Industry Responds to Durbin Letters

Written By:
WholeFoods Magazine Staff
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Washington, D.C.—American Herbal Products Association (AHPA) President Michael McGuffin met with the staff of Senator Richard Durbin, (D-IL) on July 13, addressing the senator’s about the dietary supplement industry’s compliance with the federal regulated current good manufacturing practices (cGMPs).

Durbin’s letter, co-signed by Senator Richard Blumenthal (D-CT), was in reference to a negative article published in the Chicago Tribune on June 30. It stated that the U.S. Food and Drug Administration (FDA) “found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected” in the past four years, and that “1 in 4 dietary supplement companies inspected by the agency have received a warning letter.”

In letters to AHPA and the Natural Products Association (NPA), Durbin contended that the main trade organizations for the dietary supplement industry “should play a leading role to ensure dietary supplement firms are adhering to cGMPs… before an FDA inspection or warning letter.”

McGuffin and NPA executive director and CEO John Shaw were both surprised and in disbelief of the Senators’ accusations. According to McGuffin, dietary supplement firms are still fine-tuning their GMP compliance, as it was only three years ago that new more complex regulations were made enforceable. “This learning curve is not uncommon when a manufacturing rule is revised,” said Mcguffin. Although this nonconformity is not ideal, AHPA is working with its members to improve the successful adaptation of the new rule.

“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,” said Shaw. “We look forward to working with our friends in Congress and the administration to further educate them about the multiple benefits NPA (and AHPA) members provide to millions of American consumers.”

Also receiving a letter was the Council for Responsible Nutrition (CRN), which directly responded to Durbin with a letter, as did AHPA. Both assured Durbin they are working to deter a learning curve and strive for perfection via in-depth webinars, in-person educational briefings and seminars for both member and nonmember companies. In addition, AHPA is offering trainings on microscopy, chromatography and possibly other analytical methods to obtain and evaluate FDA’s dietary supplement cGMP inspection records.

CRN expressed its dissatisfaction for the slanted writings in both Durbin’s letter and the Chicago Tribune article. President and CEO Steve Mister was angered by the FDA’s random sampling methods, which looked poorly on the entire industry as a whole. Also, stating that “1 in 4” firms held cGMP violations additionally supported the negative image, as it seemingly ridiculed the entire industry and not just the few that did not comply.

NPA, CRN and AHPA say they will continue their educational programs to help raise all related companies to conform to FDA’s new cGMP regulations.

The trades weren’t the only ones vocal on the issue. Jarrow Formulas, Inc. put together its own comments on the issue (prepared by attorneys Susan Brienza, Esq., and Scott Polisky, Esq.). They feel the Chicago Tribune writer presented skewed and erroneous facts in the article, and they says it was reckless to condemn an entire industry for the actions of a few. In contrast, they state that the supplement industry is “doing quite a fine job” of GMP compliance, also noting the many failures of the food, drug and medical device industry to maintain compliance.

 

Published in WholeFoods Magazine, September 2012 (online 7/16/12, updated 7/30/12, 8/3/12)