FDA-TRACK: Human Foods Program - Compliance and Enforcement
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The Human Foods Program is responsible for a safe food supply and ensuring FDA regulations and guidance provide clear and reliable direction and assistance to industry, both inside and outside the United States, with a goal to obtain high rates of compliance with standards necessary to protect public health and stakeholder expectations.
On this page:
FDA monitors domestic and foreign firms and the foods that they produce. FDA protects consumers from unsafe food through, among other things, research and development, inspection, voluntary destruction, sampling, recall, seizure, injunction, and criminal prosecution.
Explore the progress HFP is making towards its Compliance and Enforcement efforts below:
Environmental Sampling
Inspecting food facilities and collecting and testing samples from the environment where foods are produced are two of the many ways the FDA works to better understand microbial hazards and to help prevent contaminated products from reaching consumers.
Reportable Food Registry
Food industry officials must use the Reportable Food Registry process to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals.
Explore the FDA-TRACK: Reportable Food Registry Data Dashboard
Regulatory Consults
Timely review of regulatory cases that come from the field is important as it allows FDA to take appropriate regulatory action such as issuance of a warning letter to the regulated industry. This can lead to a timely correction of problems in the industry resulting in a safer food supply.
Regulatory and Compliance Actions
Regulatory and compliance actions are one tool used in obtaining public health protective outcomes, such as preventing unsafe products from entering the country and prompting change in non-compliant firms.
Suspension of Food Facility Registration: Facilities that manufacture, process, pack or hold food for distribution in the United Sates must register with the FDA. When a food product presents a reasonable probability of serious adverse health consequences or death to humans or animals, FDA can suspend a facility's registration to prevent it from introducing into interstate commerce food from the facility until FDA determines that adequate grounds do not exist to continue the suspension actions required by the order.
Product Seizures: A product seizure is an action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the FD&C Act. Seizures are intended to remove products from commerce and place them under custody of a court, until a court can decide whether they are violative as alleged. The FDA works through the court system to request a seizure, which is then carried out by the U.S. Marshals.
Advisory action letters include Untitled and Warning Letters. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. Warning Letters are issued for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Warning Letters are posted on FDA's website.
An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter. However, Untitled Letters serve as an initial notification to firms that FDA is aware of their violations of federal law. It often serves to document formal notification by FDA to the person or firm, and allows the firm to come into compliance without further FDA action.
Injunctions: An injunction is an order issued by the court requiring a defendant to perform an act which he or she is obligated to perform, but refuses to do; or forbidding the defendant from doing a specified act which he or she is threatening or attempting to do. Injunctions can be temporary or permanent. In certain cases, FDA may request through the U.S. Department of Justice that the court grant an injunction to stop or prevent violation of the law, such as to prevent violative products from entering interstate commerce and to correct the conditions that caused the violation to occur.
When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendant(s) fail to obey the terms of the consent decree. If a defendant violates the terms of the consent decree, the agency may initiate civil or criminal contempt proceedings or other regulatory action.
To learn more about Preliminary Injunctions, Temporary Restraining Orders and Permanent Injunctions, see Chapter 6 of the FDA Regulatory Procedures Manual.
Export Certificates for Food
FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory or marketing status, based on available information at the time FDA issues the certification. The fact that FDA issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate.
It's important to note that FDA does not require certification for exports; FDA provides certification as a service to industry to facilitate exports to countries that require certification of imports.
- The “Certificate to a Foreign Government” is available for conventional foods, food additives, food contact substances, and infant formula that meet the applicable requirements of the FD&C Act for marketing in the United States. This certificate states, among other things, that a product (or products) may be marketed in and legally exported from the United States. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request. To request this certificate, industry should visit Online Applications for Export Certificates.
- The “Certificate of Exportability” is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request. To request this certificate, industry should visit Online Applications for Export Certificates.
In 1996, the FDA Export Reform and Enhancement Act (EREA) added Section 801(e)(4) to Food, Drug, & Cosmetic Act (FD&C Act), providing authority for FDA to provide written certification that an exported drug, animal drug, or device meets the requirements of the Act or is otherwise eligible for export. EREA also provided FDA with the authority to charge $175 for certification issued within 20 days.
In 2011, the Food Safety Modernization Act (FSMA) amended Section 801(e)(4)(A) of the FD&C Act to include food (both human food and animal feed) in the list of products for which FDA has explicit authority and a mandate to issue export certification. FDA issues different types of export certification for different food products. FDA issues the “Certificate to a Foreign Government” and the “Certificate of Exportability” pursuant to section 801(e)(4) of the FD&C Act for conventional foods, seafood, infant formula, food additives, and food contact substances.
Download FDA-TRACK HFP Compliance and Enforcement Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.