The learning curve for GMP compliance is to be expected – just look at other FDA-regulated industries, Michael McGuffin, president The American Herbal Products Association (AHPA), told staff for Senator Dick Durbin in a meeting July 13.
"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," said McGuffin.
"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," he added.
"For example, FDA has reported that just 54% 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."
Senators Durbin, D-Ill., and Richard Blumenthal, D-Conn., contacted three trade associations – the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and AHPA - following 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.
Both NPA and CRN responded to the senators last week outlining efforts to ensure companies that dietary supplement companies comply with current Good Manufacturing Practices (cGMPs). AHPA will provide a written response to the senators' letter in the near future, said the association.
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.