FDA Testing of Dark Chocolate Products for Milk Allergens - Verifying the Absence Claims

Dark chocolate should be free from milk, especially when labeled as dairy free.  But can a person with milk allergies count on that?  FDA conducted analysis of 119 samples representing 52 products -  all products being manufactured in the U.S.  bearing a dairy-free or similar claim[ on their package or website, and consisting solely of dark chocolate (e.g., be free of cream or nougat filling, a candy shell, or inclusions such as nuts, fruit, or seeds).  Samples were collected from 2018 to 2019.

"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."

"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.  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."

https://www.fda.gov/food/sampling-protect-food-supply/fy1819-sample-collection-and-analysis-domestically-manufactured-dairy-free-dark-chocolate-products
FY18/19 Sample Collection and Analysis of Domestically Manufactured, Dairy-Free Dark Chocolate Products for Milk Allergen

Supplier Recall of Dark Chocolate for Undeclared Milk Allergen Triggers Customer Recalls

A number of recalls have been issued for dark chocolate products after the supplier, GKI foods, recalled the dark chocolate ingredient because it had undeclared milk.

GKI Foods LLC
Blue Marble, Roundy's Select, and HyVee

Dark Chocolate Products

CVS Gold Emblem, Ocean State Candy, Hannaford Excellent, Market Basket, & Weigels
New American Food Products, LLC
Dark Chocolate Products  

Aurora, AG Supermarkets, Belmont Market, and others
Aurora Products, Inc.
Dark Chocolate Products

Toothsome Chocolate Emporium
Rucker’s Makin’ Batch Candies, Inc.
Dark Chocolate Coffee Beans

Uncle Buck’s and Family Choice
Rucker’s Wholesale and Service Co
Dark Chocolate Peanuts

21st Century Snack Foods
21st Century Snack Foods
Dark Chocolate Almonds

Shoreline Fruit and Cherry Bay Orchards

Shoreline Fruit LLC

Dark Chocolate Covered Cherry Products

Wegmans, Alpine Valley, Circle K and others First Source

Dark Chocolate Products

Meijer
Meijer
Dark Chocolate Products

Figi
Dark Chocolate Gingersnaps


https://www.fda.gov/Safety/Recalls/ucm582769.htm
First Source Issues Allergy Alert for Undeclared Milk in Several Dark Chocolate Products Received from our Supplier GKI Foods LLC
For Immediate Release
October 30, 2017

Chocolate Products Recalled After a Positive Salmonella Result Found

A Pennsylvania firm is recalling chocolate products after one internal test result was positive for Salmonella.  There have been no illnesses reported.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519188.htm
Asher's Chocolates/Lewistown, Inc. Issues Voluntary Recall of Candy Products Because of Possible Health Risk
For Immediate Release
September 2, 2016

Nestle recalls Nesquick Chocolate Powder

Nestle is recalling Nesquick Chocolate Powder after the supplier of one the product’s ingredient issued a recall.  The ingredient, calcium carbonate, was being recalled due to the possible presence of Salmonella.  There have been no reports of illness.

 

Nestlé USA Announces Voluntary Recall of NESQUIK® Chocolate Powder

http://www.fda.gov/Safety/Recalls/ucm327533.htm

FOR IMMEDIATE RELEASE - November 8, 2012 - Nestlé USA announced the voluntary recall of limited quantities of Nestlé NESQUIK® Chocolate Powder in the 10.9, 21.8 and 40.7 ounce canisters. The voluntary recall is limited to only NESQUIK Chocolate Powder, which was distributed nationally. No other varieties of NESQUIK powder or any sizes or flavors of NESQUIK ready-to-drink are affected by this recall.

Nestlé is removing the canisters from distribution because the company was notified by an ingredient supplier, Omya Inc. that it has issued a recall of certain lots of its ingredient, calcium carbonate due to possible presence of Salmonella. Calcium carbonate is used in NESQUIK as an ingredient. There have been no reports of any illnesses or adverse health effects associated with the affected product.

To ensure the safety of consumers, Nestlé is recalling selected NESQUIK Chocolate Powder. The recall is limited to the following sizes, UPC and production codes of NESQUIK Chocolate Powder:

Size	UPC Code	Production Codes
40.7 oz. Chocolate (72 servings)	0 28000 68230 9	2282574810 2282574820
21.8 oz. Chocolate (38 servings)	0 28000 68090 9	2278574810 2278574820 2279574810 2279574820 2284574820 2284574830 2285574810 2285574820 2287574820 2289574810 2289574820
10.9 oz. Chocolate (19 servings)	0 28000 67990 3	2278574810

The affected NESQUIK Chocolate Powder was produced during early October, 2012. To locate the production code, consumers should look on the bottom of the canister, adjacent to the consumer expiration date. All affected products have an expiration date of BEST BEFORE Oct 2014.

Consumers who may have purchased the affected NESQUIK Chocolate Powder should not consume it, but instead should return it to the place of purchase for a full refund or contact Nestlé Consumer Services at (800) 628-7679.

The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating or drinking contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.

Nestlé is dedicated to the health and safety of its consumers. For these reasons, the company initiated this voluntary recall. We apologize to our consumers and sincerely regret any inconvenience created by this incident.