WASHINGTON--Dietary supplements containing omega-3 fatty acids just won the right to carry a health claim, but there are strings attached. The Food and Drug Administration (FDA) is asking for a more conclusive claim than what was suggested in the claim from Pearson v. Shalala.
The Food and Drug Administration (FDA) decided that, even though the claim was suggestive and inconclusive, the scientific evidence for the cardioprotective benefits of omega-3 fatty acids outweighed those against it. Therefore, FDA approved the following claim: "The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids in fish may or may not have on risk of CHD in the general population." This will replace the industry-suggested claim of "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease," which FDA considered suggestive, inconclusive and misleading.
"An overwhelming amount of evidence from various studies certainly demonstrates that omega-3 fatty acids [by themselves] have cardiovascular benefits," said Bob Walker, vice president of sales and marketing at Pharmline, a manufacturer of omega-3 products. He also said that there are ways to get around this modified claim. "I think there needs to be more PR and better consumer education [on the industry's part] about omega-3."
FDA explained in its Oct. 31 letter to Emord & Associates--the law firm for the plaintiffs (including scientists, dietary supplement companies and more than 700 physicians) in Pearson v. Shalala--that it used large studies that reported on people who consumed fish; from this research, it is unknown whether the fish or the omega-3 in the fish led to the resulting reduction in heart disease. By rejecting the industry-suggested health claim, FDA contradicts the American Heart Association's advice to eat at least two servings of fish per week for its omega-3's cardioprotective effects.
Jonathan Emord, of Emord & Associates P.C., said that he and his clients were pleased to see FDA permit an association with omega-3 fatty acids and the reduction of heart disease. However, he said he was disappointed that the agency will not allow this claim to be used on the food omega-3 is derived from (fish).
In addition, the claim itself is "so wordy and so incomprehensible in the second and third sentences, that we think that most consumers will simply not understand what the agency is trying to convey," Emord stated. As a result, he said that companies in the omega-3 business plan to inundate the market with a consumer-savvy revised version of the FDA claim, not only on dietary supplements but on food products as well. Emord cites the First Amendment for the companies' decision.
FDA also stipulated that labels must guide customers to consume less that 2 g of omega-3 (preferably only 1 gram) per day so as not to exceed the upper intake level of 3 g/d; the agency explained in its letter that this is a safety precaution, as every individual has different omega-3 baseline levels. For a copy of FDA's letter regarding omega-3 health claims, visit www.cfsan.fda.gov/~dms/ds-ltr11.html.