“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 a couple of weeks ago 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, while we’re waiting to find out how badly Steve Novella’s appearance on The Dr. Oz show today ends up being edited, let’s take a look at what 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. The same for a lot of phrases Mr. Fucetola and his buddies use. “Health freedom,” for instance. 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 and 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, as in, for example, the ever-infamous “boosts the immune system” or “promote 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, ultimately the FDA did shoot Haley down, but the very fact that he got away for so long 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–the same way that 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.