Salmonella – FDA Compliance Made Easy

FDA Actions Highlight New Authority under FSMA

Wed, 05 Dec 2012 19:26:13 +0000

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@sglawfl.com.

FDA Publishes Final Guidance Explaining Egg Safety Rule

Fri, 24 Aug 2012 18:53:09 +0000

On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Found here, the Guidance details the new requirements for industry under the Egg Safety Rule. The full-text of the Rule, as found in 21 CFR part 118, may be accessed here. According to the FDA, the Guidance explains the requirements of the Egg Safety Rule and in particular, answers the questions asked by industry since the publication of the final rule on July 9, 2009.

Under 21 CFR part 118, shell egg producers are required to implement preventative measures in an effort to thwart Salmonella Enteritidis (SE) contamination. In addition to these preventative efforts, shell egg producers are required to maintain certain records detailing their compliance with the final rule and to register their facilities with the FDA. According to the FDA, these measures are aimed at protecting the public health, as SE is one of the leading bacterial causes of foodborne illnesses in the United States, with shell eggs being the primary source of such infections.

While FDA guidance documents do not carry the force of law, they represent the Agency’s current thinking on the particular topics set forth therein. Accordingly, the views contained in guidance documents are indicative of the Agency’s prevailing interpretation of the rules and regulations that it enforces. Thus, in order to achieve compliance with the laws and regulations enforced by the FDA, as well as other federal agencies, it is important to look to current guidance documents to fully understand the regulatory responsibilities under federal law.

More Recalls of Pet Food in Wake of Salmonella Detection

Tue, 08 May 2012 16:28:36 +0000

The U.S. Food and Drug Administration (“FDA”) has announced the recall of additional pet food due to the detection of Salmonella. According to the FDA, WellPet LLC initiated the voluntary recall as a result of the bacteria being found in facility where the dog food is manufactured. While the Company notes that all dog food is tested prior to being released from the manufacturing facility and that none of the food was found to be contaminated, the recall is being initiated as a precautionary measure.

Diamond Pet Foods, the company responsible for manufacturing the pet food in the WellPet recall, has recently recalled several of its own products as a result of Salmonella. A list of the many of the affected products may be found here and here. In connection with the recent recall, WellPet has also notified consumers while most of its products are manufactured in its own facilities, it no longer purchases products from Diamond Pet Foods.

The FDA warns that Salmonella may pose dangers to humans as well as pets, with pets potentially serving as carriers of the dangerous bacteria. In addition, the Agency notes that humans may become infected by handling contaminated pet food, especially where hand washing is not properly conducted.