone years, including those coming up in 2017 and 2025.
Perhaps modest incentives and tax breaks can be offered to GM seed makers if they agree to phase out the development and sale of GM seeds and GM-seed-specific pesticides and help farmers in remediation efforts to restore their crops to non-patented, non-GM varieties, and agree to cease the persecution of farmers for using traditional, seed-saving practices that have been part of agriculture for 10,000 years. Certainly, the U.S. Department of Agriculture (USDA) would need to phase out its GE/GM development mission, as well.
All of this will take a great deal of political will driven by consumer grassroots’ demand, but it can be done, as we have seen in Europe.
A world free of GM plants and crops may well be the ultimate answer. Not just the “The Right to Know,” but the “Right to No.”
As in no GMOs.
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