CRN urges FDA to end confusion over dietary ingredient classifications, NDIs, when modernizing regulations


The Council for Responsible Nutrition (CRN; Washington, DC) this week submitted public comments to FDA addressing the agency’s plans to evaluate and potentially update regulations for dietary supplements.

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The Council for Responsible Nutrition (CRN; Washington, DC) this week submitted public comments to FDA addressing the agency’s plans to evaluate and potentially update regulations for dietary supplements, which FDA announced in February. FDA's deadline for public comments closed this week.

CRN’s comments largely reiterate concerns and priorities the dietary supplement association has shared with FDA in the past, including in comments filed with FDA responding to FDA's two draft guidance documents for new dietary ingredients (NDIs) in 2011 and 2016.

Crucially, CRN said, when evaluating current regulations for dietary supplements, the agency should also reevaluate its “narrow” stance on ingredients like synthetic botanical ingredients. FDA’s latest NDI draft guidance issued in 2016 indicated the agency would not consider synthetic botanical ingredients to be legal dietary ingredients. In its letter to FDA, CRN points out that when establishing dietary supplement law via the Dietary Supplement Health and Education Act (DSHEA) in 1994, “Congress made no reference to the source of dietary ingredients as being natural or synthetic, nor did Congress specify that only some of these categories of dietary ingredients may be produced synthetically while others must only come from natural sources.”

If an ingredient is chemically equivalent to a botanical constituent, then it should likewise be considered a dietary ingredient, the association wrote. “There are no scientifically justifiable grounds for treating synthetic copies of botanical constituents differently when they are chemically equivalent to their plant-derived, naturally occurring counterparts.”

CRN also requested that FDA clarify its stance on ingredient-manufacturing changes and when exactly these would render ingredients no longer eligible as dietary ingredients. “CRN requests that FDA clarify that an NDI notification for an existing dietary ingredient would be required only when the manufacturing change results in either a change in the identity of the dietary ingredient (e.g., a change in specifications needed to chemically characterize the ingredient), or a change that has a potential significant adverse impact on the safety of the ingredient for the intended use in a dietary supplement.”

To help companies better navigate and utilize the NDI process, the association recommended that FDA create a public list to classify ingredients into three categories: 1) those considered to be pre-DSHEA and that do not require NDI notification submitted to FDA, 2) those that have filed successful NDI notifications already, and 3) NDIs that are potentially exempt from notification because they are already present in the food supply, not chemically altered, and therefore do not require notification.

Confusion over these types of issues have long plagued the dietary supplement industry and impeded a well-running NDI process, CRN pointed out. If FDA is intent on changing supplement regulations for the better, the association said, then these (and other) changes should be considered. Said CRN’s comments: “If modernization of the approach to regulation is the intention, and if responsible innovation by industry is a priority goal, FDA should remove impasses to longstanding issues regarding permissible dietary ingredients, facilitate industry’s understanding of NDI notification requirements, and promote innovation by protecting the intellectual property of those that invest in science to bring new ingredients to the market using the NDI notification process as intended by DSHEA.”

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