FDA Issues Interim Final Rule Amending Health Claim Requirements
Monday, December 19, 2016

FDA has issued an interim final rule to allow more raw fruits and vegetables to bear health claims concerning the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease.

  • To make a claim regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease (CHD) 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, 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 to expand the use of the claim to certain raw fruits and vegetables that were previously ineligible to make the claim.

  • Today, FDA published an interim final rule (81 FR 91716) to amend 21 C.F.R. 101.75 to expand the use of the heath claim for dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to certain raw fruits and vegetables that were previously ineligible to make the claim.  More specifically, the Agency is amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the “low fat” definition and/or the minimum nutrient content requirement to be eligible to bear the claim.  The Agency is not amending the health claim requirements for frozen or canned vegetables at this time, but invites comment on the issue.

  • The interim final rule takes effect immediately, but industry may submit comments to FDA through March 6, 2017.

 

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