FDA Embargo

FDA embargos typically refer to state embargos since this is not an enforcement tool used by FDA or allowed under the Food Drug and Cosmetic Act (FDC&A). The FDA can issue a seizure or an injunction but both require a court order, which can take time to obtain. Many states, like California, allow embargo without a court order. For example, under the California Sherman Food, Drug, and Cosmetic Laws allows an embargo, “Whenever an authorized agent of the department finds, or has probable cause to believe, that any food, drug, device, or cosmetic is adulterated, misbranded, or falsely advertised.” Or New York under Article 71 of the Health Code, “When in the opinion of the Department a food, drug or cosmetic is unfit for consumption or use, or is adulterated or otherwise constitutes a danger or is prejudicial to the public health, the Department may seize, embargo, or condemn such material.”

Although an FDA embargo may not be available to the FDA, the agency can still partner with state agencies. In many cases, it’s common for a state agency to conduct an inspection on behalf of the FDA. This allows for both state and FDA violations and state and FDA enforcement actions too.

An embargo may better be understood by its alternative name, a stop sale order. This makes it clear, as the inspectors likely would, that all products identified as embargoed cannot be sold until the embargo is released.

Here are sime tips on managing an embargo:

• Clearly identify and qurantine all embargoed product;
• Identify and resolve the concerns of misbranding or adulteration, which may involve working with a regulatory attorney;
• Explore options for reconditioning where possible, like relabeling;
• Propose any plans for reconditioning; and
• If ordered to destroy confirm the method and type of destruction required by the embargo order.