FDA Finding 'Huge Challenges that Pertain to GMPs'

LAS VEGAS In the dietary supplement industry, good manufacturing practices or so-called GMPs have been on the books for years.

U.S. regulators, though, are still finding basic tenets of GMPs are not being adhered to, and a top FDA official said the agency wants to join with the industry to create a solution for non-compliance.

Daniel Fabricant, FDA's director of the Division of Dietary Supplement Programs, cited "huge challenges that pertain to GMPs."

"We're taking a little more of a hardline approach," he said at the SupplySide West 2012 Global Expo and Conference in Las Vegas.

If a company is violating GMPs, Fabricant said, "We are going to take that very seriously and move quickly to remedy that violation."

Fabricant cites as evidence multiple enforcement actions that FDA has publicly revealed, adding, "Obviously we have a lot more action than" what is publicized.

He expressed particular concern over unlawful claims presumably so-called disease claims that could have an impact on the public health and result in consumers delaying medical treatment.  

Among some other remarks by Fabricant.

·        FDA is going to revise the new dietary ingredients (NDIs) draft guidance to provide clarify in certain sections, although the agency isn't going to overhaul it. Fabricant said FDA has only received 50 NDI notifications to date, and the agency suspects this is well below what should have been filed.

·        Whether DMAA is a legal dietary ingredient is an open case. 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 possibly not a legal dietary ingredient.

·        A recent Office of Inspector General report, finding many supplements cannot substantiate structure/function claims, concerns FDA. Fabricant also noted the agency is finding more illegal disease claims.

·        Tainted products also are on FDA's radar. Fabricant said the agency wants to work with the industry to reduce adulteration of supplements. He praised industry efforts from the American Herbal Products Association for its website keepsupplementsclean.org and VIRGO for its SupplySide compliance program.

·        FDA is seeing too many products without adverse event reporting documentation. He said supplement companies that don't submit such reports are in violation of the Federal Food, Drug and Cosmetic Act.

·        Fabricant noted FDA's draft guidance on distinguishing beverages from supplements should be finalized soon.