Peanut product recalls are driving Congressional support for mandatory recall authority for FDA.

However, experts are not sure mandatory recall authority is the most important tool FDA needs to more effectively enforce food supply chain safety.

Stephen Sundlof, director of the agency's Center for Food Safety and Applied Nutrition, does not know of a situation in which a firm refused to comply with FDA's suggestion to recall a product, he said during a Senate Agriculture Committee hearing Feb. 5 on widespread salmonella contamination of peanut butter products.

Sundlof pointed out FDA already wields injunction and seizure powers. The agency's "bully pulpit" compels industry cooperation, he said.

Other clinical, information and communication tools would have made more of a difference than mandatory recall, say some experts.

FDA linked salmonella-tainted peanut butter to the Peanut Corporation of America's Blakely, Ga., facility four days before the first recall of products made with the firm's ingredients was announced.

Congressional critics note that because FDA does not have mandatory recall authority over food, it had to wait for PCA's approval before announcing the recall (¹ Also see "Peanut Butter Firm’s GMP “Deviation” Offers Lessons For Manufacturers" - Pink Sheet, 2 February, 2009., p. 8).

"That is not how a fully functioning regulatory agency is supposed to operate. It is dangerous, it is wrong and the American people deserve better," Rep. Rosa DeLauro said at a Feb. 4 briefing.

Recalls of products made with contaminated peanut ingredients sourced from PCA have prompted multiple food safety bills, with mandatory recall authority for FDA a recurrent theme.

DeLauro, D-Conn., chairwoman of the House Appropriations subcommittee with FDA oversight, reintroduced a bill that includes giving the agency mandatory recall authority for food - the Food Safety Modernization Act.

DeLauro's bill, H.R. 875, would also establish a separate agency - the Food Safety Administration - within the Department of Health and Human Services, formed from current FDA divisions.

At a Feb. 4 stakeholders' discussion on food safety, a Government Accountability Office executive said the congressional research service advocates giving FDA mandatory recall for food.

"Federal agencies can recall tires, they can recall toys, but they can't recall food, with the exception of infant formula," Lisa Shames, director of GAO's food safety and agriculture research, said at a Resources for the Future panel discussion.

While momentum builds behind improving food safety regulation, food and drug industry stakeholders say creating a new federal agency during this session of Congress is unlikely, primarily because of the costs.

DeLauro noted food oversight is split among multiple FDA offices - the Office of the Commissioner, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicines and the Office of Regulatory Affairs, which includes divisions around the country.

"There is no one single individual to be held to account for food safety at the FDA or anywhere else at the federal level," DeLauro said.

She said her bill includes giving the administrator of the proposed agency "sufficient enforcement authority, including authority to order recalls, seize unsafe food before it enters the market, and impose fines on companies that refuse to abide by the law."

DeLauro said there is "openness" to food safety reform, but was cautious about saying whether other members support her bill.

Sen. Dick Durbin, D-Ill., has creation of a separate food agency as a longer-term goal, according to a staffer (² [A#05160400005], p. 9). However, his FDA Food Safety Modernization Act, which he plans to reintroduce this session, and which would provide mandatory food recall authority, does not establish a separate agency.

Bloomberg News reported Feb. 6 that Agriculture Secretary Tom Vilsack supports the idea of a single food inspection agency, but believes it would be unlikely to pass this year.

Several other recently introduced bills call for mandatory recall authority for food.

Rep. Betty Sutton's, D-Ohio, Protect Consumers Act of 2009, H.R. 841, would grant recall authority for "all FDA-regulated products." She introduced a similar bill in 2007.

Rep. Diana DeGette, D-Colo., a member of the Energy and Commerce Committee, reintroduced two bills Feb. 3 - the Safe and Fair Enforcement and Recall Act and the Tracing and Recalling Agricultural Contamination Everywhere Act.

The SAFER Act, H.R. 815, would give FDA and the Department of Agriculture mandatory recall authority for food. TRACE, H.R. 814, would require USDA to establish a system for tracing products from origin to market, to improve the speed of recalls.

Value Of Threats

Daniel Fabricant, VP of scientific and regulatory affairs at the Natural Products Association, says it appears mandatory recall is coming for food products. He observed that while it might give consumers peace of mind, the authority could cost the industry if widespread recalls are ordered when only small volumes of products are affected.

Scott Steinford, president of supplement ingredient supplier ZMC-USA, sees little problem with FDA's current recall process.

"The obvious danger is, with this increased power, the FDA might have the obligation to act first and ask questions later, potentially resulting in false panic and irreparable damage to an organization," Steinford said in an e-mail.

Steinford also voiced concern that FDA might jump the gun on ordering recalls. "While it is presumed the FDA would enact mandatory recall authority as a matter of last resort, media pressure alone could promote knee-jerk reactions in advance of thorough analysis," he said.

A. Wes Siegner, an attorney with Washington-based Hyman, Phelps and McNamara, said there is no real need for the authority. "If FDA knows about the defect ... then FDA can and does effectively force a recall by threatening to make both the defect public and lack of cooperation public, as well as using or threatening use of other enforcement, such as seizure or injunction," Siegner said in an e-mail.

Still, he expects the change to happen and to have the supplement industry's support. "The overall effect on regulated industry and public health will be minimal," he said.

The Council for Responsible Nutrition has said it supports giving FDA the authority.

More News Tools, Resources Needed

Federal agencies could have responded more quickly to the salmonella outbreak with better laboratory, information and communication tools, Assistant Surgeon General Rear Admiral Ali S. Kahn told the Senate Agriculture Committee.

Salmonella cases were reported in early September 2008, but the cause was not linked to ingredients from PCA's Georgia facility until Jan. 9.

"There are a number of opportunities to really shorten this timeline." Kahn said. "We need a couple of things. The first thing we need is new tools at the local, state and national level to investigate these outbreaks." Kahn advocated equipping FDA and other agencies with laboratories and informational tools.

Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, said the salmonella situation "illustrates tremendous gaps" in the U.S. food safety system.

DeWaal said FDA should be authorized to order recalls of harmful food products. Announcements of a "voluntary recall may not compel consumers to act with requisite urgency," but FDA-mandated recalls could have more impact, she added.

William Hubbard, a former FDA associate commissioner, said food contamination outbreaks have almost tripled in the past 15 years and the U.S. food safety regulation system has become outdated. Mandatory recalls for food products is one update needed, he said. Manufacturers of contaminated products can stall before agreeing to recall requests, Hubbard pointed out. "They like to talk to their lawyers, they like to think about it. They like to take a day or two," he said.

- Katie Stevenson (k.stevenson@elsevier.com)

FDA Recall Authority Likely In Peanut Fallout, But Is It The Real Problem?

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