As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document on what constitutes a “healthy” food and proper labeling of such foods, and the Agency simultaneously requested public input on a significant number of questions related to use of this particular claim.

Last week, FDA announced two actions that are intended to further advance this public consultation process for “healthy” label claims. First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017. And it is convening a public meeting to discuss the use of the term “healthy” in the labeling of human food products, in part to further the feedback that may be received during this ongoing comment period. Continue Reading Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling.  In addition, while the process is underway, the Agency intends to exercise enforcement discretion for (meaning it will not take action against) foods labeled with the term “healthy” as long as they meet the conditions in the regulatory definition at  21 CFR 101.65(d) and other criteria laid out in a newly issued guidance document.

FDA explained in announcing this initiative late last month that:   Continue Reading Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that claim misleading, or does the food have to be completely unprocessed?  Does natural connote “healthy” and is it confused with “organic” and should it be associated only with certain nutritional benefits?  And a host of other questions intended to help the Agency determine whether it can (or will) take the next step towards establishing a regulatory definition of “natural” on food products.  Tuesday May 10th was the last day to submit comments to FDA’s Natural Docket – now closed, this docket is indicating that it received over 7,600 individual comments.  So it will not be a small task for the Agency to review and consider all of those thousands of comments – but they’ve already decided to wade into another complex and important food claim, in this case the claim “healthy.” Continue Reading Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food