The Food and Drug Administration’s (FDA) Draft Guidance on new dietary ingredients (NDIs) raises numerous concerns regarding its basis in law and reasoned policy. These concerns could cause unwarranted harm to businesses and may have detrimental effects on consumer access to dietary supplements that can provide health benefits. The Draft Guidance must be more narrowly tailored to accomplish the agency’s primary mission to protect and promote the health of U.S. citizens. FDA should thus withdraw the Draft Guidance and propose guidance or regulations consistent with the principles set forth.

In its current form, the Draft Guidance is unlawful in numerous respects. Most broadly, it is a rule in the guise of “guidance.” The Draft Guidance is an agency statement of general applicability and future effect that is designed to implement, interpret and prescribe binding standards under sections 413 and 201 of the Federal Food, Drug, and Cosmetics Act (FDCA).  As such, it should be subject to notice and comment rulemaking. The evasion of the administrative due process requirements of rulemaking in this case is especially inappropriate because the Draft Guidance is largely contrary to the FDCA.

Defining Terms

The Draft Guidance is most notably contrary to the FDCA in its interpretation of “dietary supplement.” Multiple aspects of the Guidance confirm this. First, the Draft Guidance states that the prior marketing clause in section 201(ff)(3)(B) of the FDCA applies to active moieties. This is contrary to the plain meaning of the statute whereby the prior marketing clause applies to substances rather than to active moieties. Similarly, the Draft Guidance invokes a narrow definition of “amino acid” that is contrary to the plain meaning of the statute. Furthermore, the Draft Guidance’s attempt to interpret dietary ingredients as excluding all members of a species that contains human pathogens is also clearly contrary to the plain meaning of the statute. The statute contains no such limitation and the only way that FDA can legally preclude certain strains from being used as dietary ingredients is to prove it in court.

Along similar lines, the Draft Guidance states that fermentation using a fermentation medium different from one used to make conventional foods in the food supply is an example of “chemical alteration” (within the meaning of the FDCA) and thereby necessitates submission of an NDI notification. Changes in the fermentation and/or manufacturing processes used for probiotics, however, cannot possibly be deemed to require an NDI notification. To hold otherwise would contravene Congressional intent to ensure broad and open access to safe dietary supplements.

The Draft Guidance is also incorrect in its attempt to interpret “dietary supplement” as excluding synthetic botanicals and herbal ingredients. First and foremost, the dietary supplement definition includes synthetic botanicals based on the definition of “botanical.” Even if the statute were ambiguous, FDA could not interpret it to exclude synthetic botanicals because there is no basis in science or policy for distinguishing synthetic botanicals from natural botanicals. Further, FDA does not distinguish synthetic substances from natural substances in analogous statutory provisions, and synthetic dietary botanical substances are dietary ingredients within the meaning of section 201(ff)(1)(E) of the statute. Similarly, all naturally-occurring components of food must be considered dietary ingredients pursuant to the same section. The Draft Guidance’s statement to the contrary stands in direct contravention to the statutory language.

The Draft Guidance is also unlawful, and unreasonable in regard to its proposed standards for “old” dietary ingredients. These standards are contrary to the statute and Congressional intent in a variety of ways. In the Draft Guidance, FDA states that an ingredient must have been marketed as a dietary ingredient before October 15, 1994. This definition of marketing is clearly contrary to the statute, which requires only that the ingredient have been “marketed.” The Draft Guidance is also contrary to the statute in its attempt to require that an “old” dietary ingredient be manufactured using the same techniques and extraction processes as were used 17 years ago. This is not only contrary to Congress’ stated desire for broad and open access to safe dietary supplement products, but FDA is also conflating the definition of “new dietary ingredient” with the statutory language exempting certain ingredients in food from the requirement to submit an NDI notification. 

Burden on Business

The evidentiary requirements regarding marketing are inconsistent with the statute. The Draft Guidance seeks to require contemporaneous business records that are, in many cases, no longer available largely due to the fact that there was no indication in the statute that such records would be required 17 years later. Given that companies have not retained the types of records identified by FDA, very few dietary ingredients will be able to satisfy this evidentiary burden. As a result, many dietary ingredients that were safely marketed prior to October 15, 1994, and continue to be safely marketed will be subject to NDI notification requirements, which will likely block (at least temporarily) citizens’ continued access to dietary supplements, contrary to Congressional intent.

Additionally, the Draft Guidance is unlawful in its interpretation of the FDCA, requiring that NDI notifications be submitted on a product-by-product basis. This requirement is nonsensical, unreasonable, and contrary to Congressional intent. If Congress had intended for FDA to review dietary supplements at the product level, it would have done so. The appropriate, reasonable interpretation would be to require that NDI notifications be ingredient specific, not product specific.

The final way in which the Draft Guidance is unlawful is FDA’s attempt to effectively regulate dietary supplements as food additives through the NDI notification process. This stands in direct contradiction to Congress’ intent that NDIs be regulated differently from food additives. Congress purposely created different safety standards for the two categories. The proposed NDI notification, however, is essentially a food additive petition. In the Draft Guidance, FDA has turned the NDI notification requirement into a pre-market approval requirement, has imposed food additive petition standards and has made an NDI notification even more restrictive than a Generally Recognized As Safe (GRAS) notification for food additives. This framework is directly contrary to the distinction drawn by Congress between a food additive petition that must be granted by the agency and an NDI, which is by the express terms of the statute a “notification.”

In addition to the unlawfulness outlined here, the Draft Guidance imposes unwarranted and disproportionate burdens on small and mid-sized businesses. FDA fails to address the impact on small businesses at all despite the fact the Draft Guidance has broadened the scope of the classification of NDIs and would impose dramatic changes in the information and documentation requirements for an NDI notification.

Put simply, the scientific and other documentation requirements in the Draft Guidance are unduly burdensome for small businesses that may lack the time and resources to conduct the studies or gather information that FDA now deems necessary. It was not Congress’ intent to unduly burden small businesses in this manner.

For the foregoing reasons, FDA should withdraw the Draft Guidance and propose draft guidance or regulations consistent with the principles set forth.