006: Breaking FDA Rules


USP Labs, a manufacturer of vitamins and supplements, creates several products that lead to exponential growth and success. Bodybuilders rely upon the signature product, “Jacked,” to replenish muscles after a workout. With the success of Jacked, the company grows quickly—so quickly that it faces challenges keeping up with demand. The company sourced ingredients from China, claiming that they were safe and all natural. 

The company caught the attention of the Food and Drug Administration (FDA) after some consumers complained of health problems. After an investigation, the FDA warned the company to cease and desist from manufacturing the products. USP Labs agrees to the FDA demand. Yet rather than complying with the full spirit of the settlement agreement, USP Labs makes minor changes to the products formula and changes the label to circumvent the FDA’s order.  

To prepare this case study, we relied upon press releases from the Department of Justice and other articles referenced below.

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