18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
22. What does the FDA think about making CBD available to children with epilepsy?
10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
Research and Expanded Access
14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.
Questions and Answers
 Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
Our friends at Ananda Hemp shared this excellent article to provide some insight into labeling requirements for hemp and CBD products!
GETTING TO KNOW CANNABIDIOL (CBD)
CBD is the second most common ingredient of cannabis. It is derived from the hemp plant, which is considered to be the cousin of the marijuana plant since they are the same species. Although CBD is a component of marijuana it does not produce the “high” that is associated with it. It is said that there are a wide range of health benefits related to CBD. However, the one that has the most potent evidence would be its effectiveness in treating two rare and severe forms of epilepsy. The only FDA approved medical product that contains cannabis is Epidiolex. Cannabidiol is the active ingredient in Epidiolex, the only pharmaceutical drug containing CBD that has been approved by the FDA. It is a prescription drug used to help treat seizures related to the Lennox-Gastaut Syndrome and Dravet Syndrome, two rare and severe forms of epilepsy.
WHAT ARE THE DIFFERENCES BETWEEN HEMP CBD AND CANNABIS CBD?
One of the frequently asked questions about this topic would be about the differences between hemp derived cannabidiol and cannabis CBD. In order to gain a better understanding, this article will also help clarify information about these two. The 2018 Farm Bill defines hemp as the plant Cannabis Sativa L. that contains less than 0.3% THC or the CBD cannabinoid component. THC is known to be the component that produces the “high” as a result of marijuana use. The enactment of this bill also removes hemp, from the Controlled Substances Act under federal law. On the other hand, Cannabis plants have three varieties which are Cannabis Indica, Cannabis Sativa, and Cannabis Ruderalis. These plants contain significantly higher levels of THC as compared to hemp plants and contain less cannabidiol. Basically, hemp CBD contains more CBD and less THC, while cannabis CBD contains more THC and less CBD. Other products including CBD include oils, tablets, softgels, topical salve, lotion, massage oil, etc. The marketing and sale of these products are legal in the United States but with different restrictions per state and from the FDA.
Aside from this, FDA has its general guidelines for all products it regulates. This is definitely the safest way to ensure your CBD product labeling and packaging adhere to FDA guidelines.
Due to the minimal information available about the FDA’s regulations, most CBD companies are struggling to adhere to the packaging and labeling guidelines. CBD products are often mislabeled; they may contain either significantly more or less CBD than indicated. This is a concern as it may be a threat to customer safety. A CBD product with more than 0.3% THC (delta-9-tetrahydrocannabinol – the main intoxicating ingredient in cannabis) is considered to be over the accepted amount according to FDA guidelines. Bodies respond to CBD differently, so consumers must be well-informed about the product they will be using. This is the reason why CBD packaging and labels are very important before the FDA can consider a product permissible in the CBD market. Besides, you wouldn’t want the FDA to send you letters regarding all these while your CBD business is up and running.
Best Practices to Adhere to FDA Labeling Guidelines for CBD Products
According to the Code of Federal Regulations Title 21 of the FDA, these are the requirements in holding components, dietary supplements, product packaging, and labels:
CBD labels must include:
Tackling Basic FDA Packaging and Labeling Guidelines for CBD
The type of packaging your CBD products require may vary by state, so it is best to check state regulations regarding this as well.