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GMP Compliance Still Primary Concern for Industry: NDI Notification “Not Likely” to be Enforced Through GMP Inspections

Dietary Supplements,Marketing and Advertising,Regulatory

While so many in the industry seem to be talking about NDI notifications as the biggest issue facing supplement companies, a recent poll of approximately 100 attendees at the recent United Natural Products Alliance (UNPA) seminar indicates that there’s another issue of more concern in the supplement industry today: GMP compliance. According to the survey results, reported in the August 15th “Tan Sheet” (see thumbnail image), 60% of the attendees polled said that GMP compliance is currently the most important issue facing the industry – compared to only 31% of attendees who believe that NDI notification tops the list of current concerns.

Those polled aren’t the only ones noting the importance of GMP compliance on the industry; according to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, “GMPS are probably the most substantial thing industry has to work on” – noting that the FDA “is seeing a pretty high rate of noncompliance.” Fabricant went on to note that “the industry should expect more GMP enforcement” – but also disconnected the two issues by saying that the agency would “likely not” enforce NDI notification through GMP inspections.

So, for now, NDI notifications and GMPs remain two separate issues – with, it appears, more in the industry possibly less concerned about NDIs than they are about GMP compliance in today’s complex supplement industry. Therefore, as GMP compliance continues to be a growing issue, ensure that your company is following all proper practices and adhering to all current and future regulatory guidelines – and, to best meet any potential expanded GMP enforcement, consider seeking professional legal counsel to help you navigate through this important time.

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