2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
Children and Pregnant/Lactating Women
Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.
The day the Farm Bill was signed into law, the US Food and Drug Administration (FDA) released a statement clarifying that Congress had “explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
None of these products have been proven to be safe or effective. The FDA has the power to give CBD the green light and the agency is currently considering whether to do that. They held a public hearing on May 31, 2019, and opened a docket for public comment through July 16, 2019.
What federal law says about CBD
Because CBD is also an approved prescription drug (Epidiolex), the FDA still considers CBD a drug ingredient, which means it cannot be marketed and sold as a dietary supplement with therapeutic properties (or even shipped across state lines) without first going through the FDA’s drug approval process — regardless of whether the products are derived from hemp.
If a manufacturer doesn’t have this information or isn’t willing to share it, avoid their products. Not only could you be technically breaking the law by buying it, but research also shows that it’s common for CBD products to be mislabeled, meaning they could be getting more THC than you bargained for or too little CBD to make the product effective.
What state laws say about CBD
With federal and local cannabis regulations still being worked out, finding CBD products that have the lowest legal risk requires a bit of leg work. Experts recommend being diligent about checking product labels and manufacturers’ websites for any product to understand.