A Stronger, Safer FDA

The agency's number one goal is "efficient, science-based risk management"

By Steve Ennen

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In office for less than a year, FDA Commissioner Mark McClellan is bringing guidance and muscle to an organization that was rudderless for years. Several weeks ago, Dr. McClellan outlined the agency's five-part strategic plan to "protect and advance America's health." Not only does it impact food processors; it shows a keen awareness of the prevailing issues.

Statements by the Commissioner underscore the increasingly important role of science in the food arena. Of late, we have seen science weigh in on hot-button issues such as trans fats, and we will soon see a call for food companies to embrace and adhere to its tenets.

As the FDA outlined in late summer, its number one goal is "efficient, science-based risk management. The agency's approach to [this issue] requires the use of the most current biomedical, statistical, managerial, and economic science. By employing principles and technologies that can reduce avoidable delays and cost in product approvalsby implementing more effective strategies for food imports and food safety, and by implementing an enforcement strategy that combines clear communications to industry backed up by effective civil and criminal enforcement, FDA will achieve quicker access to safe and effective new products, and reduced public health risks without unnecessary costs."

This science will extend well beyond health claims, impacting everything from sodium to carbohydrates to daily intakes.

Patient and Consumer Safety represents the second rung of the FDA's legislative ladder. "Too many American's suffer from preventable adverse events related to medical products, dietary supplements, and foods, resulting in many billions of dollars in avoidable medical costs each year. Consequently, FDA is enhancing its ,'post-market' monitoring, communication, and regulatory activities."

These communications activities will likely focus on improving the quality and clarity of information issued to consumers, and undoubtedly zero in on labeling. In fact, the agency's other rung is Better Informed Consumers. "Informed consumers represent our nation's greatest public health asset, because the choices that people make every day can have a great impact on their own health and the health of the nation. Providing consumers with all the tools they need to make better-informed choices about how to use their health care dollars, and protecting them from misleading information that wastes their money and effort, is of utmost importance to the agency. FDA is undertaking major new efforts to ensure consumers have the most up-to-date, truthful information on the benefits and risks of FDA regulated products."

In this arena, FDA fulfills two complementary roles: "ensuring that the information sponsors provide about products is accurate and allows for their safe use, and communicating directly with the public concerning benefits and risks of products FDA regulates."

Of course, counterterrorism will continue as a focus. "As the nation's leading agency in protecting the security of the nation's food, FDA is improving its capability to assess and respond The Agency is working with other government agencies and the private sector to develop and implement a comprehensive strategy to protect the food supply from attack. These include additional staff for food safety field activities, greater import presence at our nation's borders, threat assessments, and additional money for food security research. FDA's medical product centers are also working harder and more creatively than ever to speed the availability of the next generation of safer, more effective countermeasures to protect Americans against biological, chemical, nuclear, and radiological agents of terrorism. "

A healthy food supply is Dr. McClellan's goal, one that will require some additional work on the part of food companies. By strengthening its investigative arms, the FDA hopes to become more effective and also more watchful. Food companies should expect to keep pace.

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