NDI Draft Guidance: New Suggestions on What Data Firms Should Submit to Identify an NDI

Five of the dietary supplement industry’s major associations sent new comments to FDA recently regarding the agency’s new dietary ingredient (NDI) draft guidance. The comments address one particular aspect of NDI notification-namely, the specific types of information companies should submit to FDA to identify an NDI in an NDI notification.

The American Herbal Products Association (AHPA; Silver Spring, MD) led the initiative, submitting 12 pages of comments to FDA on April 27. AHPA’s document provides a detailed outline on the types of data companies should submit.

Following AHPA’s submission, four other associations submitted comments to FDA backing AHPA’s suggestions. The four are the Council for Responsible Nutrition (CRN; Washington, DC), the Consumer Healthcare Products Association (Washington, DC), the Natural Products Association (Washington, DC), and the United Natural Products Alliance (Salt Lake City, UT).

The associations are addressing the issue of NDI ingredient identification because, they allege, FDA’s initial NDI draft guidance, released in July 2011, does not specifically state what information companies should provide in an NDI notification for the identity of an NDI ingredient. But, as CRN pointed out, “the most common objection communicated by FDA in its responses to NDI notifications is that the agency ‘is unable to establish the identity’ of the dietary ingredient that is the subject of the notification.”

“This is clearly an area in which guidance is needed by the regulated dietary supplement industry,” said Michael McGuffin, AHPA’s president. “We are therefore requesting that FDA prioritize its attention to this specific issue and provide the industry with clarity on this matter.”

In fact, AHPA suggested that FDA issue new, standalone guidance specifically addressing NDI ingredient identity, even before the agency issues further revisions pertaining to other parts of the overall draft guidance.

AHPA’s suggestions for what information should be included to identify an NDI span a broad range of ingredient types, including enzyme-based ingredients, live microbial ingredients (probiotics), and fermented ingredients. They also address factors such as how to handle an ingredient blend, bioavailability data, what aspect of an ingredient’s manufacturing process should be described, and which specific ingredient specifications and analytical test data should be included.

CRN Submits Additional Comments on Chemical Alteration

In addition, on May 7, CRN submitted additional comments to FDA regarding when an ingredient is considered chemically altered and thus would require an NDI notification to FDA. In its original draft guidance, the agency listed specific manufacturing processes that it said would render an ingredient to be considered chemically altered.

The law firm that submitted CRN’s comments, Steptoe & Johnson LLP, suggested that FDA consider not only whether a manufacturing process changes the structure of a dietary ingredient but whether that resulting structure poses potential harm to consumers. “In other words, FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product,” CRN explained in a press release.

The trade associations have numerous other criticisms of FDA’s initial draft guidance. FDA has since indicated that it intends to issue a revised version of the draft guidance, although it has not confirmed a deadline for doing so.