One would assume, then, that hemp-derived CBD should be federally legal in every state because the THC levels don’t surpass 0.3%. But CBD occupies a legal gray area. Several states, such as Nebraska and Idaho, still essentially regulate CBD oil as a Schedule 1 substance akin to marijuana.
Consumers concerned about content and the accuracy of CBD products, which are not regulated by the Food and Drug Administration, can look for certification from independent lab testing or by scanning a QR code on product packaging.
“Broad spectrum” CBD typically contains at least three other cannabinoids, as well as some terpenes and flavonoids – but still no THC. “Full spectrum” CBD, also called “whole flower” CBD, is similar to broad spectrum but can contain up to 0.3% THC.
Brandon McFadden receives funding from U.S. Department of Agriculture.
The Conversation UK receives funding from these organisations
Both hemp and marijuana belong to the same species, Cannabis sativa, and the two plants look somewhat similar. However, substantial variation can exist within a species. After all, great Danes and chihuahuas are both dogs, but they have obvious differences.
Hemp, marijuana and CBD are all related, but they differ in significant ways. Here’s what you need to know about their legality, effects and potential health benefits.
“It’s a mixture of CBD, cannabidiol, THC, and the phytochemicals, the terpenoids,” Grinspoon tells High Times. “You need all three of them to get the best therapeutic effect.” For this reason, Grinspoon, Lin, and many others say that the best source for therapeutic CBD is a plant with all of its cannabinoids intact.
“CBD can be used to relieve multiple symptoms,” says Lin. “But you need to know what you are getting.”
With these sorts of benefits, it’s little wonder that there’s a booming market for CBD—and readily willing suppliers promising miraculous results.
How CBD works
Recently, at the end of a surf trip with several friends, my pal Tim passed me a pipe packed with sticky green buds. I’m not much of a social smoker (more of a one-hitter-before-chores type) so politely declined.
I took a little hit, and soon after, felt my body pleasantly melt into a lawn chair, my ability to socialize not at all impeded. Truth told, at the end of a physically exhausting vacation and a can of Tecate, I was already pretty relaxed. But the CBD seemed to deepen that state.
CBD is one of the many chemical compounds in a class called “cannabinoids” that naturally occur in cannabis plants. While THC is the most famous of cannabinoids for its ability to get us high, CBD is a rapidly rising star for its capacity to deliver mental and physical benefits without the giggles, paranoia, or couch-lock. Eaze, a marijuana delivery service that operates in California, reported an “exceptionally high” demand for CBD in 2017, which led the company to quadruple its product offerings in the category. Chris Kelly, a representative of Tikun Olam, an Israeli company at the forefront of medical marijuana, calls Avidekel—his employer’s highest-CBD strain—the “golden child” of its offerings. Rolling Stone deemed it one of the five best strains of 2017.
In addition to that good old “melting into a lawn chair” feeling, CBD’s reported benefits include relief from anxiety, joint pain, post-traumatic stress disorder, menstrual cramps, insomnia, nausea, seizures, bowel inflammation, and plain old moodiness. Today, adults in more than half of US states (and 16 countries worldwide) have legal access to marijuana for medical purposes, and it’s been legalized for recreational use in nine states, plus Washington, DC. As marijuana continues its march into the mainstream, CBD has emerged as an easy entryway for those who want to dip a toe into the wellness benefits of weed, but may be skeptical of getting stoned.
Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:
Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).
There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.
Research and Expanded Access
A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.
4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.