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CBD NEWS
Article 1:
On July 22, 2019, the FDA sent a warning letter to Joseph Lusardi, President of Curaleaf, Inc., alleging numerous violations of the Federal Food, Drug, & Cosmetic Act (“the FD&C Act”). The violations included selling “unapproved new and misbranded human drug products” (the CBD Lotion, CBD Pain-Relief Patch, CBD Tincture, and CBD Disposable Vape Pen), “dietary supplement labeling” (the FDA does not consider CBD a dietary supplement), and selling “unapproved new animal drugs” (Bido CBD For Pets).
Because the CBD Lotion, CBD Pain-Relief Patch, CBD Tincture, and CBD Disposable Vape Pen “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,” they are considered drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), and thus subject to FDA approval prior to being “introduced or delivered for introduction into interstate commerce.”
The website stated the CBD Disposable Vape Pen and CBD Tincture were for the treatment of chronic pain. The site contained a webpage entitled “Can CBD Oil be Used for ADHD?” which included the statements “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety . . . ADHD,” and “[t]he Benefits of CBD Oil for ADHD . . . It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.” The website claimed that CBD can “successfully reduce anxiety symptoms” and “be used in a variety of ways to help with chronic anxiety.” There were also claims on the site that CBD was linked to the successful treatment of Parkinson’s disease, Alzheimer’s disease, opioid-related withdrawal, cancer, and heart disease. In addition to content on the official website, the letter also targeted some of Curaleaf’s social media posts from Facebook and Twitter. One such Facebook post stated “CBD Can be a powerful ally if you’re suffering from chronic inflammation and pain,” and one highlighted Tweet stated “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.” The letter went on to say that the products in question “are not generally recognized as safe and effective for the above referenced uses.”
The letter also alleged that the products in question lacked “adequate directions for use,” that is “directions under which a layperson can use a drug safely and for the purposes for which it is intended.” This is because the conditions the products purport to treat are not those conducive to self-diagnosis and treatment by non-medical professionals.
Several places on Curaleaf’s website identified CBD as a dietary supplement, which suggested to the FDA that at some point they intended to market their products as such. The FDA has concluded that if a substance “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 has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,” products containing said substance cannot be dietary supplements. Dietary supplements also must be ingested, rather than applied topically or inhaled.
Because the FDA determined Curaleaf’s Bido CBD for Pets was “intended for use in the mitigation, treatment, or prevention of diseases in animals” it classified it as an unapproved new animal drug. The website contained statements such as, “[CBD will] [d]ecrease compulsive behavior like biting, scratching, chewing, whining, eliminating, and other symptoms of dog separation anxiety,” “alleviate fear feelings,” and “prevent the longer-term health effects of anxiety.” New animal drugs must have an approved application, a conditionally approved application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l to be marketed legally. The letter went on to urge Curaleaf to correct the violations lest legal action be taken.1
This is the first such letter sent out by the FDA since it commenced its study on how best to regulate CBD in May. Curaleaf has put out a statement asserting its intent to comply with the FDA’s directives from this point forward and address the issues highlighted by the letter.2
2 https://abcnews.go.com/Health/wireStory/fda-warns-top-marijuana-company-making-cbd-health-64519999
Article 2:
On December 20, 2018, President Donald Trump signed the Agriculture Improvement Act of 2018, Pub. L. 115-334 (“the Farm Bill”) into law.1 This law removed hemp from the definition of “marijuana” in the Controlled Substances Act. The Farm Bill defines hemp as cannabis and cannabis derivatives with a THC concentration of 0.3% or lower. Since then, the marketplace has seen a proliferation of products containing CBD. The FDA is currently attempting to determine the best regulatory approach to these products.2 On May 31, 2019, the FDA held a public hearing, Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”3
They have also taken public comments on how best to approach regulating cannabis-derived products.4 Many have encouraged the FDA to act swiftly. The National Association of Chain Drug Stores pointed to the “considerable confusion regarding many of these products being marketed for sale” as a cause of urgency. The National Cannabis Industry Association encouraged the FDA to perform testing “efficiently as well as effectively” so as to not entice budget-conscious consumers to turn to “the illicit market.” Others encouraged a lax regulatory approach. George Petrot, a hemp farmer, said that “[a]ll-natural, full-spectrum unadulterated hemp oil should be classified as a food supplement and a dietary supplement.” Connecticut’s Plant Life Group pointed to the compound’s “benign risk profile,” and recommended applying the existing regulatory framework for New Dietary Ingredients (NDIs). The American Psychiatric Association was much more skeptical, pointing to the dearth of scientific evidence for CBDs effectiveness as a treatment for psychiatric disorders, even alluding to studies indicating cannabis “may exacerbate or hasten the onset of psychiatric illnesses.” Other entities, such as the American Medical Association, merely said that more research was necessary to determine the best path forward.5
Additionally, dozens of state attorneys general wrote a letter to the FDA on the topic, asking the FDA to take the states’ feedback into account. They encouraged the FDA for what steps it had already taken and expressed interest in being included in efforts to craft a coherent regulatory framework. The attorneys general were from 34 states, two territories, and the District of Columbia.6
4. https://hempindustrydaily.com/final-chance-to-tell-fda-how-it-should-regulate-cbd/
5. https://hempindustrydaily.com/10-highlights-from-the-fda-query-on-how-to-regulate-cbd/
6. https://www.law360.com/articles/1179860/state-ags-urge-fda-to-keep-exploring-cannabis-regulation
Links to articles on CBD:
https://www.fool.com/investing/2019/07/14/us-cbd-sales-to-grow-an-average-of-107-annually-th.aspx
https://www.nytimes.com/2019/05/06/us/cbd-cannabis-marijuana-hemp.html
This CBD Stock Is Quietly Becoming a Retail Giant
https://www.fool.com/investing/2019/07/13/this-cbd-stock-is-quietly-becoming-a-retail-giant.aspx
