FDA Updates Dietary Supplement Guidance Regulation (August 2016)

The FDA is publishing a revised draft of the 2011 guidance document for dietary supplement premarket safety notifications and new dietary ingredients (NDI) reporting. These notifications are an important aspect in the regulation process for dietary supplements as they help the agency protect the public from consumption of harmful ingredients by identifying and addressing safety issues before putting products on the market. According to their website, FDA estimates that out of the 55,600 dietary supplements on the market and the 5,560 new dietary supplement products that come into the market each year, less than 1,000 NDI notifications have been received since the passing of the Dietary Supplement Health and Education Act (DSHEA) in 1994. With the new draft, FDA aims to resolve unclear points and stress the reasoning behind their recommendations.

DSHEA requires those who produce or distribute dietary supplements to report to the FDA 75 days before marketing products that contain NDIs not previously marketed in the US before October 15, 1994. Products with NDIs not in the food supply and without a submitted notification are considered “adulterated,” and may be subject to enforcement action by FDA.

The FDA is submitting the draft for public comment for a 60-day period. Comments can be made electronically or mailed to the Agency.

For assistance in determining whether or not your dietary supplements are being registered and labeled correctly, please visit our
website or call us at 530-757-1245. TSG’s team of experts, including senior regulatory consultant Bob Stewart, are experienced with ensuring product compliance for dietary supplements and helping clients adhere to federal regulations.