Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. He said the most important topic is good manufacturing practices (GMPs), but that’s not the only supplement issue that’s currently top of mind to FDA.
In short, Fabricant said these are the most pressing industry issues:
- New dietary ingredients (NDIs)—FDA is going to revise the NDI draft guidance to provide clarity in certain sections; the agency isn’t going to overhaul it. FDA doesn’t have a timeline on when it will be released. He added that in 2012, FDA has only received 50 NDI notifications; the agency suspects that this is well below what should have been filed.
- DMAA—Whether DMAA is a legal dietary ingredient is an open case, according to Fabricant. However, he said four recent peer-reviewed articles indicate DMAA isn’t in geranium oil. This means FDA most likely believes it’s synthetic and therefore, possibly not a legal dietary ingredient.
- GMPs—FDA has found that basic tenets of GMPs are not being adhered to, and Fabricant said the agency wants to join with industry to create a solution for noncompliance.
- Illegal marketing claims—The recent Office of Inspector General (OIG) report that found many supplements can’t substantiate its structure/function claims concerns FDA, he said. He added that the agency is finding more illegal disease claims that it is comfortable with.
- Adulteration—Tainted products are also a big issue. Fabricant said that the agency wants to work with the industry to reduce adulteration of supplements. He praised industry efforts from the American Herbal Products Association (AHPA) for its website keepsupplementsclean.org and VIRGO for its SupplySide compliance program.
- Adverse event reports (AERs)—FDA is seeing too many products without AER reporting documentation. Also, Fabricant said supplement companies that don’t submit AERs are in violation of the federal Food, Drug and Cosmetic.
- Energy drinks—Fabricant noted FDA’s draft guidance on distinguishing beverages from supplements should be finalized soon.
Supplement manufacturers should be aware of what areas FDA is focusing on, and use this information to check their operations to ensure they are compliant.