FDA Issues Interim Final Rule Allowing More Raw Fruits and Vegetables to Bear Health Claims

The U.S. Food and Drug Administration is amending a regulation that authorizes a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to expand the use of the claim to certain raw fruits and vegetables that were previously ineligible to make the claim.

To make a claim regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease a food must typically, among other requirements, contain a certain amount of vitamin A, vitamin C, iron, calcium, protein, or fiber and meet the definitions of a “low saturated fat,” “low fat” and “low cholesterol” food.

Some fruits and vegetables had been ineligible to bear the claim because they do not meet the health claim requirements for containing a minimum amount of certain nutrients and/or they do not meet the definition of a “low fat” food. For example, grapes, plums, beets, and cucumbers do not contain the threshold levels of vitamin A, vitamin C, iron, calcium, protein, or fiber and avocados do not meet the requirement for “low fat.”

In October 2012, the American Heart Association (AHA) submitted a citizen petition asking the FDA to amend the existing regulation about health claims and the relationship between dietary saturated fat and cholesterol and risk of CHD. The agency responded to AHA’s petition by issuing an interim final rule to allow raw fruits and vegetables to make a claim that they reduce the risk of coronary heart disease. The FDA is not amending the health claim requirements for frozen or canned vegetables at this time, but invites comment on the issue.

This interim final rule is effective immediately and has a 75-day comment period.

Source: FDA


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