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Dec 05

FDA Actions Highlight New Authority under FSMA

On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number of recalls spurred after Salmonella was discovered in the Company’s peanut processing facility. More information about the affected products and the ongoing action against Sunland, Inc. may be accessed here.

After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing any food products. A copy of the suspension order may be accessed here. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), any facility that manufactures, processes, packs or holds food for consumption in the United States must maintain an active registration with the FDA. The suspension of Sunland’s Registration came under the authority of § 102(b) of the recently-adopted Food Safety Modernization Act (“FSMA”). Under this provision, the FDA has authority to suspend the registration of a facility where:

the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals . . . .

Interestingly, under this provision the FDA may suspend the registration of a facility that: (1) created, caused, or is responsible for the public health issue, or (2) the packer or holder of such food, where this party either knows or has reason to know of such issue. In the present circumstances, because Sunland is the party responsible for processing these peanut butter products, the FDA’s suspension order alleged that the Company was responsible created the probability of adverse health consequences.

This suspension marks the first use of this new enforcement mechanism, which was granted to the Agency under the FSMA. Signed into law on January 4, 2011, the FSMA is frequently cited for expanding the FDA’s powers to proactively handle potential food-related outbreaks. However, with the Agency struggling to develop its regulations under the FSMA, industry has yet to observe much of this new authority in action. Thus, the suspension marks the beginning in what we may see as several “firsts” with respect to the Agency’s new enforcement capabilities.

For more information about maintaining compliance with the FSMA or FDA regulations pertaining to foods generally, feel free to contact us at contact@giannamore-law.com.

FDA Attorney

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