The Food and Drug Administration (FDA) asked for public input on the safety and efficacy of CBD—and more than 100 people used that opportunity to tell the agency that their pets benefit from the cannabis compound.
The volume of pet-related comment submissions stood out to the analysis firm PARC, which sifted through the thousands of submissions FDA received during the three months that the comment period for CBD regulations was open and shared its takeaways with Marijuana Moment.
Though FDA didn’t request anecdotal accounts about personal experiences with CBD—let alone comments about people’s pets—it sure received a whole lot.
More than four percent of the 4,269 comments whose text has been posted online by FDA mention dogs.
In general, the posts describe dramatic improvement in conditions such as epilepsy, arthritis, chronic pain and anxiety among pets—primarily dogs—after starting CBD treatment. Similar to stories about humans who start consuming the compound, these comments often note that CBD worked in ways that pharmaceuticals didn’t, and it didn’t carry serious side effects.
Judy Hoover said that she administers CBD to her 20-year-old dog who previously “could not go up and down the stairs.” The dog “now runs up and down the stairs,” she said. “So it does work.”
“I use CBD oil for my dog who is 13 and has autoimmune disease and hip problems,” Nikki Gurule wrote. “She stopped going on her daily walks and wouldn’t jump into the car or up on the couch anymore as she had her whole life. She was on prednisone for the autoimmune issues.”
“Since I started giving her CBD oil orally daily, she is now walking 30 min on a treadmill daily, jumping up onto the couch by herself and into the car without aid,” she continued. “She no longer limps or yelps when touched. She is off of her prednisone now and is showing improvement in all her thyroid levels and immune issues are gone.”
“Dogs don’t lie, she is feeling better and out of pain. I will continue to use CBD oil for her for the rest of her life.”
“I first became familiar with CBD oils when my dog developed arthritis in her hips and spine,” Deb McClellan, a teacher, wrote. “I honestly believe we got her an additional 2 years of comfortable, content life with the CBD oil.”
An anonymous commenter said that “CBD has been very useful for the treatment of both my dog’s and mine own anxiety.”
“My dog used to destroy many of my belongings in the house if we left him alone for too long,” the person wrote. “After beginning treatment with a low dose of CBD my dog has ceased to have that behavior and overall seems more relaxed.”
Pets also seem to indirectly benefit from CBD, according to certain posts, with owners reporting that their own use of the compound makes it easier to take dogs on walks. One person wrote that CBD allowed him to get “enough reduction from inflammation to walk the dog and play golf five days a week.”
Though the anecdotal reports are not especially scientific in and of themselves, the comments are bolstered by recent research. A study published in April, for example, showed marked improvement in dogs suffering from seizures who received CBD. A separate study from last year found that CBD oil reduced symptoms of arthritis.
It’s not clear what, if any, bearing these pet-centric comments will have on FDA’s rulemaking process for CBD, but collectively they serve as another example of the intense interest that consumers have in ensuring that the agency develops regulations that emphasize safe access to CBD products—for humans and pets alike.
Photo courtesy of Chris Yarzab.
Feds Send Warning Letter To Another CBD Company Over Medical Claims
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a warning letter to a Florida-based CBD company on Tuesday, alleging that the business made several unsanctioned claims about the therapeutic benefits of their products.
The federal agencies accused Rooted Apothecary of unlawfully asserting that their cannabidiol products could treat symptoms of conditions such as ADHD, Parkinson’s disease, ear aches, ADHD and autism. Those claims appeared on the company’s website and social media accounts, they said.
Certain products appeared to be marketed as dietary supplements, which FDA currently prohibits as it works to develop an alternative regulatory scheme for CBD.
“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Acting FDA Commissioner Ned Sharpless said in a press release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”
FDA and FTC have issued a joint warning letter to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease, among other conditions/diseases. https://t.co/tsn4SBiGzH pic.twitter.com/sG3wyURMDS
— Dr. Ned Sharpless (@FDACommissioner) October 22, 2019
We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements.
— Dr. Ned Sharpless (@FDACommissioner) October 22, 2019
“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” he said. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority.”
FTC’s complaint with the company is that it violated a law that requires businesses that advertise medical claims about their products to have “competent and reliable scientific evidence” to back them up, which could include human clinical trials. Making or exaggerating such claims through “a product name, website name, metatags, or other means” without proper evidence is also prohibited.
FTC and @US_FDA warn Florida company marketing CBD products about claims related to treating autism, ADHD, Parkinson’s, Alzheimer’s, and other medical conditions: https://t.co/cAbxPPcxk8 pic.twitter.com/GdlttyBgxv
— FTC (@FTC) October 22, 2019
Rooted Apothecary must respond to the agencies within 15 working days to explain what steps it’s taking to resolve the issues. If the company fails to do so, it is subject to legal action, including the possible seizure of its products or an injunction. It may also have to compensate customers.
FDA emphasized that CBD products—other than the prescription medication Epidiolex, for the treatment of intractable epilepsy—are not currently allowed. But it also reiterated that the agency is in the process of developing rules that could allow for the lawful marketing of the compound.
In April, FDA sent warning letters to three other CBD companies that it said was making unauthorized claims about the medical benefits of their products. FTC also submitted warning letters to three separate CBD companies for allegedly advertising misleading statements about their products last month.
These letters are examples of the agency’s use of enforcement discretion. Former FDA Commissioner Scott Gottlieb, who recently suggested that the federal government should be involved in regulating state marijuana programs, clarified in March that the agency is only going after companies that make especially misleading claims about their products.
Senate Majority Leader Mitch McConnell (R-KY), who championed a provision of the 2018 Farm Bill federally legalizing hemp and its derivatives, has urged FDA to clear a path for the lawful marketing of CBD products by using enforcement discretion while it develops an interim final rule. A bipartisan group of lawmakers made a similar request in a letter sent to the agency last month.
“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA Principal Deputy Commissioner Amy Abernethy said.
FDA’s working quickly to further clarify our regulatory approach for products with cannabis/cannabis-derivatives like CBD while using all available resources to monitor the marketplace & protect public health by taking action as needed against companies. https://t.co/HB9IhG2qud
— Dr. Amy Abernethy (@DrAbernethyFDA) October 22, 2019
We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence. We plan to provide an update on our progress in this area in the near future.
— Dr. Amy Abernethy (@DrAbernethyFDA) October 22, 2019
“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”
Photo courtesy of Kimzy Nanney.
GOP Senator Links Medical Marijuana Claims To Tobacco Industry Advertisements
Sen. John Cornyn (R-TX) said on Tuesday that claims about the therapeutic potential of marijuana remind him of decades-old tobacco industry advertisements asserting that the product had medical benefits.
In a speech on the Senate floor, Cornyn discussed a hearing that the International Narcotics Control Caucus, which he co-chairs, will hold on Wednesday to explore the public health impacts of cannabis. He said it was especially important to hear from experts about the subject as more states legalize marijuana and members of Congress, as well as Democratic presidential candidates, push to end federal prohibition.
Senate Hearing To Focus On Marijuana And Health This Week – https://t.co/aPZczm3X75
— Senator John Cornyn (@JohnCornyn) October 21, 2019
The senator made clear he’s skeptical about marijuana’s health benefits.
“There’s no shortage of people who claim that marijuana has endless health benefits and can help patients struggling from everything from epilepsy to anxiety to cancer treatments,” he said. “This reminds me of some of the advertising we saw from the tobacco industry years ago where they actually claimed public health benefits from smoking tobacco, which we know as a matter of fact were false and that tobacco contains nicotine, an addictive drug, and is implicated with cancers of different kinds.”
“We’re hearing a lot of the same happy talk with regard to marijuana and none of the facts that we need to understand about the public health impact of marijuana use,” he said.
While Cornyn recognized there’s significant support for cannabis reform, he said that ” for the number of voices in support of legalization, there are even more unanswered questions about both the short- and long-term public health effects.”
He expressed concern about increased levels of THC concentration in cannabis products and stated that it’s “true that for some people that marijuana can indeed be addictive.”
“There’s simply a lack of scientific evidence to determine the link between marijuana and various health risks, and that’s something I would think Congress and the American people would want to know before we proceed further down this path,” Cornyn said. “We don’t know enough about how this could impair cognitive function or capacity or increase the risk of mental illness or perhaps serve as a gateway for other drugs that are even more damaging to the health of a young person.”
The senator made similar remarks during a conversation with a former White House drug czar in August. He said it was important to address the public health impacts of cannabis before moving forward with legislation that would protect banks that service marijuana businesses from being penalized by federal regulators.
“With increasing use and a growing number of states giving the green light for marijuana use, we need better answers,” he said.
The surgeon general and the director of the National Institute on Drug Abuse, along with several academics, are scheduled to testify at Wednesday’s hearing.
Photo courtesy of C-SPAN.
Michael J. Fox Parkinson’s Foundation Urges Congress To Pass Three Marijuana Research Bills
A leading advocacy group that’s dedicated to finding treatment options for Parkinson’s disease is backing three pieces of marijuana research legislation in Congress.
The Michael J. Fox Foundation (MJFF)—named after the actor, who has Parkinson’s and established the nonprofit—said last week that lifting barriers to cannabis research, including rescheduling the plant under the Controlled Substances Act (CSA), is necessary to promote studies verifying marijuana’s potential therapeutic benefit for conditions such as Parkinson’s patients.
“The MJFF supports increased access to cannabis for medical research. Congress has begun to recognize this need, and there are several bills in the U.S. House and Senate designed to remove barriers that impede safe and legal access to cannabis by medical researchers,” the foundation said on its website. “The MJFF public policy team is tracking these bills and working to educate members of Congress and their staff on their importance to the Parkinson’s community.”
MJFF said it’s in favor of three marijuana bills, which would accomplish the following:
—Require the Justice Department to approve additional manufacturers for research-grade cannabis.
—Protect research institutions that conduct studies on marijuana.
—Authorize the U.S. Department of Veterans Affairs (VA) to inform patients about opportunities to participate in federally authorized cannabis studies.
—Require VA to conduct studies into the therapeutic potential of marijuana in the treatment of various conditions that commonly afflict veterans such as chronic pain and post-traumatic stress disorder.
—Reschedule marijuana from Schedule I to Schedule III under the CSA.
—Free up universities to conduct studies on cannabis by removing certain regulatory requirements.
In a letter to the Senate sponsor of that last piece of legislation, Sen. Dick Durbin (D-IL), in June, the foundation stated that marijuana’s current classification under federal law and the inadequate quality of cannabis grown at the only federally authorized manufacturing facility has meant that “researchers do not have the proper materials to conduct the necessary research.”
The foundation noted that it has submitted comments to the Food and Drug Administration arguing in favor of rescheduling in 2018 and 2019. It also applauded the Drug Enforcement Administration for announcing that it would take steps to approve additional federal cannabis farms for research.
“Current policies hinder comprehensive medical research on cannabis, making it difficult to generate the evidence needed for clear recommendations,” Andrew Koemeter-Cox, MJFF’s associate director of research programs, said. “This is especially problematic when some products may be unsafe for human use and have the potential for adverse interactions with other medications.”
Ted Thompson, the nonprofit’s senior vice president of public policy, said that removing barriers to research “is one way in which Congress can help scientific researchers determine what the benefits of medical cannabis might be for Parkinson’s disease.”
“Our role on the public policy team is to work with Congress and the administration to ensure there is access and funding for research and care initiatives that can benefit people living with Parkinson’s and, right now, that includes access to medical cannabis for research,” he said.
Photo courtesy of Brian Shamblen.