On May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC, accusing the snack bar company of misbranding its KIND products as “healthy,” and falsely labeling some of its fruit and nut snacks as low-fat or rich in antioxidants.
At that time, the FDA took the position that the snacks contained more fat and saturated fat than the definition of “healthy” allowed– at least three times the amount of fat allowed under a “low-fat” definition. And the FDA stated that Kind’s “no trans fat” claim on its labels failed to include a disclosure statement to refer to the product’s nutrition information for saturated fat content, which could have exposed Kind to the agency’s discretionary enforcement on the grounds that the impact of saturated fats on cholesterol levels was similar to that of trans fats. The FDA threatened regulatory action, potential seizures and injunctions if Kind did not correct the alleged violations. Moreover, the FDA’s action spawned one dozen class actions, which the U.S.Judicial Panel on Multidistrict Litigation consolidated and transferred to the Southern District of New York.
Kind pushed back with a Citizen Petition, which allows regulated industries or consumer groups to take the initiative in shaping any given agenda by pressing the FDA to take a specific action or refrain from taking any form of administrative action. A typical Citizen Petition sets forth (a) the agency action requested; (b) a statement of the grounds for the petition, including all supporting material and relevant information, as well as unfavorable information; (c) environmental impact (where applicable); (d) a certification as to the truth of the information submitted; and (e) the petitioner’s contact information. There are also some procedural details that must be followed. Under Citizen Petition rules, the agency is required to evaluate and respond to the petition within 180 days of receipt of the petition. (See Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33, and 10.35 for more information on the Citizen Petition process.)
The FDA’s reversal appears to have come on the heels of a presentation given last week by Kind’s General Counsel, Justin Mervis, at the Food and Drug Law Institute’s Annual Meeting in Washington, D.C. In making a persuasive case for Kind, Mervis presented a slide, entitled “the healthy divide,” which pointed out that sugary cereals, fat-free chocolate pudding, and low-fat toaster pastries met the requirements for “healthy” as a nutrient content claim in labeling, while almonds, avocados and salmon did not. Recent studies have affirmed the healthfulness of the latter three foods.
The FDA plans to solicit public comment on these issues in the near future. It looks as though “healthy” is about to get a major overhaul.