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Consumable Hemp Program - Labeling

Before a consumable hemp product is distributed or sold, the product must be labeled with the following information: 

  • Batch identification number/lot number.
  • Batch date/lot number.
  • Product name.
  • A uniform resource locator (URL) that provides or links to a certificate of analysis for the product or each hemp-derived ingredient of the product.
  • The name of the product's manufacturer.
  • A certification that the delta-9 tetrahydrocannabinol concentration of the product or each hemp-derived ingredient of the product is not more than 0.3 percent.
  • Telephone number of manufacturer.
  • Email address of manufacturer.

The label must appear on each product intended for individual retail sale. You can use a QR code but you must still have the URL on your label. The label requirements must appear on each product intended for individual retail sale.

Are there additional labeling requirements? 

Food consumable hemp products must also follow 21 Code of Federal Regulations (CFR) Part 201. Here is the link for further guidance: CFR - Code of Federal Regulations Title 21 (fda.gov)

All packaged food labels must include:

  • Common usual name of the product
  • Name and Address of Manufacturer
  • List of ingredients in descending order of predominance by net weight
    • Ingredient statements must be at 1/16 of an inch or larger
      • Ingredients must include components of the ingredients. {ie: Enriched Bleached Flour [wheat flour, malted barley flour, wheat starch, ferrous sulfate (iron), thiamine hydrochloride (vitamin B3), folic acid]}
      • The nine major food allergens {milk, eggs, type of fish (e.g., bass, flounder, cod, etc.), crustacean (e.g., crab, lobster, shrimp, etc.), tree nut (e.g., almonds, walnuts, pecans, etc.), peanuts, wheat, soybeans, sesame} must be declared using the common or usual name of the allergen. 
    • All certified colors must be identified in the ingredient statement.  {ie: FD&C yellow 5}
    • Preservatives must be followed with a statement of use. {i.e.: Calcium Proprionate (preservative)}
       
  • Net quantity of contents including metric measurements. The net quantity of contents must be separated from other text on the label and must be located in the bottom third of the label.
  • For beverages containing juice or that imply juice content, the percentage of juice must be declared on the information panel.

Complete information on food labeling can be found in the FDA Food Labeling Guide: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide.

Nonprescription drug consumable hemp products must also follow 21 Code of Federal Regulations Part 201 Labeling. Here is the link for further guidance: CFR - Code of Federal Regulations Title 21 (fda.gov)

Device consumable hemp products must also follow to 21 Code of Federal Regulations Part 801 Labeling: CFR - Code of Federal Regulations Title 21 (fda.gov).

Cosmetic consumable hemp products must also follow 21 Code of Federal Regulations Part 701 Labeling: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=701&showFR=1

Why do I have to declare allergens? 

The Food Allergen Labeling and Consumer Protection Act of 2004 identified eight major allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the ninth major food allergen recognized by the United States. Further information on food allergies can be found on FDA’s Food Allergies page, Food Allergies | FDA.

Complete information on food labeling can be found in the FDA Food Labeling Guide: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide.

Additional information

Allergens and Food Labeling - English (PDF)

Alérgenos y Etiquetas de Alimentos - Español (PDF)

Consumable Hemp Program

Consumable Hemp Program