Download CBD: Health Benefits and Uses for Pain, Epilepsy, Anxiety, and More and more Lecture notes Marketing in PDF only on Docsity!
United States of America FEDERAL TRADE COMMISSION Washington, D.C. 20580
Mary K. Engle Associate Director
September 9, 2019
VIA FEDERAL EXPRESS
Jared Forbush 4Bush Holdings, LLC 318 West 250 South Kaysville, UT 84037-
Dear Mr. Forbush:
The Federal Trade Commission ("FTC") is an independent federal agency whose mission is to maintain a competitive marketplace for the benefit of both businesses and consumers. The FTC seeks to protect consumers by enforcing laws and rules that promote truth in advertising and fair business practices, and by educating consumers and businesses about their rights and responsibilities. We are writing to express concern that you may be making false or unsubstantiated advertising claims about the health benefits of products containing cannabidiol (CBD), a chemical compound derived from the cannabis plant..
Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, prohibit unfair or deceptive advertising. Specifically, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies substantiating that the claims are true at the time they are made. This substantiation requirement applies whether the advertiser disseminates such health claims directly via traditional advertising or indirectly via the use of a product name, website name , or metatags. This requirement also extends to consumer endorsements. It' s not enough that an endorsement represents the consumer' s honest opinion or experience. Reasonable consumers may interpret an endorsement claiming a health benefit from the use of a product as representing that the product is likely to be effective in achieving that benefit. Under FTC law, an adverti ser must possess and rely on competent and reliable scientific evidence to support health claims, both express and implied, made through the use of endorsements.
FTC staff has reviewed your websites, including www.magicgreenoildrops.com, for potential violations of the FTC Act. We are concerned that one or more of the health benefit claims excerpted below may be false or not substantiated by competent and reliable scientific evidence.
Jared Forbush 4Bush Holdings, LLC September 9, 2019 Page 2
Excerpts from www.magicgreenoildrops.com
Complete Relief CBD - Clinically Validated Cannabidiol
SPECIAL REPORT: Woman Paralyzed By Pain Discovers
Breakthrough Relief Called 'Nature's Oxycontin' ....
Complete Relief CBD has been called "Nature's Oxycontin" because it quickly relieves even the most agonizing pain .... Many say it works like magic. Some say it works better than prescription painkillers like Vicodin and Oxycontin....
[Dr.] Jamie [Richardson] applied for a research grant to run the first ever FDA
approved clinical trial involving CBD. With the help of Harvard researchers and medical doctors, Jamie led a clinical trial studying the effects of CBD on pain and inflammation. The results were astonishing. Through their research, they discovered a multitude of other health benefits of CBD they never anticipated. Richardson 's team ran additional follow-up studies that concluded CBD is nothing short of a real medical miracle.
CBD has now been clinically proven to:
Reduce social anxiety, cognitive impairment, and discomfort in patients diagnosed with Generalized Social Anxiety Disorder (SAD) Decrease cancer spread by "turning off" genes involved in tumor development Combat neurodegenerative disorders like Alzheimer's by removing plaque that block neuron-signaling Reduces cigarette addiction by modulating the rewarding the effects of nicotine [R]estore respiratory stability to those experiencing sleep Apnea Clears acne by inhibiting lipid synthesis on the skin Regulates blood sugar and lowers insulin resistance Provide relief to those suffering from IBD (Chron's [sic] or Colitis) through its anti-inflammatory effects Improves symptoms of MS (multiple sclerosis) by providing durable protection to neurons Prevents obesity ....
[D r. Jamie Richardson] teamed up with his group of Harvard researchers to create Complete Relief CBD, a brand of medical grade CBD supplements developed through thousands of hours of research and clinical trials ....
Jared Forbush 4Bush Holdings, LLC September 9, 2019 Page
Excerpts from www.offer.firstclassherbalistcbd.com[... l; Linked from the "Get a Risk-Free Trial Today" Button
The Science of CBD (CANNABIDOIL)
CBD Oil has been medically proven to positively regulate your endocannabinoid system] addressing issues such as ... hypertension[] and even cardiovascular issues ....
- Psychological Benefits: .... [I]n some cases may offer a safe remedy for depression and bipolar disorders.
- Neurological Benefits: Our CBD Oil's positive impact on the neural system helps reduce age-related cognitive decline ....
REAL SUCCESS STORIES! "After a big cancer scare, I started taking CBD about 6 months ago and LOVE IT!
. My Oncologist said whatever you are doing to keep doing it. I have used a few brands and my favorite is by far Herbalist Oils CBD. My energy is slowly coming back and I feel wonderful." - Kandi
We strongly urge you to review all claims for your products, including consumer testimonials, and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a federal district court injunction or an administrative cease and desist order. An order also may require that you refund money to consumers.
With regard to the advertising claims discussed above, please notify staff attorney Keith Fentonmiller via electronic mail at kfentonrniller@ftc.gov within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC staff's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Fentonrniller at 202-326-2775.
Very truly yours, ·--vi y
Mary~ O Associate Director Division of Advertising Practices
United States of America FEDERAL TRADE COMMISSION Washington, D.C. 20580
Mary K. Engle Associate Director
September 9, 2019
VIA FEDERAL EXPRESS NuLife CBD Oils, LLC 1000 Continental Dr. King of Prussia, PA 19406
To Whom It May Concern:
The Federal Trade Commission ("FTC") is an independent federal agency whose mission is to maintain a competitive marketplace for the benefit of both businesses and consumers. The FTC seeks to protect consumers by enforcing laws and rules that promote truth in advertising and fair business practices, and by educating consumers and businesses about their rights and responsibilities. We are writing to express concern that you may be making false or unsubstantiated advertising claims about the health benefits of products containing cannabidiol (CBD), a chemical compound derived from the cannabis plant..
Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, prohibit unfair or deceptive advertising. Specifically, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, ~hen appropriate, well-controlled human clinical studies substantiating that the claims are true at the time they are made. This substantiation requirement applies whether the advertiser disseminates such health claims directly via traditional advertising or indirectly via the use of a product name, website name, or metatags. This requirement also extends to consumer endorsements. It's not enough that an endorsement represents the consumer' s honest opinion or experience. Reasonable consumers may interpret an endorsement claiming a health benefit from th.e use of a product as representing that the product is likely to be effective in achieving that benefit. Under FTC law, an advertiser must possess and rely on competent and re liable scientific evidence to support health claims, both express and implied, made through the use of endorsements.
FTC staff has reviewed your website, www.nulifecbdoils.com, for potential violations of the FTC Act. We are concerned that one or more of the health benefit claims excerpted below may not be substantiated by competent and reliable scientific evidence.
NuLife CBD Oils, LLC September 9, 2019 Page 3
Below we go into greater detail as to the specific ways that CBD impacts some of our most common ailments.
Cancer Treatment
The impetus behind creating NuLife CBD came from observing a family member's battle with terminal esophageal cancer in 2015 and how powerful and rapid a remedy CBD was during his final days. A mixture of CBD and THC supported him greatly in minimizing his pain and nausea and increasing his appetite. Using a variety of CBD products made his ultimate transition infinitely easier and less painful. Having an increased appetite and decreased nausea allowed him to maintain critical nutrition levels and keep weight on, which is important when dealing with the fallout from chemotherapy and radiation. Throughout the process of his cancer treatment, the CBD allowed him pain free nights where he was able to sleep, and in the end, it increased the overall quality of his life before passing.
According to the National Cancer Institute, "Cannabidiol (CBD) ... may relieve pain and lower inflammation without causing the 'high ' of delta-9-THC. Cannabinoids may be useful in treating the side effects of cancer and cancer treatment." CBD has also been seen as a growth inhibitor in tumors and may impact cellular dysplasia." [sic]
A Miracle Pain Remedy
Do a bit of internet research and you will discover a plethora of reviews and testimonials from people who have traded in their pharmaceutical-grade pain and anti-inflammatory medications for the all-natural benefits of CBD. CBD products are effective in treating both acute and chronic pain and can come in the form of CBD oil, CBD ointment and cannabis pain cream and gel for topical use, vaping CBD oil to be inhaled and CBD gummies, tinctures, capsules and powders to be ingested. 34-year-old Jen Barker from New Mexico had tried everything to minimize the pain she experienced each month during her menstrual cycle, often doubled over with abdominal cramping. She experienced immediate relief from her symptoms upon trying CBD capsules and after 3 months of daily usage her cycle became more manageable than ever before.
NuLife CBD Oils, LLC September 9, 2019 Page
Treatment for Epilepsy and Seizures
13-year-old Emma Crozier of Arizona uses CBD to manage the epileptic seizures that have plagued her life since the age of 2. The use of high-grade Medical CBD has reduced the number of her grand mal seizures from multiple a day to one one [sic] or two per week. According to a Consumer Reports article, FDA-approved seizure medications "fail about one-third of all sufferers, either because the drugs don't stop the seizures or because the side effects are too severe." Epileptic seizures are caused by irregularly misfiring electrical charges within the brain, which can result in convulsions and altered or impaired states of consciousness. The specific cause of epilepsy remains unknown, but can sometimes be the result of traumatic brain or head injuries, hormonal issues or the introduction of a virus.
Treatment for Multiple Sclerosis
Multiple Sclerosis or MS is a chronic autoimmune disease that affects the central nervous system, optic nerves and brain and can be incredibly painful when patients suffer from frequent muscle spasms. CBD has been shown to reduce spasm levels and greatly lower the pain of MS side effects.
Neuroprotection Against Neurological Disorders
Extensive research is currently being conducted around the positive benefits of using CBD to treat a variety of neurological disorders that cause the degeneration of the brain and nerves over time. Patients with disorders such as Alzheimer's, Multiple Sclerosis (MS), Parkinson' s disease, traumatic brain injuries and the negative effects of an ischernic attack such as a stroke have seen significant success in implementing CBD as part of their treatment plan based on its ability to reduce the inflammation that can make neurodegenerative symptoms worse.
Treatment of Depression and Other Mental Health Applications
Unlike T HC , who' s [sic] psychotropic effects can impact anxiety and paranoia levels, CBD has shown great promise in improved cognitive function and enhanced relief for patients suffering from a wide variety of mental disorders such as anxiety, depression, addiction, schizophrenia, bipolar disorder, OCD and PTSD.
NuLife CBD Oils, LLC September 9, 2019 Page 6
- External uses such as psoriasis and acne
- Antitumor cancer treatments for leukemia, cervical and colon cancers and combination therapy for breast and prostate cancer
- Treatment of antibiotic resistant bacteria
We strongly urge you to review all claims for your products, including consumer testimonials and product reviews, and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a federal district court injunction or an administrative cease and desist order. An order also may require that you refund money to consumers.
With regard to the advertising claims discussed above, please notify staff attorney Keith Fentonmiller via electronic mail at kfentonmiller@ftc.gov within fifteen (15) working days of
receipt of this letter, of the specific actions you have taken to address FTC staffs concerns. If
you have any questions regarding compliance with the FTC Act, please contact Mr. Fentonmiller at 202-326-2775.
Very truly yours,
~( MaryK. e Associate Director Division of Advertising Practices
United States of America FEDERAL TRADE COMMISSION Washington, D.C. 20580
Mary K. Engle Associate Director
September 9, 2019
VIA FEDERAL EXPRESS
Brett Benning, CEO OcannaCo. 1002 E. University Dr. Ste. 101 Phoenix, AZ 85034
Dear Mr. Benning:
The Federal Trade Commission ("FTC") is an independent federal agency whose mission is to maintain a competitive marketplace for the benefit of both businesses and consumers. The FTC seeks to protect consumers by enforcing laws and rules that promote truth in advertising and fair business practices, and by educating consumers and businesses about their rights and responsibilities. We are writing to express concern that you may be making false or unsubstantiated advertising claims about the health benefits of products containing cannabidiol (CBD), a chemical compound derived from the cannabis plant.
Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, prohibit unfair or deceptive advertising. Specifically, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies substantiating that the claims are true at the time they are made. This substantiation requirement applies whether the advertiser disseminates such health claims directly via traditional advertising or indirectly via the use of a product name, website name, or metatags. This requirement also extends to consumer endorsements. I t's not enough that an endorsement represents the consumer's honest opinion or experience. Reasonable consumers may interpret an endorsement claiming a health benefit from the use of a product as representing that the product is likely to be effective in achieving that benefit. Under FTC law, an advertiser must possess and rely on competent and reliable scientific evidence to support health claims, both express and implied, made through the use of endorsements.
FTC staff has reviewed your website, www.ocannacbd.com, for potential violations of the FTC Act. We are concerned that one or more of the health benefit claims excerpted below may not be substantiated by competent and reliable scientific evidence..
Brett Benning, CEO OcannaCo. September 9, 2019 Page 3
Excerpts from www.ocannacbd.com/cbd-a-potent-therapy-for-fibromyalgia
CBD - A Potent Therapy For Fibromyalgia
[U]sing a plant-based product like CBD oils and cream to reduce both fibromyalgia pain and inflammation... can be an excellent alternative.
Excerpts from www.ocannacbd.com/promising-affects-of-cbd-on-arthritis pain
Promising Affects [sic] of CBD on Arthritis Pain
CBD- A Potent Therapy For Arthritis CBD is best known for its analgesic properties (pain relief), anti-inflammatory abilities (reducing swelling and the localized burning sensation), along with antibacterial properties. This makes it very effective in mitigating the most common symptoms of arthritis.
CBD products can ease or eliminate arthritic symptoms ....
For those suffering from the excruciating pain of arthritis, CBD is a precious, plant-based gift.
In 2008, a review related to research on CBD and its ability to manage pain
foretold the possibility of CBD becoming a potent formulation in the near future. With every new study and report, we see more scientific evidence surfacing that shows how and why CBD is effective in treating arthritis
Excerpts from www.ocannacbd.com/testimonials-supporting-cbd-and wellness
I have good news. It DOES work Just wanted to give a review update on my newfound journey with Ocanna CBD. I think it's been a good 2 weeks or so that I've been on this CBD oil, and I have some good news. It DOES work. I utilize this amazing oil for my panic/anxiety attacks. I woke up yesterday and realized I hadn't had any in a little while, then
stopped and attributed it to this bottle of goodness. If CBD can help so many
people to either get off of meds or lessen the use of them, let's utilize it more. It
Brett Benning, CEO OcannaCo. September 9, 2019 Page 4
has piqued my curiosity so much so that I will be trying out the Chews maybe next month. Thanks Team Ocanna! -Shan Apr12,
My p atie nts with A utism Yes!!! I am recommending it after trying it myself to my patients with Autism. The topical is my favorite because can put on the bottoms of their feet or up their backs and can start with just a small amount to be sure they tolerate it well. Then can go up. Once they have used the topical, then go to the oi l. We are starting slowly with 1-2 drops th en working up. Have 2 kids on it, both are 4 years old and so far so good! Parents are happy they are sleeping through the night!
Osteoarthritis I'm a retired Marine, after spending 20 years in uniform, romping and stomping all over the globe. Unfortunately, it left me with osteoarthritis in all of my main joints. I was maxing out my pain meds and didn't want to have to get doped up with-strong narcotics, so I needed to do something. After taking CBD oil for 2 weeks I noticed a difference and after 2 months I've been able to cut my pain meds in half. As I continue to adjust the dosage of CBD, I'm hoping to cut back further on the pain meds or get off them completely. -Michael Nov 05, 201 8
A rthritis ReliefAt Last! Severe arthritis pain is an unwelcome companion in my life. Both hands and feet are so bad with rheumatoid arthritis that I've got fused joints in both. It's the bone-on-bone pain in my right hip and knee that really slowed me down though. I could hardly go anywhere because moving hurt so much. And at night - there was no quality sleep because of excruciating pain. Nothing seemed to cut the pain or give me any real relief. Then my daughter sent me Ocanna 300mg CBD cream hoping it might work. I was amazed at what a difference it made. In just a few days, I was able to walk throughout two stores alongside my husband, and never had to stop or slow down. Better yet, I'm sleeping without fighting constant pain, even when I accidentally roll onto my right side. I admit to hesitating about using a cannabis-based product (that's just how my generation views this stuff), but now that I've experienced how effective it really is, I'll never hesitate again. I'm an 85-year old believer in the power of Ocanna and their CBD cream!
f U.S. FOOD & DRUG
•••~-:!- ADMINISTRATION
WARNING LETTER
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
March 28, 2019
Young J. Lee, MD, President Advanced Spine and Pain, LLC (d /b/a Relievus) 813 East Gate Dr. Suite B Mount Laurel, NJ 08054-
RE: 565256
Dear Dr. Young J. Lee:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.relievuscbdoil.com in February 2019 and has determined that you take orders there for the products "CBD Salve," "CBD Oil" (in 5 different flavors), and "CBD for Dogs," which you promote as products containing cannabidiol (CBD). We have also reviewed your website at the internet address www. relievus.com, and your social media websites at www.facebook.com/ Re li evus/ and https://twitter.com/Relievus; these websites direct consumers to your website, www. relievuscbdoil.com, to purchase your products. FDA has determined that your "CBD Salve" and "CBD Oil" 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 "CBD for Dogs" product 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 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 www.fda.gov. In addition, the Federal Trade Commission (FTC) has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. 45(a) and 52.
Unapproved New and Misbranded Human Drug Products
Based on our review of your websites, your "CBD Salve" and "CBD Oil" 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 because they are intended to affect the structure or any function of the body.
Your "CBD Oil" products are not labeled as dietary supplements, but we note that the directions for use begin with the phrase "[a]s a hemp supplement. ... " Based on this language, it appears you may intend to market your product as a dietary supplement. However, it cannot be a dietary supplement, because it does not meet the definition of a dietary supplement under sections 201 (ff)(3)(B)(i), 201 (ff)(3)(B)(ii), and 201 (ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321 (ff)(3)(B)(i), 321 (ff)(3)(B)(ii), 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. 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. 1 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 product labeling states that your "CBD Oil" products are intended to be taken sublingually. The FD&C Act defines the term "dietary supplement" in section 201 (ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321 (ff)(2)(A)(i), as a product that is "intended for ingestion." Because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not intended for ingestion. Therefore, this is an additional reason why your "CBD Oil" products do not meet the definition of a dietary supplement under the FD&C Act.
Moreover, your "CBD Oil" product label has a nutrition facts panel. To the extent that your "CBD Oil" product label suggests that it is a food, you should be aware that it is a prohibited act under section 301 (II) of the FD&C Act, 21 U.S.C. 331 (II), to introduce or
(^1) CBD is the active ingredient in the approved drug product Epidio lex. F urthe rmore, the existence of substantial clinical investigations regarding CB D has been m ade public. For example, two such substantial clinical in ves ti gati ons include GW Pharmaceuti ca ls' investigations regarding Sativex and Ep idiolex. (See Sativex Commences US P hase IT/TIT Clini ca l T rial in Cancer Pa in and GW P harmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical T rial of Ep idiolex in the Treatment of Dra vet Syndrome). FDA conside rs a substance to be "author ized for investigation as a new drug" if it is the subj ec t of an Investigational New Drug app li cation (IND) that has gone into effec t. Under FDA's r eg ulations [21 CFR 312 .2], unless a clinical in vestigation meets the limited crite ria in that r eg ulation, an IND is required for all clinical investigations of products that are subj ect to section 505 of the FD &C Act.
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- "Cannabidiol May Provide Treatment for Alzheimer's disease"
- "Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression."
- "CBD ... can possibly be used as a therapeutic agent for treatment of type 1 diabetes at an early stage of the disease."
- "Cannabidiol May Help with Inflammatory Bowel Disease"
- "Cannabidiol May be Effective for Treating Substance Use Disorders"
- "CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin"
- "CBD may be a promising substance for people who abuse opioids."
- "CBD may be used to avoid or reduce withdrawal symptoms."
On your website www.relievus.com: Webpage titled - "Common Pain Conditions and Symptoms"
- "CBD Hemp Oil for Pain ... It can also aid in the treatment of ... depression, reduce anxiety, and relieve chronic pain and inflammation."
- "Here is a list of indications that CBD oil can help ... Alzheimer's disease ... Amyotrophic Lateral Sclerosis (ALS) ... Anxiety ... Autoimmune Disorders ... Cancer ... Chronic inflammation ... Chronic Pain ... Crohn's Disease ... Depression ... Diabetes ... Inflammatory Bowel Disease... Obsessive compulsive disorder (OCD) ... Panic disorder ... Parkinson's disease ... Post- traumatic stress disorder (PTSD) ... Rheumatoid arthritis ... Schizophrenia ... Substance Use Disorders"
On your Facebook (www.facebook.com/Relievus/) and Twitter (https://twitter.com/ Relievus) websites:
- September 14, 2018 post - "Cannabidiol Fights Against Cancer CBD and other chemicals found in Cannabis have an anti tumor effect and could be used to improve standard treatments. Please visit our website for more information! Relievuscbdoil.com. #cbd #cannabiscommunity #cannaboid ... #relievus #pain"
Your "CBD Salve" and "CBD Oil" 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 Salve" and "CBD Oil" 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 Salve" and "CBD Oil" 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
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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 201.1 O0(c)(2) and 201.115, because no FDA-approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301 (a) of the FD&C Act, 21 U.S.C. 331 (a).
Unapproved New Animal Drug
Based on our review of your websites, your "CBD for Dogs" product is a drug under section 201 (g)(1 )(B) of the FD&C Act , 21 U.S.C. 321 (g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.
Examples of claims observed on your website that show the intended uses of your "C BD for Dogs" product include, but may not be limited to, the following:
On your website www.relievuscbdoil.com: Webpage titled - "Indications"
- "Here you can find a list of indications that we can treat with our hemp oil products ... Anxiety ... Chronic Inflammation ... Cancer Pain ... Chronic Pain "
On your website www.relievuscbdoil.com: Webpage titled - "Health Benefits"
"Cannabidiol Fights Against Cancer
- CBD and other chemicals found in Cannabis have an antitumor effect and could be used to improve standard treatments.
- CBD successfully stopped cancer cells in multiple different cervical cancer varieties.
- CBD decreased the ability of the cancer cells to produce energy, leading to their death.
- CBD treatment helps lymphokine-activated killer (LAK) cells kill cancer cells better.
- CBD increased tumor cell death in leukemia and colon cancer."
"Cannabidiol Relieves Pain
- CBD significantly decreased chronic inflammatory and neuropathic pain.
- Cannabidiol shows promising results for the treatment of postoperative pain, chronic pain associated with ... cancer, rheumatoid arthritis and neuropathic pain."
"Cannabidiol May Be Beneficial in Rheumatoid Arthritis
- Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression.
- Administration of CBD protected joints against severe damage, decreased
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