iOn October 1, 2020, the U.S. Food and Drug Administration (FDA) published the results of its sampling project on domestically manufactured dark chocolate bars and dark chocolate chips labeled with claims such as “dairy free.” FDA conducted the sampling assignment to better understand the extent to which these products contain potentially hazardous levels of milk and therefore may cause serious health consequences to consumers with an allergy to milk.
FDA’s sampling assignment focused on products that did not include milk as a disclosed ingredient; were manufactured in the U.S.; bore claims such as: “dairy free,” “milk free,” “100% milk free,” and “contains no milk,” on packaging or website (this sampling assignment did not target “lactose-free” or standalone “vegan” claims in the absence of “dairy free”-type claims); and consisted solely of dark chocolate, without other component ingredients such as fillings, candy shells, fruits, nuts, seeds, etc. From July 2018 to October 2019, FDA collected 119 samples (88 dark chocolate bars and 31 packages of dark chocolate chips), representing 52 products, at retail (including online). FDA found that four of the products sampled (4 of 52 products; 12 of 119 samples) had milk levels ranging from 600-3,100 parts per million (ppm), and the potential to cause severe reactions in consumers with milk allergy.
Dark chocolate can be made with or without milk as an intentionally-added ingredient. Some dark chocolate is made without the addition of milk as an ingredient, but milk may nevertheless be found present in these products due to inadvertent cross-contact, or the fact that dark chocolate is often produced on equipment used to produce milk chocolate, and it can be very challenging to thoroughly clean the equipment between product runs.
Milk is one of the eight major allergens identified by FDA (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), and manufacturers are required to label products that contain these ingredients and/or proteins accordingly. Undisclosed allergens are a leading cause of FDA requests for food recalls. FDA believes milk is the most common undeclared food allergen, and that milk has been observed to be the leading cause of consumer adverse reactions to foods recalled due to undeclared allergens. Based on consumer surveys, millions of people in the U.S. (estimated at approx. 2% of the population) are believed to experience symptoms of milk allergy, ranging from mild to severe (including hives, facial swelling, upset stomach, vomiting, wheezing, and anaphylaxis).
In response to the findings of the sampling project, all four products were recalled by the three manufacturers involved. The Agency will continue to monitor the issue, and will conduct additional sampling of domestic and imported dark chocolate.
