On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD). Continue Reading Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!

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 First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017.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

On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under pressure in recent years from many stakeholders to develop a regulatory definition for “natural” in light of the rapidly expanding market for food and other consumer products labeled as natural.

FDA notes that it has received at least four citizen petitions, including one from the Grocery Manufacturers Association, related to this issue, and multiple requests for clarification of the Agency’s view from Federal courts in the context of private litigation (as this blog has pointed out on several occasions, see here and here). As regular readers of this blog know, lawsuits filed under consumer protection and unfair competition statutes stemming from claims that a food, and increasingly a home care or a personal care/cosmetic product, is “natural” have reached dizzying numbers in the past several years.

Although establishment of a docket to receive public submissions is a very early step, and we expect it will be many months if not years before FDA takes any sort of administrative action towards a Federal definition of “natural,” this development signals that the Agency is beginning an active review of its policy on the use of the word. The request for comments lays out a lengthy list of questions for which the Agency is seeking input, including:

Continue Reading FDA Requests Input on Use of the Term “Natural” for Foods