DeLauro/Durbin bill to set up new, food-only federal agency finds broad support from supplement industry

Rep DeLauro, chair of the House Appropriations Committee, said a new agency with a single focus would improve food safety in the United States, in particular because the organization could be headed by a subject matter expert.  The US Food and Drug Administration also has responsibility over pharmaceutical products and medical devices, and for the past 30 years has usually been led by MDs (many FDA Commissioners have also held additional academic credentials).

“Food safety is currently a second-class citizen at the Food and Drug Administration,”​ said Rep DeLauro. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death. Look no further than the recent infant formula crisis to understand the need to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market”​

In his public statements related to the bill’s introduction (which is officially titled the Food Safety Administration Act​​), Sen Durbin took a dim view of FDA’s recent track record. Rather than trying to reform the existing agency, he said it’s time for a fresh start.

“In recent years, FDA has been plagued by one failure after another—from a failure to properly recognize the dangers of prescription opioids, to a failure to protect children from e-cigarette products, to a failure to properly ensure the safety of our nation’s food supply,”​ said Sen Durbin. “The sad reality is that FDA seems unwilling or unable to use their authority to protect Americans from preventable illness and death.”  ​

The bill has received support from such groups as the Environmental Working Group, Consumer Reports and The Center for Food Safety.

CRN supports idea as long as supplements remain as part of foods

Julia Gustafson, vice president of government relations for the Council for Responsible Nutrition, said as along as dietary supplements continued to be regulated as a subset of food, CRN would be willing to further examine the proposal.

“CRN supports the efforts of Representative DeLauro and Senator Durbin to strengthen food safety and bring attention to serious concerns that food and dietary supplement oversight is not a priority for FDA. The current lack of attention and resources that appear to be available for food, and especially supplements, under the current regime is problematic and these products would certainly benefit from a new structure,”​

“If splitting the agency would mean greater attention being given to nutrition benefits and supplement enforcement, then that is a concept we would like to see move forward for further debate within Congress,”​ Gustafson added.

AHPA:  Single-focus agency might help clear guidance and inspection logjams

The American Herbal Products Association said it had been reassured prior to the bill’s introduction that supplements would not distinguish supplements from other foods, which presumably would have been a deal breaker from AHPA’s point of view.  With that issue put to rest, AHPA President Michael McGuffin said his organization’s membership has voiced support for the proposal.

“In discussing the legislation with our members, we heard strong support for reorganizing federal oversight to increase category-specific experience and expertise in the regulation of food, including dietary supplements – especially in the areas of facility compliance and development of guidances,”​ McGuffin said.

The bill has been cosponsored by Sen Richard Blumenthal (D-CT) and US Representatives Nannette Diaz Barragán (CA-44), Jimmy Panetta (CA-20), Gwen Moore (WI-04), Sheila Jackson Lee (TX-18), and Bonnie Watson Coleman (NJ-12).

NPA: Bill unlikely to advance, but springs from real concerns

Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said he doubts the proposal will move forward, but added that it arises out of a real frustration among lawmakers about perceived FDA intransigence.

“The bill is likely dead on arrival, but the hostility and outrage toward the Agency is real.  They feel that FDA has been unresponsive,”​ Fabricant said.

“FDA does have some institutional issues that need to be addressed.  They are not as nimble as they need to be, or as they used to be.  The solution is accountability.  I know from my experience at FDA that there are some portions of the Agency that would just like to be left alone.  But that doesn’t work in a situation where one out of every four dollars spent in this country is spent on an FDA regulated good,”​ he said.