Natural Products Industry Dot Edu

By James J. Gormley

These days there is much discussion — as there should be — about standards, certifications, and what’s in a given bottle of supplements (such as superior quality ingredients) and what’s not in it (e.g., GMO-free and gluten-free).

But what can empower a company to confidently map out the life trajectory of a dietary supplement from sprout to shelf? Education.

It is fortunate, then, for producers and consumers that the Natural Products Association (NPA) and UL (Underwriters Laboratories), a “global independent safety science company with more than a century of expertise innovating safety solutions” are now working together to offer “increased educational opportunities to NPA members,” according to a recent NPA announcement.

Having served on the NPA Education Committee some years ago, and having helped companies comply with regulatory requirements since then, I can confidently say that this educational boost will help participating member companies learn, brush up on, and master what is needed to navigate the oftentimes confusing seas of regulatory compliance.

From preparing for cGMP inspections, to cGMP quality control requirements, to production and process controls, to structure-function claims and labeling, to SOPs and more, the planned educational modules appear to address a whole range of critical areas important to the natural products industry.

The new partnership will combine NPA’s regulatory and compliance expertise with “top-notch training modules from EduNeering, the online regulatory training division of UL,” according to the NPA.

“Given the combined reputation and expertise of both NPA and UL, our collaborative efforts to bring elevated education to the natural products industry is the logical next step for both organizations,” said Daniel Fabricant, Ph.D., CEO of the NPA.

“NPA brings a level of regulatory expertise in Dr. Fabricant and Dr. Corey Hilmas that is unmatched in the dietary supplement industry, and UL is very pleased to be partnering with them in this new endeavor. Through this alliance, the industry and consumers will undoubtedly be better served,” said Mike O’Hara, general manager of global nutraceuticals for UL.

“Our combined vision is to see one program the industry can turn to for dietary supplement education, and we see this being that program,” Dr. Fabricant added. “We anticipate this to be the start of a lasting relationship between NPA and UL that will reflect this shared vision and impact our industry in a very profound and meaningful way.”

Given UL’s global recognition and universal adoption, I anticipate good things coming out of this collaboration, including a more savvy industry marketplace that is better equipped and stronger than ever before, which will benefit the industry and consumers.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Dan Fabricant's FDA Insights | Nutritional Outlook

In April, Daniel Fabricant, PhD, ended his three-year tenure as FDA’s Director of the Division of Dietary Supplement Programs. Fabricant has since returned to the Natural Products Association (NPA; Washington, DC), where, prior to joining FDA, he served as vice president of global government and scientific affairs. (FDA has named William Correll interim head of Dietary Supplement Programs. Correll hails from FDA’s Center for Food Safety and Applied Nutrition.)

Nutritional Outlook and industry members will be watching with interest to see how Fabricant’s inside experience at FDA with policy issues such as New Dietary Ingredients and Good Manufacturing Practices (GMPs) informs his work at NPA going forward. Upon Fabricant’s departure from the agency on April 18, 2014, FDA said: “Dr. Fabricant worked hard to strengthen the FDA dietary supplement program,” noting that, during his time there, the agency took several court enforcement actions and issued numerous warning letters to companies, including for adulteration, mislabeling, and GMP violations.

Now firmly back at NPA, this time as its CEO—succeeding John Shaw—Fabricant spoke to Nutritional Outlook’s James Gormley about a range of issues, from the future of the NPA, to emerging champions on Capitol Hill, GMPs, and more.

READ MORE: Dan Fabricant's FDA Insights | Nutritional Outlook

Health Freedom and Politics: Taking Arms Against Seas of Trouble

Whether 'tis Nobler in the mind to suffer

The Slings and Arrows of outrageous Fortune,

Or to take Arms against a Sea of troubles,

And by opposing end them […]

----Hamlet’s soliloquy

By James J. Gormley

Politics. Health. Freedom. One would like to think that freedom is intertwined with both, but often freedom is at odds with the politics of control and held at arm’s length from anything approximating true health.

Why is this? Well, one definition of “politics” is: “the debate or conflict among individuals or parties having or hoping to achieve power.”

This power can be the ability to impose nanny-state, Big Government restrictions on access to natural health products and treatments and information about them.

The power can also stem from the lobbying largesse of Big Pharma and Big Agra, economic potentates that dictate what synthetic, genetically modified, or otherwise perverted foods, plants or chemicals (or systems governing them) get their way and why natural ingredients, botanicals, or dietary supplements do not.

But politics is not inherently bad; in fact, in ancient Greece being a politician was the greatest calling to which a person could aspire. Debate and conflict are not in essence bad, either; they are merely, at best, the means by which people or nations confront problems and protect interests.

Power, like a sword, can cut both both ways, depending on who is wielding it and to what end; it is, in essence, the currency or capital that can, at best, fuel change.

So as an executive and/or decision-maker in the natural product industry, how do you navigate the political minefield that surrounds us? How do you “take Arms against a Sea of troubles, And by opposing end them […]”?

As a natural products industry, we have taken arms against many seas of trouble in the past and, in most cases at least, we have risen victorious: the Hosmer-Proxmire Vitamin Bill in the 1960s and 1970s, USDA Organic and DSHEA in the 1990s, and the recent NDI Draft Guidance (so far at least).

To better navigate these seas, here are some common questions to which I will provide answers (or at least short, pithy, and potentially obnoxious suggestions):

• What are the best ways to stay on top of the industry’s political issues? First, turn to your contacts at the Natural Products Association (NPA), the American Herbal Products Association (AHPA), and the Council for Responsible Nutrition (CRN) to find out what are the latest issues and campaigns. Then, to get your consumer’s perspective, turn to Citizens for Health (CFH), the Alliance for Natural Health (ANH-USA) and the National Health Federation (NHF), because industry issues don’t always align with consumer interests, although they should.

• What is limiting your political clout: sketchy partners, bad business practices, etc.? You want to stand out from the crowd, but in a good way. Steer clear of companies trying gimmicks (such as religious exemptions, etc.) to avoid FDA scrutiny and also those companies that think USP standards and GMPs are football abbreviations.

• When should you decide to support a politician? And, if you do, how do you go about doing that? While an individual may give a maximum of $2,600 to an individual politician, PACs (Political Action Committees) can received donations of $5,000 for candidate committees and Super-PACs have no limits. Before donating any money, check out the lawmaker’s entire voting record.

• When should you back down from an issue? Better than backing down, gauge consumer sentiment before backing an issue, so you never have to back down.

• When should you get involved in foreign politics? I don’t think we should ever get involved in foreign politics, however we should not hesitate to get involved in international food trade and safety negotiations. Industry representatives include IADSA and CRN and consumer representatives include the National Health Federation.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Menopause: On Female Power and Healthy Options (Part 2 of 2)

By James J. Gormley

Click here to read Part 1.

In 2006, I asked Jacob Teitelbaum, MD, whether menopause has been politicized.  “Not so much politicized as commercialized,” said Teitelbaum.

“There is big money to be made in supplying hormones to women in menopause. Unfortunately, natural hormones were not able to be patented, so the drug companies used Premarin, which is simply pregnant horse urine. The process for making this was patentable. Because of this, almost all marketing and research was done on Premarin. This was despite holistic doctors saying for over a decade that it was insane to use pregnant horse urine in human females.”

“Now that the research has shown HRT to potentially be dangerous, even though the research suggests that the bioidentical hormones are much safer and likely less noxious in terms of side effects; the drug companies are paying for a very expensive misinformation campaign to mislead the American public,” Teitelbaum added.

“Because bioidentical hormones present a major competition to them (they are cheaper, safer, and simply what your body is used to making), they are paying to make sure that people get confused so that they keep buying the expensive prescription forms of estrogen and progesterone. It reminds me of the old days when doctors were being paid to promote smoking and also to convince mothers that anyone who breast-fed was a primitive who was damaging her child.”

Fortunately, natural support abounds.

Many studies, for example, support the use of black cohosh for relieving menopausal symptoms. In fact, previous trials have shown black cohosh to be as effective as HRT for reducing hot flashes. St. John’s wort has been found to help relieve mild-to-moderate depression. In addition to black cohosh (Cimicifuga racemosa), other ingredients and products are also on the market, including: red clover; soy; chaste tree (Vitex); hops; dong quai; sage; essential fatty acids; and good, old-fashioned diet and exercise.

In line with this, on October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

The conference covered such topics as: the safety and efficacy record of black cohosh; the benefits of ginseng, kava, kudzu, maca, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, and multi-ingredient combinations; detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and (once again) black cohosh; and the importance of reducing body fat, in addition to supplementation with chromium, carb blockers, green tea extract, and conjugated linoleic acid.

So, all in all, there’s a lot of good research out there on safe options for female consumers (and those who love them) to empower themselves with safe, effective, science-backed supplements that will support, nurture, and cherish women on their health journeys.

Courtesy of Natural Products INSIDER Supplement Perspectives

Menopause: On Female Power and Healthy Options (Part 1 of 2)

By James J. Gormley

[Courtesy of 'marsmettn tallahassee'
via Creative Commons]

Menopause is a life stage, just like puberty. In fact, in an interview I conducted in 1996 an editor for the American Botanical Council (ABC) put it this way:

“In puberty, a girl comes into her power as a woman. In menopause, a woman’s power deepens and strengthens. Menopause is a time for self-reflection—a time to evaluate where one has been, where one is presently, and where one wants to go. It is a time when women experience what Joseph Campbell calls their ‘function to be.’ ”

This initial time of change, referred to as peri-menopause, often kicks in several years before a woman’s last menstrual period. It lasts for one year after her last period, the point in time known as menopause. In fact, a full year without a period is needed before a woman can say she’s been “through menopause.”

The average age of menopause is 51.4, but before this, as mentioned above, usually in a woman’s 40s, changing levels of estrogen and progesterone often signal what are eventually considered symptoms of menopause. Women may have different signs or symptoms during menopause, mainly because estrogen is used by many parts of her body. That does not mean that she will have all, or even most, of them.

Moreover, signs that occur around the time of menopause may actually be a result of growing older, not changes in estrogen, such as: mood changes; hot flashes; osteoporosis; sleep problems; and heart disease.

In modern times, moderate-to-severe menopausal complaints were managed via conventional medicine with hormone replacement therapy (HRT). However, since a body of published research links the use of HRT with increased risks of breast cancer and heart disease, the search for safer alternatives has intensified.

In a 2004 review article by Taya McMillan, MPH, and Saralyn Mark, MD, in the Journal of the American Medical Women’s Association, “Forty percent of all menopausal women seek medical attention to alleviate symptoms of menopause.” They added that, “increasing evidence suggests that women are looking to complementary and alternative therapies for management and treatment of menopausal symptoms.”

“While many hormonal, physiological and digestive changes take place during menopause, perhaps the aspect most focused on by women and in medical literature is the symptom of hot flashes—for many women this symptom is one from which they simply want relief,” the ABC added.

Unfortunately not content to allow women to take charge of their own health without medicalizing their bodies, the FDA, at the behest of Big Pharma, on April 29, 1998 proposed re-classifying common conditions associated with natural states, such as hot flashes associated with menopause or premenstrual syndrome associated with the menstrual cycle, as “diseases”—a proposal which generated over 100,000 comments, most of which were in strong objection.

Next time, I’ll look at the aftermath and how the natural products industry can provide a safe and healthful solution.

Click here to read Part 2.Courtesy of Natural Products INSIDER Supplement Perspectives

Newsflash: Dietary Supplements Are Safe and Beneficial: Prescription Drugs Are Not!

By James J. Gormley

On August 23^rd, Newsday, a New York City newspaper ranked by Dr. Tim Groseclose as one of the top 61 most “liberal” local newspapers in the U.S. ran an article amazingly entitled, “FDA Official: 70% of Supplement Companies Violate Agency Rules.”

By “liberal” Groseclose did not mean the classical liberalism of a Thomas Jefferson or an Abraham Lincoln but the “big government,” nanny-state modern liberalism ushered in by Woodrow Wilson and expanded upon after 1921.

So perhaps we should not be completely surprised that any liberal paper would slant its coverage to support the unaccountable bureaucratic leviathan than the FDA is today ─ but, sadly, this does not serve the paper’s roughly 378,000 daily readers, readers who are, in large part, also consumers of dietary supplements ─ or at least they were before the above-cited “the sky is falling” article.

Dietary Supplements: The Real Story

Good Manufacturing Practices (GMPs) for dietary supplements are not new. The federal Current Good Manufacturing Practices for dietary supplements (21 CFR Part 111) were issued six years ago, and the Natural Products Association (NPA) rolled out its own voluntary GMP-certification program in 1999.

Contrary to the horror show of allegedly widespread incompetence, contamination and criminal negligence portrayed by the article, dietary supplements (a class of food products) are even more regulated than is food. According to whom, you ask?

How about the country’s most respected expert on food and drug law, attorney Peter Barton Hutt, who served as Chief Counsel for the FDA from 1971 to 1975, has taught food and drug law at Harvard for over 20 years, is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 3^rd edition 2007), and has published more than 175 book chapters and articles on food and drug law and also on health policy?

“The [Food Drug and Cosmetic Act], as amended by DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, provides somewhat greater FDA regulatory authority over dietary supplements than over conventional food,” noted Hutt in a white paper commissioned by the Council for Responsible Nutrition (CRN) entitled FDA Statutory Authority to Regulate the Safety of Dietary Supplements (2^nd edition, 2011).

Safety: The Facts

According to the Newsday article, approximately 6,300 adverse event reports were submitted for dietary supplements from 2008 to 2012, a 4-year period. 

Not even considering the fact that most of these reports were likely inaccurately linked to supplements when other factors were the more probable causes, in the same period Pharmaceutical Commerce reports that were approximately 3,260,000 adverse events reported for pharmaceutical drugs!

I don’t recall seeing this stark comparison in the newspaper article.

The FDA official quoted in the story, Daniel Fabricant, Ph.D., was formerly the science head for the NPA, and was a staunch defender of natural products until he became its chief critic at the FDA.

On August 26^th, John Spilateri Shaw, the CEO of Dr. Fabricant’s alma mater, the NPA, noted in an open letter to Newsday that “industry members strongly support providing additional resources for the FDA to keep illegal products disguised as legitimate supplements off the market.”

The vast majority of “supplements are beneficial, and millions of Americans depend on them each day,” Shaw added in his letter. “Your readers should continue to use these products that safely and positively influence their lives on a daily basis.”

Prescription and OTC Drugs: Safety? Not So Much

And what about the FDA takeover of three drug plants in 2011 following “shocking conditions” at the plants where one of the most popular line of over-the-counter (OTC) pain relievers (rhymes with “i-lenol”) were manufactured. "This inspection report is pretty close to being the worst I've seen,” according to David Lebo, a professor of pharmaceutical manufacturing at Temple University in Philadelphia, in an interview for CNNMoney.

The inspections reportedly uncovered safety and quality violations in every system, control and process, from bacterial contamination, to filthy manufacturing and storage conditions, to super-potent levels of pain relievers in batches of the infant pain-relief formula.

Didn’t see much media coverage of this, did you? I only noticed an obvious absence of the products from store shelves, and that was my first tip-off.

Hutt added: “DSHEA provides greater FDA scrutiny of new dietary ingredients than exists for new conventional food ingredients and adds new safety enforcement authority for all dietary supplements that extends beyond the FDA authority applicable to conventional food.”

Adulterated Supplements Are Illegal Drugs, Not Supplements

As to cases of deliberate adulteration of dietary supplements, if the ingredients were anabolic steroids, the product in question would then be an illegal drug ─ not a supplement ─ and it is subject to action by the U.S. Drug Enforcement Administration (DEA). I have been calling for the DEA to step up to the plate since 2010.

The same with deliberate contamination with weight-loss, sleep aid, or sexual health drugs, the rare number of cases of this type of adulteration also renders this type of hybrid product an illegal drug; it is no longer a dietary supplement product or issue.

As to even more rare cases of legitimate manufacturers who unwittingly receive and use shoddy, contaminated or adulterated raw materials due to falsified documentation and certifications, it is the manufacturer’s responsibility to ensure the purity and safety of the ingredients it uses, and there are multiple mechanisms in place to quarantine, test and verify ingredients before they are included in finished dietary supplement products.

Peter Barton Hutt's Takeaway on Supplement (Hyper) Regulation

“DSHEA adds three additional procedural safeguards for dietary supplement court actions to assure that FDA will act fairly and equitably in its enforcement of safety requirements, but does not substantially change the requirements applicable to court actions involving conventional food,” noted Hutt.

According to him, “The Dietary Supplement and Nonprescription Drug Consumer Protection Act expands FDA’s regulatory authority over dietary supplements by adding postmarket reporting and recordkeeping requirements that are more stringent than those that apply to conventional food.”

“Thus, in many ways, the current food safety provisions of the [Food Drug and Cosmetic Act] provide FDA with greater substantive authority over dietary supplements than they provide for conventional food, and the modest procedural changes in the court enforcement requirements have had no impact thus far and are unlikely to have a significant impact in the future,” Hutt concluded.

To counter the article’s misleading timeline with one that more accurately reflects the safety and consumer protections surrounding dietary supplements, I offer, by way of conclusion,  this one adapted from Peter Hutt's white paper:

• 1994: Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary ingredients.
• 2002: Congress enacted the Public Health Security and Bioterrorism Preparedness and Response to provide additional authority to assure the safety of the food supply. In 2006, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act to require mandatory adverse event reporting systems for dietary supplements.
• 2007: Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prohibit the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
• 2011: Congress enacted the FDA Food Safety Modernization Act (FSMA) to improve FDA’s capacity to prevent, detect, and respond to food safety problems.

Congratulations Better Nutrition Magazine!

She's looking pret-ty spry for 75!

And by "she" I am referring to my editorial alma mater, Better Nutrition magazine, where I proudly served as editor in chief from 1995 to 2002, which is celebrating its 75th anniversary beginning with the August 2013 issue.

Better Nutrition has always stayed true to its mission and has constantly worked very hard to never let down its readers. It has a unique and trustworthy way of getting into people’s hands, too, via consumers’ favorite health-food stores.

James Gormley's "Earth Watch" column in 1995

The magazine has never been afraid to be out first on issues of great importance to its readers, whether breaking an environmental health story about the dangers of the Yucca Mountain nuclear waste repository (‘Physicists warn: nuclear waste-site dangers exist,’ September 1995), or a commentary on nutritional genocide (‘Iodine deficiency in China --- a crucial lesson for the U.S.’, August 1996), or an editorial in total support of St. John’s wort when most media outlets were publishing unfounded hit pieces (‘St. John’s wort is safe,’ June 2000).

With its editorials and its articles, Better Nutrition also helped re-popularize integrative medicine in the U.S. and was on the vanguard of the successful fight (between 1997 and 1998) to force the USDA to propose new USDA Organic standards that adhered to the right principles. 

The magazine has also never shied away from publicly defending the science and safety behind dietary supplements, whether in testimony I had an opportunity to deliver at the New York City Council ephedra hearings in 2000 or when I had a chance to "take on" pharma industry attorneys on FOX-TV’s ‘Good Day New York.’

Better Nutrition was the first health and nutrition magazine to commit to a rigorous focus on science in all of its reporting, an approach that was later emulated by other magazines. In addition, the magazine has been part of a movement that changed the nation’s mind-set from ‘5-a-day’ and mainstream ‘healthcare’ to optimal nutrition and integrative health.

The magazine has also never been afraid of getting personal, either, whether the topics were fear, the inspiration of Patch Adams, happiness, hope or thankfulness. In fact, readers have consistently shown their appreciation for Better Nutrition articles that inspired them, encouraged them or gave them hope.

James Gormley's "Editor's Desk", 1999

In January 2000, Better Nutrition printed a letter from Ronee Groff, president of the Learning Disabilities Association (LDA) of New Jersey, who wrote in about my December 1999 editorial, ‘Pass the squash, hold the fear: Meditations on racoons and a fear-free holiday season.’ She pointed out in her letter how fear, anxiety, worry and apprehension are a great part of the lives of people who are struggling with learning disorders. She wrote: ‘We believe it [the commentary] to be a wonderful piece, and we would love to communicate your words to those we believe would enjoy, and receive some strength from, the message.’

In July 2001, a reader from Mission Hills, Kansas, send in a card about the February 2001 commentary, which was entitled, ‘Never stop dreaming.’ His card, which I have kept on my own bulletin board for the last 12 years, reads: ‘I want to congratulate you on a most wonderful editorial, ‘Never stop dreaming.’ It is kept at my desk as a reminder to stop and look up. Thank you for putting a simple thought into words.’ ”

James Gormley's "Editor's Desk," 2001

Better Nutrition gave me the chance to learn quite a lot about nutrition: where we are, where we should be, and what can help get us there nutritionally. I’ve had such amazing opportunities, too, to learn and grow, including a press trip to China in 2001, a life-changing experince that I will never forget.

I have met so many caring and committed health-food retailers over the years, people who are truly on the front lines of health freedom. 

It’s given me the chance to learn about the regulations which support our right to high-quality, high-potency and innovative dietary supplements and about the political and economic forces which are taking aim at those rights, one of the reasons I decided to write Health at Gunpoint.

I am thankful to editor-in-chief of Better Nutrition today, Nicole Brechka, who gave a shout-out to me in the anniversary issue's editorial and to Vera Tweed in her history of the natural products industry this same issue.

Vera Tweed, Better Nutrition, August 2013

From the bottom of my heart, I wish Better Nutrition another 75 groundbreaking, conscious-raising years of commitment and service to American consumers and the health-food stores where they shop!

New York City: A Nanny State of Mind?

By James J. Gormley

If New York City’s Mayor Bloomberg has his way, many more people will be passing out in 100-plus-degree stairwells, since his latest initiative promotes taking the stairs over riding elevators in New York City buildings.

Mind you, while taking the stairs would theoretically be much better for cardiovascular health if air-conditioned or well-ventilated, well-lit, and safe, the problem is that, in New York City at least, many of them are not.

In fact, at the July 17^th press conference announcing this new initiative, New York City’s own health commissioner, Thomas Farley, admitted: “In too many buildings, the stairs are hard to find, kept locked, armed with alarms, or dark and windowless–making people afraid to use them.”

Aside from this, with the average high-rise height of 12-to-40 floors and the average apartment-building height of six stories---and considering that these dark, un-ventilated passageways can reach temperatures well over 100 degrees in the summer---it doesn’t help things when we consider that they are also dangerous.

As Donnel Baird noted in a July edition of the New York Times, “If cops are on the street, crime moves into the stairwells.”

Now while Bloomberg in not forcing people to take the stairs yet, just give him time.

Look at his recent herculean efforts to impose a ban on sugary drinks over 16 ounces (which doesn’t apply to some convenience stores or all supermarkets, and people can just buy extra drinks anyway).

On the website, Above the Law (abovethelaw.com), back on March 11, 2013, Elie Mystal wrote: “In case you haven’t been following along with developments inside Mike Bloomberg’s […] nanny state, last year our elected tyrant outlawed the sale of soda in sizes over 16 ounces at movie theaters and other public places. The mayor felt that nobody needed more than 16 ounces of soda in one sitting, notwithstanding the fact that nobody asked him what my mother thinks.”

Fortunately New York Supreme Court Judge Milton Tingling overturned the ban in March, stating  that “[The city] is enjoined and permanently restrained from implementing or enforcing the new regulations.” He added: “[The regulations are] fraught with arbitrary and capricious consequences. The simple reading of the rule leads to the earlier acknowledged uneven enforcement even within a particular city block, much less the city as a whole. The loopholes in this rule effectively defeat the stated purpose of the rule.”

In other words, even this were not an outrageous violation of freedom of choice and consumer rights, this law would still be a complete joke.

He specifically wrote that “to accept [Mayor Bloomberg’s] interpretation of the authority granted to the Board by the New York City Charter would leave its authority to define, create, mandate and enforce limited only by its own imagination.”

The judge went on to note that the Portion Cap Rule, if upheld, “would create an administrative Leviathan and violate the separation of powers doctrine. The Rule would not only violate the separation of powers doctrine, it would eviscerate it. Such evisceration has the potential to be more troubling than sugar sweetened beverages.”

As Mystal correctly opines, “I’ve been living under Bloomberg for so long I forgot that ‘so let it be written, so let it be done’ is not a sufficient state interest for the curtailing of individual liberties.”

As Mystal adds, you cannot legislate good health or portion control, and I agree with him and others that it is the height of arrogance to presume to do so.

That is not stopping Bloomberg spending millions of our-tax-dollar-paid NYC Corporation Counsel attorneys from pursuing this mad quest to the NY State appeals court.

In a June 6^th, 2013 Associated Press article published on the Huffington Post, David B. Caruso wrote: “Justice David Friedman said the city appeared to be asking for unprecedented authority to regulate all sorts of portion sizes, including ‘the number of doughnuts a person could eat, the number of scoops of ice cream’ and number of servings of fried chicken.”

Unlikely as it is for me to agree with the American Beverage Association, I do in this case. According to Caruso’s article, Richard Bress, an attorney for the association, “challenged the regulation acknowledged that too much sugar can be unhealthy, but he told the court the regulation was ‘a breathtaking example of agency overreach.’ "

Bress correctly told Caruso that the city’s proposal appeared to be based more on politics than science. He pointed out, for example, that no limits would be set for calorie-gargantuan milk shakes.

Meanwhile, the appeals court has not yet set a date for its decision.

Gormley Take-Away: Whether it is the FDA saying people shouldn’t have access to raw milk (because they don’t like it, apparently), or California making almost every product or material in the state labeled with a nonsensical Prop 65 warning that “this might cause cancer,” or whether it is bureaucrats like Michael Bloomberg wagging his finger at us and telling us he will decide what’s best for us and any semblance of separation of powers or consumer rights be damned, common sense cannot be regulated and consumer choice---and citizens’ rights---must be protected at all cost. What if early American decided it didn’t like religious freedom and preferred living under the domination of oppressive rule from afar? I probably wouldn’t have the freedom to question intolerably bad policies and laws and regulations like these, and you wouldn’t have the freedom to read this blog and any other articles or books questioning them either. My suggestion: use your power at the voting booth to kick out those who would create or perpetuate Nanny State, Big Government regimes and elect those who will fight for liberty, justice and health-freedom.

Beware the Devil’s Seed(s)

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.

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:

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!!

Sustainability = The New Green

By James J. Gormley

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]

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.

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!

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.

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:

1. 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.
2. 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
3. Those dietician-friendly state laws enshrine Registered Dietitians as the dominant force on each of these state licensing boards.
4. 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.
5. The association then encourages its members to file complaints with the state licensing boards
6. 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.
7. Hearings and settlements during the course of such prosecutions are conducted by or in close contact with the particular licensing board.

Progress in Illinois
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 29^th. 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!

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:

“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.

The FDA's Record on Slimming Products: Weighing In

By James J. Gormley

[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.