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While the pandemic may seem like a thing of the past, warning letters from the Food and Drug Administration (FDA) are not.

Last week, the FDA issued a new round of letters to no less than seven CBD companies that used research studies to claim or misleadingly imply that their CBD products can cure, mitigate, treat or prevent COVID-19. You can read these letters by clicking on the following links:

The issuance of these letters is not surprising. For the past two years, the agency has consistently explained that it is concerned with the fact that these deceptive and misleading product claims could cause people to delay or stop appropriate medical treatment for COVID-19, leading to serious and life-threatening harm.

These letters also coincide with two recent major development: First, the publication of scientific studies showing that cannabidiol (CBD), cannabinoid acids, and synthetic cannabis-derived compounds may prevent or treat COVID infections. Second, the FDA’s request that Congress amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) to “clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”

Although the industry is well aware of the legal risk associated with making medical claims regarding CBD, few companies seem to understand what constitutes over-the-line medical claims that put them at risk of FDA enforcement actions.

Medical claims are explicit or implicit statements that a product can be used to diagnose, cure, mitigate, treat, or prevent a disease, or affects the bodily structure or function of the end-use consumer. Generally, medical claims can only be made in association with approved drug under the Food, Drug and Cosmetic Act (FDCA).

Drugs are the most strictly regulated category of products in the United States. Federal law mandates that all new drugs manufactured and sold in the U.S. be shown to be safe and effective for their intended use before being marketed. In 2018, the FDA approved CBD as the active ingredient in Epidiolex. However, the approval of CBD in Epidiolex did not result in the approval of CBD in other drugs nor other product categories, such as foods, dietary supplements, or cosmetics.

In the past couple of years, the FDA has sent a total of 71 warning letters to manufacturers and distributors of CBD that made various medical claims about their CBD products. In these letters, the FDA consistently took the position that these statements rendered the subject CBD products unapproved drugs that violated the FDCA.

Warning letters are a valuable tool for any CBD company because they reveal the types of statements that make the FDA tick and can help them adjust their marketing practices to reduce the risk of enforcement actions.

In addition, not falling under the scrutiny of the FDA may also help CBD companies shield themselves from more-significant headaches, including potential product seizures, criminal charges, litigation, major fines, and penalties as well as state law consumer protection claims and personal injury claims.

Every CBD company that operates on the U.S. market should keep up with FDA enforcement trends and read — or have their marketing team or consultants read — warning letters. They contain pearls of wisdom that can help the industry better navigate this very strenuous regulatory landscape.

Nathalie Bougenies chairs Harris Bricken‘s hemp CBD practice group and focuses her practice on health and wellness, in addition to corporate transactions and regulatory compliance. For the past three years, Nathalie has helped clients navigate the complex regulatory landscape of hemp products intended for human consumption and advises domestic and international clients on the sale, distribution, marketing, labeling, and importation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s “Marketplace.” She also authors a weekly column for “Above the Law” that features content on cannabis policy and regulation and is a regular contributor to her firm’s “Canna Law Blog.” For three consecutive years, Nathalie has been named Rising Star by Super Lawyers.

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By No machine-readable author provided. Bogdan assumed (based on copyright claims). [GFDL or CC-BY-SA-3.0], via Wikimedia Commons

Stop Censoring CBD

Many social media companies have yet to publish formal guidance on this issue and are choosing to arbitrarily censor CBD.

By No machine-readable author provided. Bogdan assumed (based on copyright claims). [GFDL or CC-BY-SA-3.0], via Wikimedia Commons

Bill Barr A Real Stickler For The Rules When It Comes To Weed Workers Filing For Bankruptcy

Maybe they should try obstructing justice on the president’s behalf, instead.

By No machine-readable author provided. Bogdan assumed (based on copyright claims). [GFDL or CC-BY-SA-3.0], via Wikimedia Commons

Legal Weed Prices Are Sinking...Bruh

The diesel might be quite sour, but it's also very cheap.

By No machine-readable author provided. Bogdan assumed (based on copyright claims). [GFDL or CC-BY-SA-3.0], via Wikimedia Commons

Banks Still Very Much Expected To Harsh Hemp Growers’ Mellow

Just don’t, like, make too much work for the powers that be.

Deutsche Bank Managing Director, LAPD Not Yet Seeing Eye To Eye On Savage Beating "Incident"

Yesterday afternoon, Deutsche Bank vice chairman and managing director Brian Mulligan filed a claim with the city of Los Angeles, letting it be known that he plans on suing for $50 million, over an altercation with the LAPD that left Mulligan with "a broken shoulder blade and 15 nasal fractures." According to the media banker, he was minding his own business one night in May, when a couple of officers approached him, asked him what he was doing in the vicinity of a marijuana dispensary, searched his car (where they found a few thousand dollars), drove him to a motel and told him to wait there. Several hours later, still waiting, Mulligan says he started to become suspicious and decided to leave, at which point the officers returned and "began ruthlessly beating him" so badly he "barely looked human" when they were done. If this had happened to you, you might be a little upset too! The LAPD, however, claims that Mulligan has no reason to be angry with them and, in fact, owes the officers an apology, for his "outburst of erratic behavior." The police version begins with a complaint about a man going through cars in a Jack-in-the-Box in the Highland Park area, according to LAPD Officer Cleon Joseph. Moments later, a second call came from another person about a man in the same area who appeared to be on drugs and trying to break into cars...The officers determined Mulligan matched the description of the suspect, but a police drug recognition expert determined he was not under the influence of drugs. Joseph said he could not clarify whether that included alcohol. Officers then searched Mulligan's car and found thousands of dollars, Joseph said. Mulligan told the officers that he was exhausted, so the officers agreed to transport him to a motel, Joseph said. But first, they had to count the executive's cash to make sure it was all still there after they transported him to the hotel, Joseph explained. The officers gave Mulligan's money back to him, drove him to the motel and left him, concluding their response, Joseph said. A few hours later, at about 1 a.m., police received another call from the same area, this time about a man running in traffic. Officers observed Mulligan in the street, Joseph said. He defied officers' orders to get out of the street, and instead went into a fighting stance and charged at the officers, according to Joseph. Officers tackled Mulligan and took control of him, Joseph said. During the take-down, the executive sustained injuries that required hospitalization. Police reported the incident as a categorical use of force and are conducting a standard investigation to determine if the force was necessary. Mulligan was charged with resisting arrest and interfering with law enforcement. He was booked on $25,000 bail and was released from jail on May 18. Despite Mulligan acting in such a way that some people thought required "force" to deal with, a spokesman for the LA County DA's office said that there are no plans to file criminal charges and that the office would simply like to "have a discussion with him and advise him on how best to follow the law so that incidents like this don’t occur again." Brian Mulligan, Deutsche Bank Executive, Says He'll Sue LAPD Alleging Captive Beating [HP] Deutsche Bank Top Hollywood Banker Claims Police Beating [Bloomberg]