As early as December 2010, the Food and Drug Administration (FDA) is expected to begin enforcing the new calorie disclosure and nutrition labeling requirements that apply to chain restaurants, vending operations, and similar ready-to-eat (RTE) food facilities operating at 20 or more locations under the recently enacted Patient Protection and Affordable Care Act of 2010 ("health care reform legislation").
Section 4205 of the health care reform legislation amended the Federal Food Drug and Cosmetic Act (FDCA) to require covered entities to provide "clear and conspicuous" calorie information to consumers in restaurant menus, menu boards, and on vending machines. The new law also requires chain restaurants and similar RTE food facilities (e.g., delis, bakeries) to make more detailed nutrition labeling information available for restaurant foods upon request.
The new statutory requirements and FDA enforcement policies will have far-reaching implications for chain restaurants, delis, bakeries, grocery and convenience stores serving ready-to-eat foods, similar food facilities, and vending machine operations. The new law also will affect companies that supply food products to chain restaurants, vending machine operations, and other covered facilities, including suppliers of beverage alcohol products, meat, poultry, and processed egg products which are regulated primarily by other federal agencies. Consistent with existing business practices, restaurants and vending machine operations will expect their food and beverage suppliers to help provide the nutrition information that is required to satisfy the new requirements.
FDA Enforcement Scheduled to Begin in December 2010
FDA recently announced that the agency construes most of the requirements of the new law to be self-executing and legally enforceable upon the date of enactment -- i.e., March 23, 2010. FDA recently issued draft guidance explaining generally what companies must do to comply with the new requirements, and requesting public comment on the agency's regulatory compliance and enforcement policies. FDA plans to finalize the draft guidance by December 2010. Once finalized, the agency plans to begin to enforce the new law.
The FDA draft guidance leaves many unanswered questions concerning the actions companies must take to comply with the new law, and how companies can minimize enforcement and related liability risks. Companies that have specific questions concerning how the new law will apply to their activities or have other questions or concerns, are advised to submit their questions and comments to FDA promptly. FDA will accept public comments on its draft guidance document until October 12, 2010.
With respect to the limited set of requirements that are not self-executing, FDA enforcement will begin after the agency promulgates implementing regulations. FDA is required to issue implementing regulations addressing the standards that will govern the declaration of calorie information in the context of a daily diet (e.g., recommended total daily calorie intake), which is required in addition to the simple calorie/serving information which is already required under the new law. In addition, FDA is required to issue regulations governing the declaration of calorie information in the context of a total daily caloric intake and requirements governing the declaration of nutrition information for standard menu items that come in different flavors, varieties, or combinations but are listed as a single menu item. The new statute requires FDA to issue proposed implementing regulations no later than March 23, 2011. Companies that are affected by the new labeling requirements are advised to monitor the FDA rulemaking proceedings and be prepared to submit comments to FDA next year in response to the agency's proposed regulations, when published.
Federal Preemption: Voluntary Compliance Program for Smaller Companies
The new law establishes the labeling requirements for foods sold through chain restaurants, vending operations, and other covered facilities as national uniform standards under the same express federal preemption provisions that apply to nutrition labeling for packaged foods. The new law also extends the protection of these federal preemption provisions to any company that is not required to comply with the new law (e.g., a company with fewer than 20 restaurants or vending machines), but chooses to do so on a voluntary basis and "registers" for FDA's voluntary compliance program. In view of the expanding number of state and local laws adopted in recent years which impose nutrition labeling requirements on restaurant foods and other ready-to-eat foods, the voluntary compliance program may offer significant advantages to smaller companies.
FDA recently issued draft guidance concerning the voluntary compliance and registration program, which currently is open for public comment. Companies that have questions or comments on the FDA draft guidance are advised to submit them to FDA by October 21, 2010. Comments can be submitted electronically via http://www.regulations.gov
For more information on the guidance documents, please see the following:
FDA Seeks Public Comment on Nutritional Disclosures in Retail Food Outlets
Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws
Kelley Drye & Warren LLP
Kelley Drye's team of Food and Drug
lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.
For more information about this Client Advisory, please contact:
Kristi L. Wolff