Dr. Scott Gottlieb will be taking over as FDA commissioner at an interesting time.
In addition to the usual changes that take place whenever a new administration takes over — especially when the president is from a different party than his predecessor — the food industry is in the process of adapting to the Food Safety Modernization Act, or FSMA.
Signed into law by President Obama in 2011, FSMA is a sweeping overhaul of food rules and regulations to focus on preventing contamination instead of reacting to it after it happens. Such an undertaking isn’t a short process, so full adaptation of FSMA is an ongoing and will, of course, have its growing pains. Toss a new administration into the mix and there’s the potential for changes midstream and confusion over what is and isn’t going to be required.
To get a sense of how Gottlieb may approach FSMA specifically and food regulations in general, I spoke to Todd A. Harrison, a partner at Venable law firm in Washington, D.C. Harrison works in the areas of FDA and other government regulations for food safety, labeling and advertising claims.
Overall, Harrison expects Gottlieb to be more focused on the drug side as opposed to the food side. Gottlieb is a physician who teaches at New York University School of Medicine, and he served as Deputy Commissioner for Medical and Scientific Affairs at the FDA from 2005-07.
A focus on drugs as opposed to food is not unusual; most FDA commissioners tend to focus more on drug regulations and approval processes than food safety. The nation’s food supply is pretty safe overall, so FDA commissioners tend to take an “if it’s not broke” approach.
“As long as people aren’t dying in the streets from food poisoning, they aren’t worried about it,” says Harrison.
FSMA, however, is a unique circumstance for an incoming FDA commissioner, as it is the most comprehensive change to food regulations in more than 70 years. While implementation and enforcement of regulations is the role of the career staff as opposed to appointed officials, the commissioner does set FDA policy, which means that Gottlieb would have a lot of leeway to affect how FSMA is handled.
Ultimately, Harrison expects Gottlieb to have a minimal impact on FSMA. While Gottlieb and the rest of the new administration may issue fewer new regulations than others might, existing regulations will probably stay in place for the most part.
“I really don’t think there are going to be a lot of changes in their enforcement priorities,” says Harrison. “As FSMA gets implemented, they will probably issue warning letters, and the reason for the letters is as a teaching tool for companies. FDA often uses the warning letter system to send a message to the industry as a whole as to what is important to them,” as opposed to using the letters as a punitive measure.
Ultimately, Gottlieb’s influence on FSMA will probably be minimal, and even if it isn’t, it may not change much. Major food companies often have higher standards than what the FDA requires — FDA regulations are a floor, not a ceiling — so processors will probably not see much of a difference in the standards they have to meet.