Regulatory Focus™ > News Articles > FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

Posted 23 October 2012 | By

The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc. after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law.

AN calls itself an international, specialist manufacturer of all-natural nutritional supplements.

FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal current good manufacturing practice (CGMP) regulation-part of a larger trend of enforcement against the dietary supplement industry focused on such violations. Back in May, Daniel Fabricant, FDA's director of its Division of Dietary Supplement Programs, said the agency would be cracking down on manufacturers after being "aghast" at the degree of non-compliance within the industry.

FDA's warning letter to AN lists several alleged deficiencies-failure to maintain a master manufacturing record for packaging and labeling, failure to follow written quality control procedures and failure to prepare batch production records, among others-but regulators cited several examples as being particularly jarring.

During the inspection, wrote FDA, inspectors observed paper cartons of an unknown supplement product. The cartons were only distinguishable by the presence of a hand-marked letter "A," and otherwise contained no other hints of their contents. When the company official in charge of AN's managerial operations was asked what the boxes contained, FDA said she told them that she was unsure, but that the containers likely contained Vitamin A.

In a separate incidence, FDA inspectors said they witnessed employees of the company handling and packaging finished product without the use of gloves-that is, with bare hands-potentially exposing the product to microbial contamination. FDA said AN does, "Not have procedures in place to fulfill the requirements relating to preventing microbial contamination from sick or infected personnel or relating to hygienic practices," which are required under CGMP regulations.

Further, FDA said it had received assurances from the company that it intended to cease operations related to retail-sized products. "It appears that you have not ceased such operations," the agency observed.

Regulators also took issue with a number of dietary supplements it said were misbranded by virtue of their claims, which FDA said made them pharmaceutical products under the law.

One product, Nutr-E-Sol, for instance, claimed to be useful in treating diseases such as cystic fibrosis, Crohn's disease, short bowel syndrome and biliary cirrhosis-all serious diseases. The product appears to have been de-listed from the website, but remains available through a search.

Other products, respectively, claimed to treat asthma, eczema, heart attacks, cancer and urinary tract infections. Many of these products appear to still be available as well.

Regulators said they expected all such marketing activities to cease immediately, and reminded the company that it is responsible for any costs associated with the agency being required to re-inspect a facility.

Regulatory Focus has reached out to AN, and will update this story with additional information as it becomes available.


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