CBD Oil For Dogs Fda Approved

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Cannabis products are all the rage, and we’re seeing CBD products everywhere—including pet shops. So what’s the deal with CBD? Are there any safety concerns? Find out more! The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD. What's the latest on CBD oil for dogs? For your dog's health and happiness, get the facts, pros, and cons about CBD for dogs from Dr. Buzby.

CBD Oil For Dogs Fda Approved

Anywhere you look nowadays, you’re bound to spot something about marijuana and its components CBD (cannabidiol) and THC (tetrahydrocannabinol). With medical marijuana now legal in over half the states, and an increasing number of states legalizing recreational marijuana, there’s been a rise in CBD products (like oils and treats) in mainstream shops and retail chains. And recently, the trend has carried over to our four-legged-friends.

This is leading pet owners to ask: If marijuana or CBD is helpful for some people, can it help my pet? The ASPCA Animal Poison Control Center (APCC) weighs in on this trending topic.

A Little Background

One of the first things to understand is a breakdown of the properties associated with marijuana and CBD. Marijuana, also known as Cannabis Sativa, is a plant. In the cannabis plant, both THC and CBD can be found to varying degrees. The plant contains many compounds, but the one it is most recognized for is THC. THC is considered a psychoactive substance, which means that it is a chemical that changes how the brain functions, and thus can cause alterations in perception, mood, consciousness or behavior. Lately, however, CBD has been getting more and more attention for its potential therapeutic and pain management effects.

What We Know

Unfortunately, there are many unanswered questions about the effects of marijuana and CBD in pets. But research into these effects is underway. Studies are slowly being done to look at the potential benefits of CBD for controlling pain from conditions such as osteoarthritis, calming anxious pets and if it may help with treating epilepsy in dogs.

Like with any product, you should consult with your veterinarian to determine if CBD products are right for your pet, and what the proper dosage should be. There’s a lot of information online that can be misleading, and consulting with a professional should always be your first step. That’s especially important if your pet is on other medications. Mixing medications and substances can affect animals’ livers. Just like with any medication or pet product, you want to be careful of overdosing your pet and be sure to keep any CBD products safely up and out of paws’ reach.

Legal Tangles

The laws around use of cannabis in people and pets have been slow in keeping up with public opinion. The DEA still considers marijuana a Schedule I drug, meaning it is not considered to have any medical use.

Even in states where medical marijuana is legal for people, it is not legal for pets. CBD is regulated by the FDA and currently there are no FDA approved CBD products for pets. In 2018, hemp, a cannabis plant that naturally has less than 0.3% THC, was taken off the federal controlled substances list.

Many companies are marketing products to pets as hemp-based products to skirt the current legal status of marijuana and CBD for pets. However, since these products are not FDA approved, they do not undergo the same quality control measures as medications do, which could potentially prove to be problematic.

What’s Next

With public opinion largely being positive for marijuana and CBD, states are starting to look more closely at the laws and starting to reconsider them. Furthermore, with the added attention, more studies are looking at the potential effects and benefits CBD and marijuana may hold for pets. Many veterinarians are recommending CBD oils and treats for animals with certain conditions, and the popularity of this growing trend doesn’t seem to be slowing down any time soon.

APCC will stay on top of new studies and research as they develop, and keep you informed to help keep your pets happy and healthy.

If you suspect your pet has been exposed to any poisonous substances or ingested something dangerous, contact your veterinarian or call Animal Poison Control Center (APCC) at 888-426-4435 immediately.

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

  • Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
  • Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
  • The FDA has approved only one CBD product, a prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
  • It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
  • 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.
  • Some CBD products are being marketed with unproven medical claims and are of unknown quality.
  • The FDA will continue to update the public as it learns more about CBD.

Potential harm, side effects and unknowns

  1. CBD has the potential to harm you, and harm can happen even before you become aware of it.
    • CBD can cause liver injury.
    • CBD can affect how other drugs you are taking work, potentially causing serious side effects.
    • Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
    • Male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, has been reported in studies of animals exposed to CBD.
  2. CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced.
    • Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
    • Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
    • Changes in mood, most commonly experienced as irritability and agitation.
  3. There are many important aspects about CBD that we just don’t know, such as:
    • What happens if you take CBD daily for sustained periods of time?
    • What level of intake triggers the known risks associated with CBD?
    • How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
    • What is the effect of CBD on the developing brain (such as on children who take CBD)?
    • What are the effects of CBD on the developing fetus or breastfed newborn?
    • How does CBD interact with herbs and other plant materials?
    • Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
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Unanswered questions about the science, safety, and quality

You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.

The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.

Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.

The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:

  • Liver Injury: During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of two rare and severe seizure disorders — the FDA identified certain safety risks, including the potential for liver injury. This serious risk can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling. Although this risk was increased when taken with other drugs that impact the liver, signs of liver injury were seen also in patients not on those drugs. The occurrence of this liver injury was identified through blood tests, as is often the case with early problems with the liver. Liver injury was also seen in other studies of CBD in published literature. We are concerned about potential liver injury associated with CBD use that could go undetected if not monitored by a healthcare provider.
  • Drug Interactions: Information from studies of the FDA-approved CBD drug Epidiolex show that there is a risk of CBD impacting other medicines you take – or that other medicines you take could impact the dose of CBD that can safely be used. Taking CBD with other medications may increase or decrease the effects of the other medications. This may lead to an increased chance of adverse effects from, or decreased effectiveness of, the other medications. Drug interactions were also seen in other studies of CBD in published literature. We are concerned about the potential safety of taking other medicines with CBD when not being monitored by a healthcare provider. In addition, there is limited research on the interactions between CBD products and herbs or other plant-based products in dietary supplements. Consumers should use caution when combining CBD products with herbs or dietary supplements.
  • Male Reproductive Toxicity: Studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. The changes seen include decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone, among others. Because these findings were only seen in animals, it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD. For instance, these findings raise the concern that CBD could negatively affect a man’s fertility. Further testing and evaluation are needed to better understand this potential risk.

In addition, CBD can be the cause of side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.

The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:

  • Cumulative Exposure: The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week or a month?
  • Special Populations: The effects of CBD on other special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
  • CBD and Animals: The safety of CBD use in pets and other animals, including considerations of species, breed, or class and the safety of the resulting human food products (e.g., meat milk, or eggs) from food-producing species.

Unproven medical claims, unsafe manufacturing practices

Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices

Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.

Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.

In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).

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CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.

The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.

Evaluation of the regulatory frameworks

The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds

The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.

We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.

The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.

The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.

Our Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make informed choices about CBD products. Also, as the regulatory pathways are clarified we will take care to inform all stakeholders as quickly as possible.

CBD Oil for Dogs: Facts, Benefits, Concerns [2022]

What are the benefits of CBD oil for dogs? What are the concerns about CBD and dogs? CBD oil has become an increasingly hot topic in human medicine and veterinary medicine. Integrative veterinarian Dr. Julie Buzby breaks down the pros and cons. Get the latest facts, concerns, and benefits that dog parents need to know.

CBD oil for dogs: a rapidly changing landscape

In 2018, the FDA approved the first naturally derived CBD product, Epidiolex®, for controlling severe seizures in children. The research behind CBD oil for veterinary use is slowly growing, but the legal aspects remain complicated and messy.

Our veterinary team at Dr. Buzby’s—The Senior Dog Company has been researching CBD oil for dogs. For years, we’ve been discussing up-to-date information with veterinary colleagues, interviewing experts in the field, and attending lectures at veterinary conferences. At the state and federal level, information changes frequently. So much so, that it feels like it’s almost daily.

This impacts veterinarians’ ability to recommend CBD for their canine patients and discuss it with clients. Though the landscape is rapidly changing, we’re proud to share what we currently know regarding CBD and dogs.

What is CBD?

Let’s start with the basics. There are over 113 different naturally occurring compounds that can be derived from the hemp plant, Cannabis sativa. The two most well-known compounds are delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Different strains of the same hemp plant can have different levels of THC and CBD. Interestingly, the body (human and animal) has different receptors for both THC and CBD.

THC is the compound we associate with marijuana. It is responsible for the psychoactive effect, or “high” feeling after an individual smokes or cooks the marijuana plant. THC binds to CBD1 receptors in the brain that are associated with emotions, coordination, movement, memories, appetite, and pain. CBD1 receptors also are present throughout the body. THC products can be toxic to dogs in high enough doses.

CBD, on the other hand, does not have the same effects on the brain as THC. The majority of the receptors for CBD (CBD2 receptors) are associated with the immune system. When CBD binds to these receptors, it can help decrease pain and inflammation as well as trigger the body to produce its own cannabinoids, which can decrease pain.

Limiting the amount of THC in hemp

The Farm Bill, signed on December 20, 2018, legalized the production of the hemp plant as long as it contains less than or equal to 0.3% THC on a dry weight basis. This means that hemp with less than 0.3% THC is no longer considered a controlled substance.

Additionally, the USDA published the final rule regulating the production of hemp in the U.S. in January 2021. The final rule established requirements for licensing and testing THC concentrations in hemp. The goal is to encourage growing hemp of known chemical concentrations to stabilize CBD and THC concentrations in CBD products.

Keep in mind that legality varies at the state level. As you’re probably aware, state laws regarding marijuana are changing all the time.

What are the potential health benefits and uses of CBD oil in canine patients?

What are the pros or potential health benefits of CBD oil for dogs? Let’s discuss.

First of all, in human medicine, CBD oil is being studied and used for chronic pain management, epilepsy, cancer, anxiety, and many other uses. Regarding chronic pain, a study done in mice and rats showed that CBD oil helped reduce inflammation. Also, in a study done on humans, CBD oil reduced the use of opioids (oxycodone, for example) by 64%.

Preliminary research done in cancer cells shows that CBD may be involved in blocking the signals for reproduction in cancer cells. Finally, CBD may have benefits for patients with anxiety disorders by increasing dopamine. (It is worth noting that THC has the potential to make anxiety worse by increasing paranoia.)

The following two benefits have studies to back them up:

1. Research study on CBD and dogs shows it may help manage seizures.

In dogs, two studies have recently been published regarding CBD use for seizures and pain management.

A study by Colorado State University’s College of Veterinary Medicine showed an 89% reduction in seizures in dogs with seizure disorders. The study itself was very small—only nine dogs in the treatment group and seven dogs in the placebo group. However, it does demonstrate that CBD oil may help manage seizures in dogs. Colorado State University is currently conducting a larger study to more thoroughly evaluate CBD use in seizure dogs.

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2. Research study shows improvement for dogs with arthritis.

Pet parents who have used CBD oil in their pets have reported improvements in gait, sleep, and appetite. Researchers at Cornell University College of Veterinary Medicine evaluated the use of CBD oil in dogs using the gold standard double-blind study. This means both the researchers and the dog owners did not know which treatment the dog was getting. Theoretically, the results are more accurate from a scientific basis.

Of the 22 dogs with arthritis enrolled in the study, 16 dogs ultimately finished the trial. Dogs received either CBD oil or a placebo oil (olive oil mixed with anise and peppermint oil to have the same scent as the CBD oil) for four weeks, followed by a two-week washout period, then the opposite treatment for four more weeks. In this manner, all dogs were given both CBD oil and “sham” oil for one month each.

Dogs were evaluated based on owner questionnaires, veterinary physical exams, Canine Brief Pain Inventory score, Hudson activity score, and blood work (CBC and biochemical profile).

It is important to note that the dogs included in the study were allowed to stay on current medications such as NSAIDs (examples include Rimadyl, Meloxicam, Deramaxx, etc.), fish oil supplements and/or glucosamine/chondroitin supplements—as long as there were no changes made within the four weeks up to the study or during the ten weeks of the study. However, dogs were taken off Tramadol for dogs and/or Gabapentin for dogs two weeks prior to starting the research.

The study yielded two key pieces of information:
  • First, dogs on CBD oil showed an improvement in their arthritis symptoms compared to dogs on the placebo oil.
  • Second, CBD oil was safely used concurrently with traditional arthritis management medications such as anti-inflammatory medications.

What are the concerns regarding CBD oil?

What the cons of CBD oil for dogs? There are five concerns regarding giving your dog CBD oil.

1. All CBD oil is not alike.

Because CBD oil is sold as a supplement, products are not subject to the same tight regulations and standards as pharmaceuticals approved by the FDA. There can be marked discrepancy in the CBD concentration reported on the label versus the CBD concentration in the actual product.

Why is this so important? When the CBD concentration differs from the actual product, a dog is at risk of being under or over dosed .

Three different types of CBD are available: full spectrum, broad spectrum, and isolate. Full spectrum hemp products contain THC, so should be avoided for use in dogs.

CBD oil for dogs products may be human grade, contain natural ingredients, be organic, vegan, etc. These factors do not necessarily indicate whether they are good or bad pet products.

2. CBD concentrations may vary significantly from the amount specified on the label.

The FDA issued warnings in 2015-2017 to certain companies for the CBD concentration not matching the labeled amount. A study in the Journal of the American Medical Association (JAMA) evaluated different CBD extracts online and allowed for the amount on the label to vary by 10%. 43% of products had a higher concentration than what was on the label and 26% had a lower amount than specified on the label.

3. Arsenic and other toxins may contaminate CBD oils.

Depending on how it is harvested and processed and what additives or preservatives are used, CBD oils are at risk for contamination. This includes:

  • Mycotoxins (a deadly toxic substance produced by a fungus)
  • Pesticides
  • Heavy metals including arsenic

However, you can request a Certificate of Analysis from the company. This document should include a cannabinoid profile with test results showing the concentration of cannabinoids in the product, antimicrobial analysis, pesticide analysis, and elemental analysis to screen for lead and arsenic.

If you use a CBD product for your dog, make sure to check the ingredients. CBD oil products should be comprised of cannabanoid oil and a carrier oil such as hemp seed oil.

4. CBD oil is a legal “grey zone” for veterinarians.

CBD oil falls into a legal grey zone with the Drug Enforcement Administration (DEA), federal, and state regulations. Although the 2018 Farm Bill allowed for the production of specific hemp products, some states still ban CBD oil.

In the eyes of the DEA, marijuana and hemp are federally categorized as Schedule I drugs under the Controlled Substances Act, defined as having a high potential for abuse and no medical use. (Also on the list are Heroin and LSD, to give you a frame of reference.) However, state governments are given authority to determine if they will allow marijuana and hemp-based products to be manufactured and sold inside their state borders.

The Schedule I categorization by the DEA makes CBD the elephant in the exam room, so to speak. Many of my veterinary clients with senior canine companions suffering from osteoarthritis in dogs are asking me about pet CBD oil. Yet my hands are theoretically tied in recommending or prescribing the product. Why? Because according to federal law, medical professionals may not write prescriptions for Schedule I substances, and violators are subject to criminal prosecution.

Always make sure the read the label of your CBD product to ensure your pet is getting a quality product.

5. There is no FDA-approved veterinary CBD oil for dogs.

This categorization also makes research more difficult because there are extra hoops for researchers to jump through for Schedule I drugs. Further, there also is no veterinary CBD oil approved by the FDA. So state veterinary licensing boards default to holding veterinarians responsible for the guidelines established by the DEA. As a result, the American Veterinary Medical Association discourages veterinarians from even discussing CBD oil with pet owners due to legal concerns.

Promising results from dog owners

Anecdotally, a couple dozen of my patients are on CBD oil, in every case because their proactive owners heard about the product and decided to try it for their arthritic dogs. The dog owners have acquired CBD oil from a host of interesting sources—online, a relative, and a local lady who recently opened a side business selling CBD.

My veterinary clients pepper me with questions about how much CBD oil to give their dogs, safety concerns of using it along with other drugs their dogs take, and risks of long-term continual dosing. I apologize to my clients and defer their questions. Not because I am under a legal gag order but because I genuinely don’t (yet) have a lot of answers.

What can we hope for in the future regarding CBD oil for dogs?

Laws have significantly relaxed regarding hemp and cannabinoid products over the past several years. As more states change their laws regarding cannabinoids, more doors should hopefully open for veterinary use of these products.

Also, we’ve seen studies published indicating that CBD oil may have benefits in seizure and pain management for dogs. These are huge strides. Hopefully, laws will continue to relax to allow veterinarians to discuss CBD oil with their clients and to allow for more veterinary research.

Finally, we hope there will be more oversight for product quality and control so that consumers know they are getting a pure, safe product.

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