Tweet
New health claim approved for dietary supplements
FDA will now allow another health claim to appear on supplement products and packages. This claim is about EPA and DHA omega-3 fatty acids in dietary supplements and their role in helping to reduce the risk of coronary heart disease (CHD).
This claim is being allowed even though the agency had determined that it did not meet the "significant scientific agreement" (SSA) standard that had been previously established for such claims.
The qualified health claim states: "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 may or may not have on risk of CHD in the general population."
Such a claim may be used in labeling for EPA and DHA omega-3 fatty acid-containing dietary supplements, provided that such supplements do not recommend or suggest in the labeling, or under ordinary conditions of use, daily intakes exceeding 2 grams EPA and DHA omega-3 fatty acids.
FDA will now allow another health claim to appear on supplement products and packages. This claim is about EPA and DHA omega-3 fatty acids in dietary supplements and their role in helping to reduce the risk of coronary heart disease (CHD).
This claim is being allowed even though the agency had determined that it did not meet the "significant scientific agreement" (SSA) standard that had been previously established for such claims.
The qualified health claim states: "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 may or may not have on risk of CHD in the general population."
Such a claim may be used in labeling for EPA and DHA omega-3 fatty acid-containing dietary supplements, provided that such supplements do not recommend or suggest in the labeling, or under ordinary conditions of use, daily intakes exceeding 2 grams EPA and DHA omega-3 fatty acids.