CSPI Lobbies FDA for Nutraceutical Regulations
Once only the buzzword for a new food industry trend, nutraceuticals are appearing on supermarket shelves with increasing frequency. But such foods are drawing the ire of the Center for Science in the Public Interest, which is urging the government to tighten controls over "functional foods," saying too many companies are promoting unproven ingredients and making misleading health claims.
According to the CSPI, the current situation is creating a mishmash of products that confuses consumers. The center points to examples, such as a split-pea soup with the herb St. John's wort to "give your mood a natural lift," or carrot cake with heart-healthy fiber, as particularly confusing since a bowl of soup doesn't treat depression and fiber can't counter the cake's fat to make it healthful. The fear is that such products could cast doubt on true functional foods that do have scientifically proven ingredients, the group contends.
"While functional foods hold much promise, without effective regulation, they may merely become the snake oil of the next century," CSPI director Michael Jacobson wrote to FDA commissioner Jane Henney.
Nutraceuticals have become a booming industry, estimated to bring in $15 billion this year. Yet the FDA has no policy determining just what foods qualify, FDA food chief Joseph Levitt acknowledged. He adds that developing such a policy is a top priority that FDA hopes to complete this year. This is "an area of enormous public interest" that will require setting boundaries, he said.
Food industry representatives counter that CSPI's call for more regulation is "unjust and reckless rhetoric" since foods that make health related claims already must meet rigorous federal standards to assure safety and substantiation of claims.
"Health claims and structure-function claims on food labels provide important information that can be used by consumers to create more-healthful diets," said Regina Hildwine, director of food labeling and standards for the Washington, D.C.-based National Food Processors Assoc. (NFPA). "Contrary to CSPI's assertions, FDA already has full enforcement authority to ensure that such claims are scientifically supported and do not mislead consumers."
To the CSPI's credit, it doesn't appear to be calling for sweeping regulatory changes, but stricter enforcement. The Center argues that companies are taking advantage of the "lax regulatory environment to flood the market with products of dubious benefit."
"The FDA is failing to protect the public from numerous questionable ingredients and misleading claims," stated Bruce Silverglade, CSPI director of legal affairs. "All too often, companies are merely trying to cash in on the burgeoning demand for alternative health remedies."
"Brand-name food companies spend millions of dollars every year to assure that their products meet rigorous, science-based standards for quality, safety and substantiation of claims," said Dr. Stacey Zawel, VP, scientific and regulatory policy for the Grocery Manufacturers of America (Washington, D.C.). She added that all foods, including functional foods, can be effectively regulated under existing law.
Recently, the FDA took regulatory action when it stopped McNeil Consumer Products from marketing Benacol margarine as a dietary supplement rather than as a food. The product contains plant stanol esters that reduce blood cholesterol. The FDA's action prohibited the company from selling the product until it could demonstrate that the "functional" ingredient in the margarine was safe for use in foods. (See related article).
Despite such FDA action, CSPI insists that the agency has generally failed to require proof of safety for ingredients in other functional foods and has failed to stop many improper label claims.
To improve the situation, CSPI is urging the FDA to:
• Require that functional ingredients be proven safe prior to marketing.
• Require claims to be approved by the agency or be based on scientific consensus.
• Issue rules that require labels to disclose how much of a "functional" ingredient a serving of the food contains, how much people should consume, and, if appropriate, warning information.
• Prevent companies from selling "functional foods" as dietary supplements or "medical foods" in order to escape FDA regulation.
• Work with the FTC to develop a consistent policy for claims in advertising and labeling.
Industry associations remain concerned that such changes in national regulatory policy could place barriers against the availability of functional foods for consumers or make it difficult for food companies to provide consumers with information on the health benefits of certain nutrients.
"Functional foods—those foods with health benefits beyond basic nutrition—must meet the same criteria for safety and accuracy of label statements as conventional foods," said NFPA's Hildwine. "Simply put, there is no need for them to be regulated any differently than other food products. To do otherwise flies in the face of sound science."