Comments filed with FDA regarding new “Draft Guidance” about Dietary Supplements

Michael Harless Administrative Law, Health Law

Today, our firm filed comments with the Food and Drug Administration (“FDA”), criticizing various parts of the FDA’s new “Draft Guidance” with respect to dietary supplements.

First, we noted that while federal law requires that manufacturers dietary supplements give “notice” to the FDA before they introduce a “new dietary ingredient” into the marketplace. The FDA, however, has adopted an approach which requires manufacturers to submit separate notices every time they introduce a “new dietary supplement” which uses the “new dietary ingredient” in a different way.  This compounds the notice requirement for the supplements industry far beyond what Congress permitted.

Second, we noted how the FDA’s revised “Draft Guidance” adopts positions that are entirely inconsistent with the FDA’s recent attempt to ban the dietary supplement Vinpocetine from the market.  The FDA faults Vinpocetine for being a synthetically derived part of a plant, yet the Draft Guidance admits that synthetically derived natural products are still dietary supplements.  Our recent comments to the FDA on Vinpocetine, explain why that substance falls squarely under the definition of a dietary supplement.

Finally, the FDA’s Draft Guidance has announced that the agency is finally willing to adopt an official list of “old dietary ingredients” — dietary ingredients that existed before the federal law and which are thus exempt from notification.  We argued, however, that any “official list” should not be interpreted so that ingredients not on the list are presumed to need notification.  In other words, the safe harbor should only create presumptions that operate in one direction.

Our comments were filed on behalf of the Center for Medical Freedom, the U.S. Justice Foundation, and The Senior Citizen’s League.

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