FDA has made public a new guidance document meant to guide the actions of its inspectors as they enforce the registration provisions of the Food Safety Modernization Act. The document is a similar but somewhat simplified version of a guidance document the agency posted for industry in January. The new document lacks some definitions, for example, presumably assuming a level of familiarity with the statute on the part of its own inspectors.
In any case, it’s another opportunity for industry to review its registration status to avoid costly delays or worse.
“If the last time you registered was five years ago you are not in compliance. You are not legal to import food,” Marc Ullman, an attorney with the firm Ullman, Shapiro & Ullman told NutraIngredients-USA. This would include the importation of dietary supplement ingredients.
Biannual re-registrations required
Food facilities were already required to register with FDA under the 2003 Bioterrorism Act. FSMA expanded upon that requirement, mandating that facilities submit new registrations by the end of every even-numbered calendar year starting in 2012. The agency was not fully prepared to accept the re-registrations last year, and so extended the deadline of the first re-registration period to the end of January, 2013. That means, then, that every domestic and foreign facility manufacturing food and dietary supplement ingredients and finished products for the US market should have already submitted a re-registration form. It’s anybody’s guess how many have actually done so.
The situation for firms that currently are not in compliance, the fix is fairly easy, and the penalty for not paying attention to this requirement is fairly severe.
“You can do it an any time,” said Justin Prochnow, a lawyer with the firm Greenberg Traurig. “The main part of it is they can suspend a facility’s license (if you are not in compliance),” he said. “Once it gets suspended, you can’t do anything until it is reinstated.”
“The registration process is very simple,” Ullman said.