The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today.
That has been one of the concerns raised early on — namely, that the finalized rule would force a spate of recalls. “We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to Dietary Supplement Health and Education Act [passing in 1994] should remain on the market,” stated Cara Welch, VP scientific and regulatory affairs for the Natural Products Association. “The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. … These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.”
In the guidance, the FDA estimated, all told, that 55,600 supplement products are currently on the market. According to the FDA, there is no authoritative list of dietary ingredients that were marketed in dietary supplements before Oct. 15, 1994. Manufacturers and distributors would be responsible for documenting that the supplement was marketed prior to that date.
“This draft guidance document describes the agency’s interpretation of the requirements for NDIs; it is not a new regulation and does not create new rights or responsibilities for the industry,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “Nevertheless, this draft guidance does represent an important step for the dietary supplement industry — and for the agency — as it demonstrates further implementation of the requirements of the [DSHEA] and will give companies clearer understanding of [the] FDA’s expectations under the law.”
If the final implementation of the NDI rule does not necessitate the recall of supplements currently sold in mass outlets, then the announcement adds to the credibility already being enjoyed by the industry, credibility fueled by factors like supplement-specific good manufacturing practices, mandatory serious adverse event reports, industry lobbying efforts and an industry-sponsored self-regulation initiative with the National Advertising Division of the Better Business Bureau.
CRN plans to host a webinar addressing the new guidance on Sept. 14.