In its final weeks, the Obama Administration has continued to implement its food labeling policies with full force. Over the holidays and within the first few days of the new year, FDA released two draft guidance documents clarifying key aspects of the Nutrition Facts and Serving Size Rules, confirmed the compliance date for calorie labeling on menus, and extended the comment period for the use of the term “healthy” on food labeling. We briefly discuss each development below.
- Draft Guidance on the Nutrition Facts and Serving Size Rules
On January 5, 2017, FDA released two draft guidance documents to help manufacturers comply with the sweeping changes to conventional food and dietary supplement labels under the Nutrition Facts and Serving Size final rules. See our prior post here for an analysis of the new requirements, which were finalized on May 27, 2016.
The first draft guidance document, which is in the form of questions-and-answers, addresses several compliance issues, including proper declaration of quantitative amounts of vitamins and minerals, nuances related to the labeling of added sugars, and formatting of the label. Of note, the draft guidance clarifies when the new label must be included on food packages. Under the final rule, manufacturers are required to comply by July 26, 2018 (with manufacturers with less than US$10 million in annual food sales given until July 26, 2019). After publication of the final rule, however, FDA received several questions about the required compliance date for products at various points in the distribution chain. The draft guidance clarifies that FDA “would not consider the location of a food in the distribution chain,” and, instead, will consider “ the date the food product was labeled for purposes of determining the compliance date.”
The second draft guidance document provides examples of products that belong in each of the Reference Amounts Customarily Consumed (RACCs) per Eating Occasion product categories. The guidance is split into two tables: (1) RACCS per Eating Occasion for foods for infants and young children ages one through 3 years; and (2) RACCs per Eating Occasion for individuals four years and older. The 31-page document goes into extensive detail, by for example, clarifying which crackers are considered “crackers that are usually not used as a snack” (e.g., melba toast) versus “crackers that are usually used as a snack” (e.g., peanut butter sandwich crackers).
Despite release of the latest guidance documents, it is possible that the Nutrition Facts and Serving Size final rules could be delayed or repealed by the incoming administration or legislatively. The Freedom Caucus, a faction of conservative House Republicans, has requested that President-elect Trump undo both rules within his first 100 days in office, and the President-elect has previously advocated for rolling back FDA’s regulation of foods.
- Delayed Compliance for the Menu Labeling Requirements
On December 30, 2016, FDA clarified that it is extending the compliance date for the menu labeling rule from December 31, 2016 to May 5, 2017.
As we previously discussed here, FDA promulgated regulations in December 2014 requiring certain restaurants and retail food establishments to post calorie counts on their menu or menu boards. In December 2015, however, Congress passed a policy rider prohibiting FDA from enforcing the menu labeling requirements until at least one year after issuing final guidance to help industry comply with the rule. FDA finalized the guidance on May 5, 2016, and announced its intention to extend the compliance date to one year thereafter. The December 30, 2016 final rule clarifies and confirms that the compliance date for the menu labeling requirements is May 5, 2017.
- Extension of the “Healthy” Labeling Comment Period
On December 30, 2016, FDA announced that stakeholders will have an additional 90 days to comment on the use of the term “healthy” on food labels.
As we discussed here, FDA began reassessing its standards for making a “healthy” claim in September 2016, in an effort to align labeling regulations with shifting dietary recommendations and in response to requests from stakeholders, including a citizen petition filed by KIND, LLC. After several requests for an extension, asserting that the 120-day comment period did “not allow sufficient time to develop meaningful or thoughtful comments,” the Agency agreed to extend the comment period from January 26, 2017 to April 26, 2017.
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Encouraging Americans to eat healthier has been a key priority for the Obama Administration and is a signature achievement of the First Lady’s Let’s Move initiative. As such, industry will want to keep a close eye out for additional last-minute efforts to cement their nutrition and food labeling legacy.
Given that January 20 will bring a new Administration that has been openly resistant to several Obama Administration regulations, manufacturers will want to continue to look for congressional and administrative actions that aim to roll back or modify food labeling policies.