AHPA supports Sen. Durbin bill to create separate federal food agency

A bill aimed at separating the regulation of foods and drugs into separate agencies has garnered support from a dietary supplement industry trade group. 

The bill, introduced on Tuesday, July 23, by Sen. Dick Durbin (D-Ill.) and Rep. Rosa DeLauro (D-Conn.), is called the Federal Food Administration Act of 2024. Sen. Richard Blumenthal (D-Conn.) has joined as an original cosponsor. 

The bill has garnered support from the American Herbal Products Association (AHPA). Other groups that have voiced approval include Consumer Reports, STOP Foodborne Illnesses and the Environmental Working Group. 

Lawmakers: FDA’s safety failures mounting 

According to a statement issued by Durbin’s office, the move is meant to address what he and DeLauro view as recent significant failures on the food safety front. 

The statement specifically cites infant formula causing bacterial infections in babies and applesauce pouches found to be tainted with lead.  

The statement said separating FDA’s responsibilities into two new agencies —  one on the drug side with the other devoted to food — would make for clearer paths of responsibility and help regulators to better protect the public. 

“The sad reality is that FDA has not used its authority to protect Americans from preventable illness and death. For that reason, Congresswoman DeLauro and I are introducing legislation to transfer all of FDA’s food responsibilities to a new agency that, we hope, will enable greater attention and success in protecting the foods in our kids’ lunch boxes and on our dining room tables,” Durbin said in the statement. 

“I believe we need a single food safety agency solely focused on keeping the foods that we eat safe,” DeLauro said. “Creating a single food safety agency could prevent avoidable product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death.” 

Despite the institution of the Food Safety Modernization Act (FSMA), the new processes it puts into place and the new authorities it gives to FDA, the needle has not moved on food safety, according to the lawmakers’ statement. About one in six Americans contract foodborne illnesses every year. Durbin’s office notes that according to the Centers for Disease Control and Prevention (CDC), 128,000 Americans also are hospitalized, and 3,000 Americans die of foodborne diseases each year.  

The new bill would create two new agencies: the Federal Drug Administration and the Federal Food Administration. 

AHPA: Dietary supplements must remain a subset of foods 

AHPA’s support is focused on how dietary supplements would be regulated at the federal level. Like some other industry stakeholders, AHPA had expressed concerns about the implications of a pending FDA reorganization that creates a unified Human Foods Program. Under the reorg, FDA’s Office of Dietary Supplement Programs (ODSP) will report to a super-office known as the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). 

Despite reassurances from FDA officials, some industry stakeholders have expressed concerns that dietary supplement industry issues will fall farther down the ladder of agency priorities within the new structure. 

In a statement on its website, AHPA said its support for the new Durbin/DeLauro bill “follows from its endorsement of a substantively similar bill introduced in 2022. As with previous versions of the bill, AHPA's endorsement remains conditional upon the legislation continuing to ensure that the new Federal Food Administration would regulate dietary supplements with other foods.” 

Former FDA attorney: Heavy lifting to separate out food authorities already mostly done 

Bob Durkin, Esq., a partner and co-founder of the regulatory group at the law firm Amin Wasserman Gurnani LLP, has a unique perspective on the issue having spent several years at FDA, including at ODSP. He said the need for clearer paths of authority had already been recognized, and most of the heavy lifting has been achieved. 

“The organizational structure changed to really isolate the foods program from other components. Now, with the reorganization, the foods part of FDA could be moved into a new agency with the stroke of a pen,” Durkin said in a phone interview. 

“It is something that had been talked about for a while. Before, a lot of the resources in the district offices were all just mashed together,” the former FDA official added.