FY18/19 Sample Collection and Analysis of Domestically Manufactured, Dairy-Free Dark Chocolate Products for Milk Allergen
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The U.S. Food and Drug Administration (FDA) conducted an assignment to collect and test domestically manufactured dark chocolate bars and chips labeled as “dairy free” (or with similar free-of-milk claims) in 2018 and 2019 to identify and remove from the U.S. market any that errantly claimed the absence of milk.
The assignment, issued in July 2018, also was an effort by the FDA to gain insights into the extent to which domestically manufactured dark chocolate bars and chips that bear dairy-free or similar claims yet contain potentially hazardous levels of undeclared milk may appear on the U.S. market.
Milk is the most common undeclared food allergen, responsible for more than a third of all food product recalls caused by undeclared allergens in the U.S. in the past decade., Milk also has been observed to be the leading cause of consumer adverse reactions to foods recalled because of undeclared allergens, and these foods included dark chocolate products.
Millions of people in the U.S. (an estimated 2% of the country’s population) experience the effects of milk allergy, according to studies from a 2015-2016 national survey., Symptoms of milk allergy range from mild to severe and may include hives, facial swelling, upset stomach, vomiting, wheezing, and anaphylaxis, a rare, potentially life-threatening condition that can impair breathing and send the body into shock.
Dark chocolate may or may not contain milk as an ingredient. This assignment examined dark chocolate products that did not contain milk as an intentionally added ingredient, based on labeling or website claims. Milk detected in the samples tested under this assignment could be 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. Allergen cross-contact may occur during manufacturing of dark chocolate bars or chips or at the operation that supplied the chocolate ingredients to the U.S. chocolate manufacturer.
To be eligible for inclusion in the assignment, products had to be manufactured in the U.S., bear a dairy-free or similar claim on their package or website, and consist solely of dark chocolate (e.g., be free of cream or nougat filling, a candy shell, or inclusions such as nuts, fruit, or seeds).
Each sample consisted of a retail package with a minimum weight of 100 grams (0.22 pounds). The FDA collected all samples at retail, with some collection occurring via online purchase. When possible, the agency collected samples from multiple lots of each product to gain a more representative understanding of the occurrence of milk in each product.
The agency used two enzyme-linked immunosorbent assay (ELISA) test kits to determine the milk allergen levels in the samples. The quantities of milk allergen detected and reported among the findings represent the results of Neogen Veratox for Total Milk Allergen ELISA kit testing. The agency confirmed all Veratox kit findings above 5 parts per million (ppm) using Morinaga Institute of Biological Science Casein ELISA test kits.
The assignment findings are provided in this table, which consists of 119 samples (i.e., 88 dark chocolate bars, and 31 packages of dark chocolate chips). These samples represented 52 distinct products.
The FDA determined that four of the 52 products tested had potentially hazardous levels of milk allergen. These four products – all dark chocolate bars – were made by three different manufacturers. Together the four products were responsible for 12 positives out of the 119 samples.
The agency found the 12 samples from the four products to have milk allergen levels ranging from 600 ppm to 3,100 ppm. The agency determined that, at these levels, the four products held the potential to cause severe reactions in consumers with milk allergy. The FDA took action as warranted to address each of these positives.
Additionally, the FDA detected a lower level of milk allergen in a fifth product – also a chocolate bar – by another manufacturer. The quantity of milk allergen detected was 90 ppm in one sample; three other samples of the same product tested negative for milk allergen.
The FDA does not define the terms “dairy free,” “milk free” or other “absence” claims, except for “gluten free.” Absence claims are voluntary statements that indicate a specific ingredient or food component is not present in a product. Claims of this nature may be used to provide information to consumers to facilitate the avoidance of a food ingredient or a food component because of food allergies, food intolerances, religious beliefs, or dietary practices such as vegetarianism or other non-nutrition related reasons, according to 21 C.F.R. § 101.65(b)(1). Absence claims, when used, must be truthful and not misleading, per the Federal Food, Drug and Cosmetic Act.
If a product or references to a product on a company website were to bear a dairy-free or similar claim, the FDA would expect there to be no milk allergen in the product given that consumers with milk allergy depend on the accuracy of dairy-free claims for their health. The presence of milk allergen in a product bearing a dairy-free claim may lead the agency to conduct an investigation and to consider enforcement action, depending on the investigational findings. Regulatory tools at the agency’s disposal include warning letters, seizures, injunctions, and mandatory recalls (if a firm does not conduct an adequate voluntary recall). Firms typically conduct a voluntary recall when one of their products is found to contain an undeclared allergen.
This assignment resulted in the recall of the four products (i.e., dark chocolate bars) found to have potentially hazardous levels of milk allergen, namely those with detections from 600 ppm to 3,100 ppm. Two of the recalled products were manufactured by the same firm, resulting in three recall events in all.
As to the fifth product in which the FDA detected 90 ppm of milk allergen in a single sample (while three others of the same product tested negative), instead of pursuing a recall, the agency notified the manufacturer of the test result, so that it could take appropriate action.
The agency conducted follow-up inspections in keeping with the assignment. Evidence from those inspections indicated that the milk allergen detected might have resulted from chocolate ingredients sourced from suppliers or from allergen cross-contact due to the use of equipment employed in the manufacture of milk chocolate.
A limited survey by the FDA in 2013-2014 found that two out of 14 dark chocolate products with dairy-free or lactose-free claims and no allergen advisory statement had detectable levels of milk ranging from 1,100 ppm to 1,900 ppm. The agency’s 2018-2019 assignment has likewise found levels of milk allergen in certain dark chocolate products bearing dairy-free or similar claims that hold the potential to cause severe reactions in milk allergic consumers. The presence of undeclared milk allergen in dark chocolate products with dairy-free claims remains a concern to the FDA in light of these FDA findings and the history of recalls caused by undeclared milk in dark chocolate products, including those labeled as dairy-free. The FDA plans to continue to research, evaluate, and monitor the issue, including targeted sampling of domestic and imported dark chocolate as warranted, and offers the following for the consideration of consumers and industry, respectively.
Consumers with milk allergy are advised that while this assignment found that about 90 percent of the dark chocolate products with dairy-free claims tested could be considered safe for milk allergic consumers, the levels detected in the other products were high enough to cause severe reactions among those most susceptible. Although the four products with potentially hazardous milk allergen levels detected under this assignment were recalled, consumers with milk allergy who choose to eat dairy-free chocolate may wish to contact the manufacturer(s) and inquire about how the product is made, including whether the product is made on equipment dedicated to making dairy-free dark chocolate, whether the ingredients used are free of milk, and whether the manufacturer(s) test their products with dairy-free claims for the presence of milk.
The follow-up inspectional findings from the FDA’s most recent assignment suggest that a contributing factor to the cross-contact may be the use of shared equipment in the making of milk chocolate and dark chocolate. Under the FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule, manufacturers of dark chocolate produced on shared equipment with milk chocolate are required to address allergen cross-contact through preventive controls and CGMPs to prevent or significantly minimize the potential for allergen cross-contact.
FDA inspections of dark chocolate manufacturers, both domestic and foreign, will continue to include reviewing a firm’s control measures to prevent or significantly minimize allergen cross-contact and could include the collection of samples for testing. The agency will take appropriate regulatory action when investigators find that a firm is not adequately controlling allergen cross-contact or when milk allergens are detected in dark chocolate products due to allergen cross-contact or other means. Adherence to the FDA’s preventive controls rule, as applicable, is critical to help protect consumers with milk allergy.
 This assignment centered on domestically manufactured products to facilitate follow-up inspections, if warranted. The FDA also routinely samples imported products, including dark chocolate. Violative shipments are refused entry into the United States. The FDA has implemented an Import Alert (IA #99-22) for foods containing undeclared major food allergens or foods that fail to properly label major food allergens. Firms and their products, including dark chocolate, listed under this import alert are subject to Detention Without Physical Examination.
 Malyukova, I.; Gendel, S.M. & Luccioli, S. 2012. “Milk is the Predominant Undeclared Allergen in U.S. Food Product Recalls.” Journal of Allergy and Clinical Immunology. Vol. 129, Issue 2, (Supplement, page 234).
 FDA Recall Enterprise System (Data Retrieval). “All Classified Recalls Due to Undeclared Allergens, FY2010 to FY2020 (present).” Retrieved: June 11, 2020.
 Gendel, S.M. & Zhu, J. 2013. “Analysis of U.S. Food and Drug Administration Food Allergen Recalls after Implementation of the Food Allergen Labeling and Consumer Protection Act.” Journal of Food Protection. Vol. 76, Issue 11, (pages 1,933 to 1,938).
 Gupta, R.S.; Warren, C.M.; Smith, B.M.; et al. 2019. “Prevalence and Severity of Food Allergies among U.S. Adults.” Journal of the American Medical Association. Vol. 2, Issue 1, e185630. doi:10.1001/jamanetworkopen.2018.5630
 Gupta, R.S.; Warren, C.M., Smith, B.M.; et al. 2018. “The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States.” Pediatrics. Vol. 144, (Supplement 1) S28; DOI: https://doi.org/10.1542/peds.2019-2461PP
 Claims similar to “dairy-free” include “milk free,” “100% milk free,” and “contains no milk.”
 Industry may use a voluntary “lactose-free” claim to refer to products without lactose. The agency’s FY18/19 assignment did not include foods bearing a lactose-free claim. Lactose-free products are intended for consumers with lactose intolerance; generally they are not suitable for people allergic to milk, since the absence of lactose does not mean the absence of milk allergens.
 A statement indicating the possible presence of an allergen not in the product’s ingredient list.