FDA Dietary Regs Go Beyond Science and the Law

The Food and Drug Administration is supposed to be the scientific arbiter concerning the safety of dietary supplements. Instead, it is acting arbitrarily, choosing to target one product not because of any actual risk, but as an attempt to justify its own forthcoming regulations.

The FDA issued warning letters late last month to ten makers of popular workout supplements containing the ingredient DMAA. The products are supposed to give users the feel one would get after drinking a few cups of coffee.  DMAA is found in geranium plants, but it is more efficiently produced in a lab, just like many vitamins and minerals Americans use every day.

Interestingly, the FDA warnings didn’t go so far as to actually ban DMAA, perhaps realizing it doesn’t have the science or legal authority to do so. Instead, the letters threatened a ban sometime in the future — still a powerful regulatory action – and implicitly pressured the supplement makers to take their products off the market.

What would be the basis for FDA’s authority to ban a nutritional supplement it hasn’t shown to be harmful? 

The best the agency could do is cite its own bizarre draft guidance that because the DMAA used in the supplements is created in a lab, rather than extracted from geranium plants, it can’t be used as an active ingredient. Those guidelines – which do not have the force or effect of law – have not been finalized and have been criticized by the authors of the law which dictates how the agency regulates supplements.

In the draft guidance issued last year, the FDA claims that synthetic copies of botanicals (like DMAA) cannot be “dietary ingredients.” This approach simply makes no sense. The vitamins that millions of Americans take every day are synthetic copies; it’s not like oranges are being squeezed to produce the Vitamin C for daily capsules.

As the American Herbal Product Association reasonably asserts, “If DMAA exists naturally in geranium – which has been in the food supply for years – synthesized DMAA is also a lawful dietary ingredient permitted for use in supplements.” 

Senators Orin Hatch and Tom Harkin, who wrote the Dietary Supplement Health and Education Act of 1994 (DSHEA), which gives FDA authority to govern supplements, harshly criticized the agency’s draft guidance last year.  They wrote that the agency’s draft guidance undermines the very law it is supposed to interpret and that it “attempts to assert that synthetic copies of botanicals can never be a dietary ingredient, an assertion that is wholly without statutory basis, and in fact, contradicts longstanding FDA policy.”

Under the FDA’s distorted logic, if only manufacturers changed the source of their DMAA from labs to fields, the product would be perfectly fine.

Well, not exactly. The FDA, struggling to justify the warning, also makes unsubstantiated allegations about the safety of DMAA. Hundreds of millions of products containing DMAA have been sold since it became popular over the last five years with only one reported adverse effect. If only FDA approved pharmaceutical products had the same safety record. The agency should be held to higher standards.

I’m no advocate for dietary supplements. I disagree with the supplement industry’s resistance to widespread calls for DSHEA to be reformed. Most scientists, including many at the FDA, believe we should hold supplement makers to the same standards as pharmaceutical companies. Why? Because agents that claim to have a medicinal effect on the body should be shown to be safe and effective, regardless of whether they are pharmaceuticals or dietary supplements. Most simply put, if a product can change you to make you well, it can also change you to make you ill.

But here’s the kicker: this holds true whether the product is made by scientists or made by nature. Yet ironically, this is the very truism that FDA now is ignoring to force manufacturers to withdraw DMAA, since the source used in popular products such as Jack3D comes from a lab, not nature.DSHEA is flawed. But under any reasonable legal and scientific interpretation of the law, there’s no basis for FDA’s heavy handed regulatory threats against DMAA. If the agency wants more regulatory authority, it should persuade Congress to grant that authority. But until then, the agency should stick to the science and stick to the law as it is written.