Why you can't call your supplement a drug

Why you can't call your supplement a drug

The First Amendment of the Constitution enshrines the most revered of the freedoms enjoyed by citizens of the United States: free speech. Ask any of the dissidents who brought down repressive regimes in the Arab world over the past year and you’ll hear that this freedom was high on the list of things they were fighting for.

Free speech isn’t unlimited, of course. You can’t promulgate hate speech, or yell “Fire!” in a crowded movie theater. And you can’t say anything you please about your dietary supplement or natural health aid, whatever you might believe in your heart about its beneficial effects.

Why not? It goes back to the overarching legislation in the natural products business, the Dietary Supplement Health and Education Act of 1994 (DSHEA). Even though, at 20-some pages, DSHEA is a remarkably compact piece of federal legislation, it’s apparent that many in the natural products business have never read the thing.

A key part of DSHEA was to set up a system of so-called structure/function claims. You can say, “supports cardiovascular health.” You are restrained from saying, “prevents/treats cardiovascular disease.” In the view of the U.S. Food and Drug Administration (FDA), you may say the latter only if you are willing to list your product as a drug and go through the exhaustive and extremely expensive series of human clinical trials.

DSHEA sought to avoid this. Many of the bioactive ingredients that go into dietary supplements and functional foods would not be patentable in any case, and it is patent protection—and the potentially high profits that could result—that fuels the whole drug discovery machine.

But let’s say you have some promising scientific results for your product. Maybe you’ve even got a small-scale human trial or two. Or perhaps you’ve got some very convincing testimonials. Why can’t you tell your customers about them in the most convincing way possible? If you believe your product can in fact treat or prevent a given disease, why can’t you say so?

The danger of disease claims

FDA’s take is this: What if someone believed the claims you were making about how your product treats a disease. They stop taking their prescribed medication, and your product either doesn’t work like you said it did, or its effect is not as dramatic as that particular patient needs. And that person is harmed as a result. At least with a drug—or so the theory goes anyway—you have categorized as specifically as possible how the product works. 

Dietary supplements don’t work like drugs. They have generally mild, systemic effects, not the tightly focused and rapid modes of action typical of drugs. And they don’t have the side effects that typify many drugs. Drugs can be dangerous. Supplements, on the other hand, are remarkably safe. On a statistical basis, it’s far riskier to use the cleaning products in your home than it is to use dietary supplements.

So a key part of DSHEA was to preserve access to supplements, and to let consumers decide whether they thought the products worked well enough to warrant continuing to pay for them. DSHEA sought to prevent FDA from requiring pharmaceutical-level scientific proof for the effects of supplements. Had that been the case, few of the products you see now on the supplement shelves would ever have made it to market. This freedom of access is the essential freedom that DSHEA preserves. Manufacturers can make certain claims about how their products work, however goofy the language might have to sound in order to conform to DSHEA. And consumers—not FDA—decide whether those products work the way the manufacturers claim.

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