In Health Care Reform, a Nod to the Role of Nutrition

By Ricardo Carvajal –

Earlier we blogged on the provisions of the Patient Protection and Affordable Care Act (“PPACA”) that most directly affect pharmaceutical and device manufacturers.  The PPACA also contains a number of provisions that will directly and indirectly affect the food industry.  Most notably, § 4205 adds new FDCA § 403(q)(5)(H) to require restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to disclose on menus and menu boards (1) calorie content for standard menu items, and (2) information on suggested daily caloric intake.  Such establishments must also make available on the premises other nutrition information, such as the amounts of sodium and sugar per serving.  For self-service food and beverages, disclosure of calorie content is required.  Items not listed on menu boards (e.g., condiments), daily specials, temporary menu items, and foods undergoing a market test are exempt from all nutrient disclosure requirements.  For food sold from vending machines operated by a person who owns or operates 20 or more machines, disclosure of calories is required unless the machine permits a prospective purchaser to examine the nutrition facts panel prior to purchase or otherwise provides visible nutrition information at the point of purchase.

FDA is directed to issue a proposed regulation implementing the requirements of section FDCA 403(q)(5)(H) within one year of enactment.  In issuing the regulation, FDA is directed to consider factors such as reasonable variation in serving size, inadvertent human error, and space on menus and menu boards.  Any state requirement for nutrient disclosures of the type required by § 403(q)(5)(H) would be preempted if the state requirement is not identical to the requirements of that section.  However, restaurateurs and vending machine operators with fewer than 20 locations or machines could be subject to non-identical state requirements unless those restaurateurs and operators choose to subject themselves to the requirements of § 403(q)(5)(H).  State requirements regarding warnings about the safety of a food or component of a food (e.g., those required under California’s Proposition 65) would not be preempted.

Other sections of the PPACA ensure that nutrition will remain at the top of the public health agenda for the foreseeable future.  For example:

• Section 2717 directs Secretary of Health and Human Services to develop reporting requirements for use by group health plans and health insurance issuers with respect to benefits and reimbursement structures that implement “wellness and health promotion activities,” including nutrition. 

• Section 4001 directs the President to establish a National Prevention, Health Promotion and Public Health Council that is to provide recommendations to the President and Congress regarding changes in Federal policy to achieve “national  wellness, health promotion, and public health goals, including the reduction of. . . poor nutrition.”

• Section 4201 provides for the award of grants to State agencies and community-based organizations for the conduct of “community preventive health activities” intended in part to reduce chronic disease rates.  Among the activities eligible for funding are “increasing healthy food options” in schools, “creating the infrastructure to support. . . access to nutritious foods,” “developing and promoting programs targeting a variety of age levels to increase access to nutrition,” and “working to highlight healthy options at restaurants and other food venues.”  The effectiveness of these activities is to be evaluated by measuring changes in weight and changes in “proper nutrition.”

• Section 4206 directs the Secretary to fund a pilot program to develop individualized wellness plans that reduce risk factors for preventable conditions.  The plans would target at-risk populations who use community health centers funded under § 330 of the Public Health Service Act.  The plans can include nutritional counseling and dietary supplements that have health claims “approved” by FDA.  This provision could spark a renewed interest in the use and approval of such claims.

These provisions are certain to enliven the debate about what constitutes good nutrition, and how best to help consumers achieve it.