FDA Acts Against Supplement Makers

Action has been taken against three New Jersey <"http://www.yourlawyer.com/practice_areas/defective_drugs">dietary supplement and protein-manufacturing companies over filthy conditions and failure to declare allergens, announced the U.S. Food and Drug Administration (FDA). The U.S. Department of Justice, on behalf of the FDA, just filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC, and Mohamed S. Desoky, who oversees operations at all three companies.

The companies are located in Paterson, N.J., and manufacture dietary supplements and protein powders and distribute them throughout the U.S. The three firms also export powder mixes and dietary supplements for sale by private label customers.

The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions as well as under conditions that may cause major food allergens to enter into products not intended to contain them. The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found several of the companies’ products contained milk ingredients not declared on the product labels. The company also failed to clean processing equipment between batches and control allergens in the facility. Worse, FDA investigators discovered live and dead rodents and rodent urine, feces, and gnaw holes on bags of product.

In three inspections, FDA investigators noted deviations from GMP standards. Although the companies promised to make corrections, they failed to do so. Now, the complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

The FDA is advising those consumers with allergies to milk ingredients who have used these products and who are experiencing any symptoms to contact their health care professional. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator at: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm.

We recently wrote about so-called “natural” dietary supplements and related serious quality problems. According to a prior Associated Press (AP) report, tests of some dietary supplements conducted over the past decade have found that these products often contained ingredients far different than what was listed on the label. For instance, contaminants such as lead have been found in zinc, black cohosh, and ginkgo products; a fungal toxin was found in four red yeast rice products in March 2008; and last year, cryptosporidium, a waterborne parasite that causes severe diarrhea, was found in a liquid herbal supplement sold for infant colic and teething pain.

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