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With FDA’s Tightening Stance on Food Claims, What Should Manufacturers Do?

In the past year, FDA has made considerable progress (in most cases), fine-tuning the regulations on foods and dietary supplements, including the updates and changes to the Nutrition Facts Panel, the promulgation of the Generally Recognized As Safe (GRAS) final rule, release of the New Dietary Ingredient (NDI) draft guidance, etc. Though none of these listed above directly relates to claims, FDA  has signaled its tightening stance on claims through warning letters and other ways, such as requesting public comments on certain claims (i.e. “healthy” and “natural” claims) appearing on product packages. Below is a synopsis of FDA’s position on regulating product claims in recent years and how it impacts food and dietary supplement manufacturers.

In March 2016, a court case which has lasted for eight years between POM Wonderful LLC v. The Coca-Cola Company finally closed with the court rejecting POM Wonderful’s allegations that Coca-Cola’s pomegranate-blueberry flavored drink had misleading label claims. Although this Minute Maid product only contains 0.3% pomegranate juice and 0.2% blueberry juice and is primarily comprised of apple and grape juices, according to the court’s decision, it is acceptable as “Enhanced Pomegranate Blueberry Flavored 100% Juice Blend”.(1) Interestingly, during this case, one argument from Coca-Cola was the assertion of an affirmative defense of unclean hands to POM, which involved how POM utilized “health claims” not supported by “substantial scientific evidence” to advertise and promote its pomegranate juice.(2) In early 2015, the DC Circuit affirmed, in response to an allegation from Federal Trade Commission (FTC) to POM, that many of POM’s ads contained false or misleading claims which indicate how POM products can reduce the risk of heart disease, prostate cancer and other disease and health conditions.(3,4)

This allegation of false and unsubstantiated claims dates back to 2010, when FTC took action against POM. In the same year, FDA issued a warning letter to POM stating that claims made on POM’s website promoted unsubstantiated drug claims that the product can cure, mitigate, treat or prevent diseases.(5) POM was not the only company having trouble with claims at that time. In March 2010, FDA notified 17 food companies, including both large brands such as General Mills and Nestle Nutrition Gerber and smaller brands, with warning letters on misleading claims.(6) If not handled appropriately, it could be very costly for a company to respond to such warning letters. Products may need to be recalled from the shelf and new labels might have to be generated. Costs to the company could include direct revenue losses due to consumer perceptions and mistrust which could be largely influenced and manipulated by social media. The damage could extend to the brand and even a company image, which may have taken years to establish and would need to be rebuilt after such media exposures. Even worse, litigat