FDA Announces First Regulations Under Food Safety Modernization Act

FDA has issued the first two new regulations under the Food Safety Modernization Act. Effective July 3, 2011, the interim final rules are designed to strengthen FDA’s ability to help prevent potentially unsafe food from reaching U.S. consumers.

The first rule amends FDA regulations concerning the detention of food for
human or animal consumption. It allows the agency to detain food it believes
has been produced under unsanitary or unsafe conditions or is adulterated
or misbranded. Previously, the agency was able to detain food products only
when it had “credible evidence that a food product presented was contaminated
or mislabeled in a way that presented a threat of serious adverse health
consequences or death to humans or animals,” FDA said in a May 4 press
release. Now the agency can detain questionable food from the marketplace
for up to 30 days while it determines if enforcement action such as seizure or
federal injunction is necessary. Before the rule, “FDA would often work with
state agencies to embargo a food product under the state’s legal authority
until federal enforcement action could be initiated in federal court,” FDA said,
adding that it will continue to work with state agencies on food safety. The
agency requests comments by August 3. See Federal Register, May 5, 2011.

The second rule establishes a new reporting mechanism that “requires
anyone importing food into the United States to inform the FDA if any
country has refused entry of the same product, including food for animals.”
With more information about imported foods, “FDA’s ability to target foods
that may pose a significant risk to public health” will be improved under
regulations established by the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, FDA said. Comments are requested
by August 3. See Federal Register, May 5, 2011.