A recent sampling assignment conducted by the U.S. Food and Drug Administration (FDA) found 6.2 percent of dark chocolate and chocolate-containing products labeled as “dairy-free” to contain milk, although all samples positive for milk were also labeled with some form of milk allergen advisory statement (e.g., “made in a facility that also processes milk”).

The project, conducted during 2022–2023 in collaboration with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD), was intended to better understand the extent to which “dairy-free” dark chocolate and chocolate-containing products potentially contain unintended milk at levels that may be hazardous to people with milk allergies. A similar sampling assignment was carried out in 2018–2019, which only focused on chocolate bars and chocolate chips. The 2022–2023 project was expanded to include additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups, and chocolate baking powders.

In 2022–2023, PDA and MDARD collected 210 product samples at retail in the states of Pennsylvania and Michigan, respectively. Testing found 13 of the 210 samples (6.2 percent) to contain milk. The 13 samples were made by three different food manufacturing firms; 12 of the 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 were labeled 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 agreed to remove the “dairy-free” claim from its products if the cause of the presence of milk could not be determined and eliminated upon completion of a root cause analysis. Preliminary investigations, based on inspections by state agencies, implicated the supplier of dark chocolate as the likely source of milk in the products rather than inadequate sanitation or other practices at the manufacturer. FDA and state agencies will follow up with the three manufacturers to assess ongoing compliance.

Claims such as “dairy-free” and “milk-free” are voluntary and undefined by FDA. When used, such claims must be truthful and not misleading, and consumers have the right to contact the manufacturers to inquire about the production of such goods. FDA intends to continue to monitor dark chocolate and chocolate-containing products labeled as “dairy-free” for the presence of milk.