FDA on warning letters: ‘We are going to do more than just hand out paper’

By Stephen Daniells

- Last updated on GMT

Related tags: Dr fabricant, Adverse event, Good manufacturing practice, Dietary supplement

"There are obviously other programmatic areas that are important right now – adverse event reporting, the cGMPs – and these are critical." Dr Dan Fabricant, FDA
"There are obviously other programmatic areas that are important right now – adverse event reporting, the cGMPs – and these are critical." Dr Dan Fabricant, FDA
The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.

Speaking to attendees at the Council for Responsible Nutrition’s (CRN) conference in Rancho Palos Verdes in California via webcast this week, Dr Fabricant said that, while the NDI draft guidance is a hot topic for the industry, it may take up to 18 months to resolve that discussion, depending on the nature of the comments.

“I don’t want the discussion [on the guidance] to become a distraction,”​ he said. “There are obviously other programmatic areas that are important right now – adverse event reporting, the cGMPs – and these are critical.

“So while it’s important that people may have a feeling one way or the other on the draft guidance, it’s also important to stay engaged with federal partners, especially as the spiking problem persists.”

Flexing muscles?

In response to a question from the CRN’s Steve Mister about a potential FDA move beyond warning letters to actual enforcement of GMP violations, Dr Fabricant said: “I cannot talk about what the future holds but I do think we are going to do more than just hand out paper.”

There has already been an example of a more muscular approach in 2011: At the start of the June, the Department of Justice found two New Jersey based supplement companies and their owner guilty of multiple counts of criminal contempt of court for violating a consent decree​ relating to GMP violations.

Big picture

Dr Fabricant addressed CRN conference attendees on a range of topics, including GMPs, serious adverse event reporting, and the new dietary ingredient (NDI) draft guidance.

On the topic of GMPs, Dr Fabricant reserved special mention for the adulteration clause: “This is a fairly strong part of the law and no other category of food can be labeled as adulterated if they don’t meet GMPs, other than dietary supplements. So this is significant and important.”

According to FDA data, only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of this year, there have been 145 inspections.

On the topic of potential re-inspection fees based on the Food Safety Modernization Act (FSMA), Dr Fabricant could not answer definitively: “We’re just rolling those out and obviously fee waivers have to be considered, especially with the small business element. I hate to punt, but it’s going to be some time in making that distinction.”

Beyond our borders

Dr Fabricant also talked about carrying out inspections outside of the US.

“We have been doing some training of Chinese officials on the ground there to do inspections there,”​ he explained. “There are always jurisdictional issues on the ground in China but certainly we are looking at whether we can build an assignment and carry out inspections in that country

“I think the key thing is the information we have – who are the firms, can we identify the firms that are maybe more interesting, if you will, to visit.”

When asked about the potential to stop products at the border, Dr Fabricant noted a recent administrative detention, “so, I do think there are some prospects”​.

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