Virginia (202) 466-6937 | Arizona (602) 388-8899

Proposed Labeling Rule Targets Grocery Stores

FDA announced it has received hundreds of public comments on a proposed rule implementing section 4205 of the Patient Protection and Affordable Care Act (“PPACA”).  Section 4205 of PPACA requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations to provide calorie and other nutrition information for standard menu items.

In the preamble to the proposed rule, FDA explained that grocery stores and convenience that sell restaurant or restaurant-type food will likely be covered.  76 Fed. Reg. 19192, 19197 (April 6, 2011).  If grocery stores and convenience stores are covered when FDA finalizes the rule, they will have to provide nutrition information for everything from salad bars and soups to baked goods.

The potential inclusion of grocery and convenience stores is leading critics to assert that the proposed rule will greatly increase the costs of food.  According to critics, grocery and convenience stores will need to run expensive tests to get accurate nutrition information, and those costs will be passed onto consumers.

Presently, FDA estimates that the initial costs of the rule to be $1,100 per covered establishment but it acknowledges that its estimate “do[es] not show the very wide range of costs that individual establishments and chains will bear, based on their very different approaches to nutrition analysis, menu design, and overall market niche.”  Id. at 19223.

Section 4205 of PPACA was enacted to reduce obesity and its costs on society by helping consumers eat healthier by knowing how the foods they purchase at covered establishments fit within their nutritional needs.  FDA said it did not estimate actual benefits associated with the proposed rule because it is impossible to accurate predict consumer food choices.  But, FDA claimed that if 0.06 percent of the adult obese population reduced their caloric intake by 100 calories per week as a result of the regulation, the rule would break even with its costs.  Id.

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

Virginia (Firm HQ)

11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938


2730 S. Val. Vista Dr.
Bldg. 6, Ste 133
Gilbert, AZ 85295
Telephone: (602) 388-8899
Telecopier: (602) 393-4361