FDA Banning Fish Oil Pills, Says They Have No Medical Benefits
The Food and Drug Administration has decided to halt the marketing of fish oil pills, concluding that they offer no known medical benefits.
“At the present time, there is inadequate scientific evidence to support health claims on fish oils or to support claims that these ingredients have an effect on the risk of coronary heart disease,” the agency told manufacturers. The agency added that the safety of the product when taken over a long period has not been proven.
In a letter sent June 28 to 67 fish oil suppliers and made public Monday, the agency ordered them to cease further distribution of fish oil supplements or face legal action.
Fish oil capsules already on store shelves do not have to be withdrawn under the ruling, William Grigg, an agency spokesman, said Monday.
Grigg emphasized that the agency is concerned that consumers not be misled about the potential benefits of taking fish oil as a nutritional supplement.
“There is a government consensus that the cholesterol claims have not been proved and should not be used commercially,” Grigg said.
Studies released several years ago concluded that Eskimos and other societies that consume large amounts of oily fish, such as in Japan and Greenland, have low levels of serum cholesterol and few heart attacks.
In 1988, two trade associations of vitamin manufacturers applied to the FDA for permission to state on product labels that fish oil, which contains omega-3 fatty acids, has been shown to reduce the risk of heart disease.
But a subsequent study at the Minneapolis Veterans Affairs Medical Center observed that when men with high cholesterol counts took high daily doses of fish oil their cholesterol counts actually increased.
In a June 20 letter to the two associations, the FDA said that the application had taken “a number of scientific conclusions out of context” to support its claims. “FDA has not listed omega-3 polyunsaturated acids as approved food additives or as being generally recognized as safe.”
The ruling could be reversed in the future, the FDA’s Grigg said, if additional medical studies support claims that fish oil is beneficial. Furthermore, the product might be distributed in the future without health claims if manufacturers can show that taking it over an extended period of time will not cause any adverse effects, he added.
Industry representatives said that they are likely to file additional applications with the federal agency to support their claims of safety for their product as well as its health benefits.
“The FDA disallowance of those claims is based on evidence that is two years old,” said Annette Dickinson, technical director of the Council for Responsible Nutrition.
