FDA Heightens Food Safety Enforcement, Say Lawyers

By Josh Long, Legal and Regulatory Editor

WASHINGTON Some lawyers say the U.S. Food and Drug Administration (FDA) has been more rigorously enforcing food safety regulations in recent years, following a 2010 government report that identified severe weaknesses in the agency's food facilities inspection program.

Joseph Levitt, a former FDA official and partner with the global law firm Hogan Lovells, maintains FDA is more aggressively enforcing decades-old food good manufacturing practices (GMP) through more frequent and thorough inspections.

The more rigorous enforcement, he said, is occurring at the same time FDA prepares to enact regulations under the Food Safety Modernization Act (FSMA), which has been hailed as the most significant food legislative reform in decades. Some of the draft regulations are currently under review by the Office of Management and Budget, the largest component of the Executive Office of President Obama.

"I think the message to the industry is it is very important that No. 1 they be in compliance with current FDA regulations because the cop on the beat is back", said Levitt, who served for six years as Director of FDA's Center for Food Safety and Applied Nutrition. "The oversight is there."

"That means it's doubly important that companies get ready for when the new rules [under FSMA] come into play. It's both be vigilant today and be prepared for the future. That's my advice."

FDA may have increased enforcement in the wake of a government report a few years ago that analyzed enforcement actions during the fiscal years 2004 through 2008. Released in 2010 by the Office of Inspector General, U.S. Department of Health & Human Services, the report divulged that more than half of the food facilities subject to FDA oversight went five or more years without an inspection. Another finding: FDA inspections at food facilities declined to fewer than 15,000 in 2008 from more than 17,000 in 2004 despite the fact that the number of food facilities rose.

"Our report identified significant weaknesses in FDAs inspections program," a government official said in testimony before a congressional subcommittee on May 6, 2010. "If FDA does not routinely inspect food facilities, it is unable to ensure that these facilities are complying with applicable laws and regulations and that the food handled by these facilities is safe. In addition, FDA must take swift and effective action to ensure that all violations are remedied."

Stephen Gardner, director of litigation for the Center for Science in the Public Interest, a consumer advocacy organization, isn't impressed with the FDA.

"As a long-time observer of FDA activity, my own conclusion is that FDA has, if anything, all but abandoned its role in stopping misleading food claims," he said. "FDA has, only because Congress made it do, stepped up enforcement of food safety problems, so perhaps that's what the other lawyers meant. A related and inescapable fact is that food companies have stepped up food-related fraud in recent years."

A Bloomberg Markets investigation raises serious questions about food safety in the U.S., depicting conflicts of interest involving third-party auditors that jeopardize the health and life of Americans. The report also found that FDA only inspected 6 percent of domestic food producers and 0.4 percent of importers last year.

Still, some lawyers have noticed that the FDA is tougher these days on enforcement. Stuart Pape, a Patton Boggs LLP attorney specializing in FDA law, said he noticed a "dramatic uptick" in FDA enforcement in the 2010 to 2011 period, although he hasn't observed a significant increase over the last several months.

During the years 2004 through 2010, FDA sent on average 450 to 700 warning letters across all industries it regulates, said Pape. By comparison, FDA issued 1,720 warning letters in 2011.

The purpose of such letters is to notify companies that, in the opinion of the FDA, they are in violation of the law and/or federal regulations; and the food safety agency puts the broader industry on notice because its warning letters are posted on its website. Levitt cites the number of warning letters FDA has sent for non-compliance of food GMPs as further evidence of tougher enforcement. In a memorandum to clients, he and two colleagues revealed FDA issued 206 warning letters last year for adulterated food. More than half of those letters were directed to facilities processing seafood and juice products, while 88 were sent to companies processing other kinds of food.

The letters, though, rarely lead to the type of enforcement action that could paralyze or stunt a business. For instance, FDA only reported 15 seizures and 16 injunctions last year across the entire agency including food regulation, according to the agency's public figures. That compares to 10 seizures and 17 injunctions in 2010. An injunction is a civil judicial action to stop or prevent a violation of the law such as ceasing the shipment of foods in interstate commerce while a seizure directs federal authorities to take actual possession of foods.

Hogan Lovells found that FDA filed at least 12 complaints for an injunction against food companies between January 1, 2011 and April 15, 2012. The lawyers noted the agency generally filed a complaint for an injunction against food companies with a documented history of violations. Most of these companies had received a warning letter and at least one follow-up inspection by regulators.

One lawyer attributed stepped up enforcement at the FDA in recent years to a legal requirement that places the onus on the private food sector to report problems to FDA.

"You see a lot of recalls all the time now because companies are required to report when they have problems with products that rise to the level of something that needs to be reported under the Reportable Food Registry," said Anthony Young, a partner with Kleinfeld Kaplan & Becker LLP, a law firm that concentrates in FDA regulations.

The Food and Drug Administration Amendments Act of 2007 directed FDA to establish the registry, which the agency explains is an electronic portal for the industry to report to when there is a reasonable probability that food will cause serious adverse health consequences. "That's one of the reasons we are seeing a lot of this stepped up enforcement. If I report that I've had Salmonella contamination in the manufacturing of a product and that product has been released, FDA is probably going to come in and inspect me very rapidly," Young said.

The number of recalled products was fairly consistent in fiscal years 2010 (9,361) and 2011 (9,288); FDA doesn't disclose the number for 2009.

"An increase in recalls is attributable to more in-depth signaling, trending  and surveillance; streamlined decision making and quicker response time if an outbreak occurs; seamless coordination and enhanced communication; and ultimately, increased public health protection leading to effective preventive food safety practices and policies," said FDA spokeswoman Carla Daniels.

The number of recalls could increase further thanks to the broader powers that have been granted to FDA via food safety legislation President Obama signed into law nearly two years ago: FSMA.

"Importantly, FSMA enables FDA to better protect public health by strengthening its ability to regulate and granting the agency enhanced preventative and mandate authority," asserts the Center for Food Safety and Center for Environmental Health, in a lawsuit filed against FDA and OMB for alleged failure to meet crucial deadlines under the sweeping law. "The law also provides FDA with new enforcement capacity, such as mandatory recall authority, and the ability to require that imported foods comply with U.S. inspection and preventative safety measures."

Still, the regulatory bent of an agency is often dictated by politics, and the frequency and intensity of future enforcement activity at FDA could partly hinge on whether President Obama remains in the White House. If the president keeps his job after the November election, "then you have a stronger ability to be more assertive" at FDA, said one food lawyer with an international law firm, who didn't want to be identified.

And a Democratic administration is more likely, for instance, to send warning letters than a Republican administration, observed another attorney with FDA expertise. Finally, consider what Republican nominee Mitt Romney has promised -- cutting rather than expanding regulations, which his campaign says "function as a hidden tax on Americans".