F.D.A. extends comment period on use of the term ‘healthy’ in product labeling

by Jay Sjerven
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Jay Sjerven
WASHINGTON — The U.S. Food and Drug Administration on Dec. 30 announced it would extend the comment period on its guidance for industry on the use of the term “healthy” in the labeling of human food products. The comment period was scheduled to expire Jan. 26. The new deadline for comments is April 26.

In the Federal Register of Sept. 28, 2016, the F.D.A. published a notice announcing the establishment of a docket to receive information and comments on the use of the term “healthy”’ in the labeling of human food products. The notice discussed F.D.A.’s position regarding the use of the term, the events that prompted it to establish a docket to request information and comments, and specific issues for consideration.

“We have received requests to extend the comment period,” the F.D.A. said. “The requests conveyed concern that the current 120-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the questions and issues we presented in the notice. We have considered the requests and are extending the comment period for 90 days, until April 26, 2017. We believe that a 90-day extension allows adequate time for interested parties to submit comments.”

The aim of the F.D.A. is to bring the use of the implied nutrient claim “healthy” into accord with recent developments in nutrition science as reflected in the 2015-20 Dietary Guidelines for Americans and in the final rules updating the Nutrition Facts Panel and serving size information for packaged foods (issued in May 2016).

“Because the framework for many of F.D.A.’s other nutrition labeling regulations is linked to elements in the Nutrition Facts label and serving size regulations, we plan to update those other regulations, such as those for health claims and nutrient content claims (including the implied nutrient content claim ‘healthy’), to align with these most recent updates,” the F.D.A. said.

In the guidance, the F.D.A. pointed to science-based changes in perspective on fat and the relative benefits of various nutrients that should inform the approach to using the term “healthy” on food packaging.

For instance, the focus of most dietary fat recommendations has shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats.

“Consistent with consensus science and public health recommendations for dietary fats, which no longer recommend low total fat intake, we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient claim ‘healthy’ meet the low fat requirement provided that: (1) the amounts of mono and polyunsaturated fats are declared on the label and (2) the amounts declared constitute the majority of fat content,” the F.D.A. said.

The F.D.A. also pointed out nutrients of public health concern now include potassium and vitamin D as well as iron and calcium while vitamins A and C no longer are viewed as nutrients of public concern.

“We intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient claim ‘healthy’ contain at least 10% of the Daily Value (D.V.) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least 10% of the D.V. per RACC of potassium or vitamin D,” the agency noted.

The Grocery Manufacturers Association was among food industry groups requesting the extension of the comment period.

“The scope of the issues related to the use of the implied nutrient content claim ‘healthy’ is quite complex and scientific in nature, thus requiring comprehensive data from multiple facets of the nutrition science, food industry and public health community,” the G.M.A. told the F.D.A. “Therefore, industry needs time to connect with its partners to gather useful data.”

Comments may be sent electronically at www.regulations.gov. Written comments may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
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