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Summary Report: FY 22/23 Sample Collection and Analysis of Retail Dairy-Free Dark Chocolate and Chocolate-Containing Products for Milk Allergen

September 17, 2024 - from the FDA:

The U.S. Food and Drug Administration (FDA) conducted an initiative to collect and test retail dark chocolate products and chocolate-containing products labeled as “dairy free” (or with similar free-of-milk claims)[1] for milk in cooperation with the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD) in 2022 and 2023. The FDA designed the assignment, and the state agencies performed the sample collection and testing.

This initiative was part of the FDA’s continued efforts to protect consumers with food allergies and is a continuation of a similar initiative implemented by the FDA in FY2018-2019. The latest initiative included additional chocolate-containing products, such as chocolate chip cookies, chocolate syrups, and chocolate baking powders, which were not part of the previous data collections. The FY22-23 initiative also sought to gain insights into the extent to which retail chocolate and chocolate-containing products that bear dairy-free or similar claims contain unintended milk at levels that may be potentially hazardous to people with a milk allergy.

The FY22-23 initiative examined retail dark chocolate products and chocolate-containing products that were labeled as dairy-free or with similar free-of-milk claims. The state personnel only collected samples of products that did not list milk as an ingredient on the product label. Milk detected in the samples could have been present due to a variety of factors, including labeling error or allergen cross-contact. Allergen cross-contact refers to unintentional incorporation of an allergen into food; it may occur during manufacturing or at a firm that supplied a product ingredient.

The analytical results of the 210 samples collected and tested under this effort are provided in the table that accompanies this report. These samples represent multiple products from approximately 50 firms.

Of the 210 samples, 13 tested positive for milk (i.e., with levels above the limit of quantification of the Neogen Veratox for Total Milk Allergen ELISA test kit). Twelve of these 13 samples contained less than 80 ppm, with one sample testing at 1,083 ppm milk. These 13 samples were produced by three different firms: one cookie product from Firm A (out of one sample tested), eight chocolate bar products from Firm B (out of 17 samples tested), and four chocolate bar products from Firm C (out of 34 samples tested), as shown in the results table. The sample with 1,083 ppm milk was a chocolate bar by firm B.

Each of the 13 products with positive milk findings were found to have not only a “dairy-free” type of statement but also allergen advisory statements intending to indicate the possible presence of milk to consumers. Their labeling stated that the products were “…made in a facility that also processes milk,” or featured similar wording.

The use of the allergen-free claim together with the allergen advisory statements for the same allergen on a product label may provide inconsistent information to consumers and should therefore be avoided.

Preliminary investigations completed by the firms and state agencies have implicated the suppliers of dark chocolate ingredients used by the firms as a possible source of the unintended allergen presence. Firm A agreed to remove “dairy-free” claims from its products when the root cause analysis is complete and if the cause of the presence of milk could not be determined and eliminated. Firms B and C removed the “dairy-free claim” from their chocolate products and provided updated labels to the FDA and its state partners as confirmation.

In the FY 2022-2023 initiative, all samples found to contain milk had milk allergen advisory statements. The FDA advises that firms that use a voluntary allergen-free statement ensure that the product doesn’t contain the allergen and that there is no inconsistent allergen information on the product label. Consumers with milk allergies who choose to eat dairy-free labeled products may contact firms to ask them questions about how their products are made, including whether they are made on dairy-free dedicated equipment, whether the ingredients used are dairy-free, and whether they test their products with dairy-free claims to confirm the accuracy of the claims.

The presence of milk in dairy-free labeled products on the market remains a concern for the FDA, given the potential for a health hazard for consumers with milk allergies. The FDA will continue to monitor the U.S. food supply to protect consumers with food allergies.