The FDA has just posted a new alert for consumers, warning that several companies selling CBD products have violated federal regulations. FDA has issued warning letters to 4 companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest. These firms also market products for people. Agency says it is illegal to add CBD to food or label it as a supplement
If You Use CBD, the FDA Has an Urgent New Warning for You
The agency has recently clamped down on certain companies selling CBD products.
The medical use of cannabis has been a divisive topic of conversation for decades now, but in recent years, more and more people have been pushing for its acceptance. Derived from the cannabis plant, there are a plethora of cannabis products available for consumption, but most are made from the two most prominent cannabinoids found in the plant: cannabidiol (CBD), which is often revered for its health benefits, and tetrahydrocannabinol (THC), which is what produces the psychological effects that make people feel high. Despite the rising public acceptance of these products, however, there is still plenty of concern from federal regulators. In fact, the U.S. Food and Drug Administration (FDA) just released an urgent new warning targeted at CBD users. Read on to find out what the agency is alerting consumers about now.
Following the 2012 legalization of marijuana in Colorado, 17 other states and Washington, D.C., have since made it legal for people to use and sell various cannabis products. But recreational marijuana has not been federally legalized, and only one cannabis product has been federally approved by the FDA. In 2018, the agency approved Epidiolex, which contains CBD, for the treatment of certain seizures—making it the first and only FDA-approved drug that “contains a purified drug substance derived from marijuana.” This is only available through a prescription as well.
In a recent crackdown against unapproved cannabis products, the FDA issued an alert on May 4, notifying consumers that it has sent warning letters to five different companies illegally selling delta-8 products in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). According to the FDA, delta-8 THC is a cannabinoid that is not naturally “found in significant amounts” in the cannabis plant, so concentrated amounts of this substance are typically synthetically manufactured from other cannabinoids like CBD through the use of additional—and potentially harmful—chemicals.
“This action is the first time the FDA has issued warning letters for products containing delta-8 THC,” the agency noted.
The warning letters were issued to the following companies: ATLRx Inc., BioMD Plus LLC, Delta & Hemp, Kingdom Harvest LLC, and M Six Labs Inc. According to the agency, the citations address these companies selling products as “unapproved treatments for various medical conditions or for other therapeutic uses,” as well as several violations related to drug misbranding and the addition of delta-8 THC in foods.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a statement.
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The FDA noted that several of the companies were also warned about additional violations of the FD&C Act, particularly concerning CBD products. The violations included “marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.” ae0fcc31ae342fd3a1346ebb1f342fcb
“It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” the agency explained. “The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
One of the companies has also been marketing CBD products for food-producing animals, according to the FDA. The agency warned that this could also impact consumers, as there are “potential safety concerns related to human food products” such as meat, milk, and eggs produced from animals that are given CBD, “as there is a lack of data on safe CBD residue levels.”
This isn’t the first time the FDA has had to send warning letters in regards to CBD products. Over the past several years, a number of companies have been cited by the agency for “illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases.”
The FDA has been sending warning letters since at least 2015, and 12 companies—including the five just issued—have been cited in the first five months of 2022 alone. Alongside the warnings, the agency has also tested the chemical content of cannabinoid compounds in some of the products sold by these companies and “many were found to not contain the levels of CBD” they were claiming to when marketing to buyers.
“Consumers should beware purchasing and using any such products,” the FDA advises.
FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest. While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. Therefore, all other CBD products intended for use as a drug are considered unapproved drugs and are illegal to sell. Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs.
Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.
The FDA is concerned about these CBD products for food-producing animals not only because CBD could pose a safety risk for the animals themselves, but also because of lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products.
After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system. Part of the animal drug approval process includes setting a withdrawal period to establish the minimum amount of time between the last dose of a drug and the slaughter or harvesting of food products from the treated animals. Since CBD is an unapproved drug, the FDA has not had the opportunity to evaluate CBD residues in food or to establish an appropriate withdrawal period.
To date, there is a lack of data on the residues that may result when food-producing animals consume CBD products. There is also a lack of data on what levels of potential residues are safe for a person consuming the foods that come from CBD-treated animals. In addition, the manufacturing processes of unapproved CBD drug products have not been reviewed by the FDA as part of the human or animal drug approval processes. The FDA has received reports of some CBD products containing contaminants such as pesticides and heavy metals, thus introducing additional concerns for the use of CBD products.
The FDA is also concerned that consumers may postpone seeking professional medical care for their animals, such as getting a proper diagnosis, treatment and supportive care, because they are relying on unproven claims associated with unapproved CBD products. Many of the products marketed by the four companies that received warning letters made claims about alleviating anxiety. Anxiety in animals can be a signal of a range of medical conditions requiring veterinary care from a licensed professional. This is why it is critical that consumers talk to a health care professional about the best way to treat medical conditions using approved treatment options that have been proven to be safe and effective.
In addition to the CBD products marketed for food-producing animals, Free State Oils, Hope Botanicals, Kahm CBD and Kingdom Harvest also sell CBD-containing unapproved new drugs for humans and adulterated human foods. Some of the products were also marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement. These products include oils, creams, extracts, salves, and gummies.
The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency. To report a problem with an animal product, visit fda.gov/vetproductreporting. To report a problem with a human product, use FDA’s MedWatch program.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.
FDA clarifies regulatory stance on CBD products
The Food and Drug Administration has thrown some cold water on the hot market for cannabidiol (CBD) products.
In a revised consumer update released Monday, the FDA emphasized that it’s currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. The agency said it can’t conclude that CBD is “generally recognized as safe” (GRAS) by qualified experts for use in human or animal food. What’s more, the FDA noted that CBD products marketed for therapeutic uses, including topicals, haven’t been approved and their claims and safety remain uncertain.
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” Amy Abernethy, principal deputy commissioner for the FDA, said in a statement. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA, and we want to be clear that a number of questions remain regarding CBD’s safety, including reports of products containing contaminants, such as pesticides and heavy metals.
“And there are real risks that need to be considered,” she added. “We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams.
Also on Monday, the FDA issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Companies receiving the warnings included Koi CBD LLC, Pink Collections Inc., Noli Oil, Natural Native LLC, Whole Leaf Organics LLC, Infinite Product Co. LLLP (dba Infinite CBD), Apex Hemp Oil LLC, Bella Rose Labs, Sunflora Inc. (dba Your CBD Store), Healthy Hemp Strategies LLC (dba Curapure), Private I Salon LLC, Organix Industries Inc. (dba Plant Organix), Red Pill Medical Inc., Sabai Ventures Ltd. and Daddy Burt LLC (dba Daddy Burt Hemp Co.).
“CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams,” the FDA stated. “As outlined in the warning letters issued today, these particular companies are using product web pages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”
What’s the Law, What Are the Risks?
Under the FD&C Act, the FDA defines a drug as any product intended to treat a disease or have a therapeutic or medical use, as well as any product — other than a food — intended to affect the structure or function of the body of humans or animals. The FDA noted that, unlike drugs approved by the agency, it hasn’t evaluated whether these CBD products are effective for their intended use, what the proper dosage might be, how they might interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products hasn’t been subject to FDA review.
Though scientific research on CBD in consumer products remains in its early stages, some of the available data raise serious health concerns, according to the FDA. Those include potential liver injury, interactions with other drugs, drowsiness, diarrhea, mood changes, possible interference with sexual development and function, cumulative use of CBD, and the impact on vulnerable populations like children and pregnant or breastfeeding women.
Acknowledging the rising consumer demand for CBD products, the FDA said it’s exploring potential pathways for various types of these offerings to be legally marketed.
Even as various CBD offerings flood into stores, many retailers remain iffy about the regulatory framework regarding the sale, labeling and safety of hemp-containing products.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said Abernethy. “In line with our mission to protect the public, foster innovation and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
Retailers Move Cautiously
Even as various CBD offerings flood into stores, many retailers remain iffy about the regulatory framework regarding the sale, labeling and safety of hemp-containing products.
In July, the Food Marketing Institute submitted comment to the FDA on the commercialization of food, beverage and other products containing cannabis or cannabis-derived compounds, including CBD. FMI said food retailers need a “clear and comprehensive” regulatory framework for the marketing and sale of these products.
Still, grocery retailers large and small — such as The Kroger Co., Albertsons Cos., Southeastern Grocers, Whole Foods Market, Dierbergs Market, Earth Fare, Lucky’s Markets, Fresh Thyme Farmers Market and Thrive Market — have begun carrying CBD products, primarily topicals.
Late last year, the federal government changed its classification of cannabis with the enactment of the Agriculture Improvement Act of 2018, or the Farm Bill. The legislation removed hemp — cannabis or derivatives with a very low content of psychoactive ingredient THC — from the Federal Controlled Substances Act’s definition of marijuana. That meant hemp was no longer a controlled substance under federal law, even though marijuana remains a Schedule I drug.
As the FDA reiterated in its update, CBD and THC can’t be added to a food or marketed as a dietary supplement under current federal law. The FDA maintains regulatory oversight of food, cosmetics, drugs and other products within its jurisdiction that have CBD, THC or the cannabis plant itself as an additive.
“Longer term, there will likely be a route to market for CBD products, with the FDA having already approved drugs with CBD as the active ingredient,” Jefferies cannabis market analyst Owen Bennett wrote in a research note Tuesday. “In our view, though, the safety risks as well as the spike in consumer interest will likely see heavy regulation, with companies having to support product launches with detailed reports, likely including clinical studies.”
CBD market projections
Nielsen has forecast that by 2025, sales of all legalized cannabis in the U.S. will reach $41 billion, including $35 billion from cannabis products and $6 billion from hemp-derived CBD products.
Meanwhile, CPG sales and marketing firm Acosta expects CBD product sales to consumers to hit an estimated $20 billion by 2024. Of consumers surveyed by Acosta, 28% now use CBD products on an as-needed (19%) or daily (9%) basis
“We currently model 2022 CBD retail sales of $3.5 billion, compared to some blue-sky estimates as high as $22 billion,” Jefferies’ Bennett said. “We believe this [FDA] update will be a catalyst to rebase the majority of these estimates, with risks now more visible and the FDA striking a very cautious tone on the safety of CBD products.”
Chicago-based Brightfield Group, a market research firm covering the legal CBD and cannabis industries, projects hemp-derived CBD product sales to climb from $5.1 billion in 2019 to $23.7 billion in 2023, a 47% compound annual growth rate. This year, growth will be an estimated 706%. Brightfield said key CBD product opportunities include topicals (mainly for pain relief), skin care and beauty, tinctures, capsules, gummies, CBD-infused foods and pet care.
“We’re expecting to see continued strong growth in CBD. We’re expecting that the FDA will issue a framework and allow CBD to be used in foods, beverages and dietary supplements and for even more chain retailers to get on board,” Virginia Lee, CBD research manager at Brightfield Group, said at PLMA’s 2019 Private Label Trade Show in Chicago last week. “As there’s more education, both on the manufacturer and retailer ends, some of the misconceptions about CBD twill go away and more consumers will feel comfortable purchasing CBD products.”