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The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent

“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.

So it was last week when I saw two websites known for anything but science-based medicine (SBM), namely the quackery-promoting website NaturalNews.com and the quackery apologist blog Vitamin Lawyer Health Freedom Blog promoting a bill that I hadn’t heard of before, namely H.R. 1364, entitled the “Free Speech About Science” (FSAS) Act of 2011. This bill is being touted in all the usual “health freedom” venues as an antidote to what supplement manufacturers apparently see as the “overreach” of the FDA. For example, Ethan A. Huff of NaturalNews.com (where’s Mike Adams, one wonders?) urges his readers to tell Congress to support the Free Speech about Science Act of 2011., while “vitamin lawyer” Ralph Fucetola subtitles his post HR 1364, S.216 and the Struggle for Health and Food Freedom Action Item. So what do these advocates for dubious supplements say?

First, Ethan Huff:

As many NaturalNews readers probably already know, the US Food and Drug Administration (FDA) has severely limited the free speech of practically everyone besides drug companies. Supplement manufacturers, natural food companies, and even produce growers are prohibited from making honest, scientifically-proven health claims about their products, even when such claims are supported by peer-reviewed studies. As a result, millions of Americans are left in the dark about how natural foods, herbs, and supplements can help them prevent and cure disease.

This is where FSAS comes in. If passed, the bill will amend current law to allow growers and manufacturers to freely share honest information about food and supplements with their customers. While the bill will still allow the FDA and the US Federal Trade Commission (FTC) to go after companies that are truly making false claims, the agencies will no longer be able to tyrannize those companies that simply share the truth with the public.

Now, Ralph Fucetola:

Our gripe is aimed not at all those good folk who turn to Congress for protection, but at the Congress-critters who vote to protect us (or not) only to do nothing when the FDA thumbs its collective nose at Congress and the People by ignoring the protective laws Congress has adopted.

Frankly, we thought we had won the battle over being allowed to communicate truthfully about health and food in Congress and in the Supreme Court.

We thought that’s what DSHEA was supposed to have done in 1994 with its Third Party Literature Provisions.

“Communicate truthfully.” You keep using that phrase, Mr. Fucetola. I do not think it means what you think it means. Of course, I suppose Mr. Fucetola could argue that he’s not being as disingenuous as I perceive him to be in that most of the supplement hawkers making health claims for their foods or supplements probably do believe them to be true and therefore are not, strictly speaking, lying. That doesn’t mean that such claims shouldn’t be regulated.

At least Mr. Fucetola is honest enough to point out that the purpose of the DSHEA of 1994 was to permit more—shall we say?—liberal “free speech” by supplement manufacturers and sellers. That “free speech” in practice frequently means “making stuff up.” Of course, many of us here at SBM have been quite critical of the DSHEA of 1994. Although well-intentioned to some extent in trying to clarify different standards for regulation for foods compared to medications, in essence the DSHEA has turned out to be a huge boondoggle that allows supplement manufacturers to label their supplements as “foods” when they are in reality being sold for medical purposes. Even when it takes an even more “liberal” interpretation of the definition of “food” or “nutrient” to make them cover many of the supplements being sold in the U.S. Peter Lipson quite rightly referred to this law as a “travesty of a mockery of a sham,” basically pointing out that sellers of supplements, for example, have a “get out of jail free” card and can make almost whatever claims they want for supplements as long as they include a Quack Miranda warning and keep their claims vague enough. The most famous examples are claims like the ever-infamous claim that a supplement “boosts the immune system” or “promotes detoxification.” Reports from the Government Accounting Office and the Institute of Medicine recommending tighter regulation of dietary supplements have in general come to naught.

The reason such calls have come to naught is because supplement manufacturers have become an increasingly powerful lobbying force and as a result have successfully managed to beat back any serious modifications to the DSHEA. Some of this is due to the increasing popularity of supplements. (A recent survey found that 50% of adults take some form of supplement.) Some of it is also due to the increasing number of pharmaceutical companies manufacturing supplements, a product that allows them to make what they want with very little of that pesky interference from the FDA. Supplements are highly profitable, too, and it doesn’t cost $1 billion to bring a new supplement to market, as it does for many new drugs. As a result certain powerful legislators are in the pockets of the supplement industry. For example, about a year ago, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), the former of whom has received large contributions from supplement manufacturers in his state and the latter of whom is a true believer most responsible for the creation of the National Center for Complementary and Alternative Medicine (NCCAM) beat back an attempt by Senators John McCain (R-AZ) and Byron Dorgan (D-ND) to pass the Dietary Supplement and Safety Act of 2010. This law would have eliminated some of the loopholes in the DSHEA of 1994. At the time John McCain was facing a serious primary challenge to his reelection effort from the Tea Party right and caved because he decided that he couldn’t be perceived as being in favor of more government regulation.

Not surprisingly, the FSAS Act of 2011 (H.R. 1364) was introduced by Representatives Jason Chaffetz (R-UT) and Jared Polis (D-CO). Utah is, as we have seen, Orrin Hatch’s home state and a major center for supplement manufacturing in the U.S. Chaffetz, too, is in the pocket of the Utah supplement industry. Indeed, he is not only a former industry executive but also co-chairman of the Congressional Dietary Supplement Caucus, and his district is one of the biggest producers of dietary supplements in the country, boasting itself as the home of companies such as Nu Skin, Usana, MonaVie, Xango, and Tahitian Noni. As a result, his longstanding activism in promoting supplements and his potential challenge to Orrin Hatch for his Senate seat next year have led to speculation that the supplement industry might be forced to take sides. Meanwhile, other members of the Dietary Supplement Caucus include Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), as well as Representatives Dan Burton (R-IN), Frank Pallone (D-NJ), and—surprise! surprise!—Jared Polis (D-CO). Truly, big pharma may be a potent force in Congress, but “big suppa” is nothing to sneeze at, and it has major bipartisan support. Of course, this is something that advocates such as Huff and Fucetola won’t tell you.

So what does the law propose to do, really? Before I get to that, let’s go back in time a bit for some history.

A BIT OF BACKGROUND

The United States counts among its founding principles freedom and the idea that we don’t like the government telling us what to do. We’ve seen these ideas in conflict with other principles that there is a role for the government in protecting its citizens against fraud and harm that can result from adulterated food or medicines that don’t do what their manufacturers claim they can do. When the U.S. was a mostly agrarian nation with few large cities, the problems that resulted from patent medicines and adulterated food were not as major a problem as they became as more and more Americans poured into metropolises like New York and Chicago. In fact, federal protections against these sorts of fraudulent activities are a relatively recent development in the history of the U.S. Before the 1900s, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals; instead there was a patchwork of state and local laws designed to outlaw unethical practices, such as misrepresenting the ingredients of pharmaceuticals or making claims for them that can’t be backed up.

In the wake of muckraking like Upton Sinclair’s The Jungle, which dramatized the horrific conditions in meatpacking plants and the lack of attention to sanitation, which was part of a confluence of events that pushed Congress to pass the Pure Food and Drug Act of 1906, also known as the Wiley Act after its chief advocate, which resulted in the creation of the Bureau of Chemistry, which later became the Food and Drug Administration. This first incarnation of the FDA was relatively limited in power and mainly concerned with ensuring that food and drugs that were transported across state lines were properly labeled as to content. By the 1930s, however, the weakness of the Food and Drug Act was becoming apparent in the wake of reports of dangerous products that were permissible at the time, including radioactive beverages and worthless “cures” for diabetes and tuberculosis. In 1937, over 100 people died after using a drug formulated with a toxic solvent (diethylene glycol). There was little the feds could do after that; the only way they managed to prosecute the company responsible (Massengill Company) was for mislabeling the product as an “elixir,” which violated the 1906 Pure Food and Drugs Act, which stated that a company could not call a product an “elixir’ if it had no alcohol in it. Massengill paid a minimal fine, and the resulting public outcry resulted in the passage of the Food, Drug, and Cosmetic Act of 1938, which replaced the 1906 statute and greatly tightened up regulations governing the production of food, drugs, and cosmetics in the U.S.

Ever since, those selling dubious non-science-based remedies and advocates promoting “alternative” medicine, “complementary and alternative medicine” (CAM), and, more recently “integrative medicine” (IM) have been in conflict with laws that, whatever their shortcomings, demand testing for safety and efficacy. Of course, this conflict was to some extent embedded within the law itself, which regulates and protects homeopathic preparations, using the Homeopathic Pharmacopoeia of the United States as an official drug compendium.

Be that as it may, in the early 1990s, Congress was considering bills that would have increased the regulatory powers of the FDA and FTC over supplements in the wake of high profile cases of harm caused by unregulated dietary supplements. As a result, the health food industry and supplement manufacturers rallied its troops to stop such legislation with claims that Congress would take away citizens’ rights to buy vitamins and that many businesses would go under as a result fo this legislation. The end result was that Congress acted, but not to tighten up regulation. Rather, it defined “dietary supplements” as a separate regulatory category and made that regulation quite lax. Stephen Barrett of Quackwatch characterized its effect and intent thusly:

The Food, Drug, and Cosmetic Act defines “drug” as any article (except devices) “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” These words permit the FDA to stop the marketing of products with unsubstantiated “drug” claims on their labels.

To evade the law’s intent, the supplement industry is organized to ensure that the public learns of “medicinal” uses that are not stated on product labels. This is done mainly by promoting the ingredients of the products through books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet.

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

Given that the FDA is already chronically underfunded for the tasks it’s expected to carry out, for the most part, the FDA does little to regulate supplements because it has its hands full regulating pharmaceutical drugs. Perhaps the most insidious part of the DSHEA is that, while it allows so-called structure-function support claims (i.e., “boosts the immune system”) or claims based on nutritional support, it does not permit “drug claims.” The problem is, what constitutes a “drug claim” compared to a “structure-function” claim remains fairly vague, even after the FDA issued rules in 2000 that banned explicit claims that a product treats or prevents disease, there’s still considerable wiggle room, and enforcement isn’t exactly what we would call robust. In the meantime, supplement hawkers have cleverly used the Internet to circulate claims for these products that aren’t necessarily on the packages or in the package inserts.

H.R. 1364: The Free Speech about Science Act of 2011

In discussing H.R. 1364, it’s hard not to note how Orwellian the title of the act is. It’s very much of a piece with the term “health freedom.” After all, what red-blooded American could be against “free speech”? What are you, against the First Amendment or something? Are you un-American? That’s pretty much the tenor of the arguments being used to support this bill, whose full text can be found at The Library of Congress Thomas. In fact that sort of argument is right there, in the text of the bill:

The Congress finds the following:

(1) Federal regulators have forbidden–
(A) cherry growers and food producers to cite independent and respected scientific research on their produce that references health benefits; and
(B) a variety of dietary supplement makers to cite independent scientific research on health benefits from supplements from respected, peer-reviewed scientific journals.

(2) Americans want access and have a right to access legitimate scientific information about foods and dietary supplements to ensure informed decisions about diet and health care. While the American public is inundated daily with advertisements about prescription drugs for health conditions, many of which could be prevented through lifestyle changes, proper nutrition, and informed use of dietary supplements, Americans are denied access to the very information that assists in making informed lifestyle and health care decisions.

(3) Providing access to scientific information promotes self-responsibility, thereby empowering Americans to exercise independent judgment in caring for themselves and ultimately reducing health care costs and improving quality of life.

(4) The United States has a long commitment to the free dissemination of scientific research with the exception of limited extreme situations for national security. This commitment goes back to the First Amendment to the Constitution and has contributed vitally to the Nation’s economic progress.

Proponents like Huff cite cases that, on the surface at least, sound reasonable. For example, Huff makes a lot of hay over the case of Diamond Nuts, which made claims that its walnuts could lower cholesterol, protect against heart disease, lower the risk of stroke, inhibit tumor growth, and a number of other disease claims. Huff argues that these claims are “based entirely on results from legitimate scientific studies.” Of course I could argue that claims for the efficacy of homeopathy, reiki, and “energy healing” quackery could similarly be “based entirely on the results of scientific studies,” as well. That doesn’t make them any less quackery. In the case of walnuts, as you might expect, things are a bit more complicated. Basically, Diamond Nuts made its claim based on studies suggesting that omega-3 fatty acids have been suggested to do these things, and its walnuts contain omega-3 fatty acids. The FDA replied:

There is not sufficient evidence to identify a biologically active substance in walnuts that reduces the risk of CHD. Therefore, the above statement is an unauthorized health claim.

As foodsafeguru put it:

Nuts are good for you and cut out the unnecessary claims that could lead consumers to think that if they ate enough walnuts, their CHD would go away.

US Food Safety understands that nuts have had a bad wrap since last year, but say what walnuts really do for you instead of guilding the lilly and deceiving consumers.

Another case that Huff cites dates back to 2005, when the FDA sent certified letters of warning to 29 cherry manufacturers (most of them right here in Michigan!) for making undue health claims for their cherries, complaining that “such claims included the truthful statement that cherries help reduce inflammation, which they absolutely do.” Unfortunately, it was much more than that, as this typical FDA warning letter to one of the cherry growers demonstrates. In it are documented claims by Amon Orchards that cherries prevent cancer. Not only that, but, according to Amon Orchards, they also contain a “natural chemical that not only flushes cancer-causing substances out of the body, but also helps stunt the growth of cancerous cells” and “anti-inflammatory pain relievers 10 times stronger than aspirin or ibuprofen,” that can “relieve aches and pains.” Even a cherry grower in Michigan basically admits that cherry growers were making health claims about its cherries when he writes on his website:

The FDA does not want the cherry industry to tell people that recent studies show that tart cherries contain substances that are potentially 10 times stronger than aspirin or ibuprofen for relieving pain. It does not want the public to know that substances in tart cherries may kill cancer cells and prevent cancer. It makes no difference whether these statements are true. What’s important is that the public not be told that a natural substance (tart cherries) has been shown to work as well as or better than an unnatural one (ibuprofen). Only drugs, according to the FDA’s legal doctrine, can prevent, treat, mitigate, or cure disease.

This same cherry grower then goes on to list even more claimed health benefits of cherries. The problem, of course, is the same problem as with the walnuts in that most of these studies are either preclinical studies, studies using compounds isolated from natural sources, or otherwise studies whose direct applicability to health claims for the food in question are tenuous at best. None of this has stopped the health freedom movement from making histrionic claims about an overbearing FDA, perhaps the most ridiculous example of which is Bill Sardi’s assertion that the FDA had “blood on its hands” for going after the cherry growers. Also, it’s not just the little guys who get into trouble with these claims. Food giant General Mills recently got into the same sort of trouble with the FDA due to its claims that Cheerios can lower cholesterol.

I once coined a term for what the anti-vaccine movement wants parents to hear when it calls for “informing” parents: “misinformed consent.” I called it misinformed consent because the anti-vaccine movement, under the guise of informed consent, exaggerates the risks of vaccines while downplaying the benefits, all with the intent to persuade parents not to vaccinate while disingenuously claiming that that is not what they are about. What supporters of the FSAS Act of 2011 are doing is very similar in my opinion; they are trying to take away barriers to misinforming potential customers, exaggerating the potential benefits of their supplements while downplaying potential risks, all in the name of making a sale. Unlike the anti-vaccine movement, however, it’s not just ideology (in the case of anti-vaccine activists, an unshakable belief that vaccines cause autism and all sorts of other problems), but profit as well that appears to drive them. To that end, from my perspective I see them seeking the freedom to distort the medical literature to exaggerate the health benefits of their products and even make claims that they can prevent or treat disease, as the cherry growers and Diamond Nuts appear to have done.

So what would H.R. 1364 mean if it were actually passed? I must admit that I’m somewhat torn on this. On the one hand, to some extent the FDA letters do on the surface seem a bit ridiculous, at least in the case of walnuts and cherries. They even appear a bit paternalistic. On the other hand, notice how all the arguments for H.R. 1364 made by its proponents are based on examples like cherries and walnuts, rather than actual manufactured supplements. There’s a reason for that. The purpose behind this law really does appear to have very little to do with freedom of speech. Rather, its purpose appears to be to neuter the FDA with respect to claims by food and supplement manufacturers to treat diseases. Remember, under the DSHEA, supplements are considered more akin to food than medicine. In other words, for purposes of the FSAS Act, cherries, walnuts, and Cheerios function as a Trojan horse that, once brought into the protected walls of the FDA through H.R. 1364 (if made law), would soon disgorge its contents of all manner of supplement manufacturers making direct health claims to treat and cure disease based on the flimsiest of “legitimate medical evidence.” Don’t believe me? Check out this “white paper” on the FSAS Act from the Alliance for Natural Health:

A few critics will accept that there is a revolution taking place linking nutrition directly to health. But they think that we should just focus on food, not on food extracts and supplements. There are at least two problems with this. First, studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.

Second, nutrients sometimes have to be concentrated to have full therapeutic benefit. No one can get enough Vit D from food. We also get it from exposure to sunlight on our skin, but use of sun lotion prevents it. Food supplements often make sense either for routine day to day use in lower potencies or as higher potency therapies devised and supervised by doctors.

See the Trojan horse? The FSAS Act would remove the barriers to health claims made for foods like cherries or walnuts but in doing so it would also at the same time remove the barriers for the same sorts of claims for supplements that are concentrated extracts of food ingredients. Even the existing weak protections of the DSHEA would be gutted. No wonder practically every woo-supporting blogger is supporting the bill. No wonder the Association of American Physicians and Surgeons is supporting H.R. 1364 on its Take Back Medicine blog, all in concert with the Alliance for Natural Health and General Bert Stubblebines’ Natural Solutions Foundation, the latter of which is pushing an “action item” for the bill. If that doesn’t make the picture clear enough for you, look at SECTION 4(c)(2), where the “burden of proof” regarding charges of false advertising is shifted from the seller making the claim to the FDA:

In any proceeding under section 13, the burden of proof shall be on the Commission to establish that the literature being disseminated is not legitimate scientific research.

In other words, supplement manufacturers could claim anything they want, as long as they cite a scientific paper or two, and it would be up to the FDA to prove that those scientific papers aren’t “legitimate research.” What about cases where supplement manufacturers misrepresent legitimate scientific research, as the cherry growers did when they represented in vitro experiments as being evidence that cherries provide the health effects claimed in humans?

The problem, of course, is the current law and how supplements are defined. Right now, “nutritional supplements” can include substances that are not by any stretch of the imagination scientifically supported nutrients, vitamins, or minerals that are needed as part of food. As I cited above, a logical definition of “dietary supplement” would be something that really is a dietary supplement, a nutrient. That’s not how the DSHEA defines “dietary supplement,” and as a result the FDA is forced to treat foods like walnuts and cherries exactly the same as it treats melatonin capsules, vitamin D supplements, and even a “supplement” that is in reality not necessary in the diet at all and in fact started its life as industrial chelators before being touted as a treatment for autism. True, the FDA did shoot Haley down, but the very fact that he got away with promoting his chemical as a “supplement” to treat autism for long points to the problem with current law. Moreover, under the current law, the FDA has no choice but to treat health claims for Boyd Haley’s OSR#1 (the aforementioned industrial chelator) the same way it treats health claims for walnuts and cherries and other products that are undeniably food. In fact, if the DSHEA were amended to eliminate that problem and to make a distinction between actual food and the various supplements manufacturers make that have only a tenuous connection with nutrition and food, I might even be able to support something like the FSAS act—but only if it were renamed the Free Speech About Food Act and meant it.

It won’t be, though. Supplement manufacturers benefit too much from the current law, which equates supplements, no matter how removed from having any role in the diet they might be, and food. Even though the FSAS Act of 2011 would be the worst of both worlds (supplements equalling “food” plus the ability of supplement hawkers to say anything they want to as long as they can point to a scientific study or two—which, by the way, they could fund just as pharmaceutical companies do), Orrin Hatch, Jason Chaffetz, Jared Polis, Dan Burton, Tom Harkin, and the many other political allies of the supplement industry, aided and abetted by the AAPS, the ANH, and many other “health freedom” organizations, will do their best to see to that.

Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

Leave a Comment (38) ↓

38 thoughts on “The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent

  1. CW says:

    “…are prohibited from making honest, scientifically-proven health claims about their products, even when such claims are supported by peer-reviewed studies.”

    Yeah, well “Transgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity” by Alan Sokal was peer-reviewed too.

  2. David Gorski says:

    Indeed.

    And so was Wakefield’s 1998 Lancet paper and his more recent monkey study.

  3. Scott says:

    The position they seem to be claiming is that “indirectly supported by one peer-reviewed study” = “correct.” Which, as anyone at all familiar with the scientific process knows, is not right.

  4. qetzal says:

    I’d have at least some sympathy for the free speech arguments if the speech in question was true. According to the FDA warning letter linked in Dr. Gorski’s post, Amon Orchards was claiming the following on their web site:

    “Breakthrough News: Cherries Prevent Cancer!”
    “Sweet, juicy, delicious cherries are in season now through August, and research shows they can help you:
    “Safeguard against cancer. “

    Unless Amon knows of clinical trial data showing that eating cherries prevents cancer, those claims are lies.

    Similary, Bill Sardi claims that:

    It began in 1999 when a peer-reviewed report in the Journal of Natural Products, published by the American Chemical Society, the world’s largest scientific society, concluded that tart cherries may relieve pain better than aspirin and many other anti-inflammatory drugs. It turns out that consumption of about 20 cherries reduces inflammation in a similar manner as aspirin or Cox-2 inhibiting drugs without the lethal side effects of gastric bleeding or vitamin depletion associated with these drugs. The molecules in cherries, called anthocyanins, work to reduce inflammation at ten times less dosage than aspirin. [Journal Natural Products 1999 Feb; 62(2): 294—6]

    More untruths. The abstract for that publication reads, in its entirety (emphasis added):

    The anthocyanins (1-3) and cyanidin isolated from tart cherries exhibited in vitro antioxidant and antiinflammatory activities comparable to commercial products. The inhibition of lipid peroxidation of anthocyanins 1-3 and their aglycon, cyanidin, were 39, 70, 75, and 57%, respectively, at 2-mM concentrations. The antioxidant activities of 1-3 and cyanidin were comparable to the antioxidant activities of tert-butylhydroquinone and butylated hydroxytoluene and superior to vitamin E at 2-mM concentrations. In the antiinflammatory assay, cyanidin gave IC50 values of 90 and 60 mM, respectively, for prostaglandin H endoperoxide synthase-1 and prostaglandin H endoperoxide synthase-2 enzymes.

    Notice these were in vitro studies using isolated enzymes. Not even whole cells, and certainly nothing to show that “consumption of about 20 cherries” reduces inflammation in people (or even animals).

    When a non-scientist is trying to summarize scientific results, I can forgive a certain amount of misunderstanding or error. But when someone takes an in vitro study of chemicals isolated from cherries, and claims it as evidence that eating cherries reduces inflammation in people without side effects, that’s not just a misunderstanding or honest error. It’s a lie.

  5. Scott says:

    It’s also the sort of subtle distinction that necessitates a careful examination of the evidence for such a claim. Which is why we have the FDA, since the average consumer doesn’t have the necessary expertise to properly evaluate the evidence.

    All the same arguments can be made for anything that comes out of (for example) Merck’s labs. So if they REALLY believed that this was a “free speech” issue, they’d be lobbying to grant Big Pharma the same freedoms.

  6. qetzal says:

    So if they REALLY believed that this was a “free speech” issue, they’d be lobbying to grant Big Pharma the same freedoms.

    Right. They point to all the direct-to-consumer drug ads and whine about how unfair it is that they can’t make claims too. They just conveniently omit the fact that pharma’s claims have been verified and approved by FDA.

    FDA’s oversight is far from perfect, but on the whole it forces pharma to make only factually true claims, and to provide reasonably complete disclosure about a drug. That sort of oversight is the last thing these folks want. To them, free speach means some marketing guy should be able to claim that “Cherries Prevent Cancer” based on one small study of isolated chemicals in a test tube.

  7. Angora Rabbit says:

    Great article and thanks for alerting us so we can tell our representatives to vote no and keep it bottled in committee.

    I’m not sure that the researchers aren’t sometimes just as bad as the mfcrs. In my many years of reviewing NIH proposals, I’ve read too many proposals to fund research showing that Nutriceutical X will cure/attenuate Disease Y. Far too often the PI has no idea about bioavailability, metabolism, or other pharmacokinetic issues. A simple back-of-the-envelope calculation shows their test-tube concentrations aren’t achievable in vivo, even if the “active” chemical can be purified instead of administered in the food or extract.

    Like the Mfcrs, a lot of those proposals are driven by $$. The PI has applied for a patent on Nutriceutical X. Or some big farming donor endows a chair or a research fund to promote his food and thereby increase his sales. It’s sad, and yes I’m cynical about it.

  8. BobbyG says:

    The money shot:

    SEC. 4. FALSE ADVERTISING.

    (a) Dissemination of Legitimate Scientific Research in Connection With Sale or Distribution of Food or Dietary Supplement- Section 12 of the Federal Trade Commission Act (15 U.S.C. 52) is amended by adding at the end the following:

    (c)(1) The dissemination of legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers shall not be determined to be false advertising by virtue of the fact that the research does not directly correlate to the type of food or dietary supplement (including any component thereof) being sold or distributed if the dissemination includes a clear disclosure that the research does not directly correlate to such type of food or dietary supplement.

    (2) In any proceeding under section 13, the burden of proof shall be on the Commission to establish that the literature being disseminated is not legitimate scientific research.’.
    ___

    4(c)(2) “burden of proof”

    Wow.

  9. aeauooo says:

    “…studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.”

    I’ve been told by a number of CAM advocates that I should “educate” myself by Googling this – spare me!

    Does anyone have suggestions where I can find information so that I can make an informed response?

    Thanks.

  10. aeauooo says:

    Incidentally, the same people insisting that I “educate” myself do not have any idea what Dan Brown meant by “‘Google’ is not a synonym for ‘research’,” and believe that NHANES data (along with anything else from a .gov source) is government propaganda.

    I know, why bother?

  11. qetzal says:

    @ aeauooo,

    I found this study from 2005, which does suggest a modest decline for 6 nutrients (but not for 7 others) over the period of 1950-1999. Even where declines were apparent, they weren’t very large. Riboflavin appeared to deline by 38% during the period, but all the others changed by less than 20%.

    I tried looking (briefly) for related citations on PubMed, but didn’t immediately see any others that seemed relevant.

    If that’s the kind of decline being claimed, I have to say “so what?” I expect that during the same period, our portion sizes have increased more than enough to make up for any decreased nutrient content.

  12. aeauooo says:

    @qetzal

    Thanks! I didn’t find anything on PubMed or Google Scholar either.

  13. Jeff says:

    The problem, of course, is the current law and how supplements are defined. Right now, “nutritional supplements” can include substances that are not by any stretch of the imagination scientifically supported nutrients, vitamins, or minerals that are needed as part of food.

    I like the FDA’s inclusive definition of a dietary supplement. It allows maximum consumer access to naturally-occurring substances which have a history of safe use. The FDA can quickly remove any product causing harmful side-effects through its (recently aquired) mandatory recall authority.

    Why wouldn’t melatonin be classified as a nutrient? It’s produced by the human body and can be found in many plants and animals. Melatonin has been the subject of extensive research – its pharmacologic properties include the abilty to provide protection from ionizing radiation:
    http://www.ncbi.nlm.nih.gov/pubmed/15156066

    1. Harriet Hall says:

      @ Jeff,

      Whoa!
      1. A history of safe use doesn’t mean something is safe – it might be safe or it might be inadequately studied to determine whether it is safe or not. History is jam packed with things that seemed to be safe with early experience but later were found to harm.
      2. The FDA can’t easily remove a product causing harmful side effects: it requires solid evidence of harm that can be difficult to verify, it is difficult, time-and paper-consuming, controversial, gets challenged by the courts. The FDA regularly removes pharmaceuticals that have been shown to cause harmful side effects, but how often do you think the FDA has succeeded in removing supplements? Look at how difficult it was for them to remove ephedra even after a celebrity death.
      3. By “nutrient” we don’t mean everything capable of being ingested and digested, we don’t mean everything that is produced by the body or by plants and animals; the very quote you cited specifies substances that are “needed” as part of food.
      4. Radiation? The evidence is general evidence for antioxidant action in vitro. I don’t think there is any evidence of clinical benefit in human studies to reduce actual effects from radiation.

  14. Jeff says:

    Dr. Hall,

    The recently passed Food Safety Modernization Act gives the FDA, for the first time, mandatory recall authority for all food products (including supplements):

    http://leavittpartners.com/uncategorized/food-safety-modernization-act-key-provisions-3/#Mandatory recall

    Currently the FDA does not have MRA for pharmaceuticals. If harmful drug side-effects become a problem the agency simply asks the company for a voluntary recall.

    There are two melatonin studies showing a reduction of DNA damage in human blood samples exposed to radiation (pubmed/9541644, pubmed/9008723). Naturally human clinical trials would be impractical – who would volunteer?

  15. lizditz says:

    That whole “depleted soil” thing….jogged my memory

    Now plants have a very interesting part to play in colloidal minerals. Remember we said that plants cannot create minerals. If they are not in the soil, plants can’t make them. Remember US Senate document 264 says they are not in the soil anymore….Metallic minerals are taken up by plants when they’re in the soil. Plants convert them in their tissues to colloidal minerals and this is how we store minerals in our body. This is how we use minerals in our body. This is how we transport minerals from the storage place to the site of use, in the colloidal form. Well, our plants, our crops don’t have much in the way of colloidal minerals in them because we don’t have any metallic minerals in our soil. …

    Yep, the sales pitch from Joel Wallach, Dead Doctors Don’t Lie (popular in the 1990s, IIRC)

    Quackwatch on Wallach & colloidial minerals, 1998::

    The cited quotation is genuine, but it did not, as colloidal mineral promoters usually imply, arise from a government research study. In fact, it is merely a reprint of a baseless opinion piece that originally appeared in the June 1936 issue of Cosmopolitan magazine and was placed into the Congressional record by a Florida senator [5]. Most Americans are not slowly starving to death or dying from mineral deficiency.

    and:

    Ten of thousands of Americans are currently serving as unwitting subjects in an undocumented test of their safety. Some scientists are especially concerned about the widespread administration of these products to children. Unfortunately, since colloidal minerals are classified as dietary supplements, no safety or efficacy testing was required before they were marketed. Action to prohibit their sale can only be taken if it is demonstrated that the products are adulterated (i.e., toxic), misbranded, or that specific medical treatment claims have been made for them. The first colloidal mineral supplement sold commercially, which Rockland Corporation introduced in 1984, was banned because of its toxicity [47]. Called “Body Toddy,” it was reformulated, renamed “Mineral Toddy,” and currently is marketed as “Body Booster.”

    This all should sound sadly familiar to regular readers.

  16. Harriet Hall says:

    @ Jeff,

    From the FDA website: “The new legislation gave FDA authority to require a mandatory recall of product for which there is a reasonable probability that the product is adulterated or misbranded and will cause a serious adverse health consequence or death upon enactment. The responsible party must be given an opportunity to voluntarily cease distribution and recall the affected product.”

    Adulterated or misbranded. On the other hand, the FDA can withdraw approval for prescription drugs found to be harmful. A different matter entirely. It is misleading to say that the FDA “simply asks the company for a voluntary recall.”

    Who would volunteer for clinical radiation studies? There are plenty of people who have been irradiated more than others by radiation therapy, occupational exposures, multiple diagnostic procedures, etc. I don’t see why a clinical study couldn’t be done. Reduction of DNA damage in blood cells in vitro may not correspond to meaningful in vivo outcomes.

  17. What the heck, we’ve already had free speech about mortgages, where businesses could tell folks that an interest-only variable rate mortgage with a monthly payments that is 1/2 of the homeowner’s salary is a safe way to buy the home of their dreams. Why not have the same kind of free speech about health?

    Smoke a pack a day, eat a handful of cherries a day. You should be safe from cancer.

    Sometimes, I think the politician’s believe the only good consumer is either under educated, under informed, fiscally irresponsible or dead. They’re just doing their best to make everyone a good consumer.

  18. aeauooo says:

    @ lizditz

    Cosmo! I love it.

    There are people on the health forum to which I am a despised contributor who still cite Dead Doctors Don’t Lie.

  19. ebohlman says:

    Jeff: If the linear non-threshold hypothesis for the effects of ionizing radiation is correct, then even normal background radiation causes some damage in most people and if a substance was truly radioprotective, subjects taking it would show better outcomes (e.g. lower cancer rates) than those taking a placebo.

  20. Scott says:

    @ Jeff:

    Let’s also note that without the requirement to do careful safety and efficacy studies prior to sale, the theoretical ability to order recalls means virtually nothing. The FDA doesn’t have the resources to do those careful studies for every so-called “supplement” on the market, and without them it’s impossible to tell whether something is harmful or useless (the rare large and dramatic effects excepted).

    The fundamental problem with your position is this. Without the safety and efficacy studies required of pharmaceuticals, there is no way to really know whether the “supplement” is safe and effective. And that includes the manufacturer. So what you’re really advocating is that “supplement” manufacturers be allowed to market and sell products where even the sellers have no idea whether they actually have the claimed effects, or are safe to use.

    It is simply not logically supportable to reach any conclusion other than that “supplements” are drugs and should be regulated as such.

    Note that I’ve been quoting “supplements.” That’s because actual nutrients are a different story; it’s well established that (for instance) iron is needed in the diet, and if the diet doesn’t provide sufficient iron, supplementation can work. But that’s an entirely different sort of thing than most of the “supplements” out there, which are sold with express health claims, and only make vague gestures in the direction of claiming to be something missing from the diet.

  21. Maz says:

    Here is the govtrack site for the bill:

    http://www.govtrack.us/congress/bill.xpd?bill=h112-1364

    It currently has no organizations on the record opposing it — is this because it’s relatively unknown or because it’s a toxic political issue to oppose?

    Check and see if any of your representatives are on the Energy and Commerce Committee!

    Mine aren’t so I posted this on POPVOX:

    “I oppose H.R. 1364: Free Speech About Science Act of 2011 because…

    This bill allows for the unregulated dissemination of preliminary scientific data to masquerade as proven facts. I work in the research industry, and I assure you that the vast majority of all experiments in science don’t pan out. It is for this reason that the FDA currently requires that new products be proven and that any claims made be tested. This bill would gut the FDA’s ability to regulate health claims by untested products.

    If a company thinks their product can improve health and well being, let them prove it before they sell it — let’s not wait until someone dies to check out these potentially dangerous substances.

    Please, don’t support this bill — consumers trust that “health products” on the shelves of stores are both safe and well-tested. This bill would put both of those assumptions in danger.”

  22. Jann Bellamy says:

    Per Mr. Huff: “As many NaturalNews readers probably already know, the US Food and Drug Administration (FDA) has severely limited the free speech of practically everyone besides drug companies.”

    Perhaps Mr. Huff is unaware that there is already a remedy for the FDA’s alleged limitation on free speech as guaranteed by the First Amendment. That remedy is the First Amendment. If Big Suppa wants to challenge what FDA is doing an unconstitutional limitation on its right to free (commercial) speech it can, as it has done before, go into court and challenge the DSHEA, the regulations enacted thereunder by the FDA and/or specific actions taken by the FDA pursuant to the law and regs.

  23. JPZ says:

    I was a bit surprised at how little of this article dealt with science and product health claims (although I did find the discussion of all the side issues informative).

    Responsible companies do good research to support health-related claims on their products. Irresponsible companies misquote research or make invalid health-related claims on their products. But, thanks to our current regulations, both end up making the same structure-function claim. If a responsible company could make accurate, stronger claims with legitimate science, then they could more easily distinguish their products from unsupported ones. The Cheerios claim was based on a legitimate clinical trial. The FDA did not go after them for bad science – it was for how the label looked. HR 1364 could be improved (especially in enforcement), and I think it is more productive to work toward improvement rather than attacking the bill and those associated with it.

    We need new legislation to clean up our current quagmire of terribly verbose approved health claims, lawsuit-derived qualified health claims, and dowright deceptive structure-function claims. The FDA can’t change it, only Congress can do it. I’ve gone into more details about this health-related claim mess on my blog: http://www.nutrition-industry.blogspot.com.

  24. JPZ says:

    @ Scott

    You are right about dietary supplement efficacy testing, but safety testing is a little different.

    Dietary supplement ingredients are subject to safety testing in order to file a Generally Recognized as Safe (GRAS) or New Dietary Ingredient (NDI) petition with the FDA. The petitions I have filed have included GLP animal tox data and extensive human use documentation. If you can prove that a dietary supplement ingredient was in the US market before 1994, it is grandfathered in as safe (scary, I know). Then again, how many drug ingredients were grandfathered into the market without safety or efficacy testing (e.g. 1938 and 1962 grandfather clauses).

  25. Scott says:

    And yet, such things as OSR#1 get sold without any safety testing of any kind. Eventually got pulled, but it’s a glaring indication that, whatever might theoretically be required, in practice it isn’t.

  26. Jeff says:

    Scott,

    OSR#1 was never a legal product. The FDA rejected Boyd Haley’s NDI application for OSR#1. When he continued to sell the product, the agency threatened legal action:

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216216.htm

  27. JPZ says:

    @ Scott

    That seems a bit over-reaching to tar the system over someone’s crime. Isn’t that like blaming medical schools because someone pretended to be a doctor? I agree that the public would be better protected from harm if the dietary supplement regulations were reformed and the FDA was fully funded to enforce what laws are there. The people I have met at the FDA are doing the best they can with what resources they are given.

  28. Scott says:

    I’m concerned with how well the system actually does work, not how well it might work if the FDA had more resources. Not “tarring the system” or denigrating what the FDA DOES have resources to do. I place the blame firmly on the shoulders of Harkin and his ilk.

    But in any case, it does seem that I was incorrect as to the safety aspects, which I acknowledge. My fundamental points still stand as to efficacy, though.

  29. David Gorski says:

    OSR#1 was never a legal product. The FDA rejected Boyd Haley’s NDI application for OSR#1. When he continued to sell the product, the agency threatened legal action:

    OSR#1 was sold in pharmacies and on the Internet for quite some time before the FDA acted. In fact, the reason the FDA started investigating, I suspect, is because of Trine Tsouderos’ expose in January 2010:

    http://www.chicagotribune.com/health/chi-autism-chemicaljan17,0,6466364.story

    Six months later, the FDA acted. Six weeks after the FDA letter, Boyd Haley finally agreed to pull OSR#1 off the shelves. I also note that the FDA letter to which you link actually describes the NDI application process to Haley. As usual, Kathleen Seidel was on this case in 2008, long before anyone else. A post by her last year revealed that Haley had planned on submitting an NDI process but realized that it’d never fly; so instead he marketed OSR#1 as a supplement:

    http://www.neurodiversity.com/weblog/article/206/
    http://www.neurodiversity.com/weblog/article/168

    From the second post (2008):

    Whereas Prof. Haley originally stated that animal safety studies were “being done for the purpose of obtaining FDA approval for these new chelators” (2007, p. 66), in 2008 he modified the text to state that the same studies were “being done for the purpose of obtaining FDA approval for these new antioxidants” (2008, p. 64). Whereas in 2007 he maintained that his product was a pharmaceutically effective “chelator” for the removal of mercury, in 2008 he modified the text to state that his invention was an “antioxidant” that “releases” an “antioxidant chelator” for “treatment” of unspecified conditions.

    A new chelator releases a very effective mercury chelator that enters hydrophobic areas where most mercury may be located. Because of its hydrophobic nature it stays in the body for a much longer time. (Autism One 2007, p. 62)

    The new antioxidants release a very effective antioxidant chelator that enters hydrophobic areas. Entering the hydrophobic regions increases the time in the body enhancing the treatment capability. (Autism One 2008, p. 65)

    Interest in the new product mushroomed. Parent reports before and after the conference indicated a common understanding of the reason for the shift in terminology — to bypass FDA regulations for approval of a new drug formulation by representing it as a “dietary supplement.”

  30. JPZ says:

    @ David Gorski

    So, is your concern that Boyd Hailey was not caught fast enough? I think that comes back to adequate FDA funding.

  31. Jeff says:

    As usual, Kathleen Seidel was on this case in 2008, long before anyone else. A post by her last year revealed that Haley had planned on submitting an NDI process but realized that it’d never fly; so instead he marketed OSR#1 as a supplement.

    I don’t think this is correct. To market OSR#1 legally as a supplement Boyd Haley always understood he would need to submit an NDI application to the FDA and have the agency approve it. In the 2008 post “A Fine White Powder” (article/168, linked to by Dr. Gorski) Kathleen Seidel gives a detailed account of Boyd Haley’s NDI submission to the FDA, and the agency’s response:

    On February 1, 2008, Prof. Haley submitted to the FDA notice of intent “to introduce a new dietary ingredient for use as an antioxidant, N,N’-bis (2-mercaptoethyl)isophthalamide (code name CT-01), into interstate commerce on or after 15 June 2008.”.

    On June 17, FDA’s Division of Dietary Supplement Programs issued an opinion detailing specific problems with Prof. Haley’s submission. No evidence was presented to establish that OSR or its components have any established use as a food for human beings. Since cysteamine hydrochloride has been and continues to be classified as an Investigational New Drug, it cannot also be legally classified as or incorporated into a dietary supplement.

    When an NDI application is filed, the FDA has three options: Approve it, reject it, or ask for more information about the product. In Haley’s case, the FDA asked for more information. The FDA’s June 17 letter (linked to by Katherine Seidel) made it clear Haley did not provide sufficient evidence of safety for OSR#1. The agency asked these questions:

    1. “FDA requests that you submit information explaining your basis asserting “N,N-bis(2-mercaptoethyl)isophthalamide” falls under the definition of a dietary ingredient in 21 U.S.C.321(ff)(1).”

    2. “In order to determine the eligibility of “N,N-bis(2-mercaptoethyl)isophthalamide” to be a dietary supplement, FDA requests that you provide information as to whether “N,N-bis(2-mercaptoethyl)isophthalamide” may be used as a dietary source of cysteamine.”

    3. “FDA requests that you clarify the populations that are the intended consumers of this product and basis for your determination of the appropiate serving levels for each of those populations.”

    Since Boyd Haley never responded to the FDA’s request for more information his NDI application was never approved. Therefore OSR#1 could not be marketed legally as a dietary supplement.

    The NDI regulations were devised to keep potentially unsafe products like OSR#1 off the market. What was lacking here was prompt, effective enforcement by the FDA – two years went by until the agency finally threatened Haley with legal action.

  32. JPZ says:

    @ Jeff

    Another factor may be that the FDA can (and does) get taken to court by companies who feel their nutritional product petition or claim was wrongfully turned down. When the FDA loses, the enforcement situation gets increasingly unclear. The FDA may have “asked for more information” as the safer option.

    New legislation could sweep the slate clean and clarify where and when the FDA can act. Maybe it could take some steps out of the process and allow the FDA to act faster.

  33. David Gorski says:

    The NDI regulations were devised to keep potentially unsafe products like OSR#1 off the market. What was lacking here was prompt, effective enforcement by the FDA – two years went by until the agency finally threatened Haley with legal action.

    Exactly my point. Haley hid behind the DSHEA and got away with it for two years.

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