Highlights

  • Why is the Dairy-Free Label Important?

  • Issues with Dairy-Free Dark Chocolate

  • Verifying that Foods are Really ‘Dairy-Free’

The Importance of the Dairy-Free Label

Food products labeled as “dairy-free” appeal to millions of American consumers seeking to avoid milk due to a milk allergy, lactose intolerance, a vegan diet, or other reasons.  Milk is one of the Big Eight allergens required to be identified on U.S. food labels, and the reason for approximately 30% of all U.S. food recalls due to undeclared allergens.

The presence of a milk protein in food labeled as “dairy-free” could trigger a costly recall and might pose a serious health risk for consumers.  The Food and Drug Administration (FDA) is monitoring the presence of milk in dark chocolate and other foods. Do you know how to verify the absence of milk in “dairy-free” food products?  

Individuals with a milk allergy depend on the accuracy of dairy-free claims for their health, but it is difficult to avoid milk proteins in foods.  In order to find ‘dairy-free’ products, consumers must begin by reviewing the ingredients list on food labels since dairy ingredients are found in a plethora of foods ranging from baked goods to sauces. 

To complicate matters further, the Food and Drug Administration (FDA) has not established a regulatory definition for “dairy-free” claims or similar absence claims such as “milk-free,” “100% milk-free,” and “contains no milk.”   If a product is labeled as “dairy-free,” then the FDA would expect no detectable milk proteins or lactose to be present in the product. 

Lactose intolerance is a common digestive issue for millions of Americans, but it does not involve the immune system and is not a serious health problem. The FDA permits the use of a voluntary “lactose-free” claim to assist individuals with lactose intolerance, but the lactose-free claim does not suggest the absence of milk allergens.

If the FDA discovers the presence of a milk allergen in a food with a dairy-free claim, then the agency can impose several regulatory actions including mandatory recall, warning letter, seizure, and injunction.   Typically, food companies will voluntarily implement a recall if an undeclared milk allergen is suspected in a dairy-free food product.  

Searching for Milk in Dairy-Free Chocolate

While you might assume dark chocolate is dairy-free, undeclared milk is a common reason for the recall of dark chocolate products.  Milk is permitted in dark chocolate, but food manufacturers must declare the presence of milk in accordance with U.S. food allergen labeling law.  In some cases, milk protein can be inadvertently added to dark chocolate through cross-contact with shared equipment used for milk chocolate products.

Recently, the FDA disclosed the results of a new 15-month (July 2018 to October 2019) survey of dark chocolate products labeled with dairy-free or similar claims.  According to the FDA report, “potentially hazardous levels” of milk allergen (600 to 3,100 parts per million) were detected in four of the 52 dark chocolate product sampled (12 of 119 samples).  The FDA will conduct additional monitoring of domestic and imported dark chocolate to evaluate the presence of undeclared milk allergen in dairy-free products.

A product recall should be implemented following the detection of a milk protein in dairy-free dark chocolate or in any product failing to disclose the presence of a milk allergen.  Under the FSMA regulation for Preventive Controls, food manufacturers must develop and implement a food safety plan to prevent hazards, including allergens.  Food manufacturers of dairy-free products could dedicate equipment to producing dairy-free food, monitor the absence of milk from ingredients, and test finished “dairy-free” products for the presence of milk.

How to Verify Foods are Really ‘Dairy-Free’

Allergen control in food manufacturing relies on prevention and detection measures. In the recent survey of dark chocolate, the FDA researchers utilized two Enzyme-linked immunosorbent assays (ELISAs) for the determination of milk allergen levels in the dark chocolate samples.  According to the FDA, the quantities of milk allergen detected in the samples were obtained from Neogen Veratox for Total Milk Allergen ELISA kit testing and confirmed using Morinaga Institute of Biological Science Casein ELISA test kits.

Mérieux NutriSciences offers qualitative and/or quantitative testing services for allergens in all food matrices, process samples, product samples, raw materials, and finished products utilizing a range of technologies including PCR ELISA and PCR confirmation.

While testing is an important tool, routine auditing of a manufacturing facility and ingredient suppliers is a critical element of an allergen control program.  Mérieux NutriSciences offers allergen verification audits, consultants who can assist with allergen sanitation validation studies and reports.  In addition, Mérieux NutriSciences offers ingredient and label reviews to ensure compliance with the U.S. and Canadian regulations for allergen labeling.

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