The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.
And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.
A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.
DSHEA refresher
First, a bit of a refresher on DSHEA. A 2005 article in the American Journal of Law and Medicine by Peter Cohen (1.), who holds both an M.D. and a J.D., provides what I think is an apt summary of the flawed thinking underlying DSHEA, identifying these “critical weaknesses:”
- “DSHEA classifies compounds as dietary supplements based on their source, rather than their pharmacologic and physiologic properties.”
- “DSHEA assumes that components of foods cannot cause harm, even when ingested in large amounts, and that therefore supplements should be subject only to regulations dealing with foods rather with the more stringent regulations applied to drugs.”
- “DHSEA also assumes that since herbs and botanicals are ‘natural,’ they warrant regulation only to the same extent as food components, regardless of their pharmacologic, physiologic, or pathologic attributes, and irrespective of whether they are foods at all.”
- “The marketing of dietary supplements must be accompanied by a statement indicating that these substances are not intended to treat disease but rather to maintain normal bodily function. . . a meaningless distinction to most consumers.”
The dubious principles at the heart of DSHEA are exacerbated by Congress’s essentially hog-tying the Food and Drug Administration (FDA) in its ability to police the safety and effectiveness of dietary supplements, which, pre-market, is left pretty much up to the manufacturers and distributors. It is only post-market, once the harm is done, that the FDA can come in and attempt to clean up the mess. Even then, it is hampered by lack of mandatory recall authority. To ban a supplement, the FDA bears the burden of proving that a supplement ingredient presents a significant or unreasonable risk of illness or injury. As the GAO report noted, this is made difficult by the fact that there is often little scientific evidence available for the supplement in question because no evidence of safety and efficacy is required by the FDA before the product can be marketed.
There is one requirement of DSHEA with the potential to improve safety but it has been largely ignored by the supplement industry and unenforced by the FDA. Manufacturers and distributors who want to market dietary supplements containing “new dietary ingredients” must notify the FDA. Notification must include support for their conclusion that the new dietary ingredient is reasonably expected to be safe under normal conditions of use. Ingredients existing on or before October 15, 1994, were grandfathered in and did not have to meet this requirement.
(And guess what one of those grandfathered supplement ingredients was? Ephedra!)
FDA asks, very nicely, for evidence of safety
As noted in a recent New England Journal of Medicine article (2.), more than 100 million Americans consume dietary supplements, spending more than $28 billion annually. Since DSHEA was passed in 1994, the number of dietary supplements has grown from an estimated 4,000 to over 55,000. We don’t know how many of these 51,000 or so new supplements include new dietary ingredients, which should have triggered the notification requirement, but we do know that the FDA has received adequate notification for fewer than 200.
This failure of compliance and enforcement, which was noted in the 2009 GAO report, led to a requirement in the FDA Food Safety Modernization Act, effective January 4, 2011, that the Secretary of Health and Human Services publish guidance clarifying, among other things, the level of evidence needed to document the safety of new dietary ingredients.
So it came to be that the FDA, in July of last year, presented its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” As might be expected, Big Supp was not pleased. The industry’s response has been duly noted by SBM’s own David Kroll, Ph.D. The usual giant strawman, Big Pharma, was trotted out, plus overblown claims to the effect that the FDA is attempting to “ban” dietary supplements.
Let us pause here to note that what the FDA issued is guidance, not actual rules, and draft guidance at that. These are not rules anyone has to follow, nor can the FDA enforce this guidance, as is made abundantly clear in the document itself:
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
In other words, if you don’t like what we want you to do, call us and we’ll work something out. I mean, how much more accommodating could the FDA get?
And what does the FDA say supplement makers and distributors need to do? I agree with Dr. Kroll that the guidance is “a bit complicated.” Dr. Pieter Cohen, author of the NEJM article mentioned above, summed it up this way:
The safety of supplements would be evaluated according to three key factors: documented history of use, . . . formulation and proposed daily dose, . . . and the recommended duration of use.
In some cases, a documented history of use will be enough to meet the “reasonable expectation of safety” standard. In others, in vitro or animal, but not human, studies would be required.
Dr. Cohen finds the guidelines a step in the right direction, but not far enough. He does not believe the FDA should accept historical use in lieu of experimental data, nor should it allow companies to avoid human studies. In addition, the companies can cherry-pick the evidence, as they do not need to turn over unfavorable data.
A friend to the rescue
The hyperbolic response of Big Supp was taken up by the National Health Freedom Coalition, which sent out an “Action Alert” e-mail last month:
FDA’s draft guidance for new dietary ingredients is looming and attempting to eliminate thousands of dietary supplements currently on the market . . . . FDA’s plan [is] to impose cost-prohibitive requirements on manufacturers of these life-saving products!
The FDA is doing nothing of the sort and there is no evidence I am aware of that this long-ignored requirement is “cost prohibitive.” And “life-saving?” Please! But the “Action Alert” did actually alert me to the fact that the supplement industry was calling on an old friend in Congress to bail it out, Rep. Dan Burton (R-IN). Rep. Burton has introduced H.R. 3380, the “Dietary Supplement Protection Act of 2011.”
The meat of the bill, in Section 3, is short and straightforward. It creates a “new dietary ingredient definition” by amending the provision of DSHEA that grandfathered in all new dietary ingredients existing prior to October 15, 1994. By changing that date to January 1, 2007, it grandfathers in another 12 plus years of new dietary ingredients, thereby wiping the slate clean on all those new dietary ingredients the industry didn’t provide safety information for, in violation of the law.
More interesting is Section 2, which contains Congressional findings purporting to support the bill. I don’t know where Rep. Burton found these findings, but I found them to be somewhere between misleading and patently false.
Let’s take it claim by claim:
(1)Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government. The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention are well known and have been documented in scientific studies.
I had no idea that my health was the federal government’s top priority. They had me fooled on that one. I have to agree that nutrition is important, but other than supplementation for a recognized vitamin or mineral deficiency, dietary supplements have little to do with nutrition. Further, I would argue that the role of dietary supplements is well known only in the sense that the ability of Cialis ™ to make bathtubs pop up out of nowhere is well known, that is, based on phenomenally successful advertising rather than actual fact. And we have seen this claim of documentation via scientific studies before in another industry-friendly bill, The Free Speech About Science Act (which is still pending), the subject of an SBM blog post by Dr. David Gorski. He noted, quite rightly, that “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.”
(2) Since enactment of . . . DSHEA, dietary supplements have had an exemplary public health safety record. [Warning: non-sequiter approaching!] Based on national surveys, in 1994, 50 percent of the 260,000,000 Americans regularly consumed dietary supplements. In 2006, 232,000,000 adults over the age of 18 alone consumed dietary supplements, 53 percent of the United States adult population.
First, someone got his sums wrong. 232,000,000 is not 53% of the adult population in 2006, which only reached 300,000,000 total in October of that year. Second, it’s hard to argue that there is an exemplary safety record when manufacturers and distributors were not required to report serious adverse events until December of 2007. (They still don’t have to report mild to moderate adverse events.) As Dr. Pieter Cohen pointed out, quoting the IOM report, “even widespread historical use without documented ill effects is no guarantor of long-term safety.” Nevertheless, the bill makes the unfounded presumption that each new dietary ingredient introduced between 1994 and 2007 exhibits an “exemplary public health safety record” despite the fact that nobody had to report adverse events from these ingredients.
(3) There were 4,000 dietary supplements in the marketplace in 1994, and in 2006 an estimated 29,000 [different] dietary supplements were being consumed daily by Americans. Since the enactment of DSHEA, there has been 17 years of additional historical use-safety experience conducted by millions of Americans. Over 17 years, approximately 25,000 new supplements with new dietary ingredients have been approved by the Food and Drug Administration (FDA) under DSHEA and have and are being safely consumed by Americans.
This raises interesting questions: Did the health of Americans decline so over those 17 years that we required 25,000 new supplements to enhance our “structure and function?” Conversely, is there any evidence that the 29,000 we take daily have improved our health one bit? Shouldn’t we be a whole lot healthier than in 1994 if the supplements were working as advertised? Shouldn’t we be thoroughly cleansed of toxins, our immune systems boosted to the max, muscular and virile, slimmed down, impervious to cancer, with joints as supple as an acrobat’s, free of anxiety, depression, and cholesterol? I don’t know about you, but I just don’t see any evidence this has happened.
But we’re talking safety here, not effectiveness. On that point, isn’t the claim of historical use-safety experience “conducted by millions of Americans” pretty much an admission that the supplement industry has been engaged for years in a huge uncontrolled, non-IRB-approved clinical trial with all of us as unknowing subjects? And someone should go back and read the Federal Food, Drug and Cosmetic Act, where he will learn that the FDA doesn’t “approve” supplements at all, much less 25,000 of them.
(4) Since January 2007, FDA regulations governing dietary supplement manufacturer good manufacturing practices, dietary supplement adverse event reporting, and private sector voluntary testing and auditing for supplement quality and purity have improved postmarketing consumer safety. Before DSHEA, these mechanisms did not exist.
Whether true or not, what has may have happened since January, 2007, is totally irrelevant, as the bill addresses new dietary ingredients prior to January, 2007.
Sections (5) and (6) simply repeat, in different language, what has already been said about the presumed safety of supplements and has thus already been refuted.
So the rationale for deleting over 12 years of new dietary supplement ingredient safety reporting is wholly unconvincing. One wonders how much federal legislation is passed based on similarly shaky reasoning.
But wait, there’s more!
We’re not through with Rep. Burton yet. He is also a co-sponsor of two bills introduced by avowed libertarian and current Republican Presidential candidate Ron Paul (R-TX).
The first, HR 2044, is titled the “Health Freedom Act.” Currently, supplement manufacturers and distributors are limited to claims that a dietary supplement affects the body’s “structure” or “function.” They are not permitted to claim their supplements mitigate, treat or prevent any disease or condition. The bill would effectively repeal this prohibition by preventing the FDA from taking any action against such claims unless a federal court, following a trial on the merits, finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that the claim is materially false and misleading and there is no less restrictive alternative, such as a disclaimer, to render the claim not misleading.
In effect, this means that supplement makers and distributors could make such claims with impunity. First, because they don’t have to give the FDA any evidence of effectiveness prior to marketing, there is little incentive for the industry to conduct studies. So unless the FDA could convince the NIH or another entity to fund and conduct such studies, they won’t exist. Second, to mount a full-blown federal trial and to meet the “clear and convincing evidence” standard with this sort of evidentiary burden is hugely expensive and would require heavy outlays of staff time, including counsel, to prepare for trial.
The second bill, HR 2045, attacks the Federal Trade Commission, which is charged with regulating supplement advertising, and is entitled the “Freedom of Health Speech Act.” Among other limitations to be imposed on the FTC, solely with regard to supplement advertising, the bill
- prohibits the FTC from even investigating supplement advertising without possession of clear and convincing evidence that the ad is false and misleading;
- places the burden of proof on the FTC to show, again by clear and convincing evidence, that an ad is false, that the ad actually caused consumers to be misled into believing what is false to be true and that, but for the false content, the consumer would not have made the purchase at the price paid; and
- proof of falsity must be based on expert scientific opinion and published in peer-reviewed scientific publications.
As if that weren’t enough, bills before the House and Senate would amend the Internal Revenue Code in favor of Big Supp. Federal tax law allows individual taxpayers to deduct from income certain medical expenses, the rationale being that, if your medical expenses exceed a certain amount, the government should help out a bit by allowing you to deduct those expenses from taxable income. Deductible items include prescription drugs, physician care, medical equipment, and other expenses, as long as they are “for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”
House Bill 2010 and Senate Bill 1098 would expand the definition of medical expenses to include, up to $1000 per year,
amounts paid to purchase herbs, vitamins, minerals, homeopathic remedies, meal replacement products, and other dietary and nutritional supplements.
Yes, just what we need. To add insult to injury, the purchase of dietary supplements and homeopathic “remedies” will have the opportunity to add to the federal deficit.
And guess who is a co-sponsor of the House bill? Rep. Dan Burton. And who introduced of the Senate bill? Sen. Orrin Hatch (R-UT). Naturally.
Notes
(1.) Cohen PJ, Science, Politics, and the Regulation of Dietary Supplements: It’s Time to Repeal DSHEA, 31 Am J Law and Med 175, 176-77 (2005).
(2.) Cohen, PA, Assessing Supplement Safety – the FDA’s Controversial Proposal, 366 N Engl J Med 389 (2012).
