Earlier this year, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) gave an overview of the food guidance topics that the agency’s Foods Program will focus on over the course of 2022.
The expectation is that FDA will publish most of these priority documents by January 2023, although the agency cautions that it is not bound by these 30 topics and is not required to issue every guidance document on the list. It’s worth noting that food guidance documents do not have the force of law, but rather represent the agency’s current thinking on a topic.
Matt Regusci, director of growth at ASI Food Safety, notes that a lot of industry and regulatory input goes into figuring out what will be on the list; therefore, putting the list out at the beginning of the year allows the industry to know what FDA plans to tackle throughout the year and holds the government accountable for finalizing it. This also allows the food industry to watch out for new guidelines that may come out and provide input to the FDA.
“The FDA has a multiple-step process from guidance to regulation,” Regusci says. “These guidance documents help the industry to provide feedback and real-time examples of what works in theory and what works in reality. Food is not produced in a lab-like environment, so as industry leaders implement the FDA guidelines, they can provide feedback to the FDA.”
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, notes that releasing a list of topics like this is unprecedented, adding that these are clearly areas that the agency thinks are important and has 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.”
A Look at Food Safety
There are eight guidelines slated for 2022 dealing with food safety.
Significant topics regarding food safety include action levels for lead in food intended for babies and young children, 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 [is] 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.”
Sara Bratager, a food traceability and food safety scientist at the Institute of Food Technologists, notes that, given the spotlight on heavy metals in baby foods over the last year, it’s not surprising to see that three of the nine listed food safety guidance topics center on heavy metals—specifically on lead and arsenic in juices and foods meant for babies or small children.