AHPA President Meets with Sen. Durbin's Staff

WASHINGTONMichael McGuffin, president, the American Herbal Products Association (AHPA), met with members of the staff of Sen. Richard Durbin (D-IL) to discuss the senator's recently expressed concerns about the dietary supplement industry's compliance with cGMPs (current good manufacturing practices).

Sen.  Durbin's interest in this 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 Chicago Tribune article reported FDA "has found violations of manufacturing rules in half of the nearly  450 dietary supplement firms it has inspected" in the past four years, and that "one in four dietary supplement companies inspected by the agency have received a warning letter" in that time.

"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," McGuffin said.

McGuffin also said he reminded Sen. Durbin  that a learning curve is expected when a manufacturing rule is revised," he added. "For example, 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," McGuffin said. "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."

McGuffin also informed 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.

Durbin's letter, co-signed by Sen. Richard Blumenthal (D-CT), stated that AHPA, as one of the leading trade organizations for the dietary supplement industry, "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 inquires 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.

AHPA said it will provide a written response to the senators' letter in the near future.