OAR 845-026-6070: Hemp Tincture and Capsule Labeling Requirements

Prior to selling, transferring, or delivering a hemp tincture or capsule to a consumer or retailer, the responsible party must label the container holding the tincture or capsule with the following information: (1) Manufacturer’s business or trade name, place of address and, if applicable, ODA hemp handler license number. (2) Business or trade name and place of address of the person that packaged the hemp item, if different from the manufacturer. (3) Product identity. (4) Batch number. (5) Date the product was made. (6) Net weight or volume in U.S. customary and metric units. (7) Serving size and number of servings per container. (8) Amount, in milligrams, of total THC and total CBD in each serving and in the container as reported by the laboratory that tested the batch. (9) If other cannabinoids are present, the amount in milligrams of cannabinoids in each serving and in the container as reported by the laboratory that tested the batch. (10) List of all ingredients in descending order of predominance by weight or volume used to process the hemp tincture or capsule. (11) Hemp symbol. (12) Activation time expressed in words or through a pictogram. (13) The address of a publicly accessible website that would enable a reasonable person to reliably locate the certificate of analysis for the specific batch of the hemp item in the container. (14) For hemp tinctures and capsules that are adult use cannabis items, the following statement or similar wording that expresses the same facts: “This product is not approved by the FDA to treat, cure, or prevent any disease.” (15) For hemp tinctures and capsules that are adult use cannabis items: (a) A warning that states: “For use only by adults 21 and older. Keep out of reach of children.” (b) Warnings that state the following or provide similar wording that expresses the same facts: (A) “This product is derived from hemp and may contain THC.” (B) “This product may impair the ability to drive or operate heavy machinery.” (C) “BE CAUTIOUS” in bold, capital letters, followed by “Hemp cannabinoid products can take up to 2 hours or more to take effect.” (D) “Do not consume during pregnancy or while breastfeeding.” (E) “Keep out of reach of pets.” (16) For hemp tinctures and capsules that are not adult use cannabis items, the following statements or similar wording that expresses the same facts: (a) “This product is not approved by the FDA to treat, cure, or prevent any disease.” (b) “Children or those who are pregnant or breastfeeding should avoid using the product prior to consulting with a health care professional about its safety.” (17) For hemp tinctures and capsules that are not adult use cannabis items, the following warning or similar wording that expresses the same facts: “This product contains cannabinoids. Keep out of reach of children and pets.”