Miami, Fla.-based FDA Solutions Group, LLC will assist food and dietary supplement companies with the re-registrations required under FSMA, which must be completed by Dec. 31. But that’s just for starters, attorney Anne Marie Gaitan, managing director of the new firm, told NutraIngredients-USA.
“It’s been compared to the Customs Modernization Act. This is the first time in over 60 years that FDA has reconsidered all the regulation of food and really start to addressed problems on a one-on-one basis so that they can take a proactive as opposed to reactive approach,” she said.
Re-registrations just tip of FSMA iceberg
Under FSMA Section 102, all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the Food & Drug Administration (FDA) before the end of 2012. FSMA Section102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. In addition to requiring all food facilities to re-register in 2012, FSMA requires re-registration every two years thereafter.
“From our perspective it’s not just the registrations. There are over 50 guidance documents that the FDA has to issue under FSMA. We’ll be waiting to see what new changes, what new actions industry has to take and guiding them through that,” Gaitan said.
The services the new consultancy offers were structured to be easy to understand with a transparent cost structure, said Edgar Asebey. The company is structured on a set fee per service basis.
“We built it to be turnkey and, going to the website ,clients can see what the cost is going to be,” he said.
New company has experience behind it
While FDA Solutions Group is new, it is built on years of experience. The company's principals head up the FDA practice of Sandler, Travis & Rosenberg, PA, a customs, international trade and business law firm that has been a leader in helping clients comply with FDA requirements for 35 years.
Along with registration services, FDA Solutions Group also acts as U.S. Agent for its clients, the company said. This is new territory under FSMA, Asebey said.
"Before the new law, it wasn't unusual for customs brokers and freight forwarders to act as U.S. Agents," he said. "But that is definitely changing. Where before there was little if any risk involved in becoming a designated U.S. Agent, the FSMA imposes new burdens and potential liabilities on entities serving in that capacity for foreign food facilities. That has made many who have historically accepted agent status rethink whether they want to continue offering that service," he said.
Under FSMA Section 107, the FDA can begin charging a $289 per hour fee for foreign facility re-inspections, according the company. Fees could reach several thousand dollars for a single facility, and the U.S. Agent would be responsible for making sure those fees are paid, Asebey said.