“Many producers of dietary supplements could falsely believe that they are not covered by the renewal requirement since those products are excluded from many provisions of the FSMA,” Gaitan says. “However, since the passage of the Bioterrorism Act in 2002, facilities engaged in the manufacturing, processing, packaging or holding of dietary supplements have been required to register with the FDA. The FSMA did not change this requirement. Dietary supplement producers must re-register.”
Similarly, companies involved in the alcoholic beverage trade could be unaware that they too must register, Gaitan says, pointing out that the requirement stands regardless of the fact that other agencies generally regulate that industry. “Generally speaking, companies involved with the manufacture, processing, storage or packaging of alcoholic beverages that contain more than 7% alcohol are not covered under the FSMA,” she says. “But the exception-and it’s an important exception-is the FDA registration requirement. All facilities where alcoholic beverages are manufactured, processed, stored or packaged must register. In fact, this has been the case since 2003, when the FDA’s food facility registration requirement first went into effect.”
The greatest confusion over FSMA registration seems to be within the agricultural industry. According to Gaitan, agricultural products are primarily regulated by the United States Department of Agriculture (USDA), and farms are explicitly exempt from the FDA registration requirement. However, if an agricultural product undergoes any “processing” at the farm, including a post-harvest pesticide treatment, waxing, or other preservation treatment, the farm is subject to the registration requirement, unless otherwise exempt
Along with registration services, FDA Solutions Group also acts as U.S. Agent for its clients, allowing them to both register and designate an agent through its website.
The FDA Solutions Group website can be accessed in English, Spanish, Portuguese, Italian and Japanese.
SOURCE FDA Solutions Group