The U.S. Food and Drug Administration (FDA) has intensified its enforcement efforts to combat the sale of misbranded, adulterated, or illegal drug and device products in the country. In a press release issued on October 31, 2019, the FDA highlighted its commitment to preventing the distribution of such products, including the court-ordered seizure of 4,229 Internet domain names associated with the sale of misbranded or adulterated items.
To stay compliant and avoid the repercussions of the FDA’s increased enforcement, it is crucial for businesses to understand what constitutes misbranding or adulteration. The FDA meticulously reviews product claims and ingredients to keep potentially harmful products out of the U.S. market. Products deemed misbranded or adulterated may face regulatory actions, including detentions, registration suspensions, or placement on import alert.
Misbranding occurs when products make claims that violate FDA rules, especially disease claims that assert a product’s ability to cure or prevent a disease. Such claims must be approved by the FDA, and any deviation from the strict labeling rules can lead to a product being considered misbranded.
The FDA also requires approval for certain drug products marketed in the U.S. This involves determining whether a drug falls under an existing monograph or is considered a new drug product. Monographs provide established rules for existing drug products, including recognized safe and effective ingredients. Unapproved ingredients in a drug product without an approved application can render the product adulterated.
For devices, particularly Class III and some Class II medical devices, premarket approval (PMA) is required before marketing in the U.S. This involves rigorous testing to ensure device safety. The marketing of drugs and devices without the necessary approvals is considered adulteration by the FDA.
Given the FDA’s strengthened efforts, compliance is crucial to avoid costly delays and potential criminal charges. Companies are urged to adhere to FDA regulations, obtain necessary approvals, and ensure that their products meet labeling requirements to navigate the regulatory landscape successfully.