Michael McGuffin, president of the AHPA, delivered the message at a meeting last week held in Washington, DC by the US Food and Drug Administration to discuss the development of a list of pre-DSHEA dietary ingredients. This has been an issue within the industry ever since DSHEA (the Dietary Supplement Health and Education Act) was passed in 1994. The law contains within it a grandfather date of Oct. 15, 1994; anything that comes to market after that date is supposed to go through the New Dietary Ingredient Notification procedure.
The question for more than two decades has been, how does a manufacturer go about proving that its ingredient qualifies as an ODI? FDA has in the past rejected referring to lists of such ingredients that were complied by trade organizations and other industry stakeholders. However, in the most recent iteration of the New Dietary Ingredients Draft Guidance the agency signaled a willingness to work with the industry on developing such a list.
Approach needs to be altered
But McGuffin said that the way the agency is going about this effort, with its emphasis on documentary proof, is unpromising. Various types of proof of the marketing of such ingredients prior to the grandfather date, such as advertisements, sales sheets, etc., either do not provide the level of detail common in today’s marketplace, or no longer exist, as many companies have gone out of business, been acquired, etc. Having such detailed records, such as sales sheets or technical specifications on ingredients marketed more than 20 years ago, would be a lot to hope for even if a company had been in business all those years and under the same management.
"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 should accept records that are currently widely available, including the aforementioned 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 are other possible resources.
- 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 US as of October 15, 1994.
- Any authoritative list should include any traditionally processed ingredient derived from a pre-DSHEA botanical ingredient, since these can be assumed to have been on the market.
- FDA should take a broader view of what ‘on the market’ means, and 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. 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.
Best use of agency resources?
Part of McGuffin’s statement also addressed the question of whether developing a list was really the best use of agency resources. If there were some enforcement discretion applied, as detailed above, the agency could use its resources in other ways that would potentially have a greater impact on the safety of supplements.
“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.
McGuffin also cautioned those in attendance at the meeting that ODI ingredients are just old; they are not necessarily recognized as safe. Manufacturers still must insure the safety of their ingredients.