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 § 351 provides that drugs and devices will be deemed to be adulterated if they “consist in whole or part of any filthy, putrid or decomposed substance,” or if they have been prepared, packed or held in facilities which fail to comply with the standards set forth by federal law and regulation for FDA regulated drugs and devices.
Federal laws and regulations set forth with painstaking detail the applicable cleanliness standards for foods, drugs, medical devices, biologics and tobacco products, and our FDA practice group advises our clients regarding these standards on a daily basis.
Sometimes, however, FDA believes that an adulteration violation was committed intentionally, and in those cases, the FDA will pursue the violation criminally. Not surprisingly, the FDCA makes clear that the consequences of criminal adulteration violations are severe. As an example, 21 USC § 333(b)(7) provides that “any person that knowingly and intentionally taints a drug such that the drug is adulterated…and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.”
Clearly, criminal adulteration violations are serious and must be taken seriously. Our FDA criminal defense lawyers have an in-depth understanding of the FDCA and its implementing regulations governing the manufacturing of regulated articles, as well as extensive experience litigating white collar criminal cases in federal court. If you have been charged with a criminal adulteration violation, contact us now for a free consultation.