- What are cannabinoids?
- F.D.A. warning letter to Curaleaf Inc. about its “unsubstantiated claims”
- Unapproved New and Misbranded Human Drug Products
- Additional claims observed on your website in June 2019 include, but are not limited to, the following:
- Dietary Supplement Labeling
- Unapproved New Animal Drugs
- When FDA warns
- F.D.A. approved Epidiolex
- Like this:
Cannabidiol (CBD) oil comes from the Cannabis plant( Hemp). In India, it is called Bhang or Ganja
What are cannabinoids?
Cannabinoids are chemicals related to delta-9-tetrahydrocannabinol (THC), marijuana’s main mind-altering ingredient that makes people “high.” The marijuana plant contains more than 100 cannabinoids. Scientists as well as illegal manufacturers have produced many cannabinoids in the lab. Some of these cannabinoids are extremely powerful and have led to serious health effects when misused.
F.D.A. warning letter to Curaleaf Inc. about its “unsubstantiated claims”
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
July 22, 2019
Joseph Lusardi, President
301 Edgewater Place
Wakefield, MA 01880
Dear Joseph Lusardi:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://curaleafhemp.com in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).1 We have also reviewed your social media websites at http://www.facebook.com/CuraleafHemp and https://twitter.com/curaleafhemp; these websites direct consumers to your website, https://curaleafhemp.com, to purchase your products. FDA has determined that your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Unapproved New and Misbranded Human Drug Products
Based on our review of your website, your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products 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 and/or intended to affect the structure or any function of the body.
Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your product webpage for CBD Disposable Vape Pen (Relieve):
• “[F]or chronic pain.”
On your product webpage for CBD Tincture (Relieve):
• “oothing tincture for chronic pain.”
Additional claims observed on your website in June 2019 include, but are not limited to, the following:
On your webpage titled “Can CBD Oil be Used for ADHD?”
• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety . . . ADHD.”
• “The Benefits of CBD Oil for ADHD . . . It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”
On your webpage titled “How to Use CBD Oil for Anxiety”
• “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”
• “CBD oil can be used in a variety of ways to help with chronic anxiety.”
On your webpage titled “CBD Benefits: Top 5 Research-Backed Benefits of CBD”
• “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD has been linked to the effective treatment of Alzheimer’s disease . . ..”
• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
• “CBD has been demonstrated to have properties that counteract the growth of spread of cancer.”
• “CBD was effective in killing human breast cancer cells.”
• “Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol.”
On your webpage titled “Hemp Oil vs. CBD Oil: Everything You Need to Know”
• “CBD . . . can be used to help manage a wide range of health conditions, such as . . . Anxiety and depression . . . Chronic or arthritic pain . . ..”
On your webpage titled “How to Choose the Best CBD Oil for You”
• “Some of the most common reasons to use CBD oil include . . . Chronic pain . . . Mental conditions like anxiety, depression, and PTSD . . ..”
On your webpage titled “Is CBD Oil Good for Depression?”
• “A 2014 study showed that participants who received CBD oil experienced anti-anxiety and anti-depression effects from the oil.”
• “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”
On your webpage titled “What are the Benefits of Hemp-Derived CBD Oil?”
• “What are the benefits of CBD oil? . . . Some of the most researched and well-supported hemp oil uses include . . . Anxiety, depression, post-traumatic stress disorders, and even schizophrenia . . . Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
On your Facebook Social Media Account:
• April 8, 2019 posting – “CBD Can be a powerful ally if you’re suffering from chronic inflammation and pain.”
• March 14, 2019 posting – “The top five research backed benefits of CBD include: 1) neuro[de]generative disease 2) depression and anxiety treatment 3) pain treatment 4) aids in the treatment of cancer and related symptoms to cancer . . ..”
On your Twitter Social Media Account:
• March 27, 2019 posting – “#ICBD to help lower anxiety . . ..”
March 25, 2019 posting – “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended, 21 CFR 201.5. Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Dietary Supplement Labeling
Information on your website and social media accounts suggests that you may intend to market your CBD products as dietary supplements. For example, a disclaimer on your website includes the statement “Cannabidiol (CBD) is a natural constituent of industrial hemp and is a dietary supplement.” You also display a photo of a CBD product with a supplement facts panel that appears to be your “CBD Tincture” (Relax version) on your social media accounts. Furthermore, you state under the disclaimer section on your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products’ webpages that “Cannabidiol (CBD) . . . is a dietary supplement.” Based on these observations, it appears you intend to market your CBD products as dietary supplements. However, they cannot be dietary supplements because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).
FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.2 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Furthermore, your “CBD Lotion” product’s labeling states that it is intended to be applied directly to the skin; your “CBD Pain-Relief Patch” product’s labeling states that it is intended to be applied to the body for transdermal use; and your “CBD Disposable Vape Pen” products’ labeling states that they are intended for inhalation. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason why your “CBD Lotion,” “CBD Pain-Relief Patch,” and “CBD Disposable Vape Pen” products do not meet the definition of a dietary supplement under the FD&C Act. Furthermore, with respect to your “CBD Tincture” products, the “Suggested Use” section of these products’ labeling includes both “edible” uses and topical uses. To the extent that your “CBD Tincture” products are intended for a delivery method other than ingestion, as evidenced by the labeling describing topical uses, this is an additional reason why these products also do not meet the definition of a dietary supplement under the FD&C Act.
Unapproved New Animal Drugs
During a recent review of your firm’s website (https://curaleafhemp.com/collections/pet-drops), FDA determined that your firm is marketing “Bido CBD for Pets” (Pure, Bacon and Salmon Flavor), which are unapproved new animal drugs. Based on our review of the information provided, we determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. 321(g)(1)(B). Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.
Examples of claims observed on your firm’s website (https://curaleafhemp.com/blogs/cbd) that show the intended uses of these products include, but are not limited to, the following:
Found at: https://curaleafhemp.com/blogs/cbd/reasons-to-use-cbd-oil-for-dogs
• “Decrease compulsive behavior like biting, scratching, chewing, whining, eliminating, and other symptoms of dog separation anxiety”
• “Decrease autonomic arousal symptoms like fast/irregular heartbeat, panting, and general distressed feelings”
• “Alleviate fear feelings”
• “Prevent the longer-term health effects of anxiety”
• “CBD may help with cat anxiety” (https://curaleafhemp.com/blogs/cbd/cbd-oil-for-cats )
• “It’s natural, safe and will allow your dog to play, eat, and do other things dogs enjoy without the symptoms of anxiety.” (https://curaleafhemp.com/blogs/cbd/cbd-for-dog-separation-anxiety)
• “vets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.” (https://curaleafhemp.com/blogs/cbd/how-much-cbd-oil-should-i-give-my-dog )
• “Relief of seizures and neurological problems” (https://curaleafhemp.com/blogs/cbd?page=2 )
• “Soothing of trauma and anxiety” (https://curaleafhemp.com/blogs/cbd?page=2 )
• “For dogs with arthritis and other joint issues, the American Kennel Club reports that CBD treats inflammation in the muscle tissue and joints—which works to improve the overall musculoskeletal system.”
• “…this helps take pressure away from the surrounding nerve endings and directly reduces pain.”
• “Pain relief from cancer or after surgery”
• “Relief of muscle spasms”
• “Recently published research confirms that CBD helps dogs with osteoarthritis. All dogs in the trial showed marked improvement in their overall activity levels and apparent pain levels. So it’s believed that CBD would provide the same results for cats with arthritis or inflammation.”
Found at: https://curaleafhemp.com/blogs/cbd/cbd-oil-for-cats
Found at: https://curaleafhemp.com/blogs/cbd/is-cbd-oil-safe-for-dogs
“What are the benefits of using CBD oil for your pets?…..
•Pain relief from arthritis and aging”
Found at: https://curaleafhemp.com/blogs/cbd/cannabis-oil-dog-cancer
• “CBD oil can help relieve cancer pain and spasms”
• “CBD oil may slow the growth of cancer”
Found at: https://curaleafhemp.com/blogs/cbd?page=9
• “…it has been found to assist in the reduction of tumor size while stunting the potential spreading of cancer through the body.”
• “Chemotherapy, radiation treatments, and surgery can quickly push into the tens of thousands of dollars. While you may not be able to afford such cancer treatments for your dog, CBD oil is a viable and inexpensive alternative.”
• “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.” (https://curaleafhemp.com/blogs/cbd?page=3 )
• “…CBD oil has been clinically shown to help manage the symptoms of cancer treatment, which can improve a patient’s quality of life.” (https://curaleafhemp.com/blogs/cbd?page=3 )
Found at: https://curaleafhemp.com/blogs/cbd/how-much-cbd-oil-should-i-give-my-dog
• “Many dogs, especially those with thinner, shorter coats, suffer from skin conditions. Whether due to allergies or the weather, CBD oil can help improve the overall quality of your dog’s skin.”
Because the products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B). Further, these products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l. These products are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to FDAADVISORY@fda.hhs.gov.
Donald D. Ashley
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Office of Compliance
Center for Veterinary Medicine
Food and Drug Administration
When FDA warns
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
F.D.A. approved Epidiolex
F.D.A. approved Epidiolex(purified CBD extract) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).
It is THC (and not CBD) that is the primary psychoactive component of marijuana.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.
Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.
Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.
The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.
The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.
The FDA granted approval of Epidiolex to GW Research Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- National Institutes of Health
- US Food and Drug