FDA Releases Milk Allergen Findings for Dark Chocolate Products with “Dairy Free” Label Claims

The FDA recently published milk allergen test results for samples of dark chocolate and chocolate-containing products labeled as “dairy free” collected from 2022 to 2023 during a retail sampling assignment.  The study follows two previous studies conducted in 2018-19 and 2009-13 that surveyed “dairy-free” dark chocolate products for the presence of milk allergen.  Interest in the validity of “dairy free” claims for chocolate containing products was driven by the frequency of recalls associated with these products due to milk allergen hazards. The latest study provides additional evidence that milk allergen hazards continue despite label claims. 

In the most recent study, the FDA sampled 210 chocolate and chocolate-containing products (from 50 manufacturers) that included chocolate bars, chocolate chip cookies, chocolate syrups, and chocolate baking powders that were labeled as “dairy free” or with similar free-of-milk claims.  Samples were screened using the Neogen Veratox for Total Milk Allergen enzyme-linked immunosorbent assay (ELISA) test kit.  Veratox kit results above the limit of quantitation were confirmed using Morinaga Institute of Biological Science Casein ELISA test kits. 

The results indicated that thirteen of the samples contained milk.  Twelve contained levels between 16-76 ppm of milk, and one sample contained 1083 ppm of milk.  Three companies produced the 13 milk containing products that were all labeled with a “dairy-free” type of statement.  They were also labeled with allergen advisory statements indicating the products were “…made in a facility that also processes milk,” or similar wording.  Preliminary investigations by partnering state agencies 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 manufacturers agreed to remove “dairy-free” claims from their products after meeting with the FDA. 

From a regulatory standpoint, there are no regulations that define a “free from” claim for a major food allergen.  For example, if a product label or labeling were to have a “milk-free” or similar claim, the FDA would expect there to be no milk in the product from any source.  Therefore, evidence (e.g., label statements and test results) that indicates the presence of milk in such a product will lead the agency to investigate and consider enforcement action, depending on the investigational findings.  Firms may use voluntary statements, but they must be truthful and not misleading.  The use of an allergen-free claim together with an allergen advisory statement for the same allergen on a product label provides inconsistent and confusing information to consumers and should therefore be avoided.