Eighteen food industry groups sent a formal request to FDA to issue guidance as soon as possible concerning the timeline for enforcement of the new provisions under the Food Safety Modernization Act (FSMA). By law, these provisions are to become effective 18 months after enactment on July 3. FDA has informally said it will not enforce these new requirements until it issues final regulations and allows time for implementation by the food industry.
“That makes perfect sense, but because of the way the law is drafted, it is essential that the Agency state, in writing, that this will be its enforcement posture,” the industry groups said in the letter to FDA. “The uncertainty generated by a fast-approaching enforcement date, together with a lack of regulations or clear statement from FDA on enforcement posture, is generating increasing anxiety and concern within the food industry.”
The groups also said they are waiting for FDA to issue final regulations defining the terms “small business” and “very small business” under the act.