Guest article by Sebastian Krawiec
Expanding upon statements made to FDA during the public meeting, “Responsible Innovation in Dietary Supplements,” Daniel Fabricant, president and CEO of the Natural Products Associations (NPA; Washington, D.C.) submitted comments to the agency on July 15, 2019. In the comments, Fabricant asked that FDA adopt a comprehensive NDI (new dietary ingredient) enforcement strategy, instead of leaning on Congress to give the agency new authority. FDA cites a lack of resources for its inability to effectively enforce new dietary ingredient notifications (NDIN), but Fabricant says that FDA does have existing avenues it can utilize to enforce NDIs.
Fabricant uses CBD as an example of a hot button ingredient that has proliferated in the marketplace with little-to-no regulatory oversight, and has yet to be the subject of a NDIN. “CBD is the biggest product that hasn’t cleared an NDI, demonstrating that FDA doesn’t need new authorities. Rather than seeking new authorities from Congress, we urge the Agency to develop a comprehensive NDI enforcement strategy,” said Fabricant in a press release. “The Agency already has the authority to take this approach and it is consistent with the Trump Administration’s commitment to streamlining regulations to make them more responsive and efficient for consumers and businesses. The U.S. dietary supplement supply is the safest in the world thanks to the regulatory regime we have in place, and we want to keep it that way.”
Among these authorities, says Fabricant in his comments, is the use import bulletins and import alerts, which he says FDA can utilize for ingredients that have not filed an NDIN. This is called a “technical” adulteration and has been used by FDA in the way he describes for ingredients such as kratom. In import alert 54-15, for example, it states, “Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(ff)(1)]. When marketed as a dietary ingredient, FDA also considers kratom to be a new dietary ingredient under section 413(d) of the Act [21 U.S.C. 350b(d)] because, to the best of the agency’s knowledge, there is no information demonstrating that this substance was marketed as a dietary ingredient in the United States before October 15, 1994.”
The agency also cites additional concerns of toxicity from kratom, but FDA is actively citing the ingredients lack of a NDIN, and using a technical adulteration to prevent kratom’s importation into the country. “It’s not that safe products can’t be sourced from foreign countries, however, if there is no enforcement against foreign NDI products that at a minimum have not presented their specifications to the FDA, why would a domestic firm ever see the NDI gate as a real priority to the agency,” writes Fabricant. “This is the fundamental challenge the agency is facing with respect to NDIs. Statutory requirements must be enforced uniformly, and to all in the space. One company can no longer ride on the coattails of another’s work.”
Guest article by Sebastian Krawiec, as seen in Nutritional Outlook online July 18, 2019.