FDA has officially extended the deadline by which companies must comply with the agency’s changes to U.S. Nutrition Facts and Supplement Facts labels. The agency announced yesterday that smaller manufacturers with less than $10 million in annual food sales now have an additional 1.5 years to comply, to January 1, 2021. Originally, those companies were facing a July 26, 2019, deadline. FDA also extended the compliance deadline for larger firms with annual food sales of $10 million or more. Originally, larger firms faced a July 26, 2018, deadline, but FDA has now extended that deadline to January 1, 2020.
FDA announced the extended deadline yesterday through a final rule via the Federal Register. FDA issued its final rule cementing the regulatory changes to the Nutrition Facts and Supplement Facts label back in May 2016. The most significant changes include adding a “total sugar” line on the label to indicate both added and naturally occurring sugars; updating listings to reflect larger serving sizes and requiring dual-column labeling for certain larger containers; including listings for nutrients like vitamin D and potassium; and updating Daily Values. Read more about those labeling changes here as well as the “Five Biggest Challenges” with the new label.
The Natural Products Association (NPA; Washington, DC) applauded yesterday’s official deadline extension. In 2017, NPA petitioned FDA to revoke its labeling revisions. The association expressed strong objections to the new “added sugar” line on labels, calling it “unnecessary and overly burdensome.” NPA also objected to FDA’s decision not to include isolated or synthetic dietary fibers in its new definition for fiber, which was promulgated as part of the labeling changes.
Following FDA’s announcement yesterday to extend the compliance deadline, NPA released a public statement: “The Natural Products Association (NPA) today declared victory following the Food and Drug Administration’s (FDA) decision to delay its Nutrition and Supplement Facts Labeling rule, a move that will save consumers hundreds of millions of dollars. NPA worked directly to influence the Administration’s final decision, including meeting with Administration officials two times in six weeks at the Office of Management and Budget (OMB), including one with NPA board members as part of [the association’s] Natural Products Day.”
NPA’s president and CEO, Dan Fabricant, PhD, said: “We appreciate the Administration hearing us out on this issue. They clearly want a regulatory system that strikes the right balance of consumer protection and access, not killing jobs or burdening consumers with extra costs. NPA was out in front on this issue from day one, and we are pleased to see the Administration keep its promise to protect consumers and small businesses from burdensome regulations. This is a big win for our industry but more importantly for consumers that will save hundreds of millions of dollars because of our efforts.”
FDA says that the new 2020 deadline should give manufacturers sufficient time to comply with the changes. “After considering a range of stakeholder comments, the FDA recognizes the need for manufacturers to have additional time to make required changes,” said the agency on its website. “The approximately 18-month extension accomplishes this goal and will provide sufficient time to transition to the new version of the Nutrition Facts label.”
The agency said it received 50,000 public comments after it first proposed the labeling changes in 2016. Commenters expressed concerns that manufacturers would not be able to update their labels by the originally proposed deadline due to challenges such as the need to upgrade labeling software, to obtain nutrition information from suppliers, to revise the labels of a large number of products, and to reformulate products.
“We are taking this action because, after careful consideration, we have determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules,” FDA stated in the Federal Register announcing the deadline extension.