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Undeclared Allergens Most Common Cause of FDA Recall Requests

On October 23, 2014, the U.S. Food and Drug Administration (FDA) published a Consumer Update regarding undeclared food allergens (food allergens that are not listed on labels).  Labelers of FDA-regulated foods are required to list major food allergens on product labels under federal law.  When a consumer is allergic to a food ingredient, they look to labels to inform them of whether or not a food is safe for them to eat.  Therefore, when food contains an allergen but does not list the allergen on its label, it’s a serious health risk. According to the Consumer Update, undeclared allergens are the leading cause of food recalls requested by FDA.  The three allergens most commonly involved in food recalls are milk, wheat, and soy.  Other major allergens include peanuts, fish, crustacean shellfish, eggs, and tree nuts.

Recall data show that labels with undeclared allergens are often a mistake.  When a company sells similar products with slightly different ingredients, a product may end up with the wrong label.  Many mistakes are also due to computerization and labels being printed directly onto packaging.  Mistake or no, however, the public health consequences of undeclared allergens are still severe.  About 1/3 of foods reported to FDA as serious health risks from September 2009 to September 2012 involved undeclared allergens.

FDA is currently exploring new methods of allergen testing.  While the commonly used allergen detection program ELISA is fairly low-cost and easy to use, the program sometimes produces incorrect results.  So, FDA is working to develop more in-depth detection methods based on mass spectrometry and DNA.

If FDA finds a label with undeclared allergens, the product will be deemed misbranded, and FDA may demand a recall or even detain the product.  Recalls demand substantial time and money, as firms must halt distribution and resolve the issue at hand.  For example, in the case of undeclared allergens, a firm would have to produce and apply a new label onto its products.  It’s always best to review product labels before distributing products in the United States.  Registrar Corp Regulatory Specialists are well versed on FDA label requirements and offer a label review service for food and beverage companies.  We will cross-reference a firm’s product label against thousands of pages within the Code of Federal Regulations and modify the label for FDA compliance.

For more information on FDA label requirements, or to request a label review, contact Registrar Corp by phone: +1-757-224-0177 or via 24/7 Live Help: http://www.registrarcorp.com/LiveHelp.