The agency’s action, taken under authority conferred on FDA by the Food Safety Modernization Act (FSMA), follows on the heels of a determination that “…food manufactured, processed, packed, received, or held by [the] facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and that [the] facility created, caused, or was otherwise responsible for such reasonable probability.”
Peanut butter manufactured in Sunland, Inc.’s Portales, New Mexico facility was responsible for at least 41 cases of Salmonella Bredeney infections in 20 US states, according to CDC’s most recent update, published on November 8th. Ten of the 41 outbreak victims were hospitalized.
In announcing this first ever use of FDA’s suspension powers under FSMA, the agency released the following statement:
In the interest of protecting public health, the U.S. Food and Drug Administration suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.
The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.
This was the FDA’s first use of its registration suspension authority, under the Food Safety Modernization Act. This new authority enables the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.
A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.
Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.
The suspension order offers Sunland, Inc. the opportunity to request an informal hearing on certain issues related to the order. If, after providing this opportunity, the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner. The FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products.
In its letter of notification to Sunland’s President, FDA referred to a number of conditions and company actions that formed the basis for its decision, including:
- Investigation by CDC and FDA of a multistate outbreak of Salmonella Bredeney led to a determination that Trader Joe’s™ brand Valencia Creamy Salted Peanut Butter made with Sea Salt was the likely source of the outbreak;
- Sunland was the sold manufacturer of the implicated peanut butter;
- Evidence collected by FDA in response to the outbreak, including the company’s own testing records, environmental and finished product samples analyzed by FDA and observations made during FDA’s inspection of the facility established that nut butter and nut products manufactured, processed, packed and held by Sunland are contaminated with Salmonella or are at risk of contamination with Salmonella;
- Sunland’s own testing records revealed that third party testing identified the presence of Salmonella spp. in at least 40 finished products from 11 finished product lots and eight sets of environmental samples between June 2009 and September 2012; and
- Sunland distributed at least a portion of eight lots of peanut and almond butter between March 1, 2010 and September 2012 after composite testing revealed the presence of Salmonella.
The complete text of the letter can be found on FDA’s website.
Sunland’s quality assurance philosophy clearly was “keep testing until we get a Salmonella-negative result; then ship the product.” This is an approach that has been adopted all too frequently in the food industry. I have encountered it in Canada; I have encountered it in the US. It is ethically incorrect. It is scientifically incorrect.
In a word, it is WRONG.