FDA Revokes the Authorization for the Use of FD&C Red No. 3

 The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition.  FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.  Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. 

"The dye, linked in studies to hyperactivity in children and the potential to cause cancer, has already been banned in cosmetics but remains legal in food products." https://www.post-gazette.com/news/health/2025/01/05/red-dye-3-fda-food-coloring/stories/202412260101

An article in Food Safety magazine (LINK) provided this:

"FDA made its decision in response to a 2022 color additive petition filed by the Center for Science in the Public Interest, Consumer Reports, and 22 others, which cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of red dye 3 due to a rat-specific hormonal mechanism. Although FDA granted this petition, in its decision, FDA asserted that these studies are not necessarily relevant to human health; according to the agency, harmful exposure levels for male rats are much lower than for humans, and studies in humans and in other animals did not show carcinogenic effects. In a December 2024 Senate hearing, when asked why the agency still allows potentially harmful red dye 3 in food but not cosmetics, FDA Deputy Commissioner for Human Foods Jim Jones reiterated this position, explaining that the current scientific consensus is that the additive’s mode of carcinogenicity in animals is not applicable to humans."

"Regardless, beliefs that red dye 3 and other artificial food colorants are harmful to human health are widely held. In October 2024, Consumer Reports delivered another petition—with 80,000 signatures—urging the agency to ban red dye 3 in foods, citing, in addition to its potential carcinogenicity, that the dye is associated with hyperactivity and other neurobehavioral effects in children. A November letter from 23 Congress members also urging FDA to ban red dye 3 echoed the same concerns, and noted that the colorant is not allowed for food use by the EU, Australia, or New Zealand."

https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs
Constituent Update
January 15, 2025

California Establishment Recalls Taquito Products After Complaint for Metal Foreign Material

Bestway Sandwiches Inc., a Valencia, Calif. establishment, is recalling approximately 24,870 pounds of frozen chicken and cheese taquito products that may be contaminated with foreign material, specifically metal.  The problem was discovered after the firm notified FSIS that it received a consumer complaint reporting that a piece of metal was found in the frozen chicken and cheese taquito product. Another consumer reported to FSIS to have a dental injury from the product.

https://www.fsis.usda.gov/recalls-alerts/bestway-sandwiches-inc--recalls-frozen-chicken-and-cheese-taquito-products-due
Bestway Sandwiches Inc. Recalls Frozen Chicken And Cheese Taquito Products Due To Possible Foreign Matter Contamination

USDA Issues Public Health Alert for Mislabeled Chicken Empanadas Resulting in Undeclared Milk

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen product labeled as Chicken Curry Empanadas due to misbranding and an undeclared allergen. The product labeled as Chicken Curry Empanadas may actually contain Apple Cinnamon Empanadas, which contain milk, a known allergen, that is not declared on the product label.  A recall was not requested because the affected product is no longer available for purchase.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-chicken-empanada-products-due-misbranding-and
FSIS Issues Public Health Alert For Chicken Empanada Products Due To Misbranding And Undeclared Allergen

CA Firm Recalls BBQ Sauces for Undeclared Allergens

Monkey Spit, LLC, Nipomo, CA, is recalling its 12-ounce glass bottle of: 

• Monkey Mop BBQ Sauce - because it may contain undeclared milk. 
• Swamp Mob BBQ Sauce - because it may contain undeclared soy. 
• Atomic Mop BBQ Sauce - because it may contain undeclared milk and wheat. 

The recall was initiated after an FDA inspection. It was discovered that there were undeclared allergens not reveal on the product labels. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes.

This appears to be an issue related to label design where the person developing the label did not properly understand allergen labeling.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/monkey-spit-llc-issues-allergy-alert-undeclared-milkwheatsoy-monkey-spit-bbq-sauces
Monkey Spit, LLC Issues Allergy Alert on Undeclared Milk/Wheat/Soy in Monkey Spit BBQ Sauces
Summary
Company Announcement Date:  January 17, 2025
FDA Publish Date: January 17, 2025
Product Type:  Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared Milk, Soy, and Wheat
Company Name:  Monkey Spit, LLC.
Brand Name:  Monkey Spit
Product Description:  Barbecue sauces

Pancake Mix Recalled After Complaints for Undeclared Milk

The Quaker Oats Company today issued a recall of a limited number of two pound boxes of Pearl Milling Company Original Pancake & Waffle Mix that may contain undeclared milk, after being alerted by a retail partner. 

Pearl Milling was previously branded Aunt Jemima.  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/quaker-issues-limited-recall-undeclared-milk-pearl-milling-company-original-pancake-waffle-mix
Quaker Issues Limited Recall on Undeclared Milk in Pearl Milling Company Original Pancake & Waffle Mix Distributed in 11 States
Summary
Company Announcement Date:  January 14, 2025
FDA Publish Date: January 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  The Quaker Oats Company

Brand Name:  Pearl Milling Company
Product Description:  Pancake and Waffle Mix

Nutrition Bars Recalled for Undeclared Milk After 11 Suffer Allergic Reactions

Lifestyle Evolution Inc., based in Oakmont, PA is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk.  This is the same recall announced by customers selling these products, including Amazon, Costco Wegmans, Giant Eagle, on December2, 2024 and not an expansion or different recall.  The recall was initiated after the firm received 11 consumer reports of allergic reaction experienced after consuming the product. As part of the firm’s ongoing investigation, the product was tested and found to contain milk, which is not indicated on the packaging. The firm’s investigation is ongoing

There is a precautionary statement that does include milk, but this of course will not prevent a recall.    Evidently, 11 people with allergies to milk still purchased and ate this product.



https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lifestyle-evolution-voluntarily-recalls-nugo-dark-chocolate-chip-and-nugo-dark-pretzel-due
Lifestyle Evolution Voluntarily Recalls NuGo Dark Chocolate Chip and NuGo Dark Pretzel Due to Undeclared Milk
Summary
Company Announcement Date:  January 10, 2025
FDA Publish Date:  January 10, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Lifestyle Evolution Inc.
Brand Name:  NuGo
Product Description:  NuGo Dark Chocolate Chip Nutrition Bar and NuGo Dark Pretzel Chocolate Nutrition Bar

California Ice Cream Company Recalls Sorbet for Undeclared Egg

The Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white.  The recall was initiated after it was discovered that product containing (pasteurized egg white) was distributed in packaging that did not reveal the presence of (the egg white). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes.  

There have been 2 reports of minor allergic response reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mochi-ice-cream-company-llc-issues-allergy-alert-undeclared-egg-peach-mango-sorbet
The Mochi Ice Cream Company LLC Issues Allergy Alert on Undeclared Egg in Peach Mango Sorbet
Summary
Company Announcement Date:  January 09, 2025
FDA Publish Date:  January 10, 2025
Product Type: Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  My Mochi Ice Cream Company LLC
Brand Name:  My Mochi
Product Description:  My Mochi Peach Mango Sorbet

Missouri Retail Operations Recalls Mashed Potato Product for Undeclared Wheat

Dierbergs, a retail operations based in Chesterfield, Missouri, is recalling all 16oz Premium Home-Style Mashed Potatoes with a Sell By Date of January 09, 2025. The product carries an undeclared allergen of Wheat.  This is a print-and-apply label and so information was not properly captured / input into the print system.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dierbregs-markets-issues-allergy-alert-undeclared-wheat-product

Dierbregs Markets Issues Allergy Alert on Undeclared Wheat in Product
Summary
Company Announcement Date:  January 03, 2025
FDA Publish Date:  January 07, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Dierbergs Markets
Brand Name:  Dierbergs Kitchen
Product Description:  Premium Home-Style Mashed Potatoes

Coconut No Longer Considered an Allergen Requiring Labeling and Other Items from Allergen Guidance

In FDA's guidance release, Q&A document - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) that was released in early January (Link), FDA stated the nut allergens requiring labeling. Coconut, along with some other nut types, are not listed and with that, do not requiring allergen labeling.

We reached out to FDA and they provided this:

• Coconut is no longer considered a major food allergen: Coconut has been removed from the “tree nut list” (see Appendix 1, which is also at the end of this email) and is no longer considered a tree nut for allergen labeling purposes. This determination was made after a scientific evaluation was conducted using the scientific criteria outlined in FDA’s allergen framework guidance 

• Other changes to the tree nut list: [FDA] conducted a scientific review of tree nuts to determine if they are allergens of public health significance. [FDA] clarified that only the tree nuts listed in Appendix 1 are considered major food allergens. Other tree nuts not listed in the table should not be included in the “Contains” statement, even if they are used as ingredient, because the “Contains” statement is reserved for major food allergens. In addition to the removal of coconut, beech nut; butternut; chestnut; chinquapin; cola/kola nut; ginkgo nut; hickory nut; palm nut; pili nut; and shea nut were removed from the “tree nut list.”

• FDA expanded interpretation of "milk” as a major food allergen to include milk from goats, sheep, and other ruminants for food allergen labeling purposes. Milk from ruminant animals other than cows, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “goat milk”. For food allergen labeling purposes, milk and milk ingredient from animals other than cows, should also include the name of the animal source, such as “goat milk” and “whey (goat milk)” in the ingredient list or “Contains goat milk” in a separate Contains statement, or both.

• FDA expanded the definition of eggs to include eggs from ducks, quail and other fowl for food allergen labeling purposes. Eggs from birds other than chickens, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “duck egg”. For food allergen labeling purposes, egg and egg ingredients from birds other than chickens, should also include the name of the bird source, such as “duck egg” and “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate Contains statement, or both.

• Additional Information:

o  “Allergen-free” claims should not be accompanied by allergen advisory statements because this would be confusing for consumers, for example, “milk-free” and “may contain milk” should not appear on the same product label and labeling.

o Allergen declaration in an ingredients list or in a “Contains” statement should not also be accompanied by an allergen advisory statement for the same allergen, for example, “Contains milk” and “may contain milk”.

o FDA cannot change the list of major food allergens. Federal law defines “major food allergens,” but the law does not restrict our authority to require labeling for other food allergens by regulation.