WARNING LETTER
Cannafyl
MARCS-CMS 611957 —
March 01, 2021
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Mr. Edward Chaney
Cannafyl
7595 E. McDonald Dr., Suite 140
Scottsdale
,
AZ
85250
United States
info@cannafyl.com
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
March 1, 2021
RE: 611957
Dear Mr. Chaney:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://cannafyl.com in November 2020 and has determined that you take orders there for various human and animal products, all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/; these websites direct consumers to your website https://cannafyl.com to purchase your products. In addition, the FDA has observed that your website offers CBD-containing products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
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in people. The claims on your website and social media websites establish that all strengths and varieties of your “Balance CBD Drops,”
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“Relief CBD Drops,”
3
“Relax CBD Drops,”
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and “Relief CBD Salve”
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(hereinafter all referred to as “your CBD-containing products for humans”) 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, your CBD-containing products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). In addition, your “Pet CBD Drops”
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is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
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In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.
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Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
You can find specific information about how FDA regulates CBD at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
Dietary Supplement Labeling
Information on your website at https://canafyl.com/ indicates that you intend to market your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” as dietary supplements. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). 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.
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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. 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.
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Unapproved New Drugs
Based on our review of your website and social media websites, your CBD-containing products for humans 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 websites that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your website homepage https://cannafyl.com:
“CBD MAY HELP YOU WITH . . . Epilepsy[,] Multiple Sclerosis (MS)[,] Amyotrophic Lateral Sclerosis (ALS)[,] Parkinson’s[,] Inflammation[,] Dementia[,] Depression[,] Bacterial Infections[,] Diabetes[,] Rheumatoid Arthritis[,] Substance Abuse/Withdrawal[,] Heart Disease[,] Irritable Bowel Syndrome (IBS) . . . ADHD[,] Schizophrenia”
On your website https://cannafyl.com/blog/cbd-for-breast-cancer/: October 10, 2020 blog posting titled “CBD for Breast Cancer”:
“How CBD helps manage Cancer Growth . . . One of the many reasons Cannafyl decided to make a full spectrum CBD product is the research shown that having all of the cannabinoids working together synergistically provides that extra component that cancer patients fear the most, will my cancer return? Here are a few of the cannabinoids in a full spectrum CBD that are working overtime to inhibit cancer cell growth: CBD: Inhibits Tumor Cell Growth and Cancer Growth[,] CBG: Inhibits Cancer Growth[,] CBGv: Kills Cancer Cells[,] CBC: Inhibits Tumor Cells and Cancer Growth[,] THCa: Inhibits Cancer Cells”
On your website https://cannafyl.com/blog/cbd-for-opioid-addiction-withdrawal/: August 21, 2020 blog posting titled Can CBD Help with Opioid Addiction and Withdrawals?”:
“Can CBD Help Treat Opioid Addiction?” In particular, CBD has been shown to aid in the reduction of drug-seeking behavior. Because CBD may provide relief for a cross-section of symptoms – like . . . mood or anxiety disorders . . . CBD Solutions to Opioid Addiction[,] CBD has been shown to reduce anxiety and control cravings for opioids. . . . Studies have shown CBD may help reduce cravings and reduce opioid withdrawal symptoms. . . . This is why we have decided to create the Cannafyl Relief blend for those who are going through withdrawal symptoms.”
On your website https://cannafyl.com/blog/researchers-explore-how-cbd-might-positively-affect-covid-19/: August 12, 2020 blog posting titled “Researchers Explore how CBD Might Positively Affect COVID-19”:
“While researchers continue to explore several ways to fight against COVID-19, some are diving a little deeper to see if cannabis derived CBD could possibly benefit those that are suffering from severe forms of this infection. Further research has suggested that CBD is perhaps able to reduce the angiotensin-converting enzyme 2 (ACE2) expression, which is used as a cell receptor to invade human cells. . . . At Cannafyl we formulated a full-spectrum CBD infused with natural terpenes and essential oils giving you all the health benefits that a CBD product can provide, and the great news is you don’t need that much CBD to receive all of the health benefits. This is why we decided to create the Cannafyl Balance blend for your every day [sic] needs. This blend has specific terpenes that help with improving your mood, boosts energy, and also improves focus and memory, plus gives your immune system a great daily boost!”
On your website https://cannafyl.com/cbd-oil/cbd-relief-salve-full-spectrum-cbd/: product webpage for Relief CBD Salve:
“Cannafyl™ CBD Relief Salve – 500mg & 1000mg is a revolutionary full-spectrum CBD topical salve formulated to help relieve . . . neuropathy, psoriasis and much more!”
On your Facebook social media website at www.facebook.com/cannafyl: November 15, 2020 posting:
“CBD FOR HYPERTENSION? Check out this informative article that looks into the benefits of CBD on wellness. https://cannafyl.com/blog/cbd-oil-for-blood-pressure/ #cannafylcbd . . . #cbdforhypertension . . . #hypertension #highbloodpressure . . ..”
On your Twitter social media website at https://twitter.com/cannafyl: October 20, 2020 posting:
“Linalool – Found in our RELAX and RELIEF signature blends. visit our website cannafyl.com for info, blog, podcasts and videos on the benefits of CBD” accompanied by a graphic displaying the text “Linalool . . . it has very strong sedative and relaxing properties. Patients suffering from . . . depression, seizures . . . and even cancer, have all found aid in this amazing terpene.”
Your CBD-containing products for humans are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, 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. There are no FDA-approved applications in effect for any of the above-mentioned products.
Misbranded Drugs
Your CBD-containing products for humans 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. (See 21 CFR 201.5.) The aforementioned 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. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that 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, because no FDA-approved applications are in effect for your products. The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
During our review of your website, https://cannafyl.com, and your social media websites, www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/, FDA determined that your firm is marketing the unapproved new animal drug “Pet CBD Drops.” Based on our review of your website and social media websites, your “Pet CBD Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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, this product is an unapproved new animal drug and marketing it violates the FD&C Act.
Examples of claims observed on your website https://cannafyl.com, and your social media websites, www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/ that establish the intended use of your “Pet CBD Drops” as a drug include, but are not limited to, the following:
On your product webpage for “Pet CBD Drops” at https://cannafyl.com/cbd-oil/cbd/:
• “Cannafyl™’s Pet Full Spectrum CBD Tincture can help calm your dog, relieve separation anxiety and may help alleviate a variety of health issues such as arthritis and other ailments.”
• “What it does: This CBD Oil helps with anxiety, epilepsy, seizures, along with pain and inflammation.”
• “This quality makes a Full Spectrum CBD an appealing option for those who are looking for relief from pain and other symptoms…”
• “…it may ease symptoms of ailments like chronic pain and anxiety.”
On your webpage https://cannafyl.com/blog/how-cbd-can-help-your-dog/: February 10, 2020 blog posting titled “How CBD Can Help Your Dog”:
• “We have had many pet owners rave over our Cannafyl Pet full-spectrum CBD Tincture Oil, and say that this helps their best friends with pain, inflammation, cancer, and even anxiety!”
• “Cannabidiol is actually an antioxidant, which helps prevent and kill off cancer and tumor cells. This may greatly benefit dogs that are experiencing any sort of cancer treatment by helping with pain relief, effects of radiation therapy, or helping control tumor growths.”
• “When it comes to cancer spreading within the body, CBD may help treat or prevent many types of cancer such as:
o Lymphoma: Cancer in the lymph nodes
o Osteosarcoma: Cancer in the bones
o Melanoma: Cancer in the skin that spreads aggressively
o Hemangiosarcoma: cancer in blood vessels
o Mammary Gland Carcinoma: Cancer in mammary glands”
On your Facebook and Instagram social media websites at www.facebook.com/cannafyl and www.instagram.com/cannafylcbd/, respectively, January 16, 2021 postings:
“CANNAFYL Signature Pet blend focuses relief on our furry friends. Whether young or old, anxious or hurting, CANNAFYL Pet can help… #petcbd #petanxiety #petpain #nosideeffects #naturalhealingforpets #olderpets #puppyanxiety #separationanxietyinpets #reliefforpets #cannafylcbd…”
On your Twitter and Facebook social media websites at https://twitter.com/cannafyl and https://facebook.com/Cannafyl/, respectively, November 17, 2020 postings:
“I am so glad I found Cannafyl for Pets. I have a puppy at heart (13yr senior chi/mix). Being a small dog she is more prone to arthritis, disk degenerative disease… and luxating patella… Once we got her started on the guided regime within a few weeks we were seeing improvement in her… pain management…”
Your “Pet CBD Drops” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is 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. This product is not approved or index listed by the FDA, and therefore this product is 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 this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. 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.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Eric Nelson
/S/
Director of Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
____________________________
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As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
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“Balance CBD Drops” is sold in 500 mg and 1000 mg container amounts, and consumers can choose 15 mL or 30 mL bottles for each.
3
“Relief CBD Drops” is sold in multiple container amounts, including 500 mg, 1000 mg, 1500 mg, 2500 mg, and 4000 mg, and consumers can choose 15 mL or 30 mL bottles for each.
4
“Relax CBD Drops” is sold in multiple container amounts, including 500 mg, 1000 mg, and 1500 mg, and consumers can choose 15 mL or 30 mL bottles for each.
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“Relief CBD Salve” is sold in 500 mg and 1000 mg container amounts, and consumers can choose 1 oz. or 2 oz. containers for each.
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“Pet CBD Drops” is sold in a 500 mg container amount, and consumers can choose 15 mL or 30 mL bottles.
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Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
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Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
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CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See
GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome
). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
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We also note that the labeling for your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” recommends sublingual administration (under the tongue). The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the FD&C Act as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through mucosal tissues, they are not intended for ingestion. Therefore, your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” products do not meet the definition of a dietary supplement under the FD&C Act for this additional reason.
Content current as of:
03/09/2021
Regulated Product(s)
Animal & Veterinary
Drugs