Food System

FDA, Milk Allergen Test in US Chocolate

September 18, 2024

The Food and Drug Administration (FDA) conducted an initiative to test for the presence of the milk allergen in 210 samples of dark chocolate and products containing chocolate, labeled as ‘dairy free’ or ‘milk free’. (1)

Table of Contents

1) Milk, the most common undeclared allergen in the US

The milk is the most common undeclared food allergen, responsible for 43% of all food recalls due to undeclared allergens in the US from 2000 to 2010.

Followed by the eggs (21%), dried fruit with shell (18%) and wheat (17%). Allergens not declared on the label led to 302 recalls, in the period indicated, equal to 31% of the total. (2)

Milk allergy, moreover, according to two studies conducted in 2015-2016 (Gupta et al., 2019) based on over 40.443 interviews, it affects approximately 2% of the population in the United States (3,4).

2) FDA, milk allergen test in chocolate on sale on US market

FDA has therefore dedicated specific food safety monitoring initiatives to research on the milk allergen, focusing on dark chocolate and products containing chocolate.

Monitoring for the presence of milk allergens in chocolate and products containing has been the subject of three FDA monitoring initiatives in the last ten years.

2.1) Dark chocolate test, 2013-2014

The first monitoring of the FDA, in 2013-2014, concerned a total of 94 packages of dark chocolate. The products were divided into categories, based on the information reported on the label.

2 out of 14 products with indications ‘dairy-free’and’lactose free‘ and no PAL (Precautionary Allergens Labeling) on the label had detectable levels of milk between 1.100 ppm and 1.900 ppm. (5)

2.2) Dark chocolate test, 2018-2019

The second monitoring was conducted by FDA in 2018-2019 on 119 representative samples of 52 dark chocolate references (bars and flakes) produced in the USA, all labeled as ‘dairy free‘.

5 out of 52 products subjected to analysis, they showed contamination by milk allergen at various dangerous levels (from 600 ppm to 3.100 ppm for four products, 90 ppm for the fifth).

The contaminations were attributed both to suppliers of raw materials and to inappropriate management of equipment in factories where milk was also used for other product lines. (6)

2.3) Testing of dark chocolate and other chocolate products, 2022-2023

The third FDA monitoring involved 210 samples of dark chocolate and products containing it – chocolate chip cookies, chocolate syrups and chocolate cake mixes – labeled as ‘dairy free’and’milk free’.

The samples were collected at the market and subjected to analysis at the Pennsylvania Department of Agriculture (PDA) and the Michigan State Department of Agriculture and Rural Development (MDARD).

13 out of 210 samples tested positive for milk. 1.083 ppm of allergen in only one case, less than 80 ppm in the other twelve. All labels contained ‘allergens advisory statements’, such as ‘produced in a factory that also processes milk’.

3) FDA, poor protection for allergy sufferers

The unfortunate press release of the FDA dated September 17, 2024 reports the following:

– ‘FDA does not define the terms “dairy-free” or “milk-free.” Such claims are voluntary and, when used, must be truthful and not misleading‘. And yet,

– ‘allergic consumers to milk, who choose to consume dark chocolate or dairy-free chocolate products can contact the producers and find out about the production methods, to find out if the product is made with equipment dedicated to the production of dairy-free chocolate, if the ingredients used are dairy-free and if the manufacturer tests its products with “dairy-free” indications to verify the presence of milk‘. In any case,

– ‘The agency will continue to monitor dark chocolate and chocolate products labeled “dairy-free” for the presence of milk, which can cause serious health consequences for consumers with milk allergies‘. (1)

4) Food allergies, the essential solutions

Public health risks associated with the consumption of foods with undeclared allergens can and must be relegated to the past, once and for all, in the USA as in the EU and in the rest of the world.

Food business operators must provide accurate information, which should be always and in any case mandatory even in the sole case of the possible presence of allergens (‘contains and may contain‘). (7)

And above all VITAL® – the risk analysis system already recognized by FAO and WHO as suitable for protecting the health of the most sensitive allergic consumers (8) – must be recognized in all jurisdictions as the basis for organizing self-control, labelling and official control procedures.

Dario Dongo

Footnotes

(1) FDA Releases Results of Sampling of Retail Dairy-Free Dark Chocolate and Chocolate-Containing Products for Milk Allergen. Press release. 17.9.24 https://tinyurl.com/3h76j6cw

(2) Malyukova, I.; Gendel, S. M. & Luccioli, S. (2012). Milk Is The Predominant Undeclared Allergen In Us Food Product Recalls. Journal of Allergy and Clinical Immunology. Vol. 129, Issue 2, (Supplement, page 234). doi: DOI: 10.1016/j.jaci.2011.12.160

(3) Gupta, R.S.; Warren, C.M.; Smith, B.M.; et al. (2019). Prevalence and Severity of Food Allergies Among US Adults. Journal of the American Medical Association. Vol. 2, Issue 1, e185630. doi:10.1001/jamanetworkopen.2018.5630

(4) Gupta, R.S.; Warren, C.M.; Smith, B.M.; et al. (2019). The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics 144 (Supplement_1): S28. https://doi.org/10.1542/peds.2019-2461PP

(5) Survey of Milk in Dark Chocolate Products (2014). FDA https://tinyurl.com/6dyzttje

(6) FY18/19 Sample Collection and Analysis of Domestically Manufactured, Dairy-Free Dark Chocolate Products for Milk Allergen. FDA https://tinyurl.com/mse8jwnt

(7) Dario Dongo. Food allergies and PAL, Codex Alimentarius. GIFT (Great Italian Food Trade).

(8) Dario Dongo. Allergen risk analysis. FAO, WHO and ILSI confirm Vital 3.0. GIFT (Great Italian Food Trade).

(9) Dario Dongo. Allergens and RASFF, European blackout. GIFT (Great Italian Food Trade).