FDA's Meeting on Establishing a List of Pre-DSHEA Dietary Ingredients
On October 3, 2017, the US Food and Drug Administration (FDA) held a public meeting to discuss the future development of an authoritative list of "old" dietary ingredients. See the meeting announcement at 82 Fed. Reg. 42098 (Sep. 6, 2017). While the meeting represented a good first step, it is unlikely that FDA will move very quickly to compile a meaningful ingredient list. Nevertheless, dietary supplement industry members should follow the Agency's progress and take advantage of opportunities to provide input (such as the comment period following the meeting (discussed below)).
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish separate regulatory requirements for dietary supplements. 21 U.S.C. §§ 301, 321, 343, 350 (1994). As background, a "dietary supplement" is a product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredients, including (1) a vitamin, (2) a mineral, (3) an herb or other botanical, (4) an amino acid, (5) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (6) a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. 21. U.S.C. 321(ff). A manufacturer of a dietary supplement that contains a new dietary ingredient (NDI) must submit a pre-market notification, called a new dietary ingredient notification (NDIN), to the FDA at least 75 days before marketing a dietary supplement that contains an NDI. 21 U.S.C. 350b. However, dietary ingredients that were marketed in the United States before October 15, 1994 do not require pre-market review by the FDA. These dietary ingredients are referred to as "old" or "grandfathered" dietary ingredients.
Currently, there is no authoritative FDA-recognized list of pre-DSHEA "old" dietary ingredients. On August 12, 2016, FDA issued a revised Draft Guidance that indicated that it was willing to develop an authoritative list of dietary ingredients that were marketed before October 15, 1994. See Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredients Notifications and Related Issues. The meeting on October 3rd was FDA's first step in developing this list.
The FDA public meeting featured two stakeholder panels that presented on two distinct issues: (1) the standard of evidence required to show a dietary ingredient belongs on the pre-DSHEA list; and (2) the process by which dietary ingredients should be added to the list. The first panel included representatives from the National Institutes of Health, Harvard Medical School, the United Natural Products Alliance, the Council for Responsible Nutrition, and the American Herbal Products Association. The panelists proffered the following as potential forms of pre-DSHEA evidence: (1) shipping documents, (2) bills of lading, (3) records from contract manufacturers, (4) catalogs, (5) trade association lists, (6) monograph standards set by the United States Pharmacopeia, the Peterson Field Guides, the Farmer's Almanac, field books (i.e., boy scout field book), the U.S. Dispensatory, (7) ingredient or supplement marketing materials, (8) analyst worksheets, and (9) research published on PubMed.gov, among others. Affidavits would be accepted if accompanied by verifiable data.
Additionally, industry stakeholders suggested the pre-DSHEA list could include ingredients that are Generally Recognized as Safe (GRAS) and listed in FDA's Everything Added to Food in the United States (EAFUS) database; however, this recommendation was met with some opposition. Several stakeholders argued for the creation of a comprehensive list of all ingredients, to include the pre-DSHEA ingredients, NDIs notified to FDA, and ingredients already in the food supply. It was argued that this comprehensive list would provide a significantly more meaningful resource for industry and FDA.
The panelists discussed the means to define identity of an ingredient, with a focus on processes that alter an ingredient's identity. Although no conclusions were reached, the panelists considered the idea of an abbreviated notification for the new processing of an ingredient with the same or similar profile.
During the second panel, the discussion focused on the process by which ingredients should be added to the pre-DSHEA list. Panelists included the Natural Products Association, The Pew Charitable Trusts, the Center for Science in the Public Interest, Consumer Healthcare Products Association, and the Consumers Union. The panelists floated process ideas, including an expert panel to generate the pre-DSHEA list, subject to FDA review, a method to delist ingredients found to be unsafe, and to rely on information from the FDA's Adverse Event Reporting System (AERS) or the industry-created lists, which were argued to already have the necessary pre-1994 marketing evidence. One panelist suggested the process of a public docket for stakeholders to submit ingredients with the requisite supporting documentation. The FDA would then compile the nominations into a list, but would have the discretion to remove ingredients. In addition to process recommendations, much of the second panel discussion detailed the importance of the public's health and safety. The panelists urged the FDA to clarify that the list would not be a safe harbor for unsafe ingredients to continue to be sold. Panelists reiterated FDA's statement that the inclusion of an ingredient on the list does not guarantee its safety or efficacy. Further, FDA stated that a listed ingredient may be removed should the ingredient be found unsafe.
Finally, FDA discussed creating a pre-DSHEA list that would be authoritative, but not comprehensive, meaning ingredients that satisfy the pre-DSHEA requirements could be continually added to the list.
Each panel discussion concluded with questions and comments from the public. FDA will allow interested parties to comment on the public meeting by submitting electronic or written comments through December 4, 2017. Interested parties with any questions regarding the public meeting or who would like assistance in preparing comments regarding the development of a list of pre-DSHEA dietary ingredients are encouraged to contact Keller and Heckman LLP for more information.