Adulteration, GMPs top FDA watchlist

Addressing a packed room at SupplySide MarketPlace in New York Wednesday, FDA's Dietary Supplement Division Director Dan Fabricant laid out the agency's view of several key natural products industry issues, including dietary supplement good manufacturing practices (GMPs) and mandatory serious adverse events reports (SAER).

As expected, GMPs are still problematic, with 69% of inspections in 2012 requiring either voluntary or official actiononly 27% of inspections required no action. Fabricant emphasized that there are no  "carrots" with GMPs, meaning a "passed" inspection is not a certification or stamp of OK from FDA, and it is unlawful to advertise it as such.

Adulteration, both intentional and inadvertent continues to plague weight-loss, sports/bodybuilding and sex health markets, as well as botanicals in general. While these are well-known areas of concern, Fabricant noted FDA has seen emerging adulterants, including compounds central nervous system (CNS) actives.

FDA has stepped up its enforcement activities in the natural products industry. Through March 2013, FDA has sent 42 warning letters to industry companies, but Fabricant noted FDA consistently has a three-month backlog of letters signed off and ready for mailing.

Fabricant touched on DMAA, which was recently the subject of an FDA Consumer Alert detailing safety concerns. He said FDA's primary goal was to remove the product from the market, to keep the public safe from the dangers of DMAA. He acknowledged the last DMAA manufacturer holdout has announced it's reformulating to remove DMAA from products, Fabricant said additional enforcement activity is still possible. He further assured a lack of a DMAA ban does not mean it is legal to sell the compound as a dietary supplement.

Citing recent GAO (Government Accounting Office) report data, SAERs have been low in the supplement industry257 unique firms reported AERs. One issue with AERS is the agency is not seeing much follow-up on AERs, which is mandatory. There are also still many dietary supplements on the market without proper U.S. domestic contact info (street address or phone number), which amounts to misbranding.