Feb 10 2015

Regulating Supplements

While I try to stick in these articles to science and critical thinking, and try to minimize any expression of my personal ideology or political opinion, I make no secret of the fact that I support fair and effective government regulation of all aspects of healthcare. This is partly because I feel the evidence strongly supports this position, but also I am a physician so it is my additional duty to advocate for the health of my patients and society.

The inadequate regulation of the supplement industry has recently been in the news and possibly (hopefully) this issue is coming to a head, perhaps sufficiently to garner the political will to revise current regulations.

First let me point out that I consider the pharmaceutical industry and the supplement industry to be essentially the same thing, the only real difference being the different rules for their regulation. They are different regulatory categories, but the companies making drugs and supplements have significant overlap. Further, the market forces are largely the same, the major difference being that for non-over-the-counter drugs a doctor’s prescription is needed.

I am often accused by defenders of supplements, homeopathy, and “natural” medicine of favoring the pharmaceutical industry, or at least giving them a pass. This is simply not true. I favor strong regulation of the pharmaceutical industry. I have specifically advocated reforms, such as registering clinical trials so drug companies cannot hide data. I favor recent reforms limiting conflicts of interest between physicians and pharmaceutical companies, and the full disclosure of any potential conflicts when they occur. I am against pharmaceutical industry practices, such as ghost authoring white papers to promote their products. There have been numerous multi-billion dollar settlements for pharmaceutical companies breaking the rules that govern the marketing of their products.

The core regulations of pharmaceuticals, however, work. Drug companies must provide high quality evidence of safety and efficacy for their products and can only make claims that are specifically approved by the FDA. Quality control is also high. When I prescribe 25mg of drug X to my patients I can be highly confident that the tablets they take will consistently contain 25mg of drug X and have sufficient bioavailability. Adverse effects are tracked and reported. The system is not perfect, but it basically works, and largely just needs to be tweaked and monitored.

Supplements, however, are a different story entirely. Since the Dietary Supplement Health and Education Act of 1994 (DSHEA) supplements have been largely deregulated. Companies can market products to the public without submitting any evidence for safety, and they can make pseudo-health claims (so-called structure/function claims) without any oversight either. Quality control is essentially voluntary.

The only real regulation in place is generic post-marketing monitoring for fraud, through agencies like the FTC, which is a hopeless game of whack-a-mole.

The history of the supplement industry (which is really the history of snake oil) is the main reason I support effective regulations for health products. We don’t have to speculate – we know what an unregulated health-product industry will look like. Market forces seem to favor hyped claims and slick marketing, but not quality control. It is simply too difficult for individuals to detect for themselves the quality of a product they are taking, due to placebo effects and the natural variability in illnesses. Further, many products are promoted for vague benefits such as overall health, which are nearly impossible for an individual to track.

Again we know from history that worthless and even harmful products with slick health claims can be extremely popular (such as radioactive tonics).

There has been a recent slew of studies showing how poor the quality control in the supplement industry is.  I reviewed many of these studies here: Supplements often contain contaminants, unlisted fillers, and even use fillers to substitute for the alleged active ingredients. You may think you are getting Gingko, but in fact you’re getting alfalfa. Some of those substitutes may cause allergies. Supplements often have drug-drug interactions. Ingredient levels vary incredibly. Bioavailability is anyone’s guess. Supplements also often illegally and secretly contain real drugs.

The FDA will sometimes respond, when it detects such problems, with a sternly worded letter requesting the company to voluntarily fix the problem, which they often don’t.  The FDA can only pull a product from the market if it contains a regulated drug, or if the FDA meets their burden of proof demonstrating that the product has already caused harm.

Recently the New York State attorney general’s office, after an investigation, filed a cease-and-desist order against GNC, Target, Walgreens and Wal-Mart, ordering them to stop selling a number of herbal supplements that were found not to contain the ingredients on the label, and some of which contained unlisted fillers that were potential allergens.

How did the supplement industry respond?

“These actions today by the New York State Attorney General’s (AG) office smack of a self-serving publicity stunt under the guise of protecting public health.”

They simply deny the DNA barcoding technique that was used in the investigation, and swears that the industry is following best practices. However, there have been validation studies of DNA barcoding for herbal supplements. Is this enough? I don’t know, and certainly further validation studies would be welcome. I don’t think we can so casually dismiss the DNA barcoding evidence, however, as the supplement industry does.


There are serious concerns about the quality of herbal supplements, and therefore the adequacy of current regulations. Even if, however, good manufacturing practices were fully enforced, ensuring that products contained what was on the label and only what was on the label, we are still left with a much bigger question – do herbal supplements work as claimed?

The evidence is not promising. For the most popular supplements the answer ranges from “probably not” to “unknown.” Gingko, glucosamine, echinacea, milk thistle, black cohosh, and saw palmetto all do not work for their marketed indications.

We have also been given a peek at the dark underbelly of the supplement industry with the recent Dr. Oz green, coffee bean hoax.

It seems clear we need more effective regulations. However, attempts at updating DSHEA have been blocked in the senate, largely by the supplement industry’s champion, Orin Hatch. We need to muster sufficient political will to overcome the industry’s powerful bulldogs.


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