AHPA responds to Sen. Durbin-Blumenthal cGMP questions
The request from Senators Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., came in response to an article in the Chicago Tribune last month that claimed “serious and widespread manufacturing problems” among dietary supplement companies, with FDA officials reportedly citing violations in 50% of the 450 firms inspected over the last four years.
In a letter dated July 23rd, AHPA’s president, Michael McGuffin, writes: “AHPA plans to continue many of the efforts described above to assist companies that manufacture, package, label, and distribute dietary supplements marketed in the United States to improve their successful implementation of 21 CFR 111.
“For example, 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.”
Tribune tribulations
Both NPA and CRN responded mid-month to the senators outlining efforts to ensure companies that dietary supplement companies comply with current Good Manufacturing Practices (cGMPs). AHPA has now responded at length to the senators.
AHPA has now formally replied to the senators, and notes that its 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.
FDA
A spokesperson for FDA confirmed for NutraIngredients-USA last week that the quote that 50% of the industry was "failing on its face" did indeed represent a combination of OAI (Official Action Indicated) and VAI (Voluntary Action Indicated).
"For FY 2012 the number of OAI is currently about 35% and the % of VAI is about 30%. A VAI classified inspection is still indicative of GMP violations and a situation where evidence of non-compliance to 21 CFR Part 111 is documented," added the spokesperson.
Speaking at AHPA’s inaugural Botanical Congress in New York in May, Dr Fabricant told attendees that the agency viewed GMP compliance as the biggest issue for the industry. In 2011 FDA conducted 175 GMP inspections, filed its first injunction, and seized products for the first time.
Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, and 84 in 2010, according to FDA data. As of May 2012, FDA already had 38 inspections "under its belt".
FDA randomly samples dietary supplement firms based on the firms registered with FDA in accordance with the ‘Bioterrorism Act”, added the FDA spokesperson.
