FDA Extended Compliance Dates for Nutrition Facts Label Final Rules to 2020 and 2021

The U.S. Food and Drug Administration is proposing to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.

The FDA is not proposing any other changes to the Nutrition Facts Label and Serving Size final rules.

Written or electronic comments on the extension of the compliance dates are being accepted for 30 days, beginning on October 2, 2017. The FDA is only accepting comments on the extension of the compliance dates and not on the content of the Final Rules published in 2016.

Submit electronic comments to http://www.regulations.gov

The decision was cheered by the industry associations (GMA, Grocery Manufacturer Association), but not so appreciated by consumer’s groups and the CSPI (Center For Science in the Public Interest) which consider the move a danger for public health (added sugars won’t be visible until 2020…) and fear a lack of clarity on the market.

The new Nutrition Facts schemes can be already used on the labels and – in my daily experience – they are requested by many US retailers and importers to foreign clients: therefore, on this last issue, I am totally agree with the CSPI. A co-existence of two different Nutrition Facts schemes on the shelves for 3-4 years cannot help already confused consumers to clear their mind about nutrition information. It is an odd situation also for me that I am used to the convoluted EU legislation making process!

On the other hand, FDA guidance documents on the new labeling schemes will be most welcome in the meantime.

For Additional Information:

USA – FDA to Redefine “Healthy” Claim for Food Labeling

The U.S. Food and Drug Administration (FDA) today announced that it has started a public process to redefine the “healthy” nutrient content claim for food labeling. Redefining “healthy” is part of an overall plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.

While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

For readers which are not very practical with US legislation, it is useful to outline that “healthy” – while in many country is a not regulated term – is considered in USA a nutrient content claim, and it can be used exclusively when some compositional criteria related to specific nutrients are met. In that sense, you can check two recent warning letters to food business operators, where you can find relevant reference to legislation and examples of non compliance:

http://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm437839.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm425102.htm

Public health recommendations for various nutrients have evolved, as reflected by the 2015-2020 Dietary Guidelines for Americans and the updated Nutrition Facts label. For example, healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet. Also, the nutrients of public health concern that consumers aren’t getting enough of have changed.

FDA is publishing a “request for information” to solicit public input as it redefines the term “healthy.” In addition, the Agency is planning other public forums to receive additional public input.

For more information:

Federal Register Notice for the Guidance for Industry
Federal Register Notice for the Request for Information
Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages
“Healthy” on Food Labeling

(Source: FDA website)