Under U.S. federal law, the distribution or sale of adulterated drugs or medical devices is a serious criminal offense governed by 21 U.S.C. § 351.

This statute defines adulteration broadly, targeting products that pose risks to public health due to unsafe manufacturing, contamination, or deceptive practices. Violations can lead to severe penalties, including fines, imprisonment, and civil liability for companies and individuals.

What Constitutes an Adulterated Drug or Device?

A drug or device is deemed adulterated under § 351 if it meets any of the following criteria:

• Contamination: Contains filthy, putrid, or decomposed substances.
• Insanitary Conditions: Produced, packed, or stored in unsanitary environments that risk contamination or health hazards.
• Non-Compliance with Manufacturing Standards: Fails to follow Current Good Manufacturing Practices (cGMP), compromising safety, strength, quality, or purity.
• Misbranded Containers: Uses containers made of poisonous or harmful materials.
• Unapproved Additives: Contains unsafe color additives or new animal drugs that are not compliant with FDA regulations.

For example, a drug that lacks proper quality controls during production or a medical device stored in contaminated facilities would violate § 351.

Penalties Under 21 U.S.C. § 333

Violations of § 351 are prosecuted under 21 U.S.C. § 333, which outlines both criminal and civil penalties:

• First-Time Violation: Up to 1 year in prison and/or up to $1,000 in fines.
• Intentional Fraud or Repeat Violation: Up to 3 years in prison and/or fines of up to $10,000.
• Life-Threatening Adulteration: Up to 20 years in prison and/or fines of up to $1,000,000 if the product risks serious harm.

Manufacturers or distributors may also face civil penalties if their representatives violate the law, including fines of up to $50,000 for initial violations and $1,000,000 per violation thereafter.

Key Defenses and Compliance Considerations

While § 351 imposes strict liability, certain defenses may apply, such as:

• Guaranty Defense: A party may avoid liability if they receive a product with a written guarantee of compliance from the manufacturer.
• Good Faith Efforts: Demonstrating adherence to cGMP and robust quality control systems can mitigate allegations.

Adulteration charges can derail careers, shutter businesses, and endanger public health. Whether facing an FDA investigation or criminal prosecution, securing experienced legal counsel is critical to navigating complex regulatory frameworks and mounting a robust defense.

If your organization is under scrutiny for alleged violations of § 351, Sigal Law Group can help. Contact Sigal Law Group today for a free consultation.