FDA Releases Results on Sampling of Dairy-Free Dark Chocolate for Milk Allergen

Constituent Update

October 1, 2020

The U.S. Food and Drug Administration today released results from sampling of domestically manufactured dark chocolate bars and dark chocolate chips labeled as “dairy free” or with similar claims. The sampling was conducted to better understand the extent to which these products contain potentially hazardous levels of milk.  The FDA is concerned about the presence of milk in dark chocolate claiming to be dairy-free because it can cause serious health consequences to consumers with milk allergy. 

The agency collected 119 samples, representing 52 products, at retail, with some purchased on-line. The 15-month survey began in July 2018 and ended in October 2019.  The FDA found that four of the 52 products sampled (12 of 119 samples), all dark chocolate bars, had potentially hazardous levels of milk allergen.  The levels, ranging from 600 to 3,100 parts per million (ppm), had the potential to cause severe reactions in consumers with milk allergy.  In response to these findings, the manufacturers recalled all four products.  

The FDA does not define the terms “dairy-free,”or “milk-free.” Such claims are voluntary and when used must be truthful and not misleading.  Consumers with milk allergy who choose to eat dairy-free chocolate may wish to contact the manufacturers and inquire about how the product is made, including whether the product is made on equipment dedicated to making dairy-free chocolate, whether the ingredients used are free of milk, and whether the manufacturer tests its products with dairy-free claims for the presence of milk.  

The agency will continue to monitor the issue, which will include additional sampling of domestic and imported dark chocolate as warranted to detect dark chocolate with undeclared milk allergen and help ensure its removal from the marketplace. 

For more information

Allergic to Milk? Some Dark Chocolate Labeled as Dairy-Free May Still Contain Milk