Inspections, Compliance, Enforcement, and Criminal Investigations

CBD Life Holdings LLC dba Ultra CBD 2/26/15

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

FEB 26, 2015

WARNING LETTER
 
 
VIA EXPRESS MAIL
 
Mohit Asnani
CBD Life Holdings LLC dba Ultra CBD
10435 N. Scottsdale Rd
Scottsdale AZ 85253
 
Re: 445847
 
Dear Mohit Asnani,   
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.ultracbd.com in November 2014 and has determined that you take orders there for the product Ultra CBD.  FDA also reviewed literature that accompanies the sale and shipment of your product Ultra CBD and has determined that your website and the literature promote Ultra CBD for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].   The therapeutic claims on your website and in promotional literature establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
 
Under the heading, “Research”:
  • “[S]tudies have found CBD to possess the following medical properties: … Antipsychotic – combats psychosis disorders…combats neurodegenerative disorders … Anti-tumoral – combats tumor and cancer cells …combats…depression disorders”
Moreover, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your product for disease treatment and prevention on your website and are thus evidence of your product’s intended use as a drug:
  • “The Inhibitory Effects of Cannabidiol on Systemic Malignant Tumors”
  • “Cannabidiol inhibits lung cancer cell invasion and metastasis via intercellular adhesion molecule-1”
  • “Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating the Cross-talk between Apoptosis and Autophagy”
  • “Pathways mediating the effects of cannabidiol on the reduction of breast cancer cell proliferation, invasion, and metastasis” 
Examples of claims from the literature that accompanies the sale and shipment of your Ultra CBD that provide evidence that your product is intended for use as a drug include:
  • “Treats rheumatoid arthritis”
  • “CBD Promotes Cell Death in Breast Cancer Cells”
  • “CBD…Antibacterial Inhibits Cancer Cell Growth…Reduces risk of artery blockage…” 
Further, claims made on your Facebook page https://www.facebook.com/ultracannabidiol, which includes a link to your website at http://www.ultracbd.com where products can be purchased directly, provide additional evidence that your products are intended for use as drugs: 
 
Posts by your company on your Facebook page include the following:
  • On October 26, 2014: “CBD Protective Against Ebola Virus … Cannabinoids are emerging as a new class of drugs that treat infections of bacteria, fungi and virus…”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Additionally, your product is 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 this drug safely for its intended purposes. Thus, Ultra CBD is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 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 list of violations that exist in connection with your product. 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 injunction. 
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the 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 make 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 Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608).  If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.
 
 
 
Sincerely,
/S/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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