FDA Regulations On Health Supplements: Too Much Or Too Little?

There appears to be two opposing views regarding the new FDA regulations on health supplements. At least one doctor, Dr. Pieter Cohen, is of the view that the new regulations don’t go far enough. On the other hand, most supplements manufacturers and distributors are strongly opposed. So, who is right?

Well, each side naturally has points to support their view. Here’s Dr. Cohen’s side:

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, “assuming they are both safe and effective,” wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance.

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece.

By law, ingredients that were used and sold in supplements prior to 1994 can be marketed without any proof that they are safe or effective. But under a law called the Dietary Supplement Health and Education Act (DSHEA), manufacturers of any ingredient introduced after 1994 must provide the FDA with evidence supporting “a reasonable expectation of safety.”

Cohen said that part of the law “has thus far not been enforced.”

Since DSHEA became law more than 15 years ago, the number of supplements on the market has gone from 4,000 to more than 55,000. Since 1994, the FDA has received proper notification for 170 new supplement ingredients, “undoubtedly a small fraction of the ingredients for which safety data should have been submitted,” Cohen said.

The FDA has mounted a new effort to discourage the sale and use of nutritional supplements that contain ingredients that are regulated as drugs. Last year, the agency issued draft guidance meant to inform supplement manufacturers about what information they must submit to the FDA, including spelling out when an ingredient is considered old and when it’s considered new. (A synthetically produced replica of a botanical product, for instance, would be considered new).

In addition, the FDA is proposing that the guidance call for in vitro, animal, and long-term tolerability testing for supplements that would be marketed at higher doses than those historically ingested.

“The FDA’s guidance provides a thoughtful framework for evaluating the safety of new ingredients and if implemented it would lead to substantial improvement in safety,” Cohen wrote, but he said he didn’t think the FDA goes far enough.

He said under the guidance, companies can use historical data (instead of clinical trials) to prove that a supplement is safe, and Cohen said that the FDA can’t assess the safety of new products scientifically without experimental data.

Cohen also said that under the guidance, manufacturers would not be required to submit both favorable and unfavorable data to the FDA, so they could cherry-pick only positive data to submit. See full article

Here’s an opposing viewpoint:

The FDA has it dead wrong

The FDA’s proposed changes would force nearly all supplements currently on the market to apply for retroactive approval – even those that were around before 1994. The new draft guidance requires any supplement containing new ingredients, or ingredients that have been chemically altered or manufactured in a new way, to file for approval. Because the FDA defines these terms broadly, it is likely that almost all supplements on the market would meet this requirement and be forced to file an NDI. As a result, many supplements would disappear from shelves for good and those that return will likely cost consumers much more.

The documentation required by the guidance is so extensive that it seems impossible for many or most of the supplement makers to obtain the required evidence of safety. Even if companies could document 25 years of safe use, toxicology studies on animals and humans, two-year carcinogenesis studies, and the like, it’s very unlikely that FDA, with its ever increasing backlog, would ever get around to approving any of the NDIs. By the agency’s own admission, there are more than 55,000 NDIs that should be filed but haven’t been.

So, what would happen to all of those supplements? Well, if the FDA does not officially approve the NDI, the manufacturer may market the product.

However, doing so gives the FDA an open door to pull those supplements off the shelves, not because they pose any threat to public safety, but simply because the agency considers them to be “adulterated.”

If the FDA’s proposed NDI guidance is adopted, supplement manufacturers will be left with a choice: either submit their products to similarly rigorous pre-approval trials as drugs, or give the FDA the power to ban product without justification and with full impunity. Senators Hatch and Harkin are right when they insist that the FDA’s guidelines undermine the very heart of the supplement regulation they authored and Congress passed.

If the FDA continues on this rogue effort to unilaterally expand its authority, the Senate Health, Education, Labor, and Pensions Committee, which Senator Harkin chairs, should be ready to ask the agency some tough questions. See full article

It is interesting to note what Dr. Cohen’s says about the older law (DSHEA) not having been enforced, despite a rapidly growing and expanding supplements market. Note also that “The FDA has it dead wrong” article quoted above points out the “ever increasing backlog” at the FDA. Also, from what I understand, supplements makers will have to submit information by mail. I will go with the “too much” camp.

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