The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.
Background on Food Facility Registration
The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.
On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:
- Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
- Facilities are required to renew their registration every other year.
- FDA now has the authority to suspend a facility’s registration.
Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.
The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the […]
FDA announced that it has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FDA Food Safety Modernization Act (FSMA). The organization being recognized is ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) based in Milwaukee, Wisconsin. This organization is being recognized because it met the applicable FDA requirements, validated through application review and on-site assessment. FDA is recognizing ANAB for a five year term of recognition. (For more information on FDA’s standards for recognition, see: Key Facts about the Accredited Third-Party Certification Program) […]
On January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA), aiming to protect the public by ensuring the U.S. food supply is safe through prevention and enforcement. The FSMA included seven foundational rules, which we summarized in our FSMA: Stay Compliant with DTL’s ‘PICTURE’! blog. […]