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US Goes After Dietary Supplement Maker for Selling Misbranded Products

Posted  October 24, 2017

By the C|C Whistleblower Lawyer Team

Yesterday, the DOJ announced the filing of a civil complaint against New York-based dietary supplement maker Riddhi USA Inc. and its owner Mohd M. Alam. The complaint charges the company with distributing adulterated and misbranded dietary supplements and failing to comply with FDA required current good manufacturing practices. See DOJ Press Release.

According to the complaint, the FDA inspected the company in January 2017 and found numerous deviations from current good manufacturing practice regulations relating to the identity, purity, strength, and composition of the company’s finished dietary supplements. The complaint further alleges that many of these violations were identified during a previous FDA inspection of the facility and which resulted in an FDA Warning Letter. The complaint also alleges the company misbranded its dietary supplements by failing to comply with the relevant labeling provisions of the Food, Drug, and Cosmetic Act. This includes failing to properly identify on the product labels the product ingredients or place of business of the manufacturer, packer, or distributor. The dietary supplements covered in the government’s complaint include Neuroxygen, Osteo Gest, Inflam-Ease and All-Ease.

In announcing the action, the government stressed its commitment to safeguarding the public from adulterated and misbranded dietary supplements: “The Department of Justice is committed to ensuring that dietary supplement manufacturers comply with laws designed to protect consumers . . . [and] will continue to work with the FDA to protect the public from adulterated and misbranded products, and to ensure that dietary supplement manufacturers provide accurate information about what is in their products.”