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Last year was one of the most prolific in recent memory for food regulation at the Food and Drug Administration. And I’m not just saying that because the agency’s Center for Food Safety and Applied Nutrition, which I directed from 1998 to 2003, had a banner year. Under Commissioner Mark McClellan, the FDA published eight major regulations, instituted a significant new emphasis on nutrition, and issued an agencywide Strategic Action Plan. Although Dr. McClellan was nominated last month to head the federal Medicare and Medicaid programs, the agency he will leave behind can be expected to stay the course in 2004. Food regulation will be focused on four major areas: counterterrorism; nutrition and obesity; food safety; and dietary supplements. COUNTERTERRORISM The FDA’s most visible advances in food regulation last year came in response to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The Bioterrorism Act directs the Department of Health and Human Services to protect the nation’s food supply from threatened or actual terrorist attacks. Accordingly, the FDA in 2003 published four proposed regulations on bioterrorism — covering food facility registration, prior notice of imports, record keeping, and administrative detention — and two interim final regulations — on facility registration and prior notice. Completing this critical agenda — by ensuring that the new systems work smoothly, and issuing the two other final (or interim final) rules — will be the agency’s top priority for 2004. Indeed, the FDA has already issued guidance on implementing the facility registration requirements and a timetable for phased-in enforcement of the prior-notice rules. The latter will require a close working relationship with the U.S. Customs Service, now part of the Department of Homeland Security (DHS). Whether the FDA publishes “final” regulations this year for registration and prior notice, following comments received on the interim final rules, will depend on the urgency of the comments and the extent to which revised rules are needed to ensure smooth implementation. That said, the FDA’s counterterrorism program does not end with the Bioterrorism Act. A July 2003 report to HHS Secretary Tommy Thompson outlined a 10-point program to protect the security of the food supply. That report was largely incorporated into Homeland Security Presidential Directive No. 9, signed by the president on Jan. 30. This far-reaching directive goes well beyond the specific mandates of the bioterrorism law to provide a comprehensive blueprint for protecting America’s food and agricultural systems. Several points from this directive are particularly significant. First, because this is a presidential directive involving a top administration priority, it will receive the full attention of FDA and U.S. Department of Agriculture officials. Only the most compelling issues — such as BSE (i.e., mad cow disease) and obesity — will be as influential in driving food agency priorities and budgets. The best analogy would be the attention given to the Food Safety Initiative under the previous administration. Second, the food industry should take note that the directive calls for enhanced screening and inspection of imported, as well as domestically produced, food. This will build on the new authorities in the bioterrorism law, including the prior-notice regulations. The government’s focus here will also be tied, in large part, to the vulnerability assessments already conducted by the FDA, which are to be updated every two years. Third, the directive calls for a dedicated research program devoted, in part, to “prevention technologies” that would reduce the risk of select agents threatening the food supply. Any ongoing industry efforts in this regard should be coordinated with the agencies to prevent duplication and promote synergy. This research program will be enhanced by university-based “centers of excellence” that the DHS is charged with establishing. Fourth, the agencies are directed to work with the food and agriculture industries to establish an “information sharing and analysis mechanism.” This follows on previous efforts referred to as the ISAC (Information Sharing and Analysis Center). The DHS is taking the lead here. Finally, although aimed at preventing intentional contamination of the food supply, many of these steps will strengthen traditional food safety efforts as well. Faster emergency response to outbreaks, increased screening of imports, and a dedicated food science research program will all serve a dual purpose. NUTRITION AND OBESITY Although nutrition had been an FDA centerpiece a decade ago when the agency was implementing the Nutrition Labeling and Education Act of 1990, more recent priorities in food safety (and, even more recently, in food security) had left this area relatively dormant. All that changed in 2003 with the Commissioner’s Task Force on Consumer Health Information for Better Nutrition, publication of a final regulation on trans fat labeling, and establishment of the Obesity Working Group. A reinvigorated nutrition program will be one of Dr. McClellan’s major legacies. The health information task force issued its report in July 2003, laying out a new, interim process for allowing “qualified health claims” on food labels. The intent is to provide consumers with more comprehensive information about dietary choices and the link to chronic diseases, while incorporating the latest line of First Amendment cases — particularly the series of federal court decisions in Pearson v. Shalala, addressing the use of disclaimers in health claims to remedy possible consumer deception. Important follow-through on qualified health claims will come this year in at least four areas. First, the FDA is now reviewing petitions for such claims under the new procedures, and those reviews will set significant precedents. Second, the FDA is conducting consumer research on how to best qualify such claims to ensure that consumers will understand their limitations and not be misled. Third, this consumer research, together with public comments on an Advance Notice of Proposed Rulemaking (ANPR) published in November 2003, will form the basis of a proposed regulation on qualified health claims. Finally, the FDA will be defending itself in a federal suit brought by Public Citizen and the Center for Science and the Public Interest, challenging the agency’s interim approach on both procedural and substantive grounds. Almost simultaneous with announcing the task force report, the FDA published a final rule requiring the amount of trans fatty acids (trans fat) to be listed on the “Nutrition Facts” panel of food products. Food companies will need to modify their labels to incorporate this change, which takes effect on the next uniform-labeling compliance date in January 2006. Some companies will also likely reformulate their products to reduce the amount of trans fat. A follow-on to the trans fat rule is still ahead, since the FDA did not — as it had done with saturated fat and cholesterol — include a recommended “Percent Daily Value,” due to incomplete advice from the National Academy of Sciences. Instead, the FDA issued an ANPR and promised to conduct consumer research to determine the best way to inform Americans that they should look at saturated fat, trans fat, and cholesterol together in deciding what to eat. Since then, the national academy has issued further guidance regarding how the FDA might set a daily value for trans fat. It will be the FDA’s challenge to merge that scientific advice with the public comments to the ANPR and the results of its own consumer research. The third and final component of the reinvigorated nutrition program is the Obesity Working Group. Dr. McClellan formed the working group this past summer to recommend ways to address what is often called the obesity “epidemic.” The FDA held two public meetings last fall, and the working group’s report is due to be issued very soon. It is expected to consider both changes to product labels and changes to the way that nutrition information is provided at restaurants. FOOD SAFETY The biggest planned activity in the FDA’s food safety program for 2003 was the final risk assessment for listeria, issued in October. This document was the first of its kind to analyze one pathogen over an entire range of food products. It identified those food product categories that pose a high public health risk from listeria contamination as well as those that pose a very low risk. The analysis also concluded that the two most significant factors in reducing the risk were the temperature of refrigeration and the length of time the food was stored. The FDA held a public meeting in early December to solicit public comment on a draft plan to address these findings; follow-up activity in 2004 is highly likely. The FDA also looked at a series of food contaminant issues in 2003. Contaminants had received less attention during the previous administration’s Food Safety Initiative, which looked at biological pathogens. This year, acrylamide will continue to receive close scrutiny because of its very high visibility in the last two years. In addition, methyl mercury in seafood, dioxins, PCBs, and other contaminants will likely receive attention. The biggest “surprise” of the year was the finding, just before Christmas, of a single BSE-infected cow in Washington state. A speedy response from Secretary of Agriculture Ann Veneman, followed by complementary announcements from the FDA, were critical to maintaining consumer confidence in the meat supply. Both the USDA and the FDA will continue to give BSE the highest level of attention. A late addition to the fiscal 2005 budget request should carry that commitment into future years. DIETARY SUPPLEMENTS The final focus of major food regulatory attention is dietary supplements. The FDA published proposed regulations to identify Good Manufacturing Practices (GMPs) in early 2003. At the end of the year, it announced its intent to ban the widely used weight-loss product ephedra. Both actions were supported by leading segments of the dietary supplement industry as showing that the Dietary Supplement Health and Education Act of 1994 can provide effective consumer protection, while the leading maker of ephedra threatened a court challenge. Meanwhile, consumer advocates and some members of Congress called for the dietary supplement law to be made tougher. These same issues carry over into 2004. The December announcement on ephedra was quickly followed in early February with a final regulation banning the product as presenting an “unreasonable risk of illness or injury.” It was the first time the agency had defined this important legal standard. The FDA will also be working vigorously to draft final regulations covering GMPs. What we saw from the FDA over the past year is prologue for what it will likely do in 2004. Dr. Lester Crawford, who has been named to serve as acting commissioner following Dr. McClellan’s departure, was integral to the development of these policies while serving as deputy commissioner. Moreover, support for the current agenda extends all the way up through the department to the HHS secretary and even to the White House. Of course, unexpected events can upset the best-laid plans. But completion of the bioterrorism regulations, progress on qualified health claims and anti-obesity efforts, full-scale attention to combating BSE, and finalization of dietary supplement GMPs should remain among the FDA’s very highest priorities this year. Joseph A. Levitt is a partner in D.C.’s Hogan & Hartson and a member of the firm’s food, drug, medical device, and agriculture practice group. Levitt served in the FDA for 25 years, most recently as director of the Center for Food Safety and Applied Nutrition from February 1998 to December 2003. He can be reached at [email protected].

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