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  1. Warning Letters

WARNING LETTER

Daddy Burt Hemp Co MARCS-CMS 593866 —


Delivery Method:
Via Overnight Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Bob Estes
Recipient Title
CEO
Daddy Burt Hemp Co

249 West Short Street, Suite #215
Lexington, KY 40507
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States


Dear Mr. Estes:                                                                                   

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.daddyburt.com in October 2019 and has determined that you take orders there for the products “Full Spectrum CBD Oil” (750 mg Peppermint Flavor, 750 mg Peppermint Flavor (Hemp Seed Oil), and 500 mg Peppermint Flavor (Hemp Seed Oil)), “Pure CBD Oil” (750 mg Peppermint Flavor, 750 mg Natural Flavor, 1500 mg Peppermint Flavor, 1500 mg Natural Flavor, 500 mg Peppermint Flavor),[1] “CBD Gummies,” (Strawberry-Kiwi, Mixed Berry), “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream,” and “CBD Oil for Pets (250 mg Bacon Flavor),” all of which you promote as products containing cannabidiol (CBD).  We have also reviewed your social media websites at www.twitter.com/DaddyBurtHemp and www.facebook.com/daddyburt/; these websites direct consumers to your website www.daddyburt.com to purchase your products.  The claims on your website and social media websites establish that your “Full Spectrum CBD Oil,” “Pure CBD Oil,” “CBD Gummies,” “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream” 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 Oil for Pets (250 mg Bacon Flavor)” 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 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. 

The Agency is particularly concerned that you market your unapproved new drug products for uses for children.  Specifically, on your webpage titled “Using CBD for Autism Spectrum Disorders,” you state: 

  • “According to researchers, CBD shows significant benefits in mitigating and regulating negative behaviors that are common in autistic children. Their results, which were published in the Journal of Neurology reported up to an 80% success rate.”
     
  • “The findings of a recent study demonstrated that CBD had improved behavioral outbreaks, communication problems, anxiety, stress, and disruptive behavior in children diagnosed with autism.” 

Your product has not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations.  For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites. 

Dietary Supplement Labeling 

Information on your website at www.daddyburt.com indicates that you intend to market your “Full Spectrum CBD Oil,” “Pure CBD Oil,” and “CBD Gummies” products as dietary supplements.  For example, your “Full Spectrum CBD Oil,” “Pure CBD Oil,” and “CBD Gummies” products contain a Supplement Facts panel.  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.[2] 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, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), but you may present FDA with any evidence bearing on this issue.[3]

     Unapproved New Drugs

Based on our review of your website, your “Full Spectrum CBD Oil,” “Pure CBD Oil,” “CBD Gummies,” “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream” 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 www.daddyburt.com that establish the intended use of your products as drugs include, but may not be limited to, the following: 

On the webpage titled “What is CBD? Also Known As Cannabidiol”: 

  • “It could benefit the symptoms of over 50 different medical conditions including arthritis, anxiety, pain, depression, insomnia, and more.” 

On the webpage titled “CBD’s Benefits – Effects & Uses for Health Conditions”: 

  • A 2009 study concluded that CBD suppresses the body’s inflammatory response by acting on multiple anti-inflammatory pathways. Another study used a CBD cream on animals with arthritis. The researchers concluded, ‘the data indicates that topical CBD application has therapeutic potential for relief of arthritis pain-related behaviors and inflammation without evident side-effects.’ This makes CBD especially effective because it can be ingested and/or applied as a topical cream.”
     
  • “A 2016 study concluded, ‘CBD behaves in preclinical and clinical studies as an atypical antipsychotic, improving psychotic-like symptoms’.”
     
  • “Another study performed a double-blind, randomized clinical trial of CBD against a potent antipsychotic for patients with schizophrenia…The results showed ‘either treatment was safe and led to significant clinical improvement, but cannabidiol displayed a markedly superior side-effect profile.’
     
  • Other Studies have also focused on the effectiveness of CBD for schizophrenia and delivered similar conclusions.” 

On the webpage titled “CBD for Addiction – Opioids, Heroin, Alcohol & Smoking”: 

  • “CBD helps addicts break free from the chains of dependence through its ability to help reduce cravings, manage the symptoms of withdrawal, and even address some of the reasons for initial dependence.  There is significant evidence to demonstrate that CBD can also help with insomnia, anxiety, and depression which are often highly associated with substance abuse and can occur while quitting an addiction.”
     
  • “A 2012 study demonstrated that CBD reduced cravings in patients recovering from addiction and helped lower their perceived levels of stress. The therapeutic benefits of CBD help with pain management, nausea and vomiting, and the anxiety effects that are experienced as symptoms of withdrawal.  CBD can also help manage the original inflammation and pain that led to the use of prescription drugs like opioids in the first place.”
  • “CBD may help rehabilitate addicts over prescription opioids, heroin, and other illegal street drugs by reducing dependence and alleviating the withdrawal symptoms.”
  • “CBD has also been shown to reduce the rewarding aspects of multiple drugs of abuse, such as cocaine and amphetamine according to a 2004 research study.”
  •  “A 2018 study shows that CBD may help reduce some of the withdrawal symptoms of alcohol addiction such as insomnia, anxiety, and nausea.  This extensive study also showed that CBD helps reduce the addiction motivation to take alcohol, prevent relapse...”
  • “Researchers of a study published in the Journal of Addictive Behaviors concluded, ‘CBD significantly reduced the number of cigarettes smoked by ~40% during treatment.’  This suggests that CBD oil could significantly help people stop smoking by reducing the nicotine cravings of cigarettes.” 

On the webpage titled “Using CBD for ADHD & ADD – Benefits & Effects?”: 

  • “Research has shown that CBD can make people with ADHD feel better and is particularly helpful for anxiety symptoms.” 

On the webpage titled “Using CBD for Anxiety – Benefits & Effects?”:

  • “CBD has been shown to have a great deal of promise for people suffering from anxiety disorders.  According to published medical research, it shows the potential to improve:
     
    • Generalized Anxiety Disorder
    • Panic Disorder
    • Social Anxiety Disorder
    • Post-traumatic Stress Disorder
    • Obsessive-Compulsive Disorder”
  • Data shows CBD also reduces anxiety by stabilizing heart rate and blood pressure.”
     
  • “A study conducted by Brazilian researchers on generalized social anxiety showed participants who consumed CBD oil reported a significant decrease in anxiety.  This was further validated by brain scans. The researchers of this study concluded, ‘Pretreatment of social anxiety disorder (SAD) patients with CBD significantly reduced anxiety, cognitive impairment, and discomfort in their speech performance and significantly decreased alert in their anticipatory speech.’” 

On the webpage titled “Using CBD for Arthritis: Benefits & Effects”: 

  • “An early study published in 2008 found that cannabinoids could help with chronic pain. CBD is one of the 85+ natural cannabinoids.”
     
  • “In 2016, the Arthritis Foundation published information from a small human trial that found CBD improved pain and insomnia in participants who had OA, RA, and fibromyalgia.”
     
  • “Another animal study published in 2016 found that CBD, when applied topically, reduced symptoms of arthritis pain and inflammation.” 

On the webpage titled “Using CBD for Autism Spectrum Disorders”: 

  • “[S]cientific evidence shows that CBD may be an effective option to address the behaviors associated with autism spectrum disorders.”
     
  • “According to researchers, CBD shows significant benefits in mitigating and regulating negative behaviors that are common in autistic children.  Their results, which were published in the Journal of Neurology reported up to an 80% success rate.”
     
  • “The findings of a recent study demonstrated that CBD had improved behavioral outbreaks, communication problems, anxiety, stress, and disruptive behavior in children diagnosed with autism.” 

On the webpage titled “Using CBD for Depression – the Benefits?”:

  • “CBD works with the brain’s serotonin receptors. Serotonin is a mood stabilizing chemical that impacts our emotions.  Low levels of serotonin have been shown to contribute to depression.  However, CBD has been shown to increase levels of serotonin in the brain.  Scientists believe this could be a key way CBD has the potential to relieve certain depression symptoms.”
     
  • “In research studies, CBD has been effective in helping to relieve depression. In one 2018 study, in particular, animal models were given doses of CBD 24 hours before testing, and this had a rapid antidepressant effect lasting up to one week. This would be a drastic change as most current pharmaceutical anti-depressants do not have nearly as immediate of an effect on depressive symptoms.” 

On the webpage titled “Using CBD for Peripheral Neuropathy – Benefits & Effects?”: 

  • “According to a study ’analgesia is one the principal therapeutic targets of the cannabinoid system and many studies have demonstrated the efficacy of cannabinoid compounds in the treatment of neuropathic pain.”
     
  • “A study published in the International Association for the Study of Pain found CBD helps manage pain and reduce inflammation by helping regulate the absorption of chemicals that signal pain perception.”
  • “Another study by a team of researchers concluded that ‘Cannabinoids suppress inflammatory and neuropathic pain.’  This helps muscles relax and releases tension that may hinder day to day activities.” 

On the webpage titled “Using CBD for Sleep – Benefits & Effects?”: 

  • “CBD has been used for a wide variety of disorders because research suggests it has promise promoting a variety of health benefits including easing anxiety and reducing inflammation.  As research has increased over the last few years scientists have attributed many of these properties directly to CBD.  The ability of CBD to provide these benefits without any mind-altering effects gives it excellent potential for helping insomnia.”
     
  • “CBD has the potential to combat insomnia through helping the symptoms that cause the difficulty to sleep i.e., anxiety, depression, chronic pain, etc.” 

On the webpage titled “Using CBD Oil for Pain – Benefits & Effects?”: 

  • “We will highlight the scientific and medical evidence of how CBD may help relieve pain, including:
     
    • Moderating and decreasing the brain’s perception of pain
    • Reducing symptoms related to pain conditions, including inflammation and swelling”
  • “A study published in the Journal of Therapeutics and Clinical Risk Management evaluated the effectiveness of CBD in overall pain management. The research reviewed dozens of studies and clinical trials from the 1980s to 2007. The data showed great promise for CBD helping neuropathic pain, insomnia, and multiple sclerosis.” 

On the webpage titled “Using CBD Oil for Fibromyalgia – The Benefits”: 

  • “CBD studies have shown evidence that it’s effective at:
     
    • Relieving pain
    • Easing anxiety
    • Helping with insomnia”
  • “Research shows that fibromyalgia often involves a natural cannabinoid deficiency so CBD may be especially effective for fibromyalgia.”
     
  • “In 2016, a review of CBD research found evidence that cannabinoids appear to be effective for fibromyalgia. The same review also found strong evidence that CBD is effective for irritable bowel syndrome and migraines. Both of those conditions include central sensitization and are common in people with fibromyalgia.” 

On the product webpages “500mg CBD Oil – Full Spectrum,” “500mg CBD Oil – THC Free (CBD Isolate),” “1500mg CBD Oil – THC Free (Isolate) – Natural Flavor,” “CBD Gummies: Strawberry-Kiwi Flavor (Edibles),” and “CBD Gummies: Mixed Berry Flavor (Edibles)”:  

  • “Aids in managing muscle soreness and body aches.” 
     
  • “Decreases feelings of anxiety from things like overwork and family stress” 

On the product webpages “750mg CBD Oil – THC Free (CBD Isolate) Natural Flavor,” “750mg CBD Oil – THC Free (CBD Isolate) Peppermint Flavor,” and “Standard Strength CBD Oil - Full Spectrum (750mg) Peppermint Flavor,” as part of an infographic:  

  • “Anxiety ... Helps decrease social anxiety …” 
     
  • “Joint Aches ... Helps reduce painful aches from over-exertion and supports healthy joint function” 

On the product webpage “CBD Lotion - Rejuvenation Skin Lotion (400mg CBD)”:  

  • “CBD lotion has become popular for skincare and beauty routines due to the powerful antioxidant, nourishing, and rejuvenating properties of CBD.  Plus, early research is showing very promising results for using CBD topical lotions to address skin conditions such as acne, eczema, and psoriasis.”
  • “While it is still being studied, the results are very positive for individuals looking to use a CBD topical lotion for skin conditions, spot pain management, sore muscles, and sore joints.” 

On the product webpage “CBD Cream - Joint & Muscle Relief (400mg CBD)”: 

  • “While CBD is still being studied, the results are very positive for individuals looking to use a topical lotion or cream for spot pain management, sore muscles, and sore joints.  It has also been shown that CBD topical creams can be effective in helping skin conditions like acne, eczema, and psoriasis.”
     
  • “Many people seeking relief for muscle aches or joint irritation will apply CBD cream 2-3 times each day.” 

Additional claims observed on your Twitter social media site www.twitter.com/DaddyBurtHemp include, but is not limited to, the following: 

  • September 7, 2019 posting – “Amazing new study from May showing CBD's potential to help opioid addictions!  Not only can it be a pain reliever to help people avoid them in the first place, but can ease withdrawal as well.” 

Additional claims observed on your Facebook social media site www.facebook.com/daddyburt/ include, but are not limited to, the following: 

  • October 1, 2019 posting – “Have you or anyone in your life tried Daddy Burt Hemp Co. products for arthritis?  The Arthritis Foundation has released their first CBD guidelines!”
     
  • July 2, 2019 posting – “Addiction related deaths have increased nearly 500% in the last 20 years.  It’s time we start looking for a new solution to this horrible problem and #CBD may be a part of the answer.  Check out our most recent blog article to find the latest research on how CBD may be able to help manage addiction: https://daddyburt.com/learn/cbd-effects-uses/addiction/
     
  • June 26, 2019 posting – “New research is beginning to show promising results for how #CBD may be able to fight against #bacteria! The world needs new options as different diseases are gaining antibiotic resistance ... CBD as a Superbug Antibiotic?” 

Your “Full Spectrum CBD Oil,” “Pure CBD Oil,” “CBD Gummies,” “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream” products are not generally recognized as safe and effective for the 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).  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 “Full Spectrum CBD Oil,” “Pure CBD Oil,” “CBD Gummies,” “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream” 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. (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.  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, 21 CFR 201.100(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 Drugs

During our review of your website, www.daddyburt.com/shop-cbd/pet-cbd/pets/, FDA determined that your firm is marketing the unapproved new animal drug “CBD Oil for Pets (250 mg Bacon Flavor).” Based on our review of your website, your “CBD Oil for Pets (250 mg Bacon Flavor)” product is an unapproved new animal 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 firm’s website , www.daddyburt.com/shop-cbd/pet-cbd/pets/ that show the intended use of your product includes, but are not limited to, the following:  

On your product webpage for “CBD Oil for Pets (250 mg Bacon Flavor)”: 

  • “Daddy Burt’s CBD Oil For Pets can help in the following ways:
  • Support joint and hip mobility
  • Help maintain normal GI health and appetite
  • Help keep your pet calm, relaxed, and comfortable in stressful or high-anxiety situations
  • Support healthy skin and coat and moderate allergic skin reactions
  • SITUATIONS WHEN PETS COULD BENEFIT FROM CBD
  • Road trips or when traveling in a car
  • Loud noises (thunderstorms or vacuuming)
  • Having guests visiting your home
  • Pet grooming (nails, washing, and baths)
  • Being alone for long periods of time
  • A trip to the veterinarian
  • Adding a new pet to the household
  • Bringing home a new baby
  • Moving to a new home”
    On your webpage titled “CBD for Pets”:
     
  • THE POSSIBLE BENEFITS OF CBD FOR PETS?
  • Below are some of the areas where CBD has the potential to impact the health and general wellbeing of pets:
    • Anxiety – If your pet is jumpy when they hear sounds or suffer from separation anxiety, CBD oils might be a very good option for stressful situations or behavioral anxiety.
    • Pain relief – CBD for pain management is one of the most researched effects of CBD, including various studies with animal models.
    • Reduction of swelling – CBD is also known to be an anti-inflammatory agent that reduces is swelling. A 2018 animal study specifically demonstrated that CBD exerts an anti-inflammatory effect in the early phase of the wound healing process.
    • Gastrointestinal issues – A 2018 study on pregnant rats showed that CBD had a beneficial effect on the intestinal loops of rats with abdominal wall defects.” 

This 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). 

301(ll) and Adulterated Animal Foods 

Moreover, to the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.  Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, unless the drug was marketed in animal food before any substantial clinical investigations involving the drug were instituted.[4]  There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted.  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 section 301(ll) of the FD&C Act prohibits the introduction into interstate commerce of any animal food to which CBD has been added, but you may present FDA with any evidence bearing on this issue. 

You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[5]

There is no animal food additive regulation that authorizes the use of CBD.  We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act).  Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods.  FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS.  The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30).  We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958.  Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking.  In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.  

Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing.  CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act.  Introduction of an adulterated animal food 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, including 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.   

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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 Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835, or by email to FDAADVISORY@fda.hhs.gov.

Sincerely,

/S/

Donald D. Ashley

Director

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

 

/S/

William A. Correll Jr.

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

Food and Drug Administration

 

/S/

Eric Nelson

Director of Compliance 

Office of Surveillance and Compliance

Center for Veterinary Medicine

Food and Drug Administration

 

[1] On your website, your “Pure CBD Oil” products are also referred to as “CBD Isolate”and “Pure CBD Oil (THC Free).”

[2] 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 Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and 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. 

[3] We also note that it appears as though you intend for your “Full Spectrum CBD Oil” and “Pure CBD Oil” products to be used 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, to the extent that your “Full Spectrum CBD Oil” and “Pure CBD Oil” products bear directions for use as sublingual products, such products do not meet the definition of dietary supplement under the FD&C Act for this additional reason. 

[4] 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 Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and 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.