With the enactment of the Agricultural Improvement Act of 2018, the federal government removed industrial hemp, as well as its derivatives, extracts, and cannabinoids, from the definition of marijuana. It will now be lawful to grow and process industrial hemp as long as it and any resulting products do not contain more than 0.3 percent delta-9 tetrahydrocannabinol (THC). Industrial hemp contains a number of cannabinoids, chemical compounds that act on receptors affecting such things as appetite, learning, memory, anxiety, depression, and pain. One of the most widely known cannabinoids is cannabidiol or CBD.
Over the past few years, CBD has risen in popularity and can be found for sale at pharmacies, vape and smoke shops, yoga studios, gas stations, standalone dispensaries, coffee shops, and online. Retailers often tout its therapeutic use for a myriad of conditions including inflammation, chronic pain, arthritis, anxiety, depression, post-traumatic stress disorder, neurological disorders, nausea, and even diabetes and cancer. However, limited research shows that CBD has the potential to impact anxiety disorders and only at dosage levels that are higher than those currently offered by retailers. Consumers can find CBD in a variety of forms, including oil-based tinctures, flavored water-soluble drops, topicals, and vaping liquids. CBD is also being added to foods, beverages, cosmetics, and pet treats. For example, a northwest Indiana news outlet found “CBD being sold in lattes, smoothies, bruschetta, bath bombs, coconut oil, popcorn at bridal shows and in many other forms.”
The new federal law allows a state to develop and submit a plan to the U.S. Department of Agriculture for the state’s regulation of industrial hemp production. The state plan must include a mechanism for testing the hemp’s THC level to ensure it remains at or below the 0.3 percent threshold. The law also leaves in place the authority of FDA over foods, beverages, and cosmetics containing hemp-derived CBD. Shortly after the law’s enactment, FDA reiterated its stance that CBD is an impermissible additive that adulterates food. However, in late February, FDA Commissioner Scott Gottlieb announced that the agency would hold a public hearing in April 2019 and work toward new rules on the issue of foods containing CBD. In the meantime, many states face a regulatory gap when it comes to the testing and monitoring CBD products. Some states, however, have begun to expand oversight of CBD products.
Last year, Indiana enacted a new law allowing the distribution and sale of low-THC hemp extracts—that is, a compound or substance derived from hemp (e.g. CBD) that contains no more than 0.3. percent THC. The law also sets out packaging requirements for low-THC hemp extracts including a scannable bar code or QR code linked to a document containing manufacturing information, the batch number, an internet address for a website to obtain batch information, the expiration date, the number of milligrams of low-THC hemp extract, the manufacturer, and a statement of fact that the product does not contain more than 0.3 percent THC.
In Utah, new agency rules for the registration, labeling, analysis, testing, and inspection of products containing hemp derivatives such as CBD. Under the rules, all industrial hemp products are to be registered annually with the Utah Department of Agriculture and Food (UADF). Each product must also have a certificate of analysis showing test results for the percentage of cannabinoids, solvents, pesticides, microbials, and heavy metals. The label for any product containing hemp-derived CBD is to have a scannable bar code, QR code, or web address that links to information about the product’s batch identification number, product name, batch date, expiration date, batch size, production quantity, and link to the batch’s certificate of analysis. The rules also make clear that the label may not contain any medical claim. Finally, the new rules give the UDAF authority to periodically inspect, sample, test, and analyze any hemp-derived product distributed in the state.
While Indiana and Utah appear to be the only states so far to require the labeling and monitoring of CBD products, a few other states are considering legislation for the regulation of CBD products this year. In both Florida (HB 333 and SB 1058) and Oklahoma (SB 238) there are bills to establish labelling requirements for CBD and hemp extracts. Florida’s proposals are similar to the requirements in place in Indiana and Utah, whereas Oklahoma would require a label that at minimum requires the CBD’s country of origin and whether the CBD is synthetic or natural. In New Mexico, a bill (HB 581) would require anyone manufacturing a hemp-derived product such as CBD to be licensed by the state.
It is clear many states are working to develop regulatory oversight that informs and protects the public. As state and territorial health departments and their partner agencies seek adequate and reasonable oversight of CBD products.
SOURCE: ASTHO (Association of State and Territorial Health Officials)