On June 13, the Food and Drug Administration announced it would indefinitely extend the compliance deadline for the Nutrition Facts Label final rules, creating uncertainty for food and beverage manufacturers.
FDA finalized the terms of the new Nutrition Facts Label in May 2016 and set a compliance deadline of July 26, 2018. The new label focuses on a variety of key differences, namely:
Although FDA’s announcement does not alter the final rule — only the compliance deadline — food and beverage manufacturers now face the difficult choice of whether to proceed with label changes despite current uncertainty.
FDA has stated that the extended deadline will “minimiz[e] the transition period during which consumers will see both the old and the new versions of the label in the marketplace” and will allow the agency to provide manufacturers with further guidance. President Trump, however, has repeatedly identified deregulation as one of the main goals of his administration. Indeed, most of the bills that the president has signed into law have been repeals of rules promulgated during the Obama administration.
Although the deadline has passed for legislative repeal of the prior administration’s rules under the Congressional Review Act, FDA’s announcement may signal plans to withdraw these rules through a typical “notice and comment” procedure. Even if the rules are not repealed, further discussions between regulators and advocacy groups will likely affect how the rules are ultimately interpreted or enforced.
Several manufacturers have already implemented these rules in their labeling, and others have stated that they will continue with revisions despite FDA’s announcement. Whether and how to proceed is a decision that must be made on an individual company basis in consultation with knowledgeable legal and regulatory advisers.
Some of the changes to the Nutrition Facts Label, such as disclosing “added sugar,” have been the subject of mounting litigation. Over the last few years, several food and beverage manufacturers have faced significant consumer class action litigation about the amount of added sugar in their products and the potential health risks linked to consuming high-sugar foods. These suits allege that added sugar is “toxic” to the human body and seek restitution for purchases of high-sugar foods that plaintiffs claim are deceptively marketed as healthy and nutritious.
Finally, implementation of these rules may also be delayed by legal action from advocacy groups, such as the Center for Science in the Public Interest. The center has already sued FDA for its delay of a 2014 menu labeling rule that would require chain restaurants and food sellers to disclose nutritional information. We may expect similar litigation in response to this most recent announcement, given the similar posture of the Nutrition Facts Label, creating further uncertainty for food and beverage manufacturers.
Yvonne McKenzie and Alva Mather are partners in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Stefan Ellis is an associate in the Health Sciences Department.
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.