Treatment with CBD
Cannabis regulation is laws and regulations about the production and marketing of cannabis and cannabis-derived products. These include, among others:
Since 1970, cannabis is controlled as the drug class “Marihuana” (marijuana) as Schedule I under the Controlled Substances Act (CSA) due to its abuse potential because of the psychoactive effects of THC.
CBD is Schedule I, except for the medication Epidiolex, which the FDA rescheduled as Schedule V.
The 2018 Farm Bill (the Agriculture Improvement Act of 2018, Pub. L. 115-334) makes a distinct difference between marijuana and hemp.
Consequently, the 2018 Farm Bill removed hemp from the list of scheduled substances.
Nonetheless, the 2018 Farm Bill explicitly authorizes the FDA to regulate cannabis and products that contain compounds derived from cannabis under the Public Health Service Act. As such, cannabis and cannabis-based products are subjects to FDA authorities, requirements and regulations, regardless of their classification as hemp under the 2018 Farm Bill.
Whether it is legal or illegal to sell CBD products depends on the intended use and the labeling of the product. Even if the CBD product is “hemp” according to the 2018 Farm Bill, it still must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws.
Several states have passed laws to enable the medical use of cannabis and its derivatives. Additionally, several other states are considering passing such laws in the future. Such laws bypass FDA regulation and allow the use of marijuana and CBD for medical conditions, subject to a prescription by a physician.
It is illegal to sell food (human or animal) that contain THC or CBD in interstate commerce.
Foods that are made from cannabis but do not contain THC or CBD might be sold in interstate commerce.
Any ingredient added to food requires FDA approval as a food additive. As such, qualified experts have to recognize this ingredient as “generally recognized as safe” (GRAS).
For information on importing and exporting cannabis-derived products and foods, please consult:
It is illegal to market CBD products as dietary supplements. It is because according to the FD&C Act, CBD products are not dietary supplements for these reasons:
Products that are derived from cannabis but do not contain THC or CBD might be marketed as dietary supplements.
Some firms though might market CBD products claiming to treat diseases and have therapeutic uses. Such claims are illegal and unfounded. Adding CBD to food or selling cannabis-related products as dietary supplements are violations of the FD&C Act.
The FDA first issues warning letters to them to discontinue using these claims. If the recipients of such letters take no action, the FDA initiates legal action against them.
“It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” “Failure to promptly correct violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.”
“GRAS” is an acronym for Generally Recognized As Safe. Federal Food, Drug, and Cosmetic Act (FD&CA) calls a food additive anything added to food. As such, the FDA has to review and approve all food additives, unless they are already GRAS.
There are no cannabinoids inside the cannabis seeds. Therefore, of all cannabis products, the FDA considers only three hemp seed-derived food ingredients as generally safe (GRAS) for human consumption:
In essence, these three hemp seed-derived products can be legally added to and marketed in human foods, but only:
On the other hand, pet food or animal feed in the United States may not contain either whole cannabis or hemp, or cannabis or hemp products, because:
If the manufacturing of foods containing hemp follows the legal requirements and FDA specifications, then GRAS conclusions apply to them. Indeed, hemp and hemp products can be a source of:
As such, hemp can be an ingredient in:
However, products that contain hemp must declare them by name and spell them out in the list of ingredients.
Hemp contains only miniscule amounts of THC and CBD (remember: 0.3% dry weight benchmark for cannabis vs. hemp). As such, hemp products will not make you high.
Additionally, as we said before, there are no cannabinoids inside the cannabis seeds. Makers of seed-derived foods, therefore, must follow good manufacturing practices to avoid contamination of the seeds with the rest of the plant that may contain cannabinoids, such as THC.
Information on food containing THC and CBD is available here.
The FD&C Act, sec. 201(i) defines cosmetics as articles that are not soap and are intended:
If a product has the purpose of affecting the body’s function or structure; or to prevent, diagnose, or treat a disease, then is the FDA considers it a drug, even if it is both a cosmetic and a drug. In that case, FDA requires approval to be produced and marketed.
Regulations do not restrict or prohibit cosmetics with cannabis or cannabis-derived ingredients.