Inspections, Compliance, Enforcement, and Criminal Investigations

Sana Te 2/4/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  

 

February 4, 2016
 
 
WARNING LETTER
 
 
 
VIA OVERNIGHT DELIVERY
VIA EMAIL
 
Sana Te Oils
1332 Barranca
Newport Beach, CA 92660
 
Re: 479858
 
Dear Sir/Madam:                                                                                            
                                   
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.sanateoils.com and your Etsy.com marketplace store at the Internet address www.etsy.com/shop/SanaTePremiumOils in January 2016, and has determined that you take orders there for the products “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL,” both of which claim to contain cannabidiol (CBD). You sell the “Premium Hemp CBD Oil Capsules” in various amounts such as 10mg, 12.5mg, 25mg, and 50mg capsules and in various packaging sizes, such as 2-count, 10-count, 30-count, and 300-count. We also reviewed your Facebook page at https://www.facebook.com/pages/Sana-Te-Oil/ which includes a link to your website at http://www.sanateoil.com where products can be purchased directly. The claims on the above websites establish that these products are drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and 321(g)(1)(C)]. 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.
 
Examples of some of the claims on your website www.sanateoils.com that provide evidence that your products are intended for use as drugs include:
 
On the webpage titled “Frequently Asked Questions”:
 
Under the heading, “What are the benefits and uses?”
  •  “Sana Te Oil relieves pain, combats anxiety…it’s an…anti-depressant, anti-inflammatory, reduces tumor, combats cancer cells…”
 
Under the heading, “What ailments can it [CBD oil] help?”
  •  “ALS, MS, Cancer, Crohn’s, Lyme’s, Neurofibromaitosis [sic] … Chronic Pain, Anxiety, … Rheumatoid Arthritis, Schizophrenia, Diabetes, PTSD, Alcoholism, Drug Addiction, Strokes, Cardiovascular Disease, Insomnia, High blood Pressure, Lupus, Inflammation, Antibiotic-Resistant Infections, Scars, Open Wounds…”
 
Under the heading, “How does it [CBD oil] work?”
  •  “The cannabidiol…decalcifies your pineal gland…”
 
Examples of claims made on your Facebook page https://www.facebook.com/pages/Sana-Te-Oil/, which includes a link to your website at http://www.sanateoil.com where products can be purchased directly, provide additional evidence that your products are intended for use as drugs:
 
Under the “About” tab:
 
  • §“This [CBD] oil is a natural way to treat & CURE disease such as: Crohn’s, Lyme’s, Cancer, Neurofibromaitosis [sic], Lupus, Rheumatoid Arthritis, ALS, MS, Chronic Pain, Insomnia, High blood pressure, Hypertension…”
 
Under section 201(g)(1)(B) of the Act, your “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” products are drugs because they are articles intended for use in the cure, mitigation, treatment, or prevention of disease. Additionally, under section 201(g)(1)(C) of the Act, your “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” products are drugs because they are articles (other than food) intended to affect the structure or any function of the human body.
 
Your products “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” 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. §§ 331(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 “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” 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, “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” 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 section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Your product webpages on your Etsy.com marketplace store refer to your “Premium Hemp CBD Oil Capsules” and “Premium Hemp CBD Oil Vile [sic] 5mL” products as “supplements.” You should be aware that, based on available evidence, FDA has concluded 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 a substance (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 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[1]. 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 FD&C 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 FD&C Act, but you may present the agency with any evidence that has bearing on this issue.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. 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 violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Mabel Lee at Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions concerning this letter, please contact Ms. Lee at FDAADVISORY@fda.hhs.gov.
 
Sincerely yours,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition
 
 
cc:  
Admin@sanateoil.com
 

[1] 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.

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