Pretzel Dogs Recalled Due to Use of Soy Lecithin Not Listed on Label

A Pennsylvania firm is recalling pretzel dogs due to the fact that soy lecithin was not included on the label.  In this case, the soy lecithin was used as a processing aid, more specifically a release agent (like Pam).  But the need to claim soy lecithin, when used as a processing aid, was not always clear cut.
 
From the Food Allergy Research and Resource Center (FARRP website link below),

The Food Allergen Labeling and Consumer Protection Act in the U.S. requires the labeling of soy lecithin when used in any capacity, including use as a processing aid.

But in the past, it was not as clear with regard to soy lecithin.  More from FARRP:

Additionally, on February 25, 2013, the FDA withdrew its May 2, 2006 guidance entitled "Guidance on the Labeling of Certain Uses for Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act" which originally indicated a willingness by FDA to use "regulatory discretion" in dealing with the labeling of soy lecithin in circumstances where soy lecithin is used as a stick-release or pan-release agent, a common processing aid use in the food industry. The FDA now requires source labeling of soy lecithin when used as a release agent applied directly to the food contact surfaces or as a direct ingredient in the product formulation, with the exception of the specific

Another thing that FARRP points out is that the level of allergen present on the product when used as a processing aid may be well below the limit that will cause anyone to have a reaction.  However, there may be that one case.

It is important that food operations review their use of processing aids.  If allergens are present such as soy lecithin, it needs to be included on the label.

 

USDA News Release

http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-079-2014-release-EXP

  

Pennsylvania Firm Expands Recalls Pretzel Dog Products Due To Misbranding and Undeclared Allergens

Class I Recall 079-2014-EXP  Health Risk: High Nov 18, 2014 

 

Congressional and Public Affairs  Marie Bucko  (202) 720-9113

 

WASHINGTON, Nov. 18, 2014 – City Line Foods Manufacturing Co., a Lancaster, Pa., establishment is expanding their recall to include an additional 12,282 pounds of frozen pretzel hot dog products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. This brings the total pounds of product recalled to 1,208,951 pounds. The products contain soy lecithin, a known allergen which is not declared on the product label.

 

The recalled products were produced Nov. 14, 2013 – Nov. 14, 2014.

 

The following products are subject to the expanded recall:

"Kunzler Cheddar Pepper Frank Pretzel Dogs."

"Kunzler Pretzel Dogs."

"Kunzler Turkey Pretzel Dogs."

"Berks All Beef Pretzel Franks."

 

The following products are subject to the FSIS recall issued November 15, 2014.

"Auntie Anne’s All Beef Classic Pretzel Dogs."

"Auntie Anne’s Fundraising Pretzel Dogs."

"West Creek Black Angus Beef Pretzel Dogs."

"Kunzler Pretzel Dogs."

"Kunzler Turkey Pretzel Dogs."

"Berks All Beef Pretzel Franks."

"Nathan’s Famous Pretzel Dogs."

"City Line Foods Pretzel Dogs."

 

The products subject to recall bear the establishment number "EST. or P-34073" or "34073" inside the USDA mark of inspection. These products produced were shipped nationwide for retail distribution and fundraising. This recall does not affect Auntie Anne's pretzel stores found in malls, airports and other venues nationwide.

 

The problem was initially discovered by FSIS personnel during a routine labeling review. FSIS inspectors found that a releasing agent used on contact surfaces during production included soy lecithin, which was not disclosed on the product label. The additional product was discovered by the establishment while reviewing records as part of their recall activity. They then notified FSIS personnel of the issue. FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

 

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

 

Consumers with questions about the recall can contact Heather Neary, Auntie Anne’s Inc.’s Chief Marketing Officer, at 1-717-435-1558.

 

 

 

 

 

FARRP     

http://farrp.unl.edu/resources/gi-fas/opinion-and-summaries/soy-lecithin

Soybeans and Soy Lecithin

 

Soybeans are well-recognized as allergenic foods. The soybean allergens are found in the protein fraction. The vast majority of this protein is removed in the soy lecithin manufacturing process. Soy lecithin does contain trace levels of soy proteins and these have been found to include soy allergens. However, apparently, soy lecithin does not contain sufficient soy protein residues to provoke allergic reactions in the majority of soy-allergic consumers. Many allergists do not even advise their soybean-allergic patients to avoid soybean lecithin when it is included as an ingredient on food products. From this practical standpoint, we can surmise that most soybean-allergic individuals do not react adversely to the ingestion of soybean lecithin.

 

Yet, there is, of course, the possibility that some of the more sensitive soybean-allergic consumers might react to ingestion of soybean lecithin, so of course we do advocate the source labeling of lecithin when it is used as a direct food ingredient.

 

The oily matrix of lecithin and the low protein levels provide a challenge to current analytical methodology. Regarding detection of soy lecithin in food products, the amount of soy lecithin used in most food products would leave residues at levels well below the limit of detection of currently available detection methods.

 

No conceivable allergenic risks would occur from the use of shared equipment for products that contain soybean lecithin and products that do not. The amount of soybean protein that could conceivably be transferred to the next product manufactured with this shared equipment is extraordinarily low. Therefore, "allergen clean-outs" are not necessary, in our opinion, for shared equipment in situations where the first product contains soy lecithin as an ingredient and the second does not, if soy lecithin is the only ingredient in the formulation that is derived from a commonly allergenic source.

 

The Food Allergen Labeling and Consumer Protection Act in the U.S. requires the labeling of soy lecithin when used in any capacity, including use as a processing aid. To date, the Food & Drug Administration has granted only one exemption to soybean lecithin labeling from this law. On February 22, 2013, FDA granted a source labeling exemption for select soy lecithins produced by Solae, LLC when used as a release agent applied directly to food contact surfaces. Soy lecithin products produced by other manufacturers are not currently exempt from source labeling for this purpose. Additionally, on February 25, 2013, the FDA withdrew its May 2, 2006 guidance entitled "Guidance on the Labeling of Certain Uses for Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act" which originally indicated a willingness by FDA to use "regulatory discretion" in dealing with the labeling of soy lecithin in circumstances where soy lecithin is used as a stick-release or pan-release agent, a common processing aid use in the food industry. The FDA now requires source labeling of soy lecithin when used as a release agent applied directly to the food contact surfaces or as a direct ingredient in the product formulation, with the exception of the specific Solae soy lecithin products directly applied to food contact surfaces as outlined in the Exemption Notification.

 

With respect to the cleaning of shared equipment following the processing of formulations containing soy lecithin, FALCPA does not stipulate the conditions under which extensive allergen clean-up must be conducted. When processing equipment is then used to manufacture other products that do not contain intentionally added soy lecithin, dilution would occur with the other product and would quickly reduce any soy allergen residues by additional orders of magnitude. With this reasoning, no conceivable risk exists from the use of shared equipment in this circumstance and no need exists for extensive allergen cleaning if soy lecithin is the only source of allergen concern. Attempts to assess the adequacy of any preventative controls would be unnecessary because the allergen residue testing methods would be insufficiently sensitive to detect soy protein/allergen residues on processing equipment surfaces, rinse water or in any subsequent products manufactured on shared equipment. Allergen clean-up after formulations containing soy lecithin as the sole ingredient derived from commonly allergenic sources is not necessary in our opinion as outlined above.