Medical marijuana, CBD oil and other cannabis products have soared in popularity in the last decade. But due to the lack of safety oversight and federal regulation, many CBD and cannabis products have been deemed potentially hazardous, mislabeled or falsely advertised.
As a result, manufacturers and sellers in the cannabis industry have been targeted in complex cannabis marketing lawsuits. Plaintiffs across the U.S. have filed CBD class action cases based on product liability, toxic exposure, false advertising, and deceptive marketing claims.
While a number of states have legalized CBD and marijuana products for medicinal and recreational use, experts warn that some health risks exist. As seen this last year with the rise in THC vaping-related illnesses and deaths, there are health hazards that users of some cannabis products should be cognizant of.
American companies who produce, market and distribute CBD, marijuana and cannabis products have a legal and ethical duty to do so responsibly. With that said, few studies exist on the safety of many CBD products that hit the market.
There is little literature to suggest CBD products are completely safe for long-term use, and yet the cannabis industry touts the benefits of their product while downplaying the potential unknown risks.
Joe Lyon is a highly-rated Cincinnati, Ohio Product Liability and Toxic Tort Attorney reviewing current cannabis marketing litigation, false advertising claims, and CBD class action lawsuits on behalf of plaintiffs nationwide.
CBD Safety & FDA Warnings
The cannabidiol (CBD) industry is quite robust and has seen considerable growth in the last couple of years. But there is very limited safety information for the large majority of marketed CBD products, and few have been evaluated for potential adverse health effects.
The U.S. Food and Drug Administration (FDA) announced in November 2019 that the federal safety agency had numerous “unanswered questions” and “data gaps” regarding the toxicity of CBD products. The FDA in turn sent warning letters to at least 15 vendors of CBD-containing products.
The current legal status for CBD companies to market and sell their products is still in question. In a statement, the FDA noted that marketing CBD “by adding it to a food or labeling it as a dietary supplement” is illegal and violates the Food, Drug, and Cosmetic Act. The CBD companies who received warning letters included:
- Koi CBD LLC—Norwalk, California
- Pink Collections Inc.—Beverly Hills, California
- Noli Oil—Southlake, Texas
- Natural Native LLC—Norman, Oklahoma
- Whole Leaf Organics LLC—Sherman Oaks, California
- Infinite Product Company LLLP—Lakewood, Colorado
- Apex Hemp Oil LLC—Redmond, Oregon
- Bella Rose Labs—Brooklyn, New York
- Sunflora Inc.—Tampa, Florida
- Healthy Hemp Strategies LLC—Concord, California
- Private I Salon LLC—Charlotte, North Carolina
- Organix Industries Inc.—San Bernardino, California
- Red Pill Medical Inc.—Phoenix, Arizona
- Sabai Ventures Ltd.—Los Angeles, California
- Daddy Burt LLC—Lexington, Kentucky
FDA CBD Regulation
Under the FD&C Act, any product intended to have a therapeutic or medical use, or marketed to treat a disease, and any product intended to affect the function of the human body, is a drug.
At the time of publication, the FDA had not approved any CBD products other than one prescription product (Epidiolex) to treat rare forms of epilepsy. CBD is sometimes used to treat child epilepsy syndromes like Dravet syndrome and Lennox-Gastaut syndrome (LGS), which may not respond to anti-seizure medications.
In April 2020, the U.S. Food and Drug Administration issued warning letters to two more companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the law, particularly with claims that they can treat medical conditions. The agency states it is committed to protecting the public health and ensuring that consumers are not deceived by marketing materials.
The FDA states that they recognize the potential opportunities that cannabis-derived compounds may offer, but they say some companies are marketing products containing cannabis in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Some brazen acts by companies may even put the health and safety of consumers at risk.
Deceptive Advertising Lawsuits
The FDA has sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, mitigate, treat or cure serious diseases. Some of the CBD products were in further violation because the products were added to food or marketed as dietary supplements without meeting the legal definition of a dietary supplement.
Unlike drugs and supplements approved by the FDA, there has been no real evaluation of whether most CBD products are effective for their intended use, what the proper dosage may be, how they can interact with FDA-approved pharmaceuticals, or whether they have severe side effects.
Consumer safety attorneys worry that some consumers may delay true medical care, proper diagnoses, and treatment due to unsubstantiated claims associated with CBD products.
Plaintiffs lawyers involved in cannabis marketing class action lawsuits have raised other legal and public health concerns, including:
- Is it legal to market CBD products for use with infants and young children? A younger user base may be at greater risk for adverse reactions or allergic responses, and have drastically different tolerances in absorbing, metabolizing, and excreting CBD.
- Vaping-related illnesses and deaths have been occurring in almost every state, and unregulated cannabis products have been implicated in some of the cases.
- Some CBD products are marketed as dietary supplements, even though they do not meet the FD&C Act definition of a dietary supplement.
- Some CBD companies have made outrageous health benefit claims, with little to no scientific evidence to back up their claims.
- CBD products may be contaminated and lead to consumer toxic exposure injuries. With very little regulation and minimal quality control requirements, companies may sell toxic products without proper warning labels.
What is CBD?
CBD, or cannabidiol, is an active ingredient in cannabis or marijuana. CBD is a component of medical marijuana, though it is derived from the hemp plant, a relative of the marijuana plant. The exact federal legal status of CBD (cannabidiol) looks much like the complex legal issues surrounding marijuana.
All states have legalized CBD with some areas of restriction, though the federal government still places CBD in the same drug class as marijuana. Some CBD manufacturers and sellers have come under government scrutiny and face legal battles for making false, indefensible claims about the health benefits of CBD.
Product liability attorneys have argued that some CBD companies are violating consumer protection laws and engaging in deceptive marketing campaigns. A number of CBD class action lawsuits have been filed across the nation.
There is a lack of citable medical research available, though CBD may be useful in treating symptoms of anxiety, insomnia, and chronic pain. Though many users report a variety of health benefits, medical science as a whole does not yet entirely endorse the products, and CBD is mostly available as an unregulated health supplement. Moreover, consumers may not know exactly what they are purchasing and using.
CBD Health Benefits & Side Effects
The U.S. Food and Drug Administration has decided to remain cautious and has refused to deem CBD products safe for human use. Even so, consumer demand is robust, and there may be some health benefits associated with CBD.
A study from the European Journal of Pain concluded that CBD could help manage pain and inflammation due to arthritis. There is also evidence that some rare forms of epilepsy can be treated with CBD with more effectiveness than existing anti-seizure medications.
On the other hand, reported side effects of CBD include nausea, fatigue and irritability. CBD can also raise levels of other medications in your blood. Because the FDA does not regulate dietary supplements, there is no telling what ingredients are added to CBD products. There is also no precise dosage information that has been established as a CBD standard.
Some CBD products have claimed to be treatments for opioid addiction, with little to no evidence of their efficacy. The FDA released the following statement: “The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims.”
The FDA sent warning letters were issued to two companies: BIOTA Biosciences, LLC of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire for marketing products for serious diseases, as an alternative to opioids, and distributing injectable CBD products.
If injected into the bloodstream, the FDA is concerned that unapproved products could pose a serious risk of harm to users.
Under the FD&C Act, any product intended to treat a disease or have a therapeutic or medical use is a drug. As it stands, the FDA has not yet approved any CBD products other than one prescription drug product to treat rare forms of epilepsy.
Are CBD Products Legal?
The legal status of CBD is rather vague, and at the moment the federal government has chosen not to interfere with existing interstate commerce. Outside of states where CBD is sold in shops, consumers can obtain CBD online without a medical cannabis license.
The government’s position on CBD depends in part on whether the CBD comes from hemp or marijuana. CBD products derived from hemp are not considered controlled narcotics, but the same is not true for CBD products derived from marijuana plants and contain more than 0.3% THC on a dry weight basis.
In the U.S., there is only one federally certified, pharmaceutical-grade grower and processor of cannabis. Other manufacturers and suppliers of cannabis and CBD products are subject to attack for failing to meet quality and product supply standards.
Of course, the states that have legalized medical and recreational marijuana have their own established standards and guidelines. States have created a legal and regulatory patchwork across the country. With many state laws open to interpretation and the legal status of new cannabis products in flux, consumer safety and product liability attorneys have worked diligently across state lines to build CBD class action claims against negligent CBD defendants.
Consumer safety attorneys and product liability lawyers are currently arguing cases based on various legal theories, including false advertising, illegal mislabeling claims, deceptive marketing, product defects, contaminated products, unfair business practices, and personal injury. CBD class action lawsuits seek rightful compensation for plaintiffs and substantial punitive damages.
CBD Product Contamination & Toxic Exposure
A large portion of cannabis oil imported into the U.S. is produced in emerging markets where safe manufacturing practices and cannabis regulations are underdeveloped. Imported CBD products may be contaminated with lead, arsenic, pesticides and other toxins. Many consumers may not even be aware that the CBD products they are purchasing are made abroad.
Companies that sell to American consumers have a duty to establish safe manufacturing and quality assurance programs. CBD vendors that simply choose to trust their product suppliers are liable for any injury that results from a contaminated or defective product.
In 2019, the Michigan Marijuana Regulatory Agency issued a warning to medical marijuana and CBD product users that stated contaminated products can cause coughing, wheezing, pulmonary dysfunction, abnormal heart rate and blood vessel damage.
Companies manufacturing or supplying CBD products are urged to establish proper testing protocols in order to accurately test for safe levels of heavy metals, pesticides and other impurities.
CBD Consumer Health Risks
Safety profiles for CBD products are still being established, and products will vary with the levels of THC and CBD included in a particular product. As with prescription medications, children are more susceptible than adults to drug-related effects.
Whether a cannabis product is ingested as a pill, liquid, vapor, cream or in edible food form, there are potential health risks. Scientists believe the route of exposure (inhalation vs. consumption) significantly impacts the dose delivered.
Thousands of vaping-related illnesses in the United States have concerned consumer safety advocates and FDA officials. The health risks of vaping any cannabis or nicotine products are currently under review. The FDA has warned consumers to refrain from vaping any unregulated product while health experts ascertain what causes vaping-related respiratory illness.
Cannabis Marketing & Mislabeling Lawsuits
There continues to be concern that some people wrongly think that all of the CBD products on the market have been evaluated by the FDA and determined to be safe. There is a growing consumer sentiment that using CBD “can’t hurt,” though studies have not been conducted widely enough to support this claim.
From the consumer safety perspective, there is too little known about the health effects of cannabis and CBD products to make far-reaching health benefit claims. CBD class action lawsuits have targeted companies that engage in product mislabeling schemes, false advertising and deceptive marketing campaigns.
No product containing cannabis or cannabis derived materials can be marketed as a drug dietary supplement or food product without FDA approval. Furthermore, companies cannot legally market CBD and cannabis products with health benefit claims.
Plaintiffs and attorneys claim companies must demonstrate product transparency as consumers have a right to know about the safety and efficacy of CBD and cannabis products.
Any company who makes unsubstantiated health benefit claims about their products risk false advertising legal backlash. Some companies have even stated their products may help prevent cancer, dementia and Alzheimer’s, all claims without established medical evidence.
Currently, it is a legal risk for companies to make detailed statements about their CBD product’s safety and efficacy. Most have not been studied over the long term, and there is no private or public database that gathers adverse events reports for CBD products.
Due to the lack of regulation and the sheer number of new consumer CBD products released each year, class action litigation is expected to grow in the near term.
Several federal class action lawsuits have been filed against CBD manufacturers and sellers, alleging that the vendors are violating state consumer protection laws. Plaintiffs have filed individual vaping illness lawsuits, deceptive advertising claims, as well as class action product liability suits.