FDA unveils fast-track health claims system
system for health claims, which will make it easier for companies
to promote the health benefits of their products.
The Food and Drug Administration (FDA) has unveiled a new ranking system for health claims, which will make it easier for companies to promote the health benefits of their products.
The process, developed by FDA's Task Force on Consumer Health Information for Better Nutrition, shortens the time-consuming reviews of scientific evidence and literature supporting current health claims. Under the new proposals, four different levels of claims, perhaps to be ranked from A -D, will rate the amount of scientific evidence and agreement backing the claim. Claims with little evidence would be ranked D, with inclusion of an FDA disclaimer, such as 'FDA concludes that there is little scientific evidence supporting this claim'.
The agency suggests the system will give consumers "accurate, up-to-date, and science-based information about the health consequences of these products". According to FDA, it is an attempt to improve the information offered to consumers on the health value of foods so that they can make better choices, and help slow down the growing trend of obesity. Some groups have been critical of the system however.
The Center for Science in the Public Interest (CSPI) says the process will lower the standards for making health claims on foods. "Manufacturers will be able to make claims about thehealth benefits of their products based onpreliminary scientific evidence that may not standthe test of time. This action represents thebiggest rollback in food-labeling standards in 20years," said a CSPI statement.
The consumer group added that the FDA's grading system for health claims is untested and should not be used until the agencyhas completed consumer behavior research thatshows that consumers will not be misled. The FDA announced plans to carry out research, and encourage other research groups to research, the most effective way to present scientifically based, non-misleading information to consumers -- as well as identifying the kinds of information known to be misleading.
The American Medical Association also said it would oppose the 'qualified health claims on the labels of conventional foods. In a May 23 letter to the FDA, the AMA said that, "while the FDA's goal of improving American diets is a worthy one, consumer confusion is likely to result if the nation's food industry is allowed to place nutritional labels on food without stringent scientific evidence to back claims".
Food manufacturers were of course largely in support of the news. "The ability to use qualified health claims by the food industry will provide food manufacturers with new incentives to develop and market new healthier-for-you products," said the Grocery Manufacturers of America's director of scientific and nutrition policy, Alison Kretser.
She added however that the group would prefer to let each company find "the best language for each qualified health claim," rather than use the agency's wording.
FDA Commissioner Dr Mark B. McClellan said: "The FDA review process for making qualified claims, when combined with our strong enforcement work, will reward companies that make healthier products while more aggressively enforcing the law against companies that appeal to consumers through false and misleading health claims."
Alice Lichtenstein, vice-chairperson of the American Heart Association's Nutrition Committee and a professor of Nutrition at the Friedman School of Nutrition at Tufts University in Boston, also welcomed the decision. "Consumers are bombarded with health claims everywhere they go - in grocery stores and in the media. It is often confusing, if not impossible, to figure out which claims have merit. This FDA guidance will help consumers sift through the noise by providing useful information that will allow them to make food choices that could help prevent heart disease, stroke and other chronic illnesses."
The FDA highlighted four areas likely "to achieve the most impact on the public health in the most economical way", which are to be reviewed in coming months. These include a health claim for the benefits of eating several servings a week of fish and other foods high in omega-3 fatty acids to reduce heart disease risk, and another concerning the benefits of eating five to nine servings a day of fruits and vegetables for reducing the risk of some cancers and other chronic illnesses.
Vegetable oils containing unsaturated fats and nuts for other sources of saturated-fat-containing protein are also on the agenda for review.
The task force is working closely with the Federal Trade Commission (FTC) and the National Institutes of Health (NIH), according to FDA.
The agency intends to begin applying these interim guidances for health claim petitions submitted on or after September 1, 2003, it said. Further information on the initiative is available online.
