FDA cops (more) GMP criticism

By Shane Starling

- Last updated on GMT

Related tags: Dietary supplement, Fda

Insufficient inspection numbers, unclear ingredient identity testing and supplier audit requirements to meet Good Manufacturing Processes (GMPs), are some of the problems blighting the recently introduced regulation, says a Californian-based supplier.

Responding to a recent FDA-praising podcast with George Pontiakos, the president and chief executive officer of fellow Californian supplier, BI Nutraceuticals, Robinson Pharma marketing manager, Kenn Israel, said the FDA’s GMP enforcement, was, at best, a bit off.”

“I would tend to think that the lack of clear rules would upset the team at BI that has done so much to provide quality ingredients and an excellent support infrastructure,”​ Robinson told NutraIngredients-USA.com.

“Suppliers like BI would be favored if there were more clarity and more enforcement. FDA action would likely provide a significant disincentive to trade with BI's most unscrupulous competitors.”

In the podcast, Pontiakos said the FDA was doing a good job on GMPs and administering the Dietary Supplements​ and Health Education Act (DSHEA), a view that provoked Israel to contact NutraIngredients-USA.com.

More for your dollar

“While FDA should be applauded for having a clear sense of priority and has correctly placed food safety as its principle goal, they have not lived up to their stated objectives and delineated responsibilities,”​ he said.

“They had previously articulated a goal of performing 180-200 audits of mid-sized companies in support and enforcement of the GMP rule and have fallen far short. They need to clearly define and streamline the ODI/NDI issue and have failed to meet the requirements of the law for timely processing of applications. They have not provided clear guidance on ingredient identity testing requirements or what constitutes an effective supplier audit process. Bottom line for may tax dollar I expect more from the FDA​.

He added: “With all due respect - BI does not have to comply with the new rules - their customers do. While I agree with Mr Pontiakos that a free and open market is preferable in some cases it does not provide results we all want.”

Israel said until his email inbox ceased to indicate large numbers of products for, “erectile disfunction, penis enlargement, unsubstantiated cancer claims, flu cures, and overnight effortless weight loss” ​the FDA could not be said to be doing a good job.

“My inbox also provides hundreds of opportunities to buy herbal ingredients and nutraceutical ingredients at costs well below that of the biomass from which they are extracted and in quantities far in excess of what nature provides.”

Related topics: Regulation, GMPs, QA & QC

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