Supplement industry responds to Senate query on alleged GMP compliance shortcomings
WASHINGTON — The dietary supplement industry recently responded to a Senate query around why the dietary supplement industry is failing to live up to Food and Drug Administration regulations.
Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., contacted three dietary supplement trade associations — the Council for Responsible Nutrition, the American Herbal Products Association and the Natural Products Association — regarding a Chicago Tribune report published last month that suggested the supplement industry was falling short of operating in compliance to good manufacturing practices. "It's downright scary," Daniel Fabricant, head of the FDA's division of Dietary Supplement Programs, told the Chicago Tribune in the June 30 report. "At least half of industry is failing on its face."
"An article published in the Chicago Tribune … reports that in the last four years, the Food and Drug Administration found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it inspected," the senators wrote in a letter to the NPA. "Further, 1-out-of-4 dietary supplement companies inspected by FDA received a warning letter. … To ensure consumer safety, we are eager to hear of the industry's plans for improving the successful adoption of cGMPs by companies that manufacture, package, label and distribute dietary supplements marketed in the United States."
In a letter addressing Blumenthal, NPA executive director and CEO John Shaw wrote, "NPA believes the FDA's reckless comments in the Chicago Tribune article distort the full picture of our membership's overall safety record. In fact, supplements have an excellent safety record, but we appreciate this opportunity to provide more information to you."
"Consumers deserve to know that, without question, their dietary supplement products are safe and made to high quality standards," commented Steve Mister, CRN president and CEO, in a separate letter to Durbin. "We will continue to support FDA in its efforts to assure compliance with the cGMPs; however, the information apparently reported by [the] FDA should also be kept in context."
CRN cautioned the senators against making premature conclusions solely based on the FDA's report that 1-in-4 dietary supplement companies warranted a warning letter following an inspection. The FDA concentrates its enforcement efforts on companies already suspected of being in violation of cGMPs, Mister suggested. "The firms [the FDA] selects for inspections are not a random sampling of the entire supplement industry, nor are they representative of the many firms in full compliance with the GMP requirements."
In response to Fabricant's quote that "half of industry is failing on its face," Mister responded: "The statistics the agency recently presented to industry do not bear out that statement. Based on [the] FDA data shared with the industry in June, a statement, such as, 'at least half of those inspected (as opposed to the industry in general) produced a notation for some form of follow-up action' would be accurate only if one were to include a category of notations for 'voluntary action indicated.'"
VAIs, Mister noted, are minor violations that are oftentimes corrected on the spot and do no warrant subsequent regulatory action.
“We were surprised about the commentary given by the FDA to the Chicago Tribune last week, especially considering our strong ongoing relationship with the FDA to address related concerns," Shaw stated. "We look forward to working with our friends in Congress and the administration to further educate them about the multiple benefits [dietary supplement manufacturers] provide to millions of American consumers.”
For the original Chicago Tribune story (free registration required), click here.
For the letter from Sens. Durbin and Blumenthal to the NPA, click here.
For CRN's response letter, click here.
For NPA's response letter, click here.