“The most common question we get from our members is whether something is an old ingredient and therefore off-limits to FDA or a new dietary ingredient, which triggers the NDI notification process. While future dietary ingredients may be appropriately subjected to that process, we are developing a safe harbor list now for greater clarity as to exactly what ingredients fall safely into the approved category and can be used in products today,” said NPA CEO Dr Dan Fabricant.
The NPA list is being developed for the industry based largely on evidence from past media reports, advertising, and other public sources, said the association.
Dr Fabricant told us that the organization has good documentation dating back decades - labels and label information from its retailing magazines, and other documents - that make it very clear which ingredients were used and how. "I think it would make it very tough for the Agency to argue against," he said.
NPA hopes to complete the Safe Harbor database of dietary ingredients in the near future, and will engage FDA in the coming months on its methodology and evidence, said the association. "This is going to be very substantial," said Dr Fabricant.
Dr Fabricant acknowledged that there are industry lists from the late 1990s and NPA’s own list from 1996, and the Agency has stated that it is unlikely to solely use the 1992 edition of Herbs of Commerce to determine if an ingredient was available before the passage of DSHEA.
“The 1992 Herbs of Commerce book includes house plants and herbs not intended for human consumption, so it was not recognized by FDA as an authoritative list of pre-DSHEA dietary ingredients. It also focuses on herbs and does not include the myriad of other dietary ingredients falling within the statutory boundaries of a dietary ingredient created by DSHEA,” added Dr. Fabricant.
"In short, we have the evidence FDA is seeking to make these determinations, and we look forward to engaging FDA on developing a safe harbor list. We cannot afford to sit on our hands any longer," said Dr Fabricant.
In response to the announcement, Steve Tave, Acting Director of the FDA's Office of Dietary Supplement Programs, said: "Based on comments that we received from stakeholders in response to the 2011 draft New Dietary Ingredient guidance, the FDA stated in the revised NDI draft guidance that we published last month that we are prepared to develop an authoritative list of pre-DSHEA ingredients. As we explained in the revised draft guidance, we expect industry to play a significant role in compiling the data on which that list will be based.
"In our August 12, 2016 Federal Register notice announcing the availability of the revised draft guidance, we specifically invited comments on how we should develop and implement that list, as well as what method of compiling independent and verifiable data would be most effective. The comment period remains open, and we intend to carefully review all comments we receive on this and other subjects of the revised draft guidance as part of an open public process. As the Federal Register notice explained, comments should be submitted to the docket."
NDI Draft Guidance Language
Q. Is there an authoritative list of dietary ingredients that were marketed prior to October 15, 1994 (a so-called “grandfathered list” or “old dietary ingredient list”)?
A. Not currently. Some trade associations and other industry groups have compiled lists of “old dietary ingredients,” 15 though FDA is unable to verify the accuracy of these lists because we have not seen documentation showing that the ingredients on such lists were marketed as dietary ingredients prior to October 15, 1994 […] However, in response to comments, we are prepared to develop an authoritative list of pre-DSHEA ingredients, based on independent and verifiable data. Because FDA does not generally have access to marketing records for dietary ingredients and dietary supplements, the documentation of pre-DSHEA marketing would have to be supplied by industry.
FDA’s current thinking is that the two main factors for placing an ingredient on an authoritative list of pre-DSHEA ingredients would be: (1) adequate documentation of marketing for use as or in a dietary supplement in the U.S. before October 15, 1994: and (2) a precise description of the identity of the ingredient marketed. Records offered to support an item’s inclusion on the list should specify the date of marketing in the U.S. and clearly identify the ingredient marketed on that date. Documentation of an ingredient’s identity should be sufficiently precise to uniquely identify the ingredient.