The first pitch expected after Wednesday's FDA announcement: salmon and other fatty fish contain omega-3 fatty acids that are thought to — but not proved to — reduce the risk of heart disease.
Until now, the FDA standard for health claims about food has been rigid. Before oatmeal could claim to be good for the heart, for instance, there had to be scientific consensus that oatmeal's fiber helps maintain low cholesterol levels.
The new hurdle is similar to the one the courts have established for dietary supplements. They are allowed to carry "qualified health claims" — meaning there is no consensus, but a lot of scientific research supporting a particular nutrient's effect.
Food makers, irked by the disparity between the previously rigid standards governing them and what the $17 billion dietary supplement industry could claim, welcomed the plans.
The steps are "leveling the playing field for conventional foods," said Rhona Applebaum of the National Food Processors Association.
"This breaks a logjam," added Gene Grabowski of the Grocery Manufacturers of America.
But consumer advocates decried the move.
A qualified food claim is comparable to the airline industry saying, "this airplane may be safe," said Bruce Silverglade of the Center for Science in the Public Interest. "Most consumers ... don't like wishy-washy advice from health agencies."
The FDA also promised more crackdowns on dietary supplement makers who make fraudulent claims
U.S. marshals acting on an FDA request this week seized $100,000 of a supplement called EverCLR that was sold illegally as a treatment for herpes and other viruses. Federal law prohibits dietary supplements from being sold as disease treatments, and the FDA spent two years trying to persuade EverCLR's maker to stop its marketing voluntarily.
"FDA will not tolerate fraudulent schemes that deceive or endanger the public," the agency said in a report outlining plans to enforce often-neglected laws against false health claims.
It is the strongest warning so far after a year of signals that the agency increasingly is frustrated with cases of deception in the industry.
"We're putting manufacturers on notice about what is coming," new FDA Commissioner Mark McClellan said Wednesday. "We had a major seizure this week, and you can expect more coming."
The agency cautioned that makers of foods and dietary supplements must get FDA approval before putting those claims on their products.
Both plans "will help consumers get accurate, science-based information" necessary to improve their health, McClellan said after a brief White House visit to discuss the changes with President Bush.
The FDA's main authority over supplements is ensuring that health-related claims on labels and in ads are truthful.
Dr. Sidney Wolfe of the consumer group Public Citizen said he hopes the pledge turns out to be "more than just public relations." Overall, he said, "what the FDA's done in the area of enforcement of dietary supplements is appalling, it's dangerous."
Congress exempted dietary supplements from most federal regulation in 1994, allowing them to be sold without proof that they are safe or benefit health. The FDA can try to force risky supplements off the market only after the agency has proof of people being injured.
The agency is embroiled in controversy over whether it should force one supplement, ephedra, off the market or restrict sales because of reports linking the pills to heart attacks and strokes.
Annette Dickinson of the Council for Responsible Nutrition, the trade group that represents mainstream dietary supplement makers, said a misleading claim hurts consumers and is an "unfair business practice for the responsible industry that doesn't make those claims."
Calls to Halo Supply Co. of San Diego, which made the EverCLR supplement that was seized, were not immediately returned.