By: Jay Manfre, Esq.
Collins Gann McCloskey & Barry, PLLC
https://supplementcounsel.com Disclaimer: This post is for informational purposes only; not to be construed as legal advice. Attorney Advertising.
**Only if it is an FDA-approved CBD drug with no more than 0.1 percent THC. Any non-FDA-approved CBD extract that falls within the CSA definition remains schedule I.
Disclaimers… don’t you just love them? It’s like saying “Steroids are legal, hurray!” …But only if you have debilitatingly low testosterone, diagnosed after taking two blood tests that were conducted before 11:00 am on an empty stomach, and your doctor prescribes them. Not very helpful.
On September 28, 2018 the Drug Enforcement Administration (DEA) issued a final order placing “certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA).” The action taken by DEA comes as a direct response to the recent FDA approval of Epidiolex, an oral solution consisting of CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex was created by GW Pharmaceuticals, Inc., a UK-based company, who formed US-based Greenwich Biosciences, Inc. (GW) to bring Epidiolex to the US. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from cannabis.
Prior to the DEA announcement, CBD was a schedule I substance, which meant that under the law CBD had “no currently accepted medical use in treatment in the United States.” Due to the fact that Epidiolex was approved by the FDA for the precise purpose of treating a medical condition, it was essentially just a matter of time before the DEA addressed this contradiction.
CBD isn’t a controlled substance… is it?!
At this point, some of you are probably screaming at the computer “CBD FROM HEMP IS NOT A CONTROLLED SUBSTANCE.” I get it — bear with me here as the legal and regulatory considerations surrounding CBD are complex, to say the least. Scientifically speaking, both Marijuana and Hemp come from the same species of plant, Cannabis sativa L. The difference between Marijuana and Hemp is that Hemp is typically grown to contain a much lower concentration of tetrahydrocannabinols (THC), the psychoactive constituent, and higher concentrations of other cannabinoids such as CBD. Marijuana, on the other hand, is typically grown to contain much higher levels of THC. Although Marijuana and Hemp vary greatly in this regard, the CSA defines “marihuana” as
“all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”
— Controlled Substances Act, Sec. 802 – Definitions
To the DEA, there’s no difference between hemp and marijuana!
As can be seen from the definition above, the Controlled Substances Act does not distinguish between Hemp and Marijuana, nor does it distinguish between the levels of THC in either. The CSA simply accounts for the plant Cannabis sativa L. Some have made the argument that CBD is present in the parts of the Cannabis plant that are excluded from the CSA definition, such as oil from the seeds of the plant. The DEA addressed this argument and stated:
“According to the scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, except for trace amounts (typically, only parts per million)that may be found where small quantities of resin adhere to the surface of seeds and mature stalk. Thus, based on the scientific literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the cannabis plant that are excluded from the CSA definition of marijuana, such as oil from the seeds. The industrial processes used to clean cannabis seeds and produce seed oil would likely further diminish any trace amounts of cannabinoids that end up in the finished product. However, as indicated above, if a product, such as oil from cannabis seeds, consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360), even if it contained trace amounts of cannabinoids.”
— DEA Clarification of the New Drug Code (7350) for Marijuana Extract
Accordingly, based on the DEA’s view of the scientific literature, CBD is a controlled substance, unless it comes from a part of the Cannabis plant that is excluded from the CSA definition.
Who wins with the CBD rescheduling?
With all that being said, what is the significance of the rescheduling of CBD? In terms of people suffering from seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, the rescheduling of CBD is a major win. Epidiolex can now be legally prescribed to children two-years of age and older in the United States. Further, this also opens the door for potential new applications for CBD in treating other types of medical conditions to be created in the future without the need to reschedule each specific new drug containing CBD.
What about CBD as dietary supplements?
However, if you are reading this blog, you are probably more concerned with what this means for dietary supplements containing CBD. The short answer is, this does not change the regulatory status of CBD as a dietary supplement.
In its final order, the DEA specifically stated, “Nothing in this order alters the requirements of the Federal Food, Drug, and Cosmetic Act that might apply to products containing CBD.” When the FDA announced the approval of Epidiolex, its commissioner, Scott Gottlieb, M.D., took the time to specifically address dietary supplements containing CBD:
“We remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims… The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims.”
— Scott Gottlieb, FDA Commissioner
FDA: CBD is not a supplement
The FDA’s opinion continues to be that CBD is not dietary ingredient/supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, a dietary supplement does not include
“an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or an article authorized for investigation as a new drug, an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.”
— The Dietary Supplement Health and Education Act of 1994 (DSHEA)
Was CBD sold as a supplement before 2007?
GW began conducting substantial clinical investigations on Epidiolex in 2007, and the drug was subsequently approved by the FDA on June 25, 2018. As a result, under the DSHEA definition above, in order for CBD to potentially be considered a dietary supplement, CBD would have had to have been marketed as a dietary supplement or food prior to GW’s clinical investigations, which began in 2007.
Proponents of CBD as a dietary supplement have argued that there is evidence that CBD was in fact marketed and sold as a dietary supplement prior to 2007. However, the FDA has stated that it has not received any documentation supporting that claim. Based on the FDA’s position, the investigation and approval of CBD as a pharmaceutical drug, and the DEA’s final order, it appears that unless the industry can come forth with evidence to support that CBD was marketed as a dietary supplement or food prior to 2007, CBD sold as a dietary supplement will continue to be a misbranded drug and subject to enforcement.
Is the CBD genie too far out of the bottle?
Although the FDA has stated that CBD is not a dietary supplement under DSHEA, how will the FDA enforce against an industry that continues to grow and expand every day? The FDA has limited resources and is primarily concerned with safety. As a result, the FDA is unable to bring enforcement actions against every company that is marketing and selling CBD as a dietary supplement. Based on what we have seen thus far, it appears that FDA tends to focus its enforcement actions on companies selling CBD that make “disease claims” on its labels or websites.
Marketing teams making claims? Better make them stop
Companies that claim its CBD product can “reduce inflammation,” “relieve pain,” or treat another medical condition are the most likely targets for an FDA warning letter or other enforcement action. In addition, we may see increased enforcement from the FDA now that GW’s Epidiolex is an approved drug. The FDA wants to encourage companies to invest the time, studies, and resources into bringing a new drug to market. If the FDA does not enforce against companies that are selling CBD as a dietary supplement, GW and other pharmaceutical companies may be less inclined to go through the expensive and time-consuming FDA approval process for future Cannabis derived drugs.
Will GW Pharmaceuticals protect its turf?
In addition to potential FDA enforcement, we may see GW initiate private actions against companies that are selling CBD as a dietary supplement. GW holds multiple patents relating to CBD and other Cannabinoids. In order to protect its investment, it’s possible that GW will sue dietary supplement companies in federal court. If you are a frequent reader of PricePlow, you likely have seen companies within the dietary supplement industry bring actions against other companies for violating patents. Do the GW patents only cover pure CBD compositions or do they also cover the so-called “full spectrum hemp” extracts? Additionally, do the patents only cover CBD for use in treating specific conditions rather than general health and well-being? Regardless of the specifics, it will be interesting to see how these cases play out if GW decides to bring cases based on patent infringement.
Long story short? Marketing and selling CBD as a dietary supplement carries risk
While the rescheduling of FDA-approved CBD from schedule I to schedule V was a positive and necessary action taken by the DEA, it does not change the regulatory status of CBD as a dietary supplement. CBD sold as a dietary supplement, in the view of the FDA, continues to be a misbranded drug.
Will the approval and rescheduling of Epidiolex lead to increased enforcement or, is the Genie so far out of the bottle at this point that the growth of CBD as a dietary supplement will continue to boom? Stay tuned for more CBD updates and other industry related developments with PricePlow and the Supplement Counsel!