The U.S. Food and Drug Administration, in cooperation with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD), has released results from its retail sampling of dark chocolate and chocolate-containing products labeled as “dairy free” that were collected and tested for unintended milk in 2022 and 2023. The sampling was conducted to better understand the extent to which these products potentially contain unintended milk at levels that may be hazardous to people with milk allergy.

This sampling initiative was part of the FDA’s continued efforts to protect consumers with food allergies and is a continuation of a similar effort by the FDA implemented in FY 2018-2019. Unlike the earlier assignment, which focused on chocolate bars and chocolate chips, this recent effort included testing for milk in additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups and chocolate baking powders that were labeled as “dairy free.” In 2022 and 2023, PDA and MDARD collected 210 samples at retail in the states of Pennsylvania and Michigan, respectively. The testing found that 13 of the 210 samples tested were positive for milk. These 13 samples were made by three different food manufacturing firms. Twelve of these 13 samples contained less than 80 parts per million (ppm) of milk, with one sample testing at 1,083 ppm. Additionally, the 13 products found to contain milk had labeling with milk allergen advisory statements, such as, “...made in a facility that also processes milk.”

In response to the findings, two manufacturers removed the “dairy free” claim from their chocolate products. The third manufacturer likewise agreed to remove the “dairy free” claim from its products, if the cause of the presence of milk could not be determined and eliminated pending completion of a root cause analysis. Preliminary investigations, based on inspections by state agencies, have implicated the supplier of dark chocolate as the likely source of milk in these products rather than inadequate sanitation or other practices at the manufacturer. The FDA and state agencies will follow-up with these manufacturers and assess their ongoing compliance.

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, the agency says. Consumers with milk allergy who choose to eat dairy-free dark chocolate or chocolate-containing products can 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 says it will continue to monitor dark chocolate and chocolate-containing products labeled as “dairy free” for the presence of milk because it can cause serious health consequences to consumers with milk allergy.