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FDA: All Stick (and No Carrot)

October 24, 2015 10:29 am0 commentsViews: 1

After a meeting with Cara Welch, Ph.D., acting deputy director of the Division of Dietary Supplement Programs at FDA, in late January 2015, the following bullet points with regards to dietary supplement GMP compliance were seen as takeaways:

• Read the preamble to the GMPs (good manufacturing practices) for dietary supplements
• Larger firms are not receiving Warning Letters
• Rely on consultants to assist with compliance efforts, if necessary (because the agency isn’t going to publish any kind of supplementary “GMP compliance guidance” – see bullet 1)
• Specifications (setting and meeting) continue to be the number one issue of noncompliance.

Given the consistency of issues found in most warning letters, agency personnel were asked if there were plans to move outside of its enforcement-only mode and provide industry with additional, more detailed guidance, such as information on setting specifications, documentation for meeting specifications, and the like.

Though the answer was as expected and delivered with some measure of jocularity—the agency is all stick, and no carrot—the message was clear: FDA is not in the business of assisting industry with how to meet the regulations. It’s one and only job is enforcement. The quandary industry likes to tell itself is, “How do we know how to appease the stick-wielder if it won’t tell us how to meet the requirements?”

The stick-wielder’s answer to that was also simple: “Read the preamble. We told you everything you need to know with regard to how to apply the rules. And if you still can’t figure it out—hire someone who can translate it for you—either as a consultant or as an employee.”

As a consultant, this feels admittedly more than a little self-serving, but beyond that it’s simple guidance as to what industry needs to do in order to come into compliance.

The comment that was made about larger firms not having, in general, received warning letters was relayed to indicate that these firms had, again in general, figured out how to comply with the rules. Outside of having more funding, personnel, etc., as compared to a smaller firm – what’s different?

It raises the question: are the regulations genuinely so onerous that a smaller firm cannot meet them—or that smaller firms often don’t have the ability to comprehend and apply the controls and systems needed to ensure compliance (and may struggle to afford to hire someone who does)? Or is it that there are firms who are continuing to operate under the mantra of “do [whatever you are or aren’t doing] until you get caught”?

Bottom line here is this: don’t look to agency personnel for be-all-end-all answers to GMP compliance questions. Though that isn’t to say that they won’t set a meeting and talk to you one-on-one, but a tell-all for industry just isn’t going to happen, and GMP compliance is relative to specific business practices and elements.

It’s also something of a fairy-tale to expect the agency to effectively address every safety and compliance issue within the dietary supplements industry given two facts: it doesn’t have the resources (and likely never will), and in a post-market surveillance system as mandated by the Dietary Supplement Health and Education Act of 1994 (DSHEA), policing the industry is quite impossible, particularly given the incredible number of products in the space (estimated at somewhere around 80,000). In fact, when FDA was subsequently asked how the elements of the Food Safety Modernization Act (FSMA) related to supplementswould be implemented given the agencies lack of resources; the answer was, “We’re going to lean on the states.”

That all said, a potential change in the agency’s stance was recently delivered by Welch, acting director of the dietary supplement division, at an industry event held at SupplySide West. She said: “On GMP compliance, we want to identify the good players. Are there some product types that are largely compliant? We want to start identifying those over the next five years.”

Perhaps this message indicates that the agency, though it continues to see overall GMP compliance within the industry as an issue, will start to look at how it can also support the positive elements of industry while policing those within it that need such enforcement.

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