Background
The proposal, contained within Obama’s budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a “single new agency within The Department of Health and Human Services,” according to the budget. “This new agency would be independent from FDA and have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation,” the White House explains in the budget. “The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement and research efforts across all food types based on scientifically supportable assessments of threats to public health. The agency would also serve as the central point for coordinating with State and local entities and food safety stakeholders.”
The proposal is markedly similar to one introduced in late January 2015 by Sen. Dick Durbin and Rep. Rosa DeLauro, both Democrats. Their bill, the Food Safety Act, would also consolidate food regulation power within a new independent food regulator they called the Food Safety Administration (FSA). The bill would have major implications for FDA, and not simply because of the loss of its authority to regulate traditional foods. Also covered under FDA’s definition of “food” are dietary supplements, which are defined under the Dietary Supplement Health and Education Act (DSHEA)as “a food.” The question, then, is whether FDA would continue to regulate dietary supplements, or whether it would cede that authority as well to the new FSA.
What’s in the FDA Name?
Another matter of perhaps more readily apparent concern: Would FDA—the Food and Drug Administration—have to change its name? Some industry commentators weighed in on social media, offering alternative names should the agency lose its food authority. The Medical Device, Drug and Tobacco Agency (MD DATA) was one suggestion, reflecting the wide range of the regulators’ responsibilities. Another looked to the Centers for Medicare and Medicaid Services (CMS) for inspiration, saying it should be known as the Federal Drug and Device Administration (FDA), if only to preserve its existing acronym.
Industry Skeptical
Prominent members of the dietary supplement industry; however, don’t seem to be too worried about the potential effects of either measure thus far. In an interview with Regulatory Focus, former FDA regulator and current Natural Products Association (NPA) CEO Daniel Fabricant said he believed both proposals stood little chance of passage. “Frankly speaking, the [Food Safety Act], as it is proposed, is dead on arrival,” Fabricant said, noting that it has been introduced several times before to no avail. Fabricant also downplayed the significance of Obama’s endorsement of the proposal. “It’s still dead on arrival,” he said. “The President hasn’t had much success in terms of passing a budget,” he observed. Fabricant, formerly the head of FDA’s Division of Dietary Supplements, said he would prefer that FDA retain regulatory authority over supplements. “We’d prefer to continue to keep things as they are,” he said, while adding that he’d like to see FDA’s focus on supplements “be elevated.” FDA’s dietary supplement regulators have become much more active in their oversight of supplements in the last several years, Fabricant said—a trend he’d like to see continue in the future. The risk, he said, is that supplements might be a lesser priority at a food-focused super-agency like FSA.
Obama’s Pitch: Increase Government Efficiency
Perhaps wary of the difficulty of obtaining bipartisan support for the proposal, Obama’s budget has explained it in terms it hopes will garner Republican support. Between the U.S. Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) and FDA, seemingly similar products and species can undergo an almost Kafka-esque oversight process.
Explained the White House:
“While FDA is responsible for most foods, FSIS is responsible for meat and poultry. While FSIS oversees processed egg products, FDA oversees shell eggs. FDA is responsible for seafood, but FSIS is responsible for catfish. FDA and FSIS can each have jurisdiction over the same category of food at different points in the food chain: a cheese pizza and its ingredients are regulated solely by FDA, but both agencies play roles in regulating the components and manufacturing of a pepperoni pizza. FSIS inspects manufacturers of packaged open-face meat or poultry sandwiches, while FDA inspects manufacturers of closed-face meat or poultry sandwiches.” In a Congress controlled by Republicans, that argument might win some support. But as Fabricant notes, this isn’t the first time the proposal has been introduced—and ignored.
Will FDA be able to keep its name? Stay tuned.
REFERENCE: RAPS; Regulatory Focus; 02 FEB 2015; Alexander Gaffney, RAC