| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| || |
February 4, 2016
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Karen I. Butler
Dear Ms. Butler:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.PainCBD.com (which redirects to Paindmso.com) and www.PainBomb.com in January 2016 and has determined that you take orders there for the products “PainBomb+CBD” and “35.5% Cannabidiol,” which you claim contain cannabidiol (CBD), as well as the product “PainBomb.” FDA also reviewed literature which accompanies the sale and shipment of your products. The claims on your websites and accompanying literature establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
Although you market “35.5% Cannabidiol” as a dietary supplement, FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if an article (such as CBD) 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.
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
. 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 FDA’s regulations (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 Act. 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 section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue.
Examples of claims observed on the accompanying literature and your websites that establish the intended use of your products include, but may not be limited to, the following:
On the accompanying literature titled “PainBomb + CBD”:
- “Treat & Manage Pain from Arthritis, Cancer, Sciatica, Multiple Sclerosis, Carpal Tunnel Syndrome, Glaucoma, Shin Splints, Fibromyalgia, TMJ, Sports Injuries, Eczema, Insect Bites, Jaw & Tooth Pain, & Much More!”
- “RELIEVE PAIN & TREAT THE FOLLOWING CONDITIONS: . . .
o Autoimmune disorders – massage painbomb deeply into pituitary glaNd reflex ~ often . . .
o cancer pain & bone metastases – massage deeply into affected areas, as many times as necessary . . .
o Glaucoma – massage into eyebrows (avoid eyes) & base of toes . . .
o Multiple sclerosis – Apply to Areas afflicted by pain . . .
o neuropathy – massage pain bomb deeply into areas of irritation. for diabetic neuropathy, massage painbomb deeply into the pancreas reflexes”
On the accompanying literature titled “Cannabidiol Oil (CBD)”:
- “Scientific and clinical studies underscore CBD’s potential as a treatment for a wide range of conditions, including arthritis, diabetes, MS, chronic pain, schizophrenia, PTSD, antibiotic-resistant infections . . .”
- “Diseases and disorders for which Cannabidiol and other cannabinoids have shown great promise: . . .ADD/ADHD, . . . AIDS/HIV, . . . Amyotrophic Lateral Schlerosis (ALS), . . . Artherosclerosis (Hardened Arteries), Autism, Autoimmune Disorders . . . Brain Injury, Cancer, Cancer 2, Cancer 3 (Glioma), Chronic Inflammatory Disease, Chronic Obstructive Pulmonary Disease (COPD), . . . Creutzfeldt Jakob Disease (Mad Cow), . . . Fibromyalgia, Glaucoma, . . ., Heart Disease, Hepatitis, Herpes, Huntington’s Disease . . ., Leukemia, Liver Disease, Lupus, . . . MRSA, Multiple Sclerosis, . . . Osteoporosis, . . . Schizophrenia, . . . Shingles, . . . Skin Tumors, . . . Stroke/ Traumatic Brain Injury, . . . Ulcerative Colitis”
- “PainBomb+CBD is Money-Back Guaranteed to relieve even the worst types of pain, including that of bone cancer.”
On the website www.Paindmso.com:
“Some Medical Benefits of Cannabidiol (CBD): . . .
o It is a powerful pain reliever and is effective for both peripheral neuropathic pain and central pain.
o It has been shown to inhibit cancer cell growth.
o Is a neuroprotectant and a powerful antioxidant. It has applications in treatment for Alzheimer’s, Parkinson’s, cerebral ischemia as well as brain and nerve damage from strokes.
o It is an anti-psychotic and recent research has indicated it is effective in treatment of schizophrenia.
o Has been found to be effective in treating gastrointestinal disorders like IBD and Crohn’s Disease.
o CBD is proving to be effective in easing symptoms of a wide range of difficult-to-control conditions, including: rheumatoid arthritis, diabetes, alcoholism, PTSD . . .”
On the website www.PainBomb.com:
“CBD is being scientifically studied and proven to successfully treat many diseases . . . Parkinson’s, neuropathy, diabetes, chronic pain, MS, PTSD, and many more are responding greatly to treatments involving CBD and other cannabinoids.”
“ATTENTION CANCER PATIENTS - - BREAKING NEWS: It has recently been brought to our attention that PainBomb is SUCCESSFULLY RELIEVING BONE METASTASES PAIN in a clinical setting.”
“PAINBOMB HAS RELIEVED PAIN AND TREATED THE FOLLOWING CONDITIONS: Arthritis pain, back pain, bone metastases/cancer pain, diabetic neuropathy, . . . fibrocystic breasts, fibromyalgia, glaucoma pain, gout, . . . lupus, . . . MS, osteoarthritis, restless leg syndrome, rosacea, sciatica, shingles . . .”
“PainBomb is also Antiseptic, Antibacterial, Anti-Viral & Anti-Tumoral.”
Your products “PainBomb+CBD,” “35.5% Cannabidiol,” and “PainBomb” 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 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 Act [21 U.S.C. § 301(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “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). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products “PainBomb+CBD,” “35.5% Cannabidiol,” and “PainBomb” are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “PainBomb+CBD,” “35.5% Cannabidiol,” and “PainBomb” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 301(a) of the 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 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
10903 New Hampshire Ave, WO51
Silver Spring, MD 20993-0002
Ilisa Bernstein, Pharm.D., J.D.
Office of Compliance
Center for Drug Evaluation and Research
 See “Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,” available at http://www.gwpharm.co.uk/Commences%20US%20Phase%20IIIII%20Clinical%20Trial.aspx and “GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome,” available at http://www.gwpharm.com/GW%20Pharmaceuticals%20Receives%20Investigational%20New%20Drug%20IND%20from%20FDA%20for%20Phase%2023%20Clinical%20Trial%20of%20Epidiolex%20in%20the%20Treatment%20of%20Dravet%20Syndrome.aspx.  Similar claims also appear on the www.Paindmso.com website.  Similar claims also appear on the “PainBomb+CBD” literature.