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FDA, Stakeholders Meet, Mull Over Pre-DSHEA Dietary Ingredients List

AIDP

On October 3, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of pre-Dietary Supplement Health and Education Act of 1994 (DSHEA) dietary ingredients.

According to a release from Washington, D.C.-based law firm Keller and Heckman LLP, the meeting featured two stakeholder panels that presented on two distinct issues: the standard of evidence required to show a dietary ingredient belongs on the pre-DSHEA list; and the process by which dietary ingredients should be added to the list. The first panel included representatives from the National Institutes of Health (NIH), Harvard Medical School, the United Natural Products Alliance (UNPA), the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA).

The panelists proffered the following as potential forms of pre-DSHEA evidence: shipping documents, bills of lading, records from contract manufacturers, catalogs, trade association lists, monograph standards set by the United States Pharmacopeia (USP), the Peterson Field Guides, the Farmer’s Almanac, field books (i.e., boy scout field book), the U.S. Dispensatory, ingredient or supplement marketing materials, analyst worksheets, and 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.

AHPA President Michael McGuffin stressed that the FDA must make some significant changes to previous positions on new dietary ingredients (NDIs) in order to successfully create an authoritative list of old dietary ingredients (ODIs) in a statement delivered at the meeting.

“AHPA and its members will need to see a significant shift in the agency’s thinking if we are to embrace the current effort,” McGuffin said. “The effort by FDA to create an ‘authoritative list’ of ODIs or pre-DSHEA ingredients as previously described in FDA’s revised draft NDI guidance issued in 2016 is unlikely to be successful in actually compiling a list of these ingredients.”

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 (NPA), The Pew Charitable Trusts, Center for Science in the Public Interest, Consumer Healthcare Products Association (CHPA) 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.

McGuffin also questioned if developing a list of pre-DSHEA ingredients was the best use of resources.

“If FDA and especially the Office of Dietary Supplement Programs has resources to spare, AHPA believes these resources might be better addressed to improving a mutual agency-industry understanding of the FDA’s current good manufacturing practice regulation for supplements and to assisting manufacturers, especially small entities, to comply with this complex rule,” he said.

The NDI provision of the law only establishes that old dietary ingredients are old; it does not establish that every old dietary ingredient is safe in any quantity for any person, McGuffin reminded meeting attendees. Whether a supplement is made with pre-DSHEA ingredients or new dietary ingredients it is held to the same standard under the adulteration clause of the Food, Drug and Cosmetic Act (FDCA) and is adulterated if it “presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labelling,” or under ordinary conditions of use.

On Hyman, Phelps & McNamara’s official FDA Law Blog, A. Wes Siegner, Jr., who provides counsel on FDA and Federal Trade Commission (FTC) regulation of foods and dietary supplements, commented, “As FDA’s focus should be ingredient safety, the obvious conclusion is that FDA should turn its attention from ODIs and instead work with industry to identify any ingredients for which safety concerns exist, and then, using the existing adulteration provisions of the FDC Act as well as an appropriate interpretation of the NDI provision, either remove these ingredients from the market or require NDI notifications. As this change in focus will require an abandonment of FDA’s long held but ill-conceived views of DSHEA, the necessary change will not likely occur without guidance from FDA’s new leadership, under the watchful eye of Congress.”