"Essentially, we want to use our regulatory tools, insights and experience to facilitate the development of new products. The way we want to achieve this goal is by reducing and managing the risks that affect a manufacturer's decisions whether to develop a new product or not," Dr. Lester M. Crawford, acting FDA commissioner, said this week at the institute's annual conference in Las Vegas.
Comparing the food industry's research and development efforts with those of the drug industry, Crawford noted that the former does not have to contend with costly and lengthy clinical trials. However, he continued, food manufacturers have to deal with a myriad uncertainties as they consider new products for the marketplace.
"Some of the questions they face may involve the performance of new production technologies; some may be of regulatory nature; and some may bear on the outlook for public acceptance of the product. This is their 'critical path' whose decisions we want to make less risky, and we're in an early thinking stage how it can be done," Crawford said. "We believe that our agency has an obligation to reduce barriers and clear up uncertainties affecting technological progress that contributes to the safety of regulated products. This is part of our mission of protecting and advancing the public health."
Reflecting on the challenges that have been facing the FDA and the food industry in the past year, Crawford assured the audience that the government has undertaken wide-ranging steps that have strengthened food safety and security. For instance, he said, as of June 24, 109,000 foreign firms have complied with the government's registration requirement, which constitutes more than half of the 208,000 food facilities registered so far.
Furthermore, food inspectors have been posted in 90 ports of entry, which is more than double the amount of two years ago. Food examinations at the border have increased sixfold, he added. "In addition, we have commissioned 8,150 customs officers to carry out these examinations in ports where we have no presence," Crawford noted.
Crawford indicated that addressing the hazards of bioterrorism and other food-related issues, such as obesity, are top of mind for the FDA and make up almost half of his priority agenda. The task of improving the safety, quality and variety of the 80% of America's food supply that falls under its jurisdiction is central to the FDA, he said.
The FDA, he continued, is guided by two strategic objectives: achievement of science-based risk management of public health issues, and advancement of more efficient development and production of regulated products. Its goals are:
To modernize the good manufacturing practices and reduce the uncertainties surrounding the introduction of new health care and food products;
To confront the obesity epidemic and the threat of bioterrorism;
To reform FDA's inspections policies;
To improve the labeling of prescription drugs; and
To resolve the drug importation issue.
"Although the bioterrorism statute is mainly designed to protect imports, we are significantly strengthening the security and safety of all food, both domestic and foreign," Crawford indicated.
Obesity: The Enemy Within
In addition to food safety and food security, Crawford also devoted a great deal of his speech to what he intimated to be the enemy within, the national obesity crisis. He said the creation of the Obesity Working Group last year, which included participation of experts from academia and government agencies, was worthwhile.
"The overriding lesson of our inquiry is that the obesity epidemic has no single cause: it is the confluence of numerous factors acting together over time. Controlling obesity, therefore, will be a long-term process requiring numerous coordinated programs. And to succeed, we have to persuade our public that weight maintenance is governed by an iron equation: calories in must equal calories out," Crawford observed. "Our Working Group found that a surprisingly large segment of our population is not aware that excessive weight is a health problem. It is a blind spot that cuts across gender, socioeconomic status, age and ethnicity. Studies indicate that many people consider the extra pounds of minor significance, and therefore have little incentive to get rid of them."
The FDA, he said, intends to educate consumers about their dietary needs and nutritional requirements of food as well as revise current food labels, which have not been effective in helping shape consumers' dietary choices. One of the reasons for the label's failure to do their job was because consumers, themselves, do not understand the information on the Nutrition Facts panel.
"In 1992, fewer than 56% of Americans were overweight, and fewer than 23% were obese. Today, 65% of all Americans are overweight, and over 30% are obese. Children and adolescent obesity rate is double of two decades ago. In 1992, the obesity-associated mortality was 300,000 a year; today, it is 100,000 higher," he said.
The FDA will upgrade the food labels with an emphasis on calories rather than fat in weight maintenance. The agency is also considering increasing the type size for calories, eliminating the listing of calories from fat and adding a column for calories as a percent daily value for the entire contents.
"Next, we will encourage food manufacturers to label as a single serving such food items, for example, snack packages and bottles of soda, which are usually consumed on a single occasion. We're also encouraging firms to make it easier for consumers to compare different types of food by using labeling statements that are permissible under current regulations. For example, such label could state that "one medium apple has 47% fewer calories than one ounce of potato chips." Crawford said.
The FDA also plans to kick off a national education campaign directed at children to get out the "Calories Count!" message.
As for foodservice, Crawford said restaurants would be encouraged to provide nutrition information about the meals on their menus. "We're urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign, and we're encouraging consumers - who spend 46% of their food dollars eating out - to routinely request nutrition information in restaurants. We plan to run a pilot program to test this proposal in a controlled restaurant setting," Crawford detailed.
Finally, the FDA proposes to update good manufacturing principles that have not been addressed in nearly two decades. Crawford said that since then food manufacturers have used new technologies to put on the market a constantly expanding variety of processed, packaged and refrigerated products, which have become a popular part of the American diet. Crawford indicated that portable soup, drinkable yogurt, squeezable peanut butter, and bagged lettuce salads did not exist two decades ago, as well as low-carb foods, Tex-Mex foods, and vanilla-flavored sodas. He added to this already extensive array of food products millions of shipments of fresh produce imported in and out-of-season from around the globe.
"All of these developments have increased food safety hazards. On top of that, we've seen an emergence of new food pathogens, and a demand and expectation of millions of consumers want to be protected from the hazards of food allergens. This was not the case two decades ago. So although our food supply is as safe as any in the world, the 20 year-old rules safeguarding it need to be updated," he pointed out.
In order to accomplish the task of filling the gaps in predictive knowledge about food safety and security as well as obesity, Crawford called for industry cooperation in developing, for example, methods for the rapid detection and identification of pathogens in foods. "The common denominator and overarching aim of these and all other priority projects of our agency is to reduce and manage the risks affecting the health of our public, and thereby advance the vitality of our nation," he said.
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