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Allergen Statement is Required




In chocolate, more cocoa means higher antioxidant capacity. Chocolate and cocoa powder are derived from cocoa beans that contain hefty quantities of natural antioxidants called flavonoids. Researchers found natural cocoa contains the highest capacity of the antioxidant procyanidin. Antioxidants are thought to be effective in helping to prevent cancer, heart disease, and stroke.

However, if you’re allergic to milk and you love dark chocolate, how do you know whether you can indulge in a dark chocolate bar without having an allergic reaction?


Food allergic reactions vary in severity from mild symptoms involving hives and lip swelling to severe, life-threatening symptoms, often called anaphylaxis, that may involve fatal respiratory problems and shock.

The FDA conducts inspections and sampling to check that major food allergens are properly labeled on products and to determine whether food facilities implement controls to prevent allergen cross-contact (the inadvertent introduction of a major food allergen into a product) and labeling controls to prevent undeclared allergens during manufacturing and packaging.

Furthermore, the agency works with firms to recall products, and provide public notification to immediately alert consumers. In addition, the FDA has the authority to seize and remove violative products from the marketplace or refuse entry of imported.

Milk is a permitted ingredient in dark chocolate, but it is also one of eight major food allergens (substances that can cause reactions that are sometimes dangerous).

U.S. law requires manufacturers to label food products that are major allergens, as well as food products that contain major allergenic ingredients or proteins.

The nine major food allergens are

  • milk
  • eggs
  • fish
  • crustacean shellfish
  • tree nuts
  • peanuts
  • wheat
  • soybeans
  • sesame

Chocolates are one of the most common sources of undeclared milk associated with allergic reactions.

Milk can get into a dark chocolate product even when it is not intentionally added as an ingredient, because most dark chocolate is produced on equipment that is also used to produce milk chocolate.

To help ensure this, the Food Allergen Labelling and Consumer Protection Act (FALCPA) was passed in the U.S. in 2004. On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the United States effective on January 1, 2023.

Milk may either be included in the ingredient list or in a statement such as “Contains milk.”

Allergen statements such as “May contain milk,” or “Manufactured on equipment that processes products containing milk,” suggest there may be milk present.

Advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.

The manufacturer’s, packer or distributer’s name, address and a contact telephone number must be on the packaging.


Labeling of a food product is deemed to be misleading if it fails to reveal material facts.

  • Unlike drugs, supplements or conventional foods are not intended to treat, diagnose, prevent, or cure diseases.
  • The Nutrition Facts label is required on most packaged conventional foods and beverages.
  • Allergen Statement is required.

The main ingredients in dark chocolate are cocoa and related products.