Last week, the U.S. Food and Drug Administration (FDA) made two major announcements pertinent to industry and consumers.
First, on January 14, 2025, FDA issued a pre-published notice of proposed rulemaking to require front-of-package nutrition labels (FOP) on most foods that bear a Nutrition Facts label. If finalized as proposed, the rule would require a mandatory compact informational box, entitled “Nutrition Info,” to be displayed on the food package’s principal display panel (PDP) to provide consumers with standardized, interpretive nutrition information that, FDA posits, would help them quickly and easily identify how that food can be part of a healthy diet. The Nutrition Info box would include information on saturated fat, sodium, and added sugars, with interpretive descriptions (“Low”, “Med”, “High”) based on the percent Daily Value (% DV) per serving, and would appear on the upper third of the PDP, e.g.:
The Nutrition Info Box would be required for foods that must bear nutrition information. Exemptions would also be available, including for small packages with less than 12 square inches of labeling space, gift packages, and unit containers in multiunit retail packages. FDA proposes to include modified requirements for certain types of packaging, such as aggregate displays, dual-column labeling, and foods sold from bulk containers. The rule, if finalized as proposed, would also amend nutrient content claim regulations to modify the definitions for low sodium and low saturated fat nutrient content claims. FDA believes these revisions are necessary to align with current nutrition science and ensure consistency with the proposed rule.
Second, on January 15, 2025, FDA released a pre-published version of a final amendment and order granting the Color Additive Petition from the Center for Science in the Public Interest, et al. and revoking the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs. FDA concludes “Red No. 3 is safe and meets the required safety standards for a color additive,” but states that under the Delaney Clause, it must “revoke the approval for Red No. 3 because it has been shown to cause cancer in male rats.” The Delaney Clause, a 1958 amendment to the federal Food, Drug and Cosmetic Act, forbids any additive if it is found to induce cancer in humans or animals; FDA has no discretion and must ban the additive irrespective of whether the additive would pose any risk to human health under its permitted conditions of use.
The Order is effective on January 15, 2027, for foods, and January 15, 2028, for drugs, meaning that the regulations authorizing Red No. 3, will be revoked on those dates. FDA advises that food manufacturers who use Red No. 3 in food will have until January 15, 2027, to reformulate their products; drug manufacturers will have until January 15, 2028; any products in commerce after those dates, respectively, are adulterated and cannot be lawfully marketed.
With the change of Administration on January 20, 2025, we anticipate additional announcements that will impact stakeholders. If you have any questions or would like additional assistance please contact kkaplan@ofwlaw.com.
