FDA Suspends Sunland’s Food Facility Registration

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.


Recalls and Alerts: November 21, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

For current information on retail distribution of peanut butter products recalled due to Salmonella Bredeney, please consult the Trader Joe’s/Sunland Peanut Butter Recalls tab.

For current information on retail distribution of beef products containing Canadian beef recalled due to E. coli O157:H7 contamination please consult the Canada/USA Beef Recall tab.

United States

  • Allergy Alert: Whole Foods Market recalls Cookies-by-the-Pound Wedding Cookies and Cookies-by-the-Pound Almondine Wedding Cookies, because they contain undeclared pecans and almonds, respectively. The recalled cookies were distributed in Alabama, Georgia, North Carolina, South Carolina and Tennessee between October 22 and November 15 2012.
  • Allergy Alert: Sara Lee® recalls Sara Lee Butter Streusel Coffee Cake (Best by Oct 16, 2013; UPC 3210002342), due to the presence of undeclared pecans. The recalled product was distributed nationally.
  • Food Safety Recall: Boulder Ice Cream (Boulder, CO) recalls the following ice cream and gelato products that contain peanut ingredients supplied by Sunland Inc., due to potential contamination with Salmonella: Boulder Ice Cream Peanut Butter Cup (16 oz; Best by 08/16-13 or earlier; UPC 65388802142), Sorano Gelato Chocolate Peanut Butter (16 oz; Best by 08-10-13 or earlier; UPC 65388807004), Boulder Homemade Chocolate Peanut Butter Gelato (5 L Pan; Best by 10-03-12 or earlier; UPC 65388850103), Boulder Ice Cream – Peanut Butter Cup (2.5 Gal Tub; Best by 07-24-12 or earlier), Boulder Ice Cream – Elvis (2.5 Gal Tub; Best by 07-24-12 or earlier), and Yoki Bliss – Peanut Butter (4 x 1 Gal; Mfg Date 09-24-12 or earlier; UPC 65388806112).
  • Pet Food Safety Recall: Carolina Prime Pet Inc. recalls Priority Total Pet Care All Natural Bullstrips (5-ct pkg; UPC 0-21130-42080-3; Lot codes 200827 12 S 3195 and 20090312 S3195), after the Colorado Department of Agriculture finds Salmonella in the product. The recalled Bullstrips were sold in Safeway stores in Arizona, California, Colorado, Delaware, Hawaii, Maryland, Nebraska, Nevada, New Mexico, South Dakota, Virginia, Washington DC and Wyoming as well as Vons, Pavilions and Pak ‘N Save stores in California; Randalls and Tom Thumb stores in Texas; Genuardi’s stores in Pennsylvania and New Jersey, and Dominick’s stores in Illinois.
  • Outbreak Alert (Final Update): CDC reports that the multistate outbreak of Listeria monocytogenes that sickened 22 persons in 13 states and the District of Colubmia appears to be over. Twenty people were hospitalized, and four of the outbreak victims died. Two of the deaths were related to the outbreak illness. The outbreak was traced to contaminated imported Frescolina Marte brand Ricotta Salata Cheese, which was manufactured by Chiarappa S.R.L. (Conversano, Italy).


  • Allergy Alert (Denmark): Tamaco Food A/S recalls imported Lactose-free Emmentaler (220g; Best before 12/12/2012, 20/12/2012 and 03/01/2013), because the product contains more than 0.01g of lactose per 100 grams of cheese.
  • Food Safety Alert (UK): The Food Standards Agency warns consumers not to eat peanut butter and peanut based products manufactured by Sunland, Inc. and imported from the USA, because of possible Salmonella contamination. Consumers should discard the affected products, which may have been purchased on the internet or from specialist shops that sell imported American food products.
  • Food Safety Recall (Finland): Nestlé Finland recalls Puffet IC Vanilla (110 ml; Best before 05.04.2014; Batch code 2286401812), because some pieces may contain metal fragments.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Sunland Products Shipped to Canada, Europe, Hong Kong

Peanut butter and peanut products manufactured by Sunland, Inc. – the company responsible for at least 41 Salmonella Bredeney illnesses in 20 US states – were exported to Canada, Hong Kong and the European Union, according to reports on various government web pages.

Yesterday (November 20th), the Rapid Alert System for Food and Feed (RASFF) carried a notification that various outbreak-related peanut and peanut-based products from the USA were distributed to France, Italy, Norway and the United Kingdom. Earlier today, the UK Food Standards Agency posted the following Food Alert for Action:

The Food Standards Agency (FSA) is warning consumers not to eat certain peanut butter and peanut-based products which have been imported from the US because of possible contamination with salmonella. Salmonella is a bacterium that causes food poisoning. The Agency has issued a Food Alert for Action.

An outbreak of a strain of salmonella called Salmonella Bredeney in the US has been linked to peanut butter produced by a company called Sunland Inc. As a result, the manufacturer is recalling a wide range of peanut butter and peanut-based products. Other products containing nuts and seeds are also being recalled.

An initial recall of products in the US in September did not affect the UK as the products involved were not distributed in Europe. However, because the product recall has widened, US authorities have now alerted the European Commission to possible distribution of affected products in a number of member states, including the UK.

It is not thought that these products are on sale in the major supermarkets in the UK, but they may have been bought on the internet or from specialist shops that import American food products. The Food Standards Agency has requested distribution information from the US authorities. In the meantime, the Agency has asked local authorities to check businesses in their areas that may have imported or sold the affected products and to remove any remaining products from sale.

Liz McNulty, from the FSA’s incidents team, added: ‘Investigations are ongoing, but as we get more information from the US and local authorities in the UK we will be able to narrow down the list products to just those we know have been sold in the UK. If consumers have a product made by Sunland Inc they should check the batch code against the list on US FDA site provided at the link top right. If the product is on the list it should not be eaten and returned to where it was bought.’

The Health Protection Agency is currently not aware of any cases of illness in the UK that may be associated with the outbreak. A full list of products recalled in the USA to date can be found at the link to the FDA site.

Italy, France and Norway have yet to post any warnings.

On November 8th, Hong Kong’s Centre for Food Safety alerted the public that two of the recalled products – Sunland Organic Valencia Peanut Butter Creamy and Sunland Organic Valencia Peanut Butter Crunchy – had been imported into Hong Kong and were under recall. Canadians have received ten Sunland-related recall notices so far; the first one was issued on September 25, 2012 and the most recent on November 16th.

While no other countries appear to have been affected by the massive peanut-product recalls, the use of Sunland peanut products in a large number of other specialty foods combined with the ease of purchasing products across national boundaries via the Internet – especially in the EU – places consumers around the world at risk. Please consult the Sunland recall tab for a comprehensive list of recalled Sunland products and of foods that may contain a recalled Sunland peanut product.