Fabricant: Focus on GMP compliance, not NDI draft guidance

Fabricant: Focus on GMP compliance, not NDI draft guidance

FDA's Fabricant says industry can expect more inspections, injunctions and product seizures related to cGMP violations and that the agency won't likely enforce the NDI draft guidance.

On Tuesday, Daniel Fabricant, director of the Food and Drug Administration's (FDA) Division of Dietary Supplement Programs, told attendees of the American Herbal Products Association's (AHPA) inaugural Botanical Congress in New York that industry companies can expect more inspections, more injunctions and more product seizures from FDA related to current good manufacturing practice (cGMP) violations.

Citing 21 CFR Part 111, Fabricant said FDA conducted 175 inspections in 2011, filed its first injunction, and seized products for the first time. In 2012, he noted that 138 inspections were already "under our (FDA) 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."

Addressing concerns to the contrary, Fabricant reiterated that the agency is not preparing to enforce the draft guidance on new dietary ingredients (NDIs). 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 the big issue on the table was the NDI draft guidance.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 And it is just a draft guidance. I think everyone's heard me say that a million times, and we'll make it a million and one: It's just a draft guidance.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 most common areas of cGMP noncompliance discovered during FDA investigations, according to Fabricant, 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

During his presentation, Fabricant addressed serious adverse event reporting (SAERs), stating it should be understood that "submitting an AE does not establish a causal relationship to indicate the AE is unsafe; not submitting or failing to submit an AE does not indicate the product is safe, though it is a violation of the Act."

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