21 USC § 331 makes clear that federal law prohibits “the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded,” and “the adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.” Additionally, 21 USC § 352(f) provides that a drug will be deemed to be misbranded unless its labeling contains adequate directions for use, which typically requires the directions to allow a layperson to use the drug safely and for the purposes for which it was intended.
As with adulteration cases, the FDA can pursue misbranding cases criminally, and the consequences can be severe, especially when the FDA believes that the violation was committed with the intent to defraud or mislead. We routinely see criminal misbranding charges filed in cases involving unapproved new drugs, as well as those involving drugs which have been imported into the United States from other countries, including Canada.
Our FDA criminal defense lawyers have an in-depth understanding of the FDCA and its implementing regulations governing the labeling of regulated articles, as well as extensive experience litigating white collar criminal cases in federal court. If you have been charged with a criminal misbranding violation, contact us now for a free consultation.