As previously reported in this blog, Section 4205 of the Patient Protection and Affordable Care Act of 2010 requires chain restaurants to list calories on menus for "standard menu items" and to provide other nutritional information in writing upon request. On April 6, 2011, the FDA issued proposed regulations implementing Section 4205. These regulations address issues such as what businesses are subject to the law, what constitutes a menu, how nutritional information must be presented, and other issues. In some respects, the proposed regulations are more restrictive than expected. For example, the FDA proposes to regulate accuracy using the standard currently applicable to disclosures made in the Nutrition Fact Box on packaged foods. Under this standard, food must contain at least 80% of the declared amount of certain "good" nutrients such as dietary fiber and proteins, and must not exceed the declared amount of certain "bad" nutrients, such as calories and fat, by more than 20%. The FDA's adoption of this standard appears to conflict with Section 4205's mandate that restaurants be required only to have a "reasonable basis" for disclosures. Other aspects of the proposed regulation are less aggressive than some observers had anticipated. For example, the proposed regulation does not requires nutritional disclosures for alcoholic beverages. The FDA reasoned that it is not clear from the face of Section 4205 whether Congress intended to require labeling for alcoholic beverages, and that labels for alcoholic beverages themselves are also regulated by the Alcohol and Tobacco Tax and Trade Bureau. In still other areas the regulation strikes more of a middle ground. For example, Section 4205 applies to restaurants and "similar retail food establishments." Under the proposed regulation, a business is a "similar retail establishment" if it sells restaurant-type food and its "primary business activity" is the sale of food. In turn, "primary business activity" means either that that business holds itself out as a restaurant, or that over 50% of its floor space is devoted to selling food. Practically speaking, this approach renders businesses such as convenience stores and grocery stores subject to menu labeling, but excludes entities such as movie theaters, hotels, trains and planes. Comments on the proposed regulation are due by June 6, 2011, and given the ramifications of menu labeling on industry participants, we expect that the FDA will receive many comments on the proposed regulation. In terms of timing, the FDA has said that it hopes to issue a final rule near the end of 2011, and that it expects to begin enforcement 6 months after the issuance of the final rule. The FDA also proposed a separate regulation implementing calorie labeling requirements for vending machines. Comments on that proposed regulation are due on July 5, 2011. – Dan Kracov and George Langendorf
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