When is CBD illegal? A summary of CBD’s shifting regulatory position.
The verdict is in: cannabis law is significantly crazier than cannabis itself.
On June 25, 2018, the U.S. Food and Medicine Administration (FDA) approved a prescription drug produced from marijuana for the first time ever. Epidiolex (cannabidiol or CBD) was licensed for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare pediatric epilepsy diseases. The Drug Enforcement Administration (DEA) declared on September 27, 2018, that Epidiolex and future drug products containing CBD produced from marijuana with no more than 0.1% tetrahydrocannabinols would be placed under Schedule V of the Controlled Substances Act (CSA). These events mark historical turning points in Cannabis’ evolution from a source of textiles and remedies in the early nineteenth century to a controlled substance and presently an FDA-approved drug.
Cannabidiol (CBD) is one of over one hundred cannabinoids contained in Cannabis sativa, also known as “marijuana” or “hemp”. CBD was initially isolated in 1940 and structurally described in 1963.
CBD is poised to become the darling of the medical Cannabis movement, with predicted retail sales of CBD products – hemp, marijuana, and pharmaceutical – exceeding $1.9 billion by 2020.
Let’s review everything you need to know about When CBD Is Illegal.
When CBD Is Illegal? Convoluted Law.
Even after the approval and scheduling of Epidiolex, CBD’s regulatory standing in the United States remains murky despite its increasing popularity and use. The origin of CBD is essential to understanding its legal status. Botanically speaking, the most prevalent source is the Cannabis sativa L. (Cannabis) plant, which includes both marijuana and hemp. Genotype, phenotype, Drug-type Cannabis vs. fiber-type Cannabis, etc.) but from a regulatory standpoint, the distinction between marijuana and hemp is based on chemical composition, specifically as it relates to the concentration of delta-9 Tetrahydrocannabinol (THC), the primary psychoactive component of Cannabis. Hemp is officially recognized as a Cannabis sativa cultivar with low THC contents. In the United States, THC concentrations cannot exceed three tenths of one percent (0.3%). International limits on THC concentrations for hemp vary. CBD generated from hemp and marijuana each have their own distinct regulatory status and legal concerns.
CBD from marijuana is still classified as a Schedule I restricted substance by the DEA under the 1970 Controlled Substances Act, despite the categorization of Epidiolex. As a result, CBD derived from marijuana is considered to have no recognised medical purpose, no acceptable safety for use under medical supervision, and a significant addiction potential. While the scheduling of Epidiolex is the first time the DEA has acknowledged that marijuana has a “currently established medicinal purpose,” it does not alter the regulatory position of CBD itself.
The DEA released an internal instruction on May 22, 2018, which stated, “Products and materials derived from the Cannabis plant that do not meet the CSA’s definition of marijuana (such as sterilized seeds, oil or cake formed from the seeds, and mature stalks) are not regulated under the CSA.” Although these declarations established that CBD obtained from sources other than cannabis was not a restricted substance, they did not specify that CBD derived from industrial hemp was legal. In addition, these plant sections are not viable sources of CBD. As a result, misunderstanding remains.
When CBD Is Illegal? Well, CBD can also be derived from certain varieties of hemp. Throughout history, hemp has been cultivated as an industrial crop to manufacture fabrics, rope, and other products from its long stalks. 13 Despite not being officially defined or named in the CSA, since the enactment of the CSA in 1970, the DEA has regarded it a controlled substance.
The Hemp Farming Act of 2018, S. 2667 (2018 Hemp Bill) officially and permanently removed hemp from the list of prohibited substances on December 20, 2018. The 2018 Hemp Bill reclassifies hemp as all portions of the Cannabis Sativa plant that contain less than 0.3% delta-9 THC by dry weight, including “derivatives”, “extracts”, and “cannabinoids.”
Importantly, the 2018 Hemp Bill clearly eliminates popular hemp products, such as CBD derived from hemp, from the CSA’s jurisdiction.
Prior to the adoption of the 2018 Hemp Bill, domestically grown hemp was only federally permissible when grown under a state-approved pilot program. In 2017, hemp was cultivated on a total of 23,343 acres in 19 states. As of the date of this writing, 41 states have enacted laws allowing them to participate in hemp pilot projects authorized by the 2014 Farm Bill. 15 Currently, only a fraction of hemp-derived CBD products sold in the United States are derived from domestically grown hemp. This will change as the Hemp Bill of 2018 encourages increased investment in this sector.
In addition to industrial hemp, CBD extracted from “non-psychoactive hemp” imported into the United States may also be legal. Non-psychoactive hemp is the phrase used by the Ninth Circuit Court of Appeals in a pair of parallel cases brought against the DEA by the Hemp Industries Association (HIA) about a DEA rule that would have made it illegal to import hemp products containing even trace quantities of THC. 16,17 In a judgement issued on February 6, 2004, the Court determined that the DEA had exceeded its authority in implementing the rule and declared it null and unlawful.
In its ruling – which did not mention CBD specifically – the Court referred to “non-psychoactive hemp” and stated in a footnote, “The non-psychoactive hemp used in Appellants’ products is derived from industrial hemp plants grown in Canada and Europe, the flowers of which contain only a trace amount of the THC contained in marijuana varieties grown for psychoactive use” (emphasis added). It is unclear if the Supreme Court effectively approved the importation of the entire hemp plant, including the “flowering tops,” as long as it contains no more than trace levels of THC, or whether it just reaffirmed the exception for mature stalks in a different context. This difference has never been discussed. Cases involving hemp that came before and after this judgement do not resolve the problem.
Despite the uncertainty and the FDA and DEA’s position, CBD products derived from hemp are already available online and over-the-counter (OTC) in the majority of the United States as nutritional supplements. In contrast, CBD products derived from marijuana can only be purchased by qualifying patients in jurisdictions with medical marijuana laws (30 states and D.C. as of this writing) or by consumers in states with adult-use/recreational marijuana legislation (9 states and the District of Columbia as of this writing).
When CBD Is Illegal? Before Epidiolex
Prior to the approval of Epidiolex, the FDA stated specifically that “CBD products are excluded from the definition of dietary supplement” due to CBD’s position as an Investigational New Drug (IND) under the Food, Drug, and Cosmetic Act (FD&C Act).
20 CBD is no longer a Schedule I controlled substance (IND). It has been approved. Therefore, CBD cannot be incorporated in a nutritional supplement.
This exclusion is not altogether unprecedented. Biostratum, a pharmaceutical company, asked the FDA to take action against makers of dietary supplements containing pyridoxamine since it had submitted an IND application for pyridoxamine dihydrochloride. Three and a half years passed before the FDA formally determined that these items violated its regulations. The sale of pyridoxamine-containing dietary supplements is not permitted at this time.
Another precedent can be used to predict how the FDA may adjust its enforcement strategy in the future. In April 1997, the FDA informed Pharmanex, a maker of dietary supplements, that its mevinolin-containing dietary supplement Cholestin was a medication and not a dietary supplement. Mevinolin, also known as monocalin K, is a component of red yeast rice that has been demonstrated to reduce cholesterol levels. Mevinolin is chemically comparable to Merck’s FDA-approved medication lovastatin (brand name Mevacor). The FDA determined that Cholestin was created with lovastatin quantities that exceeded traditional red yeast rice products, and that the product was therefore more akin to a medicine than any red yeast rice product offered over-the-counter. While Cholestin is no longer available, other red yeast rice products with naturally occurring amounts of lovastatin remain on the market.
When CBD Is Illegal? In the Cholestin case, the FDA’s argument rested on the fact that the concentration of lovastatin in red yeast rice products above a conventional threshold. The great majority of currently marketed hemp-derived CBD oil products possess CBD concentrations below 5 percent by weight, in contrast to Epidiolex, which has > 99 percent CBD. Given this history, it is feasible, if not probable, that the FDA may prohibit products containing extracted CBD but not hemp extracts with naturally occurring CBD amounts.
With the FDA’s approval of Epidiolex and its public announcement that CBD products are excluded from the statutory definition of a dietary element, the future of CBD products sold online and over the counter is unknown. The FDA is permitted to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act) against CBD-containing goods. Notably, the FDA is a public health organization with multiple competing goals and a limited budget for enforcement. When deciding on an enforcement action, the FDA considers a number of considerations, including the advantages and risks. To yet, the risks connected with CBD products derived from hemp are mostly unexplored.
In the absence of strong FDA monitoring and oversight, CBD products are commonly mislabeled. Independent research has proven that the CBD content of nearly 70% of online CBD products may be mislabeled (43 percent of products were underlabeled and 26 percent were overlabeled for actual CBD content). In 2015-16, the FDA issued warning letters to 25 entities for rule breaches. The FDA has also issued cease-and-desist letters to firms for making drug claims about CBD products, such as that they treat or even cure cancer.
TO SUM IT UP IN A NUTSHELL
CBD’s current legal and regulatory status is complex and in flux, particularly in relation to its legal standing under the CSA and regulatory status under the FD&C Act. Although the ramifications of these intricacies are far-reaching, limitations in clinical research have impeded our knowledge of crucial safety and efficacy factors. As a result, individuals are already utilizing CBD products to treat medical ailments without the assistance of knowledgeable healthcare professionals.
Although the approval of Epidiolex has led to the scheduling of drug products containing CBD derived from marijuana containing no more than 0.1% tetrahydrocannabinols, it is unclear how this would impact the FDA’s enforcement priorities regarding hemp-derived CBD products. Increased enforcement could reduce accessibility.
In contrast, adoption of the 2018 Hemp Bill might liberate the supply chain and avoid enforcement by establishing a de facto legal market for hemp-derived CBD products that is distinct from the Epidiolex medical market. Or, perhaps items with modest quantities of CBD, such as red yeast rice, will remain below FDA enforcement priorities.
We hope this article helped you better understand the topic of “When CBD Is Illegal”.
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