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Updated: Associations welcome Durbin-Blumenthal cGMP dialogue & FDA explains GMP violation stats

By Stephen DANIELLS , 12-Jul-2012
Last updated the 13-Jul-2012 at 17:31 GMT

The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have welcomed requests from Senators Durbin and Blumenthal to outline cGMP education initiatives, but questions have been raised as to the numbers cited by FDA officials regarding GMP violations.

The request from Senators Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., came in response to an article in the Chicago Tribune last week 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 the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have responded to requests from the senators asking them to outline efforts to ensure that dietary supplement companies comply with current Good Manufacturing Practices (cGMPs).

A spokesperson for the American Herbal Products Association (AHPA) confirmed that a formal written response to the two senators will be released shortly. “There's quite a bit of information to relay to them,” he said.

Not representative

Despite welcoming the approach by Senators Durbin and Blumenthal to create a working dialogue to address concerns, the associations are questioning the data cited in the Tribune article regarding the number of violations.

FDA’s Dr Dan Fabricant, is quoted in the Tribune as saying: "At least half of industry is failing on its face".

Steve Mister, President and CEO of CRN told NutraIngredients-USA that the association and its members take cGMP compliance very seriously. “While I am concerned that there are pockets of the industry that have their heads stuck in the sand [regarding cGMP compliance], these pockets are not representative of the industry,” said Mister.

VAIs

In his letter to the senators and published on the CRN website (available here ), Mister writes: “Based on FDA data shared with the industry in June, a statement such as ‘At least half of those inspected (as opposed to the industry in general) produced a notation for some form of follow-up action’ would be accurate only if one were to include a category of notations for ‘voluntary action indicated’ (VAI).”

“VAIs are issued for those items observed during an inspection where ‘objectionable conditions were found and documented but the ORA District and/or FDA Center is not prepared to take or recommend any regulatory action at the time since the objectionable conditions may not meet the threshold for regulatory action and the firm has voluntarily corrected the conditions during the inspection or has promised immediate correction following completion of the inspection’.”

“Consumers deserve to know that, without question, their dietary supplement products are safe and made to high quality standards.

“We appreciate that FDA is enforcing the regulations […] We agree with FDA that the goal should be 100 percent compliance by 100 percent of supplement companies.”

OAI + VAI

A spokesperson for FDA confirmed 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.

"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 the American Herbal Products Association's (AHPA) 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. 

Fully-regulated industry

Newly-appointed NPA Executive Director and CEO John Shaw said: “Like the senators, we’re concerned any time a violation may be found with a supplement manufacturer and it’s an issue we take seriously.

“It’s important to emphasize that dietary supplements are part of a fully-regulated industry and good manufacturing practices apply to all supplement manufacturers, large or small.”

Shaw also expressed surprise with quotes attributed to FDA in last week’s Chicago Tribune article. Shaw said NPA has a “strong ongoing relationship with the FDA to address related concerns”.