FDA seeks public comment on dietary ingredient information

The US Food & Drug Administration (FDA) has called for public comment on the proposed collection of information regarding new dietary supplements.

The announcement was made in the 19 March issue of the Federal Register​. The FDA is required to give a 60-day public comment period on all proposed changes to the way in which it gathers information.

The public is being asked to comment on changes to the information supplied by manufacturers or distributors of dietary supplements, or of a new dietary ingredient, upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe at least 75 days before going on sale.

The agency is seeking public consultation on whether the proposed collection of information is necessary, including whether it will have practical utility. It is also interested in comments on ways to enhance the quality and clarity of the information collected, ways to minimise the burden of collecting the information and the validity of its proposed methodology.

Manufacturers must submit notification of the basis for their conclusion that the supplement or ingredient will reasonably be expected to be safe, and must provide their complete name and address, the name of the new dietary ingredient, a description of the dietary supplements that contain the new dietary ingredient and the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe.

These procedures are designed to enable the FDA to monitor the introduction into the food supply of new dietary ingredients and dietary supplements that contain new dietary ingredients, in order to protect consumers from unsafe dietary supplements. The FDA uses the information collected under these regulations to help ensure that a manufacturer or distributor of a dietary supplement containing a new dietary ingredient is in full compliance with current legislation.

The FDA said it expected there to be only a minimal burden on the industry to generate data to meet the requirements of the new legislation because it was only seeking information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the law.

It said that extracting the information and presenting it in the required format would take around 20 hours of work per submission.