K. Corby-Edwards Analyst in Public Health and Epidemiology
rates of obesity and the resulting effects on citizens’ health and health care
costs have prompted federal, state, and local policymakers to consider a
number of policy options to reduce obesity levels in the U.S., such as
exercise promotion, nutrition education, and taxation of certain foods.
Labeling of the nutritional content of foods purchased and consumed outside the
home has been recommended by researchers and policymakers as one tool to
address rising obesity rates.
The Federal Food, Drug, and Cosmetic Act (FFDCA, P.L. 75-717, as amended)
authorizes the Food and Drug Administration (FDA) to regulate labeling of
most foods other than meat and poultry. Section 4205 of the Patient
Protection and Affordable Care Act (ACA, P.L. 111-148, as amended) amended
the FDA’s nutrition labeling authorities under the FFDCA to require nutrition labeling
of foods sold in some chain restaurants and vending machines, both of which
were previously exempt from the FDA’s nutrition labeling regulations.
While the ACA provided general requirements for restaurant menu nutrition
labeling, it required the FDA to promulgate regulations specifying the
scope of entities affected by the law, the scope of food covered by the law,
and certain details regarding how the required calorie and nutrition
information is conveyed to consumers.
The FDA’s proposed rule on nutrition labeling in restaurants and similar retail
food establishments (SRFE), published in April 2011, proposed definitions
for a number of terms that are not defined in law. It proposed two options
for determining the entities affected by the rule, set requirements for
covered restaurants and SRFE to implement the rule, provided details for voluntary
registration of establishments that are not covered by the rule but that elect
to be subject to the requirements of the rule, proposed an effective date,
and outlined enforcement mechanisms for establishments that fail to
comply. The comment period on the proposed rule ended on July 5, 2011. The
FDA is currently finalizing the rule, and the agency has indicated that it
expects to issue the final rule in November 2012.
Several potential concerns for Congress have been emphasized regarding
implementation of the proposed rule. First is the scope of the entities affected
by the rule. The second is the food that will require calorie and nutrient
information under the rule. Other related concerns include the presentation
of calorie and nutrient information and the amount of time businesses will have
to implement the rule. Some Members of Congress are concerned that the FDA’s
proposed rule reaches beyond congressional intent and the agency’s
authority, and have introduced legislation that would limit the scope of
the FDA’s proposed rule.
This report provides a brief overview of the FDA’s authority to regulate
nutrition labeling, modifications to these authorities under the ACA, and
a discussion of selected aspects of the proposed rule. Concerns regarding
the proposed rule raised by industry, Congress, and the public are also
Date of Report: November 19, 2012
Number of Pages: 21 Order Number: R42825 Price: $29.95
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