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FDA Release Results of Sampling of Retail Dairy-Free Dark Chocolate and Chocolate-Containing Products for Milk Allergen
Thursday, September 19, 2024
  • On September 17, 2024, the U.S. Food and Drug Administration (FDA) released results from 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. FDA worked in cooperation with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD). The sampling and testing was conducted to determine whether these products may contain unintended milk at levels that may be hazardous to people with milk allergy.
  • Unlike FDA’s earlier assessment (FY 2018-2019), which focused on chocolate bars and chocolate chips, this recent effort included tested for milk in additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups, and chocolate baking powders that were labeled as “dairy free.”
  • Thirteen of the 210 samples collected by PDA and MDARD tested positive for milk. 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 (e.g., “…made in a facility that also processes milk.”
  • The 13 samples at issue were made by three different manufacturing firms. 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 pending completion of a root cause analysis.
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