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.

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?

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

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.

Promo Video for "Health at Gunpoint: The FDA's Silent War Against Health Freedom"

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.

Maybe Food: Why What We're Feeding Babies Is Iffy at Best

By James J. Gormley

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:

1. Fruit juice offers no nutritional benefit for infants younger than 6 months.
2. Fruit juice offers no nutritional benefits over whole fruit for infants older than 6 months and children.
3. Fruit drinks are not nutritionally equivalent to fruit juice.
4. 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]

"Rules for a Young Lady" from The Journal of Health, 1829

Compiled by James J. Gormley

 

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.

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

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 6^th 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. 

Courtesy azrainman.com

For example, in 1991 a company genetically engineered a tomato with a gene from the arctic flounder in order to convey a trait of cold-storage resistance to the tomato. 

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 5^th 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 3^rd, 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

In addition to providing a disgraceful “gravy train” for unscrupulous consumers and avaricious attorneys, it does nothing to truly help consumers as its labeling requirements make it seem that virtually every product a consumer sees, walks on, sits on, wears, consumes or somehow comes in contact with is carcinogenic. It becomes the state government version of a student with bad study habits who yellow-highlights 99 percent of the text in a chapter as a test preparation, which of course is the same as not highlighting anything.

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

Clear-cutting across virgin lands annihilates natural vegetation, bringing on what is called natural erosion. 

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.

Children Are Not Little Adults

By James J. Gormley

One of my back-to-school memories in the late-1960s and early 1970s was going to the five-and-dime with my mother and choosing brand-new marble “composition pads” and #2 pencils. 

A 1970s-era ad ... the thinking has changed since then.

Although I preferred Jules Verne to geometry --- and really “digged” my summer vacations --- I was still psyched at the beginning of each new school year. I think it had something to do with the seemingly infinite possibilities for learning and success, fun and friendship. A clean slate (or blackboard).

Today, not every child has it as seemingly worry-free as that, unfortunately. In 2007, 5.4 million American children aged four to 17 were reported to have attention deficit hyperactivity disorder (ADHD) and, of these, over half of that number were being medicated for this disorder. In addition to that, autism afflicts more than 2 million people, the incidence of which increased 172 percent in the 1990s.

Artificial additives are linked to ADHD and, in addition, one of many contributing factors to this developmental disability is believed to be mercury exposure, including the historical use of thimerosal in vaccines.

According to Robert F. Kennedy, Jr., in a 2005 Rolling Stone article, “The FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen.” In 2012, thimerosal is still being used in vaccines.

Kennedy added: “If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children [with thimerosal], their actions arguably constitute one of the biggest scandals in the annals of American medicine.”

And as if things were not challenging enough for children without even considering exposure to toxins, the Federal Interagency Forum on Child and Family Statistics noted that the percentage of overweight children aged six to 17 years between 1976-1980 and 2003-2004 has gone from 5.7 to nearly 17 percent; in addition, 2 million adolescents (or 1 in 6 overweight adolescents) aged 12 to 19 have pre-diabetes, according to the American Diabetes Association.

There are, however, some indications of improvement in the lives of American kids. The percentage of children living in households classified as “food insecure” has gone down and educational attainment in high school is improving, noted the Forum.

One thing much better today for kids is the variety of dietary supplement options, from multivitamins to immune-boosters to omega-3s and more. Not only is the selection better in health-food stores but so is the manufacturers’ focus on including natural-source ingredients and excluding what I would have called “yucky” but my kids would probably call “nasty” artificial colors, flavors, binders, excipients and preservatives.

As customers visit retailers looking for healthy snacks, yogurt smoothies and kids’ vitamins, retailers can serve as an island refuge in a sometimes scary ocean of supermarkets and mass market behemoths.

Armed with good information, high-quality products and trustworthy guidance, you can help your end-user customers genuinely help their children.

In the meantime, the kids can get back to perhaps avoiding geometry and reading Jules Verne’s Journey to the Centre of the Earth, er … or would that be The Hunger Games?

Note: The title for this piece came from an ad I found (manufacturer name and ad copy cropped out) from July 23rd, 1978, subtitled: “Because Children Are Little Adults.” Of course, kids have different metabolisms and nutritional needs over and above the fact that they may be 25 to 50% less heavy than an adult, but this was the thinking in the late-1970s!

Courtesy of the SupplySide Community

Global Regulations: India | Nutritional Outlook

Global Regulations: India | Nutritional Outlook

By James J. Gormley

On April 12, the International Alliance for Dietary/Food Supplement Associations (IADSA; Brussels) commented in a press release that India’s recently-rolled-out regulations for its 2006 Food Standards and Safety Act (FSSA) “will boost foreign investment in the sector now that health supplements are clearly featured in the country’s food laws.”
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In Memoriam: Joe Bassett, Health-Freedom Legend

In Memoriam: Joe Bassett, Health-Freedom Legend

Joseph M. Bassett

Joseph M. Bassett, the co-owner of two Bassett’s Health Food stores and a long time leader in the natural products industry, died on June 6th; he was 79 years old. According to his obituary, Bassett died of complications of a bladder and kidney infection.

He was a U.S. Army veteran who served honorably during the Korean War. Bassett and his wife Patricia started Bassett’s Health Foods in 1969, bringing vitamins and supplements to the Toledo, Ohio area. The retail outlet also offered a range of private label products, with formulas developed by Bassett using his knowledge of nutrition. He was trained and licensed in nutritional and massage therapies.

He was also vigorously involved in supporting consumer access to dietary supplements, actively participating as a member of the National Nutritional Foods Association (NNFA, now the Natural Products Association, or NPA).
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Do Democrats Hate Supplements?

By James J. Gormley

I thought that would get your attention.

Of course the answer is not (categorically) yes.

There are staunch and stalwart dietary supplement champions on the “D” side of the aisle, such as Sen. Tom Harkin (D-Iowa), and one of the greatest supplement industry gladiators of all time, Democratic Sen. William Proxmire (Wisconsin), whose name is attached to one of the most important pro-supplement bills ever passed in the last 100 years, what is often referred to as the Proxmire Vitamin Bill of 1975, or Senate Bill 548, which was signed into law in 1976.

As we approach the November 2012 elections, we may well wonder if one party or another is a better champion of dietary supplements. Some political observers have suggested that the Democratic party may boast a few more anti-supplement foes in Congress than does the Republican party. But do party labels matter when it comes to dietary supplements?

What the Experts in Washington Tell Us

Edward Long, Ph.D., vice president of  Washington, D.C. lobbying firm, Van Scoyoc Associates Inc., told "The Gormley Files" in 2008 that there is no one completely pro-supplement and pro-health freedom party, and that different ideologies run through both major parties.

“There are two strains of Democrats,” noted Long. “One is a populist strain, which goes back to the 1890s, the goo-goos, the good government people who believe that American citizens need to be protected by government in every possible way and to be told what to do. It’s from this camp that a few of dietary supplements’ greatest critics have emerged.”

“Then there’s the more liberal, anarchistic side of the Democratic Party that goes back to the 1960s and 1970s, which holds that mainstream medicine doesn’t really work. It’s out of this strain that we have found a few of dietary supplements’ greatest advocates.”

What about the Republicans? Long said that while there is a sizeable subset of the Republican Party that is opposed to regulation, and over-regulation, in general, “there’s another strain that believes that, in certain cases, we need more regulation.”

Red States, Blue States and Purple States?

Unfortunately, however, goo-goos from the Democratic Party have been consistently proposing, co-sponsoring and advocating for the worst anti-supplement pieces of legislation since the bi-partisan passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

In May 2012, the latest challenge to dietary supplements was Sen. Durbin’s Senate Amendment 2127 that was defeated by a vote of 77 to 20.

Assuming blue states lean Democratic, red states lean Republican, and purple states are up-for-grabs, 13 out of the 20 Senators (or 65%) who voted in favor of Durbin’s amendment (or more technically, voted for it to stay attached to Senate Bill 3187) were from blue states, four were from purple states (20%) and three were Democrats from red states (15%). Here was how the voting went.

Looking back to last year, Sen. Leahy’s Food Safety and Accountability Act, S. 216 (originally introduced as S. 3767), which could potentially criminalize nearly anything related to food and food supplements that the FDA wants, was a fully Democrat-sponsored bill that passed the Senate last April. Looking at this year, it has now moved on to the House.

Also, Democrats have received (and continue to receive) a great deal of criticism from constituents and stakeholders for their weak (or non-) response to the FDA's outrageous NDI Draft Guidance that was proposed last year.

Of course not all anti-supplement legislation originates on the “donkey” side of the aisle. In 2010, Sen. John McCain (R-AZ) introduced the widely vilified Dietary Supplement Safety Act of 2010, or S. 3002, which the Senator was forced to withdraw after massive grassroots opposition.

Of the two much-despised House bills from 2009 (Rosa DeLauro’s HR 875 and Jim Costa’s HR 1332), the former was a 100% Democrat-sponsored bill (with 41 co-sponsors) and the latter was largely (approximately 66%) backed by Democrats.

And for clarity’s sake, it is important to remember that although almost all (if not all) anti-supplement bills are couched in names that carry the word “safety” in their titles, they do not advance safety at all but, instead, reduce consumer access to high-quality, innovative supplements; they are, therefore, anti-safety bills or, at a minimum, anti-health!

Gormley Take-Away: The point of this commentary is not to point any fingers at any one party, as all American patriots are presumably both democratic and republican (lower-case intentional). It is merely to recommend that you do your homework before the November presidential and Congressional elections so that you know which candidates seem most likely to be supportive of health freedom and supplements . . . and which do not. You may also be able to educate your U.S. legislator on the issues if he or she is not familiar with the science, benefits and safety of nutritional supplements. Ask your legislator to join the Congressional Dietary Supplement Caucus, which is currently co-chaired by 2 Democratic Congressmen (Frank Pallone and Jared Polis) and 2 Republican Congressmen (Dan Burton and Jason Chaffetz); Sens. Orrin Hatch (R) and Tom Harkin (D) have previously served as co-chairs. Your U.S. legislators can reach the Caucus at 202-225-2161 (Cannon House Office Bldg., Room 501).

The FDA's DMAA Gamble

By James J. Gormley
Senior Policy Advisor, Citizens for Health

Courtesy of the SupplySide Community

On April 24^th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of law and subject to seizure.

And, oh, by the way, since DMAA is a synthetic version of what may or may not be a constituent in geranium, it could not even be an NDI if it wanted to be, according to the FDA.

The FDA is resting its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA’s NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated.

Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C, alpha lipoic acid, and various amino acids.

In truth, DMAA is a constituent of the geranium (Pelargonium graveolens) plant, having been identified in the oil obtained from the steam distillation of the stems and leaves. This DMAA-containing plant has been used for centuries as a food item (e.g., leaves are infused for teas and added to desserts and confections, flowers are used in salads, while the oil has been used as a flavoring agent). In fact, the geranium plant and its oil are generally recognized as safe (GRAS). In terms of safety, GNC, for example, has sold 440 million servings of DMAA since 2007, with only one reported adverse event.

The FDA is following on the heels of the Defense Logistics Agency, which took products containing DMAA off military base shelves earlier this year based on two cases of death anecdotally linked to DMAA—despite the fact that the Pentagon has acknowledged no link between DMAA and the soldiers’ deaths.

On September 6^th, 2011, Barry Lynch from Cantox Health Sciences International issued an open memo in which he stated that not only do published data already exist (Ping et al., 1996) confirming that DMAA does occur in geranium oil, but also that USPlabs (the maker of Jack3d) has obtained new data “from two independent and highly respected analytical chemistry laboratories, utilizing advanced validated […] instrumentation and methods, [that] corroborate the original data published by Ping et al., and further demonstrate the occurrence of DMAA in the geranium plant […] and its edible oil.”

To be clear, the FDA is outrageously overstepping its bounds by using (although not overtly citing) non-binding opinion from a draft guidance document in Warning Letters in order to not only scare the named companies from using DMAA any longer but to also cause a widespread chilling effect in the marketplace where gun-shy companies preemptively pull an ingredient that is attracting the FDA’s attention rather than go to bat for it or join with other companies that are.

We see this happening already. Even companies that did not receive a Warning Letter are reformulating or have already reformulated their products into non-DMAA alternatives.

This is exactly what the FDA wants. Use inexpensive Warning Letters (as opposed to attempting to drag companies into Federal Court or to actually prove anything, which it cannot) to frighten the marketplace into “complying” with a version of the law that the Agency wished were in place but is not.

But no matter, if the industry decides that is much easier, and safer, to just sacrifice DMAA to avoid nasty letters from the FDA and to shield itself from frivolous class-action lawsuits citing non-binding Warning Letters, then it will have conceded defeat without a live bullet having even been fired.

And this is not to be critical of industry firms either, which honestly need to balance legal and regulatory exposure with the perceived or actual value of keeping a now-controversial ingredient in products, not to even mention public companies’ shareholder concerns and jittery insurance company worries.

That being said, the whole ugly mess reminds me of the early years in our current millennium when ephedra’s neck was on the proverbial chopping block. Many of us testified on behalf of this wonderful master botanical and tried to enlist the aid of an ephedra council from which the members had fled as if from a burning house---the San Diego ephedrine scandal did not help things, to put it mildly.

Now we have an ingredient on the chopping block.

It may not be a master herb with thousands of years of traditional use. It is not a full-spectrum botanical. And it has been included in some products whose marketing is not what we would hold up as a shining example of advertising probity and conservatism. But it does represent a line in the sand drawn by the FDA.

If we were to fully cave on DMAA, the FDA will use this as precedent for establishing a beach head on the shore of “nothing synthetic can be an NDI,” and then where will we be and what will we have gained---or lost?

Going GE-Free and GMO-Free Labeling: The Right Way to Do It

By James J. Gormley

On March 12^th, 55 members of Congress submitted a joint letter to the U.S. Food and Drug Administration (FDA) in support of a legal petition backed by over 400 organizations and businesses calling on the agency “to protect  consumer  rights  and prevent consumer  deception by requiring the labeling of genetically engineered  [GE] foods.”

With over 500 organizations and companies now behind it and over 1 million petition signatures submitted to the FDA before the FDA’s comment deadline, it is clear that there is a renewed groundswell of consumer support for the labeling of GE (or genetically modified, GM) foods and ingredients.

On Tuesday, March 27^th, the FDA responded to the petition by saying it had not yet made a decision and needs more time; it also only recognized 394 signatures rather than 1 million, an anomaly due to the FDA’s peculiar way of handling and recording petition drives and form letters.

Nevertheless, 17 states have reportedly introduced GE-labeling legislation, with bills in Connecticut and Vermont currently standing the best chance of passing. Meanwhile, Californians are being mobilized to secure a place for a mandatory GE-labeling ballot initiative in time for the November general election.

Let's Be Careful What We Ask For

Do we remember the last time there was a mandatory labeling initiative in the Golden State? The year was 1986. That was when “The Safe Drinking Water and Toxic Enforcement Act” was passed into law via a direct voter initiative.

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.

In addition to providing a disgraceful “gravy train” for unscrupulous consumers and avaricious attorneys, it does nothing to truly help consumers as its labeling requirements make it seem that virtually every product a consumer sees, walks on, sits on, wears, consumes or somehow comes in contact with is carcinogenic. It becomes the state government version of a student with bad study habits who yellow-highlights 99 percent of the text in a chapter as a test preparation, which of course is the same as not highlighting anything.

Let's Think It Through First

So the cautionary here is: We must be careful what we ask for, because if we don’t think through the proposed pieces of legislation downstream to the level of roll-out, regulation and enforcement, and how they will affect the labeling of food supplements and other functional or fortified consumables, then we might well be in for a surprise.

For example, it is known that between 65 to 72 percent of corn in the U.S. in GE (some estimates have this as 88 percent), in addition to 94 percent of soy, 95 percent of sugar beets and over 90 percent of canola (rapeseed). Not only that, but 75 percent of wheat farmers are interested in “going GE” and over 30 percent of riceland has already been contaminated by herbicide-resistant GE rice.

In fact, on a global scale, over the past 15 years more than 2.47 million acres (an area larger than China and the U.S. combined) have been planted with GE crops.

“By anyone’s reckoning, it’s a fast-moving train,” wrote Cookson Beecher of Food Safety News on January 27^th. “Biotech crop cultivation jumped 87-fold between 1996 and 2010, making genetically engineered crops the fastest-adopted crop technology in the history of modern agriculture.”

Let's Support Non-GE From The Ground Up

So, in a practical sense, if we don’t support market changes from the ground up, we may hurt some of the same health-food companies we are trying to help. For example, if only 6 percent of soy acreage is non-GE, there may not be a sufficient supply to meet the demand of consumers who are looking for GMO-free soy protein isolate powder at their local store.

In addition to issues of a nearly non-existent supply, there are also important price considerations for consumers and stakeholders to consider. According to chef Eric Ripert as quoted by FoodNavigator-USA.com, if people want to solely eat non-GMO, “they need to increase their food budgets---and prioritize their spending on food over luxuries, such as the latest iPhone.” He also suggested that people could consume smaller portions.

So if we are going to encourage that producers shun 65 to 95 percent of ingredients on the market, what mechanisms are we going to campaign for to increase investment in sustainable, GMO-free cropland? It takes over 3 years to convert from non-organic to organic, and organic farms do not currently receive USDA subsidies. That needs to change.

We need to generate the political will in Washington and Maryland to make sure that attractive subsidies, interest-free loans, equipment discounts and tax breaks are offered to farmers for converting their farms to organic and for new, family farmers to get started. This must be supported by consumers and by the food and food supplement producers who can, and should, commit to sourcing their ingredients with suppliers who work with these family farms.

And consumers must be made aware of the importance of purchasing products made with these ingredients while keeping in mind that it will take some years for the market and the products to catch up to the demand, and to be patient with companies who are committed to increasing their percentage of non-GE ingredients each year in line with the ever-increasing supply of those ingredients.

Gormley Files Take-Away: If we support the market of and for non-GMO this way, organically if you will, we will reduce or eliminate the economic incentives for agri-business to take over the last-remaining cropland and will encourage a staged, gradual conversion of farmland to sustainable, non-GMO crops in a way that helps family farmers, helps suppliers, helps food supplement manufacturers, helps health-food retailers and helps consumers---all without devastating supply or retail prices, collapsing markets and disappointing consumers.

The FDA’s Double-Barreled Shotgun Aimed at Dietary Supplements

By James J. Gormley

The Food and Drug Administration (FDA) plans to publish a proposed rule to revise the Nutrition Facts panel and related rules by the end of 2012.

According to Elaine Watson in Nutraingredients-usa.com, the FDA said it is “expected to look at serving sizes, daily values, adjustments to label formats and additional nutrient declarations, all of which have the potential to cause controversy.”

For example, if the FDA proposes that daily values be based on Estimated Average Requirements (EARs) instead of Recommended Dietary Allowances (RDAs) or Daily Reference Values (DVRs), the published dosage needed to achieve 100 percent of your daily value would drop dramatically, since EARs are significantly lower than are RDAs.

 
In essence, consumers might believe they are getting enough or a high-potency level of certain nutrients and forego purchasing or buying dietary supplements.

Suppliers of the country’s National School Lunch Program would probably be overjoyed since they could provide less nutritious foods to our kids and still “honor” their USDA contracts.

This new food-labeling scheme is reminiscent of the nutrient potency-labeling shenanigans that  preceded the Proxmire Vitamin Bill battle, albeit, in this case, attempting to dumb down foods while making them appear to  be more nutritious.

As Steve Mister and John Hathcock PhD (from the Council for Responsible Nutrition) wrote:

"In the early 1970s, FDA proposed to restrict the potency of vitamins and minerals in supplements to 150 percent of the Recommended Dietary Allowance (RDA); levels above that would automatically redefine a supplement as a drug and require the agency’s premarket approval. FDA ignored the fact that even some unfortified conventional foods can contain many multiples of the RDA for certain nutrients (e.g., vitamin B12 in liver) and thus be far more ‘potent’ than the vitamin supplements it sought to regulate. Consumers and the industry resisted, and Congress passed Section 411 (Rogers-Proxmire Amendment) to the Food, Drug and Cosmetic Act (FDCA), which specifies that FDA may not classify a supplement as a drug solely on the basis of potency."

The NDI Draft Guidance is engineered to gut, through misinterpretation, many of the most important features of the Dietary Supplement Health and Education Act of 1994 (1994), a law that was partly stimulated by FDA attempts to regulate dietary supplements as food additives, as Mister and Hathcock recently wrote in Nutritional Outlook magazine:

"Thwarted in that effort to call supplements unapproved new drugs [prior to Proxmire], FDA next attempted to classify dietary supplements as unapproved new food additives, thereby imposing on particular dietary ingredients the same requirements for premarket approval as applied to chemicals that were added to food for non-nutritive reasons.  [ ...] Congress then passed DSHEA, which states that dietary supplements shall not be regulated as food additives."

If the NDI Draft Guidance were to be finalized as written, and enforced along the same lines, many of the innovative dietary supplement products consumers use and rely on today would go the way of the dodo bird.
 
The Gormley Files Takeaway: Via two very different tacks, the FDA is attempting to overtly (in the case of the NDI Draft Guidance) and covertly (in the case of the food labeling scheme) roll back or undermine, respectively, the two biggest health-food-industry and consumer victories ever won against the FDA.