FDA Seeks Comments on FSMA Amendments

The U.S. Food and Drug Administration (FDA) has issued an advance notice of
proposed rulemaking under the Food Safety Modernization Act (FSMA) that
seeks information to help the agency “implement and enforce” amendments
to the reportable food registry (RFR) provisions of the Federal Food, Drug,
and Cosmetic Act. Among other things, the new provisions permit FDA to (i)
require that parties submit to FDA “consumer-oriented” information regarding
certain reportable foods—defined as foods for “which there is a reasonable
probability that use of, or exposure to, such food will cause serious adverse
health consequences or death to humans or animals”; (ii) use such information
to create consumer notification summaries for the agency’s Website; and
(iii) obligate certain grocery stores that sell reportable food to display the
notification summaries.

FDA has requested input from the food industry, consumer organizations
and other parties on certain topics, including (i) “what information should be
required in consumer notifications so that consumers can determine whether
a food in their possession is a reportable food”; (ii) “the format in which the
information should be presented”; (iii) what types of retail establishments
should be considered “grocery stores” subject to the consumer notification
requirements; (iv) the impact on grocery stores from posting the information;
and (v) whether FDA should require industry to submit consumer-oriented
information for foods that will not be sold in retail stores. Comments will be
accepted through June 9, 2014. See Federal Register, March 26, 2014.

Issue 518