Speakers included Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP. Dr. Cara Welch, NPA vice president of scientific and regulatory affairs, served as moderator. The webinar lasted about 90 minutes and included a spirited exchange between Fabricant and Bass on the important issues raised by the draft guidance. They also took questions from the audience.
NPA Executive Director and CEO John Gay said, “We are pleased that so many signed up to learn about the impact that the NDI draft guidance may have on the industry. NPA’s education session, the first in the industry, provided an excellent opportunity to hear directly from the FDA about what this guidance means and get additional perspective from industry experts.”
Gay added, “Several participants expressed concerns about how the draft guidance may affect their business. NPA is concerned that the ability of Americans to get the supplements they want and need may become more restricted. We believe it’s vital that consumers continue to have access to popular, safe dietary supplements.”
Some key quotes from the webinar:
Dr. Daniel Fabricant: “The FDA estimates there are about 55,600 dietary supplements on the market, yet we’ve only received 700 NDIs in the past 16 years, approximately 50 NDIs per year…We believe, as I hope the industry believes, that consumers should have access to supplements that meet quality standards, that are free from contamination, accurately labeled, and that, especially for new ingredients, have an assurance of safety.”
“I think it’s been clear that people should have kept records. Again, there is a definition in DSHEA of when that time signature started…The best policy is for any company to maintain its own records confirming long term use of an ingredient.”
Scott Bass: “I think everybody has had the reaction that this document elevates NDI submission to the food additive or GRAS levels. There are problems inherent in that…A great concern that I have, and I think that exists, is that we may be condemning products that have been on the market for almost 20 years that people have presumed to be legal, other than your basic vitamins and minerals. It could be that every product is in play.”
“There just aren’t records for a lot of these ingredients and that was known at the time. If you got in before October 1994 with no known safety problems, you were grandfathered in. That’s where we thought things were until the last couple of years. The industry is surprised that what they thought were acceptable products for 15-20 years now might be on the block.”