Department of Environmental Health Public Health Inspections 200 W. 14th Ave., Suite 200 Denver, CO 80204-2732 Phone: 720-865-5401 Fax: 720-865-5532 www.denvergov.org/phi Information Regarding Cannabidiol (CBD) Products Sold or Manufactured in Denver In recent months, Denver has seen an increase in the sale of cannabidiol (CBD) products intended for human consumption. As the local health authority, the Denver Department of Environmental Health (DEH) is responsible for addressing potential consumer safety concerns relating to products sold or served in Denver. Some of the CBD products being sold in Denver are manufactured outside the oversight of any regulatory agency. In Denver, manufacturers of ingested or inhaled CBD products are subject to Denver regulations (Chapter 23 D.R.M.C., §24-16 through 24-18, D.R.M.C.) and DEH inspection. All CBD products and additives in these products that are sold in Denver must meet safe manufacturing standards, come from an approved source, and comply with all relevant laws. The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the introduction or delivery for introduction into interstate commerce of any new drug that has not been approved by the Food and Drug Administration (FDA). To date, FDA has not approved any drug product containing CBD. In addition, FDA has concluded that CBD products are excluded from the definition of a dietary supplement in the FD&C Act. Furthermore, under the FD&C Act, it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added. It has come to DEH's attention that some CBD products originate from unregulated manufacturing facilities, have been illegally shipped across state lines, contain unapproved ingredients, or have been made in unsafe manufacturing conditions. When DEH encounters these products, retailers and manufacturers may be subject to DEH enforcement and requests for additional information to demonstrate that the product was manufactured safely. Examples of information that may be required by DEH include: • • • • • • • Manufacturer name and address Manufacturer proof of license, registration, inspection, or review of processing from a state or local Colorado authority SOPs for the production of the subject product(s) List of all ingredients and/or additives used for production and information to substantiate their safe source Product labeling Quality control procedures for verifying the product formulation and absence of contaminants such as pesticides Additional information as needed Potential concerns with some CBD products that have been identified include CBD ingredients originating from other countries, improper labeling to communicate intended use of products, unsubstantiated health claims on labels of CBD products, and potentially unsafe manufacturing conditions such as no hand washing equipment or inadequate sanitation procedures. Retailers and manufacturers of CBD products are encouraged to contact DEH at phicomments@denvergov.org with any questions. G:\All Shared\Communications\Meghan's Files\Public Health Inspections\CBDdocument.docx