The FDA’s NDI Rules Threaten Thousands of Supplements

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The landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as food and not drugs. This is critical to maintaining access to high quality, natural food-supplements.

This law required the FDA to create a notification system for new dietary ingredients (NDIs)—supplements introduced or substantially modified after 1994. But for the next seventeen years, supplement manufacturers had very little guidance on what constitutes an NDI and when or how to send an NDI notification. The government has arbitrarily ignored (or worse, arbitrarily enforced) this section of DSHEA, doing as it liked, without spelling out the rules.

In 2011, just before the July 4 holiday weekend and hoping to limit media attention, the FDA issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in DSHEA.

This was intended to be a notification system only, but—in an astounding perversion of congressional intent—the guidance attempted to establish a draconian pre-approval system for supplements, which placed an intolerable financial and logistical burden that most supplement manufacturers could never meet. Joanna M. Shepherd Bailey, PhD, professor of law and economics at Emory University, found that up to between 22,240 and 41,700 dietary supplements to be removed from the market. The nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion, and between 55,720 and 104,475 jobs in the supplement industry could be lost.

In 2012, ANH-USA and other stakeholders won a major concession on the NDI guidance: the FDA agreed that it requires substantial revision—a response to our sustained public messages opposing the current NDI draft guidance, and to pressure from several senators. FDA withdrew the document, and has not since re-issued an updated draft—meaning supplements companies are in the dark about how to comply with the NDI process—even though the FDA has taken actions against companies on this basis.

While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (i.e., supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.

There is also a danger that many “grandfathered” ingredients will be considered NDIs because of the FDA’s loose definition of what has been “substantially modified” or “chemically altered.” Supplements that have been slightly altered, even if they were originally marketed before DSHEA was passed, could become NDIs if the FDA says so. It may include a change in the manufacturing process—and there have been many such changes in the past eighteen years!

Generally speaking, the NDI process presents a grave threat to thousands of supplements. Because industry does not yet have final guidance from the FDA on how to comply with the NDI notification process, there are no NDIs on file for many supplements. If a drug company were to file an Investigational New Drug application and publish research on a nutrient, and no NDI had been filed on that nutrient, Big Pharma could develop a synthetic version of it, then petition the FDA to ban the natural version from the market—as happened with pyridoxamine.

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