Issue link: http://www.e-digitaleditions.com/i/845331
32B July 2017 Tablets & Capsules S regulatory compliance FDA draft Guidance on new dietary ingredients: Do you need to file? Amy Scanlin EAS Consulting Group The August 2016 draft Guidance on new dietary ingredients (NDIs) broadened the definition of what the FDA considers an NDI, leading many manufacturers to wonder if they should submit notifications for products they've had on the market for years. This article explains the issues and discusses steps man- ufacturers should take to avoid FDA action. ince the Dietary Supplement Health and Education Act (DSHEA) became law in 1994, companies have needed to prove the safety of their dietary supplement ingredients before products reached the market. Ingredients that were marketed in the USA prior to October 15, 1994, how- ever—a period known as pre-DSHEA—were grandfa- thered in and considered safe by the FDA. Post-DHSEA, any manufacturer planning to use a new dietary supple- ment ingredient must submit a new dietary ingredient notification (NDIN) prior to distribution. If a notification receives no comment from the FDA, the manufacturer can market products containing the ingredient [1]. That seems straightforward, but manufacturers may have to do some research to prove that the ingredients they use in their products are pre-DHSEA because there is no FDA list of pre-DSHEA ingredients. Furthermore, while lists of pre-DSHEA ingredients compiled by the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association, or other organizations may be helpful, the Agency doesn't recognize them. And even if manufacturers can prove their ingredients were mar- keted pre-DSHEA, they may still be required to file an NDIN, according to the August 2016 draft Guidance [2]. It's important to understand this draft Guidance, because in many cases the FDA interprets guidances, even draft guidances, as de facto regulations. The August 2016 draft Guidance on NDIs, which replaces one issued in July 2011, expands the definition of NDIs to include pre-DHSEA ingredients that have been significantly altered. Alteration includes changing the manufacturing process, changing the dosage form in which the ingredi- ent is used, combining ingredients, and/or using extrac- tion processes and/or delivery systems different from those used before 1994. Changes that require NDINs How different is different enough to warrant an NDIN? "Where it becomes a gray area for manufacturers is in the definition—or interpretation—of what consti- tutes a chemical, manufacturing, and/or use change of an ingredient that was on the market prior to October 1994," said Tara Lin Couch, an EAS independent advisor for dietary supplements. "The FDA has provided a very broad definition, so broad that some trade organizations such as the CRN estimate that 50 to 60 percent of dietary supplement products on the market need NDINs." Chemical alteration, according to the draft Guidance, includes any "attempts to selectively increase the concentra- tion of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the