Learn why FDA officials warned thirteen companies making cannabidiol (CBD) products for pets that their sales were illegal. The FDA has lagged far behind in regulating CBD and other cannabis-derived products, resulting in a miasma of confusion for veterinarians, who in most states, are prohibited from recommending the drug; for companies that market products for pets; and for pet owners, who must take their chances…
13 CBD pet product companies warned by FDA
On November 25, the FDA announced that it sent warning letters to the CBD product makers.
Thirteen companies making cannabidiol (CBD) products for pets were among the 15 warned by the U.S. Food and Drug Administration that their sales of CBD-containing pet and human items violated the Federal Food, Drug, and Cosmetic Act (FD&C Act). On November 25, the FDA announced that it sent warning letters to the CBD product makers.
In many of these warning letters, the FDA noted that the the presentation and marketing of these brands of CBD pet products means that the items, “are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.” FDA officials used marketing materials posted on CBD pet product companies’ websites for many of these assessments.
FDA warning letters to CBD pet product companies:
, of Norwalk, California
- KOI Naturals CBD Spray for Pets
, of Beverly Hills, California
- Mr. Pink Natural CBD Oil for Pets (also referred to as Vegan Bacon Flavored Pet CBD Oil)
, of Southlake, Texas
- Pet CBD Oil
, of Norman, Oklahoma
- Native Pet CBD Oil (150 mg, 300 mg and 600 mg)
, of Sherman Oaks, California
- CBD-EX, CBD-MAX 1000 mg, CBD-RX, CBD Defend and CBD Enflame
, doing business as Infinite CBD, of Lakewood, Colorado
- Pet Droppers and Launch Pad
, of Redmond, Oregon
- Apex CBD Livestock Pellets, Apex Organic K9 Oil and Apex CBD Dog Treats
, of Tampa, Florida/Your CBD Store, of Bradenton, Florida
- SunMed Bacon Dog Treats, SunMed Pet Bark Bits Beef, SunMed Dog Lamb Bits and SunMed Pet Tincture
, of Charlotte, North Carolina
- Natural Flavor Pet Drops and CBD Pet Treats
, of San Bernardino, California
- Hemp Pet Tinctures and Hemp Pet Treats
, of Phoenix, Arizona
- Red Pill CBD Pet
, of Los Angeles, California
- Pets Tincture and Chill Chews Soft Chews for Dogs
, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky
- CBD Oil for Pets (250 mg bacon flavor)
CBD not Generally Recognized as Safe (GRAS) for pet foods
FDA officials also announced that the agency would not classify CBD as generally recognized as safe (GRAS), which would have allowed the ingredient to be used in foods based on historical human and animal use. The agency stated that it lacked sufficient empirical evidence supporting the safety of CBD consumption.
Tim Wall covers the dog, cat and other pet food industries as senior reporter for WATT Global Media. His work has appeared in Live Science, Discovery News, Scientific American, Honduras Weekly, Global Journalist and other outlets. He holds a journalism master’s degree from the University of Missouri – Columbia and a bachelor’s degree in biology.
Wall served in the Peace Corps in Honduras from 2005 to 2007, where he coordinated with the town government of Moroceli to organize a municipal trash collection system, taught environmental science, translated for medical brigades and facilitated sustainable agriculture, along with other projects.
FDA continues to ‘caution ‘ pet owners about CBD products as companies and veterinarians clamor for clear guidelines
Until a few weeks ago, dog owners searching for a way to calm their anxious canines could purchase “Nobel Hemp Pet Comfort Tincture” on the website of M Six Labs, one of many companies marketing cannabis-derived products for pets. The company claimed on its website that the tincture, which contained cannabidiol or CBD, could aid pets’ seizure disorders, ease pain and inflammation and “reduce anxiety and nervousness.”
CBD: “unnapproved new animal drugs”
In early May, however, M Six Labs received a sharply-worded letter from the U.S. Food and Drug Administration, which has jurisdiction over cannabis and cannabis-derived products. Sale of the CBD tincture and several other products intended for pets sold by the company, the FDA letter said, violated the federal Food, Drug and Cosmetic Act because CBD was an “unapproved new animal drugs” whose safety and effectiveness had not been scientifically demonstrated. If the violations were not addressed, wrote the agency, “this matter may result in legal action.” Similar letters were sent to other companies that market cannabis-derived products.
Despite his website’s promises about aiding seizure disorders, easing pain and reducing anxiety, Mark Hubbard, chief science officer of M Six Labs, said in an interview with The Canine Review, “We’re not making any medical claims and any intention to use [our products] for any medical benefit are not our intention.”
“This entire industry is very gray—there are no parameters that are black and white.”
However, in response to the FDA’s warning, Hubbard said, M Six Labs removed the claims about the effectiveness of the tincture and other pet products from its website. Pet products, he said, represented a small fraction of the company’s business, which mostly sells products intended for humans. “We’re changing all the labeling that was in question, all the statements that were within the website, removing blogs, scrubbing social media pages,” Hubbard said. But he added, “This entire industry is very gray—there are no parameters that are black and white.”
By 2028, an almost $5 billion dollar industry
Over the last four years, sales of CBD pet products have mushroomed into a major industry; the global market for the products is expected to reach $729 million this year and swell to more than 4.79 billion by 2028, according to an analysis last year by Research and Markets, a marketing research and consultancy firm. Most states now have statutes legalizing marijuana for medical and/or recreational use. And at the federal level, although marijuana remains illegal, the 2018 Farm Bill allowed the commercial production of hemp, a cannabis plant that contains CBD but has lower concentrations of tetrahydrocannabinol or THC. THC is the compound that produces a “high.” But the FDA has lagged far behind in regulating CBD and other cannabis-derived products, resulting in a miasma of confusion for veterinarians, who in most states, are prohibited from recommending the drug; for companies that market products for pets; and for pet owners, who must take their chances, not knowing what chemicals might be mixed into a product they buy or how much CBD it really contains.
CBD oils, gummies, chews…”bath bombs”
It was the Farm Bill, which authorized the sale and use of hemp-derived products that contained less than .3 percent THC, that opened the door for the burgeoning CBD market. There was soon a proliferation of CBD tinctures, oils, gummies, chews, capsules, salves, drinks and other products for human (one website advertises CBD “bath bombs”) —and an abundance of claims about their health-enhancing abilities. The pet industry quickly followed suit., pet owners justified the industry’s optimism. In a 2021 survey of 1448 pet owners by Leafreport, a firm that provides analysis and research for the CBD industry, half said they had given CBD to their dogs or cats. A smaller but more rigorous 2019 survey of dog owners in Canada, led by Lori Kogan, a professor of clinical sciences at Colorado State University’s College of Veterinary Medicine and Biomedical Sciences, found an even higher number 79.8 percent. The owners in the study, published in The Canadian Veterinary Journal, said they bought the products to treat anxiety, pain, inflammation, seizures or other conditions in their dogs.
Mark Greenfield, a physical therapist and personal trainer in Manhattan, said he and his wife sometimes give CBD to Sheldon, their almost two-year-old Bichpoo, to calm him down. “He’s so high energy sometimes, he doesn’t know how to turn things off,” Greenfield said. “Sometimes at night when we all need a break, or during the day when it seems as if he just can’t calm down or is a little wired or stressed, we’ll give it to him. He has four, five, six hours of exercise, but he’s still at it, he’ll bark at us and want to play.” He added that at first, they gave Sheldon CBD-infused treats, but he stopped eating them, so they switched to packets of CBD peanut butter they found at a local pet store. Like many pet owners, Greenfield said he believes CBD worked for Sheldon, “It definitely has an impact on him.”
Yet the sale and use of cannabis products has also created new problems for pet owners and the veterinarians they rely on to keep their pets healthy. Research on the effectiveness and safety of cannabis for pets is scant, and only a handful of the studies have been submitted to peer-review, leaving many veterinarians leery of CBD or marijuana products when so little is known. Studies that do exist have found that THC, at least in large concentrations, can be toxic for dogs, who are more sensitive to the compound than humans, but whether smaller doses can be safe and effective is far from clear.
CBD, however, appears to be relatively safe, although at least one study found elevated liver enzymes in dogs given the drug, and there were other milder side effects like diarrhea or vomiting. But, a 2020 review of cannabis studies in dogs, published in the journal of the American Veterinary Medical Association (AVMA), found evidence that CBD was effective in treating seizures and pain from osteoarthritis in dogs.
The dearth of extensive research has not stopped cannabis companies from making extravagant claims about their products’ ability to treat a host of illnesses. Dr. Trina Hazzah, co-founder and president of the Veterinary Cannabis Society, said she has seen companies making unproven claims for their products’ effectiveness in treating a variety of illnesses, including cancer. The companies, she said, often use studies of mice to back up their assertions. But, she said, “You can’t translate from a mouse study to a dog that has cancer.”
CBD-related cases reported to the ASPCA’s Animal Poison Control Center rose dramatically —from 65 cases to 662 cases — in the five years from 2017 to 2021, according to Savee Daigo, a spokeswoman for the center. She said the center would not be able to provide a breakdown indicating the species of the pets or whether they ingested CBD products intended for pets or humans.
Veterinarians say that part of the problem is that the universe of cannabis-derived products for pets is virtually unregulated. The FDA, which in 2018 approved Epidiolex, a CBD solution, as a treatment for people with rare and severe forms of epilepsy, has yet to approve any other CBD products, which are considered drugs, as a treatment for pets or humans.
The FDA declined comment when asked for a timeline for when other cannabis-derived products might be approved. But an emailed statement provided by Anne Norris, an agency spokeswoman, said, “We want to stress that the FDA has not approved cannabis for any use in animals and the agency cannot ensure the safety or effectiveness of these products. For these reasons, the FDA cautions pet-owners against the use of such products.” In 2015 and 2016 the FDA conducted analyses, published on its website, of more than three dozen cannabis-derived products containing CBD, some aimed at pets, and found that many contained higher or lower concentrations of CBD than their labeling claimed. No analyses have been published for subsequent years, but the statement Norris provided to The Canine Review said that the agency is continuing to do research on CBD products.
Preliminary results of a two-phase “marketing and sampling” study it is conducting, the statement said, indicated that “fewer than half of the tested products which presented label claims contained CBD at concentrations within 20% of their claimed amount, and some contained psychoactive, intoxicating cannabinoid THC.”
The disconnect between federal and state regulations and the explosion of CBD products in the marketplace is frustrating for veterinarians, who are often asked about CBD products by their clients. Because neither medical marijuana laws nor the 2018 Farm Bill contain language specific to animals, many states—including Colorado, where marijuana is legal for recreational use by humans— prohibit veterinarians from recommending or prescribing CBD for their nonhuman patients. In some cases, licensing boards even forbid vets to discuss CBD with their clients. And while at least four states — California, Michigan, Nevada and Utah — have tried to remedy this legal absurdity by passing laws that allow veterinarians to discuss or recommend CBD, veterinarians in most states, whether fearful of losing their licenses of the limited scientific evidence, avoid doing so, or do so very quietly.
Michael San Philippo, a spokesman for the American Veterinary Medical Association (AVMA), said the Association did not “have anyone available” to comment on the use of cannabis-derived products for pets and directed The Canine Review to the organization’s website, where it warns veterinarians, in bold type, that “state laws legalizing [cannabis] use in people do not apply to cannabis use in animals.” The website also notes that “although cannabinoids such as CBD appear to hold therapeutic promise in areas such as the treatment of epilepsy and the management of pain and inflammation associated with osteoarthritis, the available scientific evidence pertaining to their use in animals is currently limited.” In 2019, the AVMA’s website says, the organization urged the FDA “to provide regulatory clarity about expectations for the labeling, safety, and use of cannabis-derived and cannabis-related products.”
Dr. Hazzah , the co-founder and president of the Veterinary Cannabis Society, said the AVMA has to “ride a very fine line because they want to stay legally sound but at the same time the organization clearly is supposed to support veterinarians.” But other veterinarians say that without clearer guidelines, they are flying blind as to what they can and can’t do.
Kogan, of Colorado State, found in a different survey of veterinarians, that “participants felt their state veterinary associations and veterinary boards did not provide sufficient guidance for them to practice within applicable laws.” “You can go into any store and buy cannabis products for your pet, but you can’t talk about it,” Kogan said. “No wonder people are confused.”
Erica Goode is a former New York Times editor and veteran reporter. She served as the managing editor of Inside Climate News from 2020-2022 and continues her work with ICN as an editor of special projects.
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