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:

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"

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.

NHRI Symposium Heralds A New Era for Dietary Supplements

 By James J. Gormley

The ballroom was packed at the Natural Health Research Institute (NHRI) 6^th Annual Scientific Symposium in Schaumburg, Illinois on October 28^th, as well it should have been not only considering the event title, which was “Cutting Healthcare Costs Through Prevention: Measuring the Efficacy, Safety, and Cost Savings of Dietary Supplements,” but also given the stellar lineup of world-class experts.

The speakers were:

• Meg Jordan, PhD, RN, Department Chair and Professor of Integrative Health Studies at the California Institute of Integral Studies, and Director of Integrative Practice at the Health Medicine Institute;
• Mark Blumenthal, Founder and Executive Director of the American Botanical Council (ABC) and Founding Member of the American Herbal Products Association (AHPA)
• Allen Dobson, PhD, Health Economist and President of Dobson DaVanzo and Associates;
• Artemis Simopoulos, MD, Founder and President of the Center for Genetics, Nutrition and Health; and
• Russell Jaffe, MD, PhD, Fellow of the Health Studies Collegium and Founder of PERQUE.

Meg Jordan

Dr. Jordan, whose presentation was entitled “Let Sanity Reign: The Undeniable Health-Wealth Connection for a Happier, Healthier Society,” electrified the audience with what could have been an indictment of how unhealthy the U.S. is but, instead, pointed the ways we can build a well-being society that takes into account: spirituality, nutrition-food, physical health, social belonging, intimacy and love, financial well-being and occupation-livelihood.

Mark Blumenthal

Mark Blumenthal’s talk was entitled: “Review of Safety and Benefits of Numerous Herbs and Phytomedicinal Dietary Supplements as Demonstrated by Systematic Reviews and Meta-Analyses of Controlled Clinical Trials.” Mr. Blumenthal stunned many attendees with the statement that over a 3-year period, the annual number of herbal medicine papers rose from 739 in 1977 to 6,364 in 2007, most of which were scientific reviews and randomized controlled trials. 

He compared thenumber of studies with the imbalanced, typicaly negative coverage of herbal studies by the mainstream press, especially noticeable in journals that have the highest ratio of pharmaceutical ads, and reviewed the worldwide research on a wide range of medicinal plants.

Allen Dobson

Dr. Dobson’s presentation, “Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements,” reviewed the billions of dollars in healthcare savings that could be achieved by widespread public-health promotion of a number of nutrients (including: calcium with vitamin D; folic acid; omega-3 fats; and lutein with zeaxanthin). Of great interest to many in attendance, he punched a number of holes in the recent multivitamin and vitamin E studies that have achieved such infamy.

Artemis Simopoulos

Dr. Simopoulos’ talk was entitled: “Economic and Health Implications of Changing America’s Oil: The Omega-3 Opportunity.” She outlines the many downsides of the dramatic decrease in omega-3 fat consumption over the past 150 years due to agribusiness and food processing and the reasons why it is utterly imperative that we, as a society, significantly increase our consumption of omega-3 fats and decrease our intake of omega-6 fats.

Dr. Jaffe closed out the presentations with a talk entitled, “Evidence of Savings Through Application of Supplements to Treat Dietary Deficiencies.” He explained how by our correcting essential nutrient deficits relating to diabetes alone could save $135 billion each year, and that supplements for other health areas can save America an additional $50-100 billion annually, all while improving quality of life.

Russ Jaffe

With the event having been organized by the NHRI and the American Nutrition Association, the NHRI is an independent, non-profit organization that supports science-based research on natural health and wellness. It is “committed to informing consumers, scientists, the media, policymakers and legislators about scientific evidence on the efficacy and cost-effectiveness of diet, supplements and a healthy lifestyle in order to improve health and wellness, and reduce disease, around the world.”

Un-Health and the Crisis of Modern Civilization

By James J. Gormley

The modern healthcare crisis is a modern crisis in health, first and foremost, before we even get to access to the question of “care.”

To put this point in perspective, let’s take a step back to late 2010, when British researchers published their examination of nearly 1,000 mummies from ancient Egypt and South America. They found that only a few of these ancients suffered from cancer before they died.

The findings suggest that cancer is not a naturally occurring condition and that modern lifestyles and industrial pollution are the main cause of the 33 percent cancer rate seen in the industrialized world today.

In an October 2010 article in England’s The Telegraph, Dr. Rosalie David, a biomedical Egyptologist said that in ancient times, cancer was extremely rare. “There is nothing in the natural environment that can cause cancer, “ said David. “So it has to be a man-made disease, down to pollution and changes to our diet and lifestyle—cancer appears to be a modern disease created by modern life.”

Since the life expectancy of people in the ancient world was between 25 and 40, we might attribute the low incidence of cancer to the abbreviated lifespan — for example, if certain cancers take 25 to 30 years to develop then it would be expected that the incidence of cancer would be low. That might have held water except for the fact that the main reason the life expectancy estimates were so low was because the infant mortality rates were so high: as high as 30 to 40 percent.

The Discouraging News in 2011

It is known that breast, prostate and colorectal cancers are increased in certain societies, such as the U.S., and it is believed that this is partly due to the fast food consumption in this country in comparison with diets rich in fiber, seafood, lean meat, vegetables and fruit.

In the U.S., breast cancer hit about 208,000 women last year, and it was estimated that 39,840 women would die from it. Colorectal cancer, which is perhaps the type of disease most closely linked to dietary choices, killed 51,370 people in 2010. In terms of incidence, there were 101,700 new cases of colon cancer last year and 39,510 new cases of rectal cancer.

Smoking is linked to cancers of the lung, bladder, mouth, colon, kidney, throat, voice box, esophagus, lip, stomach, cervix, liver and pancreas.

In terms of lung cancer, there were 222,520 new cases in 2010 and approximately 157,300 deaths, making lung cancer the leading cause of cancer death by far, accounting for nearly 30 percent of all deaths from cancer.

In terms of cancers with a strong environmental/industrial exposure component, while asbestos is linked primarily to lung cancer, exposure to benzidine (a chemical found in certain dyes) is mainly associated with bladder cancer.

Diabetes, Heart Disease and the Quality of Life Killers
Moving outside the realm of cancer, type 2 diabetes, of course, is largely caused by lifestyle choices, such as diet and physical activity. Type 2 diabetes, in which the body gradually loses its ability to use and produce insulin, accounts for 90 to 95 percent of cases.

Although diabetes kills less people, nearly 26 million Americans (or nearly 8 percent of the population) have diabetes and 79 million people have pre-diabetes. People with diabetes can experience numerous serious and deadly complications, including heart disease and stroke, blindness, chronic kidney disease, and amputations.

The no. 1 killer, of course, is heart disease. Clocking in at 26.8 million non-institutionalized people with diagnosed heart disease, heart disease kills 616,067 people each year.

What makes matters even worse, 33 percent of adults have hypertension and 15 percent have high cholesterol. Nearly 70 percent of Americans are overweight or obese. Add these factors together, and stroke may be in the picture, which by itself strikes down 135,952 people a year.

Quality of Life Indicators
And the discouraging news is not only about killer diseases; it’s also about conditions that impact our quality of life, that hobble us with all of the pains and aches that can make living feel like a torture.

Arthritis is one such quality-of-life killer, one which is diagnosed in 52.1 million people. Other critical, life-impacting conditions and areas for concern are: osteoporosis (including hip fractures); osteoarthritis and joint pain; and cognitive decline (including memory loss).

The Encouraging News in 2011
According to the U.S. National Institute of Environmental Health Sciences (NIEHS), as many as two-thirds of all cancer cases are linked to environmental causes and have some (or many) risk factors or exposures that can be modified or prevented, respectively.

Environmental factors include: radiation and industrial exposure (e.g., asbestos and pesticides). Lifestyle factors include: cigarette smoking, excessive alcohol consumption, poor diet, lack of exercise, excessive sunlight exposure, and social behaviors that increase exposure to certain viruses (e.g., HPV).

Research bears out the fact that nutritional supplements can provide powerful support in any effort to address the lifestyle part of the risk factors for the diseases of aging.

B Vitamins
In April 2010, Japanese researchers published a landmark study in the journal, Stroke, which examined data from 23,119 men and 35,611 women between the ages of 40 and 79.

After 14 years of follow up, it was found that men who had higher consumption of folic acid and vitamin B-6 experienced significantly fewer deaths from heart failure. Women who consumed higher levels of B vitamins experienced fewer deaths from stroke, heart disease and total cardiovascular death.

Calcium and Vitamin D
A wide body of scientific research supports the use of supplements to prevent fractures, especially hip fractures, in older people. A 2011 review in the journal, Metabolism, confirmed this: “Combined therapy, with calcium and vitamin D, has been shown to reduce hip fracture risk,” especially in frail elderly patients.

Glucosamine and Chondroitin
A two-year follow-up on the GAIT study of glucosamine, chrondroitin sulfate, their combination and the arthritis drug, Celebrex, published in 2010, carried forward the 2008 findings that showed glucosamine provided beneficial effects in knee pain and mobility.

Memory and Cognitive Function
Anyone who has a family member who seems to be overly forgetful, or who may be struggling with signs of age-related cognitive decline, should be familiar with a recent study published in the journal, Alzheimer’s and Dementia, which provides yet additional evidence that older adults who took 900 mg supplements of purified DHA (an omega-3 marine oil) for six months experienced improved memory and overall brain health.

Gormley Take-Away? While politicians and healthcare policy experts debate how best to fix our nation’s healthcare mess, if we focus on health, including responsible self-care using diet, exercise and judicious nutritional supplementation, the mammoth healthcare structure that is built may very well wind up with a significant number of empty beds that were supposed to have patients on them. This is something to work towards, to be sure: a medical complex in search of patients!

Lawmaking and the GAO Report: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?