On December 15, as part of its ongoing enforcement offensive to police the dietary supplements industry, the FDA issued a broad new warning about some dietary supplements, body-building products, and purported sexual enhancement products in a “Dear Manufacturer Letter” to manufacturers and trade groups.

The FDA has issued nearly 300 alerts about dietary supplements in recent years. “These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” Dr. Margaret A. Hamburg, commissioner of the FDA, said in a statement. “The manufacturers selling these tainted products are operating outside the law.”

Dietary supplements, unlike drugs, do not have to be approved by the FDA for safety or effectiveness before marketing. They can make general claims about health or well-being but they are not permitted to claim to prevent or cure specific diseases. In the letter, the FDA addressed the three most common types of illegal supplements: weight-loss products, body-building products, and purported sex enhancers.

Readers are encouraged to study the excellent articulation by Dr. Hamburg of the “Park Doctrine” regarding vicarious criminal liability of corporate actors for FD&C Act violations. This discussion highlights the “strict liability” aspects of the Park Doctrine. The defendant’s personal knowledge of the violation is not an element of proof for the prosecution. The author of this Weblog did his Supervised Research for his Juris Doctor at Rutgers University on the Park Doctrine (United States v. Park, 421 U.S. 658 (1975).

The Dear Manufacturer Letter is posted below: