FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers


FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers


The US Food and Drug Administration’s (FDA) top dietary supplement regulator said at an industry conference meeting he is “aghast at the degree of non-compliance” when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA.

Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, said the industry has been exhibiting a level of non-compliance he says is troubling.

“We’re seeing some of the same mistakes from warning letter to warning letter, and that’s concerning,” said Fabricant. “Whether it’s failure to prepare batch records, problems with specifications-there are failures of adequate quality control.”

Adverse event reporting also garnered Fabricant’s attention, who said there are “pretty good indications” many manufacturers are failing to report even the most basic information to FDA.

Fabricant said FDA is aware of concerns some manufacturers are simply paying contract laboratories for favorable results without actually having its products tested, and is looking to focus its enforcement efforts-for now-on manufacturers and distributors.

In 2010, one of the Sun Ten Factory located in the United States (STPCA dba Sun Ten Laboratories) received certification through the National Products Association (NPA) as a GMP compliant Dietary Supplement manufacturing facility.  STPCA dba Sun Ten Laboratories offers botanicals, Chinese herbal extracts, unique formulations, nutraceuticals, vitamins and minerals.  It also conducts the contract manufacturing services to help develop and manufacture products. Please click here for details.


1.       http://www.raps.org/focus-online/news/news-article-view/article/1367/fda-aghast-at-lack-of-cgmp-aer-compliance-by-supplement-manufacturers.aspx

2.       http://www.nutraingredients-usa.com/Regulation/Dan-Fabricant-FDA-somewhat-aghast-at-degree-of-cGMP-non-compliance (Dan Fabricant: FDA ‘somewhat aghast’ at degree of cGMP non-compliance)

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