Summary Report: FY 22/23 Sample Collection and Analysis of Retail Dairy-Free Dark Chocolate and Chocolate-Containing Products for Milk Allergen
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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 sample collection and testing were conducted under the FDA’s Laboratory Flexible Funding Model Cooperative Agreement Program (LFFM), with PDA and MDARD participating. The LFFM is a comprehensive emergency response and surveillance cooperative agreement between the FDA and Food Emergency Response Network (FERN) state partner laboratories and supports a wide range of analytical activities in the disciplines of microbiology, chemistry, and radiochemistry. The LFFM aims to enhance the capacity and capabilities of state human and animal feed testing laboratories in support of an integrated food safety system. Surveillance testing is a major focus of the LFFM; state partners collect and analyze human and animal food products for chemical and microbiological hazards.
Methodology
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.
PDA and MDARD collected all samples at retail in their respective states. When possible, PDA and MDARD collected samples from multiple lots of each product to gain a greater understanding of the occurrence of milk in different lots of the same product.
PDA and MDARD used enzyme-linked immunosorbent assay (ELISA) test kits to determine the milk levels in the samples. This report provides the test results in parts per million (ppm) of milk.[2] The quantities of milk detected and reported among the findings represent the results of a Morinaga Institute of Biological Science Casein ELISA test kit following screening testing from a Neogen Veratox for Total Milk Allergen ELISA test kit. PDA and MDARD confirmed all Veratox kit findings above the limit of quantitation using Morinaga Institute of Biological Science Casein ELISA test kits.
Findings
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.
Regulatory Approach
In addressing each of the 13 samples that tested positive for milk, the FDA evaluated the facts and circumstances specific to each situation.
As background, firms may use voluntary statements to provide information to consumers that specific allergens are absent from the product. Other than the term “gluten-free” [3] there are no regulations defining specific conditions (e.g., allergen levels) for a product to make a “free” claim from a major food allergen source. If voluntary allergen-free claims are used, they must be truthful and not misleading. 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 product will lead the agency to investigate and consider enforcement action, depending on the investigational findings. The agency may also pursue additional follow up actions, including discussing the findings with the firms, conducting follow-up inspections, or issuing warning letters.
In certain instances, firms may choose to voluntarily place allergen advisory statements on products to alert consumers to the possible presence of major food allergens due to cross-contact. When used, allergen advisory statements are not a substitute for adherence to current good manufacturing practices and food allergen preventive controls. These statements must also be truthful and not misleading. 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.
Follow-Up Actions
The FDA conducted case-by-case evaluation of the samples that tested positive for milk and consulted with its state partners. The FDA’s review included an evaluation of the health hazard posed by each product, considering the factors applicable in each case, which included the level of milk in the product, estimated amount of product consumed per eating occasion, likelihood of consumption by allergic consumers and other relevant information, such as possible consumer adverse reactions. The FDA and its state partners are not aware of any consumer adverse reactions associated with the 13 products that tested positive for milk. The FDA, along with its state partners, met with each of the three firms (A, B, C) to review the findings and to discuss the firms’ next steps to ensure their products are safe and in compliance with applicable regulations.
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. The FDA and state agencies will follow-up with these manufacturers to ensure their ongoing compliance.
Discussion
The FDA’s FY 2018-2019 dairy-free dark chocolate assignment found that four out of 52 products tested had potentially hazardous levels of milk, with levels ranging from 600 ppm to 3,100 ppm.
The FY 2022-2023 initiative was slightly different in scope in that it included both dark chocolate products and chocolate-containing products. However, among this more recent initiative’s 104 dark chocolate products (bars and chips), only one product tested at 1,083 ppm milk, with the remaining 11 positive dark chocolate product samples at levels below 80 ppm milk.[4] The recent findings suggest that firms producing dairy-free products may be improving their allergen cross-contact controls, this producing a downward trend in the percent of dairy-free dark chocolate products with potentially hazardous levels of milk, compared to the FY 2018-2019 sampling. However, these two initiatives were not designed to support statistical comparison;[5] they were intended as surveillance efforts to examine dairy-free labeled products for undeclared milk.
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.
[1] Claims similar to “dairy-free” include, “milk free,” “100% milk free,” and “contains no milk.”
[2] Specifically, nonfat dry milk. The results from this analysis are reported as nonfat dry milk (NFDM) after conversion by calculation from ppm protein from the original analysis.
[3] 21 CFR 101.91 sets forth conditions for use of the “gluten-free” claim.
[4] One of the 13 positive samples was from a chocolate chip cookie (sample No. 56), and thus it is not included in the count of 12 positive dark chocolate products.
[5] Additionally, the study from FY 2018/2019 reported results from Neogen Veratox for Total Milk Allergen ELISA test kits ppm while the current results were from Morinaga Institute of Biological Science Casein ELISA test kits.