The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing practice (cGMP) violations.
Speaking at the American Herbal Products Association's (AHPA) inaugural Botanical Congress in New York this week, Dr Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, told attendees that said FDA conducted 175 GMP inspections in 2011, filed its first injunction, and seized products for the first time.
Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010, according to FDA data. In 2012, FDA already has 138 inspections "under its belt".
“It won't be the last time we use those authorities," said Fabricant. "It's something to be mindful of. It's something we take very seriously, as you've seen from the actions."
The increase in inspections has been followed by a significant uptick in the number of warning letters for GMP violations: In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations – from failure to establish product specifications to failure to maintain adequate records, according to Ivan Wasserman and La Toya Sutton from Manatt Phelps & Phillips in Washington, DC .
On the topic of the NDI draft guidance, Dr Fabricant reiterated that the agency is not preparing to enforce the draft guidance.
He recalled a presentation he gave last year where "... the big issue on the table was the NDI draft guidance. I'm sure for many of you it still is. And it is just a draft guidance. I think everyone's heard me say that a million times, and we'll make it a million and one: It's just a draft guidance.
"GMPs (are) the biggest challenge ... facing the dietary supplement industry, at least that's the way the regulators see it, and we hope everyone understands that."
The industry is making progress with GMPs, however, and Dr Fabricant recently told attendees to a webinar on cGMP compliance organized by the Natural Products Association (NPA) that he was “very excited” by what progress had been made so far in raising awareness about cGMP requirements.
Despite such progress, the same mistakes continue to be made by companies, he said.
Dr Fabricant told attendees at the AHPA Botanical Congress that the most common areas of cGMP noncompliance discovered during FDA investigations, include:
- Failure to prepare a master manufacturing record
- Failure to prepare a batch record
- Failure to establish specifications
- Failure to determine if specifications are met
- Failure of adequate quality control