Obesity trends among U.S. adults. Obesity is defined as a body mass index (BMI) of 30 or more, or about 30 pounds overweight for a 5 foot 4 inch woman. Source: Behavioral Risk Factor Surveillance Survey, Centers for Disease Control.

WASHINGTON, DC—The Food and Drug Administration, one of the government’s most overworked and underfunded agencies, has taken on the task of coordinating a comprehensive federal response to the obesity crisis.

Echoing calls to action from Health and Human Services Secretary Tommy Thompson and former Surgeon General David Satcher, FDA commissioner Mark McClellan has made obesity a top FDA priority. FDA’s Obesity Working Group, convened last August, will issue a preliminary report late this winter outlining an action plan to coordinate research on diets, pharmaceutical therapies and dietary supplements, as well as regulatory and education initiatives on food package and restaurant menu labeling.

“We need to focus on what we know about which types of programs work (to help people lose weight). People need to know what to do, how to do it, and what benefits will come of it. This needs to be communicated with clear, coherent, effective messages,” said Robert Brackett, PhD, a microbiologist who recently became head of FDA’s Center for Food Safety and Applied Nutrition (CFSAN).

Speaking at a conference on obesity sponsored by the Food and Drug Law Institute, Dr. Brackett stressed the need for a concerted effort between federal and local agencies, the medical community, the food and restaurant industries, and leaders of agribusiness.

A Tall Order

FDA will certainly have its hands full. To date, the agency has had little experience with large-scale public health efforts, particularly ones of this scope requiring extensive inter-agency and inter-industry collaboration. The anti-obesity campaign will require FDA to work closely with the Department of Agriculture, the Centers for Disease Control, all relevant institutes within the National Institutes of Health, the Public Health Service and others.

The objective is to craft actionable messages the public will easily understand.

That’s a far cry from the current situation in which confusion reigns. Beyond the relatively obvious facts—that weight gain is due to an excess of calories consumed relative to calories burned, and that an increase in fruits, vegetables and whole grains helps with weight loss—obesity research and nutrition recommendations are a quagmire of conflicting messages.

Alan Rulis, PhD, senior advisor to CFSAN, said FDA’s effort will focus on the following six questions:

• What is the available evidence on the effectiveness of various educational campaigns to reduce obesity?
• What are the top priorities for nutritional research to reduce obesity in children?
• What is the available evidence that FDA can look to in order to guide rational, effective public efforts to prevent and treat obesity by behavioral or medical interventions or both?
• Are there changes needed to food labeling that could result in the development of healthier, lower calorie foods by industry and the selection of healthier, lower calorie foods by consumers?
• What opportunities exist for the development of healthier foods/diets, and what research might best support the development of healthier foods?
• Based on the scientific evidence available today, what are the most important things that FDA could do that would make a significant difference in efforts to address the problem of overweight and obesity?

Dr. Brackett said FDA is eyeing the emerging science of nutritional metabolomics, the study of how diets interact with individual genotypes.

FDA will also concentrate on new drug development. “We’ve realized that obesity is not a short term issue. It is a life-long, chronic condition. We need durable effects, but from drugs that give long term safety,” said Dr. Brackett. To that end, FDA recently set a one-year minimum for treatment in all future obesity trials. Unfortunately, there are few promising new drugs on the horizon. “We have to see what are the roadblocks to new drug development.”

The Administration will also be looking closely at dietary supplements for weight control. Scrutiny is likely to be intense in the wake of the recent ruling on the sale of ephedra as an anti-obesity treatment (see related story).

Menu Labeling Under Consideration

Issues related to food and menu labeling will also be top priority. The recent inclusion of trans fat counts on food labels is only the beginning. In the near future, food packages and restaurant menus may include information about total calories, as well as macronutrient breakdowns. A variety of approaches are under review. While labeling efforts have their advocates, there are equal numbers of skeptics who question the impact of labeling on obesity.

Not surprisingly, the restaurant industry is lukewarm about menu labeling. Steven Grover, vice president of Health and Safety Regulatory Affairs for the National Restaurant Association, pointed out that little has changed since 1990, when the Nutrition Labeling Education Act required uniform nutrition information on all retail food products. “If labeling made such a difference, we shouldn’t be seeing the current surge of obesity. Frankly, we (the restaurant industry) do not feel that the NLEA was a success.” He added that the industry would likely be amenable to a voluntary menu-labeling program, but would oppose any federal mandate.

The Right Agency for the Job?

Some public health experts, even those within the agency, question whether FDA is properly equipped to take on the daunting job of countering obesity.

“FDA is not really good at education. We are very good at food safety from the point of view of regulating ingredients and setting standards, but we haven’t really done a lot of food education,” said Marsha Wertzberger, Esq., an attorney who served in the FDA’s office of general counsel for seven years. She added that FDA has no jurisdiction over vending machines in schools, food taxation laws, and other important factors. “We can’t push physical education programs, or develop sidewalks in communities that don’t have them, or build recreational facilities in ghetto areas. This all requires state and local action.”

Also at issue is whether FDA is adequately funded to handle the obesity challenge. “It would be nice to have unlimited funds, but the reality is, we do not,” said Dr. Rulis. He said the anti-obesity effort will likely pull funds from some of FDA’s other core responsibilities, such as identifying and investigating environmental toxins and food additives.

Michael Jacobson, PhD, co-founder of the Center for Science in the Public Interest, a non-profit health advocacy group, expressed serious doubt about the federal government’s abilities and interests in addressing obesity. “If the government were really concerned with obesity—and I don’t think it is—legislators would take the bull by the horns. They would take bold … actions rather than jiggering around at the edges and arguing about what is the appropriate serving size of a Coke. As it is, we’re sending Cub Scouts out with popguns to fight a serious war.”

Among the actions Dr. Jacobson suggested are a mandatory calorie count on all food labels and restaurant menus, a ban on all junk food and fast food advertising aimed at children, and small taxes on unhealthy foods such as soft drinks and processed meat products. Such tax revenue could be put toward public health programs. “A dozen states now have junk food taxes. California raises roughly $300 million annually, and New York raises $200 million. A one-cent per can tax on soda would raise more than $1 billion per year nationwide.”