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  4. Sampling to Protect the Food Supply
  5. Dairy-Free Chocolate Products and Milk Allergens
  1. Sampling to Protect the Food Supply

Dairy-Free Chocolate Products and Milk Allergens

The U.S. Food and Drug Administration (FDA) and state partners have conducted multiple field activities to collect and test dark chocolate bars, dark chocolate chips, and other chocolate-containing products labeled as “dairy free” (or with similar free-of-milk claims) to identify and remove from the U.S. market any that errantly claimed the absence of milk.

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.[1], [2], [3] Milk also has been observed to be the leading cause of consumer adverse reactions to foods recalled because of undeclared allergens,[4] 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.[5], [6] 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.

Using the Data

The agency monitors dark chocolate and chocolate-containing products labeled as “dairy-free” for the presence of milk because it can cause serious health consequences to consumers with milk allergy.

Depending on the findings of its surveillance sampling, the FDA may take action as follows:

  • Implement more targeted sampling if trends are identified; for example, if positive samples come from a specific geographic region, a specific facility, or during a particular season;
  • Conduct follow-up inspections;
  • Work with state or international regulatory partners to take corrective actions and implement preventive controls;
  • Develop new or enhanced industry guidance; and
  • Conduct outreach and information sharing to better protect consumers.

Reports:

Endnotes:

[1] Sharma, G.M., Ma, Y., Luccioli, S. 2023. “Recalls Associated with Food Allergens and Gluten in FDA-Regulated Foods from Fiscal Years 2013 to 2019.” Journal of Food Protection. Vol. 86, Issue 4,

[2] 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).

[3] FDA Recall Enterprise System (Data Retrieval). “All Classified Recalls Due to Undeclared Allergens, FY2010 to FY2020 (present).” Retrieved: June 11, 2020.

[4] 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).

[5] 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

[6] 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: The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States

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