AHPA responds to senators' request for cGMP compliance efforts

AHPA responds to senators' request for cGMP compliance efforts

McGuffin's response letter outlined AHPA's many efforts to help supplement companies get in compliance.

The American Herbal Products Association (AHPA) responded on July 23 to a request made in a July 6 letter by Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., requesting that AHPA, as one of the leading trade organizations for dietary supplements, inform the senators about AHPA's efforts to ensure that supplement companies are complying with the current good manufacturing practice (cGMP) regulations. Additionally, the senators expressed an eagerness to hear of the industry's plans for improving the successful adoption of the rule.

The July 6 letter from Durbin and Blumenthal was in reference to an article published in the Chicago Tribune on June 30. The Tribune article reported that the Food and Drug Administration (FDA) had found violations of manufacturing rules in half of the dietary supplement firms it had inspected in the past four years.

AHPA President Michael McGuffin had previously met with Durbin's staff on July 13 to discuss these issues.

In AHPA's response letter, McGuffin noted that all companies that manufacture, package, label, or distribute dietary supplements in the United States have been required to be in compliance with the rule (21 CFR 111) for between just over two years to just over four years.

AHPA's efforts to ensure that supplement companies are complying with the current good manufacturing practice (cGMP) regulations include:

  • The preparation of numerous documents and seminars, beginning in 2006, to highlight key elements of cGMP and compliance with the rule
  • Production of training classes in microscopy and thin-layer chromatography to assist companies to learn the skills needed to use these tools to meet the dietary-ingredient testing requirements of the cGMP
  • Distribution to AHPA members of many of FDA's warning letters to dietary supplement companies, some of which cite cGMP issues
  • Collection, analysis, and organization of records of FDA dietary supplement cGMP inspections to better understand the specific sections of 21 CFR 111 that are the subject of FDA observations during cGMP inspections.

AHPA is gathering the information about cGMP inspections to inform its ongoing process of identifying the most important areas of focus for future seminars and other communications to members.

The letter also outlines AHPA's plans for improving the successful adoption of the rule: "AHPA intends to continue to produce and provide seminars and associated guidance documents on cGMP-related issues; to produce trainings on microscopy, chromatography, and possibly other analytical methods; to obtain and evaluate FDA's dietary supplement cGMP inspection records; and to distribute FDA warning letters related to cGMP matters."

In closing, McGuffin requested that the senators contact him should they require any additional information about any of AHPA's past and current efforts, as identified in the letter.

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