On April 20, the FDA issued warning letters to two CBD companies – BIOTA Biosciences and Homero Corp., dba Natures CBD Oil Distribution – directing them to remove statements from their labeling and advertising on websites and social media claiming that CBD can cure opioid addiction among other illnesses. I am attaching the FDA’s warning letter, as it provides very useful information to the market as to the FDA’s current views of CBD products. As set forth in the warning letter, the FDA continues to view CBD as (1) an unsafe food additive; (2) not satisfying the definition of a “dietary supplement,” and (3) as unapproved new drugs if marketed as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.” In the case of Homero, the CBD products were advertised with the following claims, among others:
“Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”
“CBD Oil Inhibits the reward-facilitating effect of morphine”
“Vaping CBD Oil to Treat Asthma . . . Your best best [sic] to combat Asthma is by vaping CBD Oil.”
“Natures Pure CBD is a strong anti-oxidant that can alleviate lower epileptic seizures, psychotic disorders, and has neuroprotective qualities.”
Although the cannabis reform movement has made incredible strides over the past 25 years, our industry and the medicinal potential of the plant are still not recognized at the federal level. The COVID-19 pandemic is drastically altering our lives but difficult times are able to expose many truths, including the understanding that legalization and safe access to cannabis is critical, especially during a crisis.
Thankfully, many states already have come to the realization that cannabis, especially medicinal use, is not a luxury but a necessity. Although states are restricting access to public places and prohibiting gatherings, many governors have designated cannabis dispensaries as an “essential service.” […]
“Opponents of federal legalization are likely to argue the categorization was merely a natural extension of the law in states that have already legalized medical marijuana to treat certain conditions, and that the uniqueness of the COVID-19 situation limits the ‘essential’ designation to that very urgent and unprecedented fact pattern,” Seth Goldberg, attorney and partner at Duane Morris LLP told mg.
New Jersey’s top lawmakers have decided to let voters decide on legalization of cannabis during the 2020 presidential elections.
The constitutional amendment introduced today, November 18, 2019, by Senate President Stephen Sweeney and Senator Nicholas Scutari would legalize the use of recreational marijuana for anyone at least 21 years of age, and establish a Cannabis Regulatory Commission to oversee the new market.
The amendment does NOT detail the taxation rate, which was $42 an ounce in the original bill. It is also not clear if the commission will have 5 members, like the original bill.
According to NJBiz., Gov. Phil Murphy and legislative leadership long-resisted pursuing legalization via a ballot question because any, inevitable, changes to the program would have to go before voters in yet another ballot referendum.
“We made further attempts to generate additional support in the Senate to get this done legislatively, but we recognize that the votes just aren’t there,” reads the joint statement from Sweeney, D-3rd District, and Scutari, D-21st District.
To appear on the 2020 ballot as a constitutional amendment, both houses would need to pass the measure by a super-majority by the summer, or they would need to pass it 2x in both houses by a simple majority for 2 years in a row.
Just hours earlier, several progressive and social justice groups made a plea to legislative leadership to push through a legalization bill, pointing to a growing increase in low-level cannabis offenses which have disproportionately affected people of color.
Among other key provisions, the new regulatory framework provides for USDA’s approval of State and Tribal Land hemp programs established under the 2018 Farm Bill, which will end debate as to whether hemp activities in a State or Tribal Land receiving such approval are federally lawful. To be approved, those plans will have to contain stringent requirements for testing the THC content of hemp to ensure it does not meet the definition of marijuana, and contain procedures for the enforcement of violations of the State or Tribe’s hemp program. Importantly, the regulatory framework provides for USDA’s granting of hemp production permits in states and territories that do not establish hemp programs for approval by USDA.
Yesterday, I blogged about a Washington Post article that reported that vitamin E acetate in marijuana vaping products is being considered as possibly being linked to alleged vaping related lung injuries. I cautioned cannabis manufacturers, processors and dispensaries, i.e., the cannabis supply chain, that articles like WP’s, which referred to vitamin E acetate in cannabis vapor as a “contaminant,” could be the impetus for product liability lawsuits.
Today, WP provided an update to yesterday’s article. WP now states as many as 450 vaping illness cases have been reported across 33 states. Up from yesterday’s report of 250 cases across 25 states. WP’s new article refers to the vaping related health claims as possible a “new lung disease” based on a study by the New England Journal of Medicine that reports about a possible lung disorder being experienced by certain consumers of vape. However, WP appears to acknowledge scientists have not yet identified a specific chemical in vape, or whether vaping of nicotine or marijuana, is resulting in an increased risk of the lung disorder reported by NEJM. Indeed, scientific research and investigation is needed in this area.
Nevertheless, as I explained yesterday, having represented pharmaceutical companies in product liability matters involving alleged “contaminants,” product liability lawsuits are often, if not usually, filed without any scientific proof of injury causation. Accordingly, the cannabis supply chain should be careful to ensure the safety of their products, and implement necessary compliance measures.
Likewise, cannabis consumers should be mindful that many of the reports of vaping related health issues concern “black market” vape products, not those manufactured by state-licensed cannabis companies who are required by law to maintain strict standards for their products.
Today, the Washington Post reported that federal and state regulators have identified the chemical vitamin E acetate as being contained in certain cannabis vaping products allegedly linked to lung injuries. According to WP, 215 cases possibly arising out of cannabis vapes containing the chemical have been reported in 25 states, and two deaths have been linked to marijuana vaping.
WP refers to vitamin E acetate in cannabis vapor as a “contaminant,” which is a loaded term that could get the attention of the plaintiffs’ product liability bar. Articles like this are often the impetus for lawsuits to be filed. Consequently, products’ liability claims may soon become a reality for the cannabis vape supply chain.
However, as even the WP article makes clear, whether vitamin E acetate in marijuana vapor can cause an increased risk of injury of any kind to vaping consumers is being investigated, and has not been proven. The article also identifies the fact that many users of marijuana vape also vape nicotine, which is likely one of many confounding factors. Thus, product liability claims asserting injuries from marijuana vaping brought now are likely to be unsupported by science.
Nevertheless, those in the cannabis supply chain, e.g., manufacturers, processors, and sellers, should be aware of the likelihood of such claims, as product liability claims are often asserted without any scientific evidence of causation. Those in the supply chain should know that a range of compliance measures can be implemented to better protect against against such claims.
Imagine for a moment that you are arrested for alcohol possession back when alcohol was illegal. Then, imagine you served a sentence in prison for that possession, perhaps an inordinately severe incarceration sentence. Then imagine that you get out of prison and find it almost impossible to find a job, find housing or obtain a loan due to your criminal record. Then imagine, to make things worse, that alcohol is now legal, yet you are still saddled with this criminal history which leaves you no room for social advancement.
Imagine also that in spite of your lack of chances to obtain a job, that the very illegality you were arrested for not only becomes legal through legislation, but also fosters a burgeoning industry in the prohibited substance, primarily by nondiverse corporate entities and persons. Sounds a little bit like a nightmare, but that is exactly the scenario that is developing around cannabis and medical cannabis across the country.
On July 22, the FDA issued a Warning Letter to Curaleaf with regard to Curaleaf’s “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape.” The Warning Letter explains FDA’s view that Curaleaf’s CBD products are effectively “unapproved new and misbranded human drug products” because the claims Curaleaf has made about them on Curaleaf’s website and social media accounts demonstrate “they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body,” but Curaleaf has not obtained prior approval from the FDA to market them as such. The Warning Letter also explains the FDA’s view that the subject products are not “dietary supplements” because (i) CBD has already been approved as an active pharmaceutical ingredient (epidiolex), (ii) CBD was not marketed as a dietary supplement or a conventional food prior to such FDA approval of CBD as an API; and (iii) the subject products are not “intended for ingestion,” which is a requirement of a dietary supplement. The FDA also warned about Curaleaf’s products with respect to animals, which I have not summarized. The FDA provided Curaleaf 15 days to establish a corrective action plan and to report such plan to the FDA. The Warning Letter demonstrates the FDA is actively monitoring CBD manufacturer websites and social media for over the line claims, and that CBD manufacturers need to follow the FDA’s guidance given the unsettled regulatory structure with respect to CBD.
As with CVS, Walgreen’s decision to sell hemp-derived in CBD in select states, as opposed to rolling those products out nationally, is likely the result of the still developing federal regulatory framework for hemp, which includes forthcoming regulations and guidance from USDA and FDA, and differences in the laws pertaining to hemp and hemp-derived CBD products from state-to-state.
Notwithstanding the challenging regulatory environment, the mass marketing of hemp-derived CBD, now that hemp is no longer a federal controlled substance, provides a lucrative opportunity for the hemp-derived CBD supply chain – cultivators, processors, and retailers, including the major pharmacy chains. However, the “select state” approach Walgreens and CVS have taken demonstrates that careful is analysis of the federal and state laws and regulations at play is necessary before entering the hemp-derived CBD market.