KAILUA-KONA — A recent state Department of Health directive on the legality of the manufacturing, distribution or sale of myriad cannabidiol (CBD) products in the state has resulted in a measure of public confusion.
DOH said in a release issued Wednesday that no CBD products can be processed, distributed or sold legally in Hawaii without a prescription. A primary point of confusion for some members of the public has been whether the source of the CBD might impact its legal status.
“Regardless of whether CBD is derived from hemp or cannabis, it is not approved for distribution or sale by the U.S. Food &Drug Administration or Hawaii state statutes,” Janice Okubo, DOH communications director, wrote in an email to West Hawaii Today on Friday. “The (2018) Farm Bill made hemp cultivation legal, but it retains the authority of the FDA over cannabis-derived products. Hemp is cannabis.”
Okubo delved deeper into the nuance that may be the cause of some confusion surrounding the issue.
“The 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act,” she wrote.
“FDA treats products containing cannabis or cannabis-derived compounds as any other FDA-regulated products — meaning they are subject to the same authorities and requirements as FDA-regulated products containing any other substance,” Okubo continued. “This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.”
DOH and FDA continue to hold the positions that CBD is potentially associated with health risks, that CBD is not an approved food, beverage, or cosmetic additive, and that CBD is not legal for sale even under the definition of a dietary supplement.
These prohibitions are linked to the fact that CBD is an active ingredient in an FDA-approved prescription drug, Okubo explained.
She also reminded the public that marketing CBD products with claims of specific health benefits “would constitute prohibited misbranding or false advertising.” Marketing concerns, however, will cease to be a problem if Hawaii proprietors follow the DOH directive and remove CBD products from their shelves and stands.
In its release, DOH warned that any establishment failing or refusing to comply with its orders “may be subject to the loss of their state food establishment permit and/or closure of their business by health inspectors.”
Up to this point, DOH has responded only to complaints on a case-by-case basis of businesses selling CBD products. The department didn’t outline specific types of pro-active enforcement it has planned moving forward, saying only in its release that “DOH inspectors will continue to respond to concerns…”
More info:
For additional information on state and federal requirements for products containing CBD and answers to basic questions go to https://health.hawaii.gov/food-drug.
Retailers selling products containing CBD, as well as members of the public with general inquiries, may contact DOH’s Food and Drug Branch at doh.fdbinfo@doh.hawaii.gov.
Permitted food establishments may contact DOH’s Sanitation Branch using information posted at https://health.hawaii.gov/san/contact-us.
Farmers or others in the agricultural industry may contact the Hawaii Department of Agriculture’s Industrial Hemp Pilot Program at hemp@hawaii.gov.
The FDA provides updates on the federal regulation of CBD products and answers to frequently asked questions at https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm.
