Regulatory Focus™ > News Articles > US Government Agencies Crack Down on Dietary Supplement Manufacturers

US Government Agencies Crack Down on Dietary Supplement Manufacturers

Posted 17 November 2015 | By Zachary Brennan 

US Government Agencies Crack Down on Dietary Supplement Manufacturers

In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-based USPlabs that alleges the company engaged imported ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.

USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory, according to the indictment.

USPlabs has been on FDA’s radar for a while, particularly as back in March, the agency found the active ingredient for Prozac in one of the company’s fitness products.

Previously in November 2013, FDA warned consumers not to use certain USPlabs products found to contain a new dietary ingredient that had not been shown to be safe for use by consumers.

The ingredient, aegeline, is a synthetic version of an alkaloid that exists, in natural form, in a tree that grows in parts of Asia. In addition, the products had adverse events linked to acute liver failure or non-viral hepatitis so severe that several patients needed liver transplants, and one resulted in death.  

Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy, said in a statement: “The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to protect Americans and bring justice.”

Bethel Nutritional

Also as part of the sweep, the DOJ filed a complaint in federal court in the District of New Jersey, on behalf of the FDA, against Bethel Nutritional Consulting.

According to the complaint, Bethel distributed adulterated and misbranded dietary supplements and unapproved new drugs throughout the US. The defendants agreed to be bound by a consent decree of permanent injunction that orders them to cease operations until FDA determines that they are in compliance with the law.

FDA said its inspections of Bethel’s operations have revealed deviations from current good manufacturing practice regulations, resulting in adulterated dietary supplements, and deviations from labeling requirements, causing the dietary supplements to be misbranded.

In addition, FDA says it continues to warn consumers about the risks associated with some over-the-counter products falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancementweight loss and body building.


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.