We needed to be sure that Congress and FDA recognized that dietary supplement GMPs had significant overlap with the proposed mandatory preventive controls for food facilities. Consequently, it made sense to ensure that supplement facilities avoided the specific regulations that would have resulted in overlapping inspection standards and dual requirements.
As a result, many companies don’t have to worry about FSMA, now that it is law. However, there is something coming in the next few months that will absolutely affect every dietary supplement company, and all companies in our industry should be ready to meet these requirements. One of the components of FSMA was a revision of the Bioterrorism Act of 2002, which required all domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register one-time with FDA. Under FSMA, all food facilities (including those that manufacture supplements) must now not only register with FDA, but must also update their registration every two years. Furthermore FDA now has the authority to suspend facility registration for unsanitary conditions, lack of record-keeping and flagrant violations of laws, such as manufacturing tainted products. That’s right; if FDA determines a serious health hazard is associated with food from a registered facility, the registration of the facility could be suspended. This additional tool for the agency gives it another way to take enforcement action against companies adding unapproved pharmaceuticals to products that are being illegally marketed as dietary supplements. We strongly support the agency in using this provision to shutter a facility engaging in that type of behavior.
Failure to register itself will be a GMP violation, which could have serious consequences. With the deadline for registration approaching rapidly, industry is still left with unanswered questions. One big question, for instance, is if you are a global company, with operations all over the world, how cumbersome will the registration process be for the thousands of facilities used globally? How exactly does a U.S. agent for a foreign facility acting as the contact person for the company provide an assurance that FDA will be permitted to inspect foreign facilities at the times and in the manner permitted by the Food Drug & Cosmetic Act?
FDA recently posted new information on its website that introduces and encourages industry to use an online registration option. However, there a many other details the industry has yet to learn about facility registration. The agency has indicated that it will meet the deadline, and industry should be aware that FDA might issue its final rule without much notice or fanfare. At the very latest, we would expect it to go into effect in December, but companies should be prepared for it to begin as early as the regulation’s actual deadline—October 1. It is never too early to start thinking about how your company will fulfill its obligation to this piece of the regulation.