AHPA recommended that the Food and Drug Administration (FDA) make significant changes to previous positions on new dietary ingredients (NDIs) in order to successfully create an authoritative list of old dietary ingredients (ODIs) in comments submitted to FDA.
AHPA's comments were submitted in response to FDA's request for input on issues related to the future development of a list of dietary ingredients marketed in the United States prior to October 15, 1994, when the Dietary Supplement Health and Education Act (DSHEA) became law.
"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."
Recommendations suggested by McGuffin at the meeting include:
- The agency must accept records that are currently widely available, modified as needed to make corrections or to remove a few specific listed ingredients. These include the lists submitted by industry in the years just after DSHEA was passed, AHPA's two editions of Herbs of Commerce, and the numerous other publications like herb books, farmers almanacs, herbal ingredient catalogs, and pharmacopoeial references.
- FDA should abandon any quest for absolute proof of pre-DSHEA marketing and move toward exercising enforcement discretion for dietary ingredients that are acknowledged as very likely to have been marketed in the U.S. as of October 15, 1994. This suggestion is consistent with FDA's statement in its September 6, 2017 Federal Register notice that the agency should "better focus our enforcement efforts in alignment with our strategic priorities of consumer safety, product integrity, and accurate information."
- Any authoritative list should include any traditionally processed ingredient derived from a pre-DSHEA botanical ingredient, since it should be assumed that every botanical raw material that was marketed in the U.S. pre-DSHEA was also marketed in an extract form manufactured through traditional processing (e.g., tinctures, oils, vinegars, etc.).
- FDA should move away from its prior position that only pre-DSHEA use of an ingredient in a product that would today be identified as a dietary supplement actually demonstrates an ingredient to be a pre-DSHEA ingredient. AHPA believes that Congress intended the mere presence in the marketplace of any orally consumed dietary ingredient - whether in a conventional food, a supplement-form product, or an ingredient used in a traditional therapeutic product other than a new drug - to be sufficient to establish the ingredient as an existing, or old, dietary ingredient. The separate adulteration provisions of the law protect against any use of such ingredients unless reasonably expected to be safe.
- FDA should clearly communicate that there is no requirement for a dietary supplement company to document that pre-DSHEA ingredients used in their dietary supplements are ODIs.
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," McGuffin said.
The NDI provision of the law only establishes that old dietary ingredients are old; it 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 labeling," or under ordinary conditions of use.