Confusion on FDA Registration Requirement Could Put Companies Across Supply Chain at Risk

Sandler Travis and Rosenberg, PA reported the following in their trade report published today:

Companies involved in the manufacture, processing, packaging or storage of food products, including dietary supplements, alcoholic beverages and some agricultural products, must register with the Food and Drug Administration by Jan. 31, 2013, or face the consequences of being in violation of the Food Safety Modernization Act. But many of the companies affected by the new law may be unaware that the requirements apply to them. 
 
"We are finding that a lot of businesses affected by the new registration renewal requirement are unaware of their obligations," explains Ann Marie Gaitan, managing director of FDA Solutions Group, a company that specializes in helping businesses meet FSMA requirements. "The confusion arises because there are so many laws that overlap. The danger is a company will inadvertently fail to renew under the FSMA and face a denial of entry of its goods into the U.S.," she adds. "That could be catastrophic for businesses across the supply chain."

Under FSMA Section 102, all domestic and foreign facilities that manufacture, process, pack or store food, beverages, food ingredients, pet foods or dietary supplements are required to renew their current registration with the FDA before Jan. 31, 2013. FSMA Section102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. FSMA also requires registration renewal every two years in even-numbered years.

"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 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 U.S. Department of Agriculture 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.

"If your company is involved in any industry that manufactures, produces, packs or stores a consumable product, you should thoroughly research the FSMA requirements. Don't just assume you are not covered because your industry is regulated by agencies other than the FDA," Gaitan says.

Further information about the requirements for registration can be found on FDA Solutions Group's Web site. The company offers a simple online process that allows companies to submit their food facility registration renewal electronically, at any time of the day and from anywhere around the world. 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 Web site. The FDA Solutions Group Web site can be accessed in English, Spanish, Portuguese, Italian and Japanese. More information about FDA Solutions Group and its services can be found online or by calling 305.702.3161.