American Herbal Products Association (AHPA) President Michael McGuffin met with members of the staff of Sen. Richard Durbin, D-Ill., in Washington, D.C., on July 13 to discuss the senator’s recently expressed concerns about the dietary supplement industry’s compliance with federal regulations concerning current good manufacturing practice (cGMP).
Durbin’s interest in the issue was communicated in a letter to AHPA dated July 6, 2012, and was in reference to an article published in the Chicago Tribune on June 30. The Tribune article reported that officials of the Food and Drug Administration (FDA) had determined that the agency “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 that time.

Durbin’s letter, co-signed by Sen. Richard Blumenthal, D-Conn., stated that AHPA “should play a leading role to ensure dietary supplement firms are adhering to cGMPs and are implementing cGMPs before an FDA inspection or warning letter.” The letter also inquired about AHPA’s efforts to ensure that supplement companies are complying with the cGMP rule and expresses an eagerness to hear of the industry’s plans for improving the successful adoption of the rule.

“In meeting with the senator’s staff, I expressed AHPA’s shared commitment to increasing conformity to the supplement cGMP, for which compliance by the smallest companies has been in place for just two years,” Mr. McGuffin said. “But I also communicated that a learning curve was completely expected when we changed from the previously required food cGMP regulation to the significantly more complex new rule and that this learning curve is not uncommon when a manufacturing rule is revised.

“For example,” he continued, “FDA has reported that just 54 percent of seafood companies were in compliance with the new manufacturing rule issued for that industry five years after it was established in 1997.

“In addition, FDA continues to classify more than one-third of recorded food-related inspections as indicating either ‘official action’ or ‘voluntary action,’ the same two categories described in the Chicago Tribune article as ‘violations’ when reviewing supplement manufacturers’ inspections.”

Mr. McGuffin also informed Sen. Durbin’s staff about some of the work that AHPA has done, and will continue to do, to keep its members informed on cGMP issues. This work has included numerous publications and educational seminars and an ongoing process for distribution of FDA’s warning letters to member companies.

AHPA said it would provide a written response to the senators’ letter in the near future.