The increasing number of cannabis-derived products (including those products derived from hemp), especially cannabidiol (better known as “CBD”), that are being distributed and sold, are generating concerns with the public health community about product safety and drug interactions, truth-in-labeling, false health claims, and quality control. Hawaii law prohibits adding any cannabis-derived substances to food, beverages or cosmetics for manufacture, distribution or sale. The U.S. Food and Drug Administration (FDA) has not approved the use of CBD in over-the-counter products and does not consider these products safe.
Hawaii statutes are aligned with the FDA’s standards to protect the health of Hawaii residents, and support Hawaii Department of Health (DOH) policies that restrict the distribution of products not approved by the FDA.
- Products containing CBD are not generally considered safe and there may be potential health risks associated with them.
- It is illegal to add CBD to food, beverages and cosmetics that are manufactured, distributed and sold in Hawaii.
- CBD may not be sold as a “dietary supplement.”
- CBD may not be marketed by asserting health claims because that would constitute prohibited misbranding or false advertising.
- CBD is the active ingredient in an FDA-approved prescription drug. Therefore, it cannot be put into food, beverages and cosmetics, sold as a drug without a prescription, or marketed as a “dietary supplement.”
Food and Drug Administration consumer update, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” March 5, 2020: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis?utm_campaign=What%20You%20Need%20to%20Know%20About%20Products%20Containing%20CBD&utm_medium=email&utm_source=Eloqua
Food and Drug Administration statement, “Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds,” December 20, 2018:
Food and Drug Administration statement, “Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products,” April 2, 2019: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635048.htm
Hawaii Revised Statutes, Chapter 328:
Hawaii Administrative Rules, Chapter 11-50: https://health.hawaii.gov/san/files/2017/09/HAR-11-50-amended-9.1.2017.pdf
Centers for Disease Control and Prevention – Synthetic Cannabinoids: An Overview for Healthcare Providers: https://www.cdc.gov/nceh/hsb/chemicals/sc/healthcare.html#one
Centers for Disease Control and Prevention: Horth RZ, Crouch B, Horowitz BZ, et al. Notes from the Field: Acute Poisonings from a Synthetic Cannabinoid Sold as Cannabidiol — Utah, 2017–2018. MMWR Morb Mortal Wkly Rep 2018;67:587–588. DOI: http://dx.doi.org/10.15585/mmwr.mm6720a5
Food and Drug Administration press announcement, “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity,” March 5, 2020: https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market
FDA and Cannabis: Research and Drug Approval Process, January 14, 2020: https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
FDA Regulation of Dietary Supplement and Conventional Food Products Cannibis and Cannibis Derived Compounds: https://www.fda.gov/media/131878/download
What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding from FDA: https://www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding
FDA Highlights on Epidiolex: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf
Journal of Clinical Pharmacology: White, C. (2019). A Review of Human Studies Assessing Cannabidiols (CBD) Therapeutic Actions and Potential. The Journal of Clinical Pharmacology. doi:10.1002/jcph.1387: https://accp1.onlinelibrary.wiley.com/doi/abs/10.1002/jcph.1387