The Natural Resources Defense Council (NRDC) has issued a report claiming
that the U.S. Food and Drug Administration’s (FDA’s) generally recognized as
safe (GRAS) process for identifying food additives not required to undergo
premarket approval is flawed and calling for legislation to change the process.

According to NRDC, minimal FDA supervision and “a gaping loophole that
allows companies to simply declare as safe hundreds of chemicals added to
our foods—without any notification to the FDA or the public,” mar the U.S.
food safety protection system.

Under federal law, substances added to food are deemed food additives
subject to FDA’s premarket approval unless they are considered GRAS by
qualified experts or otherwise excluded from the food additive definition.
While food companies can notify the agency that experts have made a
GRAS determination, the law does not required them to do so. NRDC claims
that it has identified “275 chemicals from 56 companies [that] appear to be
marketed as GRAS and used in many food products based on companies’
safety determinations that, pursuant to current regulations, did not need to
be reported to the FDA or the public,” and cites instances in which “companies
have sometimes certified their chemicals as safe for use in food despite
potentially serious allergic reactions, or adverse reactions in combination with
common drugs.” See NRDC Press Release, April 7, 2014.

 

Issue 520

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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