FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response (CFSAN) gave a peek into the important food guidance topics that the agency’s Foods Program will focus on over the course of 2022.
The hope is that FDA will publish a majority of these priority documents by January 2023, though the agency does note that it’s not bound by these 30 topics and is not required to issue every guidance document on the list. Its worth noting that food guidance documents do not have the force of law, rather they represent the agency’s current thinking on a topic.
Steve Gendel, principal of Gendel Food Integrity Consulting and a member of the Food Quality & Safety Editorial Advisory Board, who spent 24 years at FDA, says that releasing a list of topics like this is unprecedented, adding that these are clearly areas that the agency thinks are important and have been working on. “[They] encompass many different areas—all things that are of some priority for the Foods Program,” he says. Several topics listed involve FDA’s approach to enforcement actions.
According to an FDA spokesperson, the list was released to continue providing transparency for stakeholders regarding its Foods Program priorities. Guidance documents represent FDA’s current thinking on specific topics and the information can help stakeholders plan for potential changes that may impact their businesses and organizations.
Ten of the topics deal with the Food Safety Modernization Act (FSMA). “When the FDA started implementing the FSMA regulations, it was a very big deal for the industry,” Gendel says. “A number of years ago, they issued a [preventive controls] guidance document that started to fill in all the information the industry needed, but it covers a lot of different things, and the initial guidance had several placeholders for chapters and subjects they said were coming soon.”
Many of the promised topics are included in the new round of food guidance areas for 2022, with an emphasis on FDA enforcement activities. The guidance list includes topics dealing with the accredited third-party certification program; the implementation of the standards for the growing, harvesting, packing and holding of produce; and potential hazards for foods and processes. Additionally, nine of the topics deal with food safety and three with labeling. Other topics of note deal with allergens, nutrition, and dietary supplements.
Among the most significant topics regarding food safety are Action Levels for Lead in Food Intended for Babies and Young Children; Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Action Levels for Lead in Juice; and Foods Derived from Plants Produced Using Genome Editing.
“If you look at the things on this list, there are several that relate to heavy metal topics, which has become of interest to the agency, and something that has received a lot of public attention,” Gendel says. “This is an effort by the agency to demonstrate its transparency and, to me, what’s interesting is that it does cover a wide array of topics. Creating guidance is important for the agency, the public, and everyone.”
A full list of the topics can be found on FDA’s website.