Inspections, Compliance, Enforcement, and Criminal Investigations

Dose of Nature 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
 
Richard Richardson, CEO
Dose of Nature
746 East 1910 South
Suite 4
Provo, UT 84606
 
Re: 479871
 
Dear Mr. Richardson:                                                                                    
                                   
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.doseofnature.com, www.healthydoseofnature.com, and www.puredoseofnature.com, in January 2016, and has determined that you take orders there for the products “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,”  “Red Strap Sweet Nectar – 250mg,” “Sweet CBD 250 mg – Water Soluble CBD,” and “Red Strap Hemp Extract Vape 100mg – 15 ML.” Your website labeling indicates that these products contain cannabidiol (CBD). In addition, we determined that you take orders at the above websites for the following products that do not claim to contain CBD: “OncoBomb Cancer Support” and “Nano SilverStrap.” We have also reviewed your websites at the Internet addresses www.doseofnature.info, www.redstraphemp.com, and www.cancerandcbd.com, all of which provide a link to your website www.doseofnature.com where your products can be purchased directly. The claims on your websites establish that the products listed above 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 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.
 
Based on the product labeling, it appears you may intend to market your “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” “Red Strap Sweet Nectar – 250mg,” “Sweet CBD 250 mg – Water Soluble CBD” and “Red Strap Hemp Extract Vape 100mg – 15 ML” products as dietary 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.
 
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 websites that provide evidence that your products are intended for use as drugs include:
 
On the website www.puredoseofnature.com:
           
On the webpage titled, “Nutritional Supplements” regarding your “Red Strap 250 mg Hemp Extract – Clinical Grade” and “Nano SilverStrap” products: 
  • “Chronic Pain…Cancer…Chronic Pain …”
On the webpage titled, “Cancer” regarding your “RedStrap Hemp Extract Quick FX 1x - 288mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” and “OncoBomb Cancer Support” products:
  • “Cancer alone is scary enough. However, with added treatments and the anxiety that comes with trying to beat it, cancer tends to be a psychological disease…Calm your nerves and lessen your aches and pains with hemp oil from Dose of Nature” 
On the webpage titled, “Chronic Pain” regarding your “RedStrap Hemp Extract Quick FX 1x - 288mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” and “Nano SilverStrap” products:
  • “If you are experiencing chronic pain…With hemp extract from Dose of Nature…Discover relief today.”
On the webpage titled, “Lyme” regarding your “RedStrap Hemp Extract Quick FX 1x - 288mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” and “Nano SilverStrap” products:
  • “Recovering from Lyme disease can be a long and grueling process during which you can experience a number of terrible side effects. Dose of Nature has a number of products that can assist you…dealing with muscle pain, fatigue, migraines and more.”
On the webpage titled, “PTSD” regarding your “RedStrap Hemp Extract Quick FX 1x - 288mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” and “Nano SilverStrap” products:
  • “If you suffer from Post Traumatic Stress Disorder (PTSD)…Dose of Nature would like to help you. We have a variety of products that can minimize any suffering PTSD is causing you.”
On the webpages for your “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg,” and “Red Strap Sweet Nectar – 250mg” products:
  • “The natural health benefits and properties of medical hemp extracts are well-researched and well-publicized, including anti-anxiety, anti-cancer, anti-inflammation…anti-pain…Cancer…Chronic Pain…Lyme…PTSD…”
On the webpage for “OncoBomb,” and the website www.healthydoseofnature.com, under the subheading titled, “Cancer Protocols” on the product webpage for “OncoBomb”:
  • “OncoBomb 001 is a natural, effective, targeted, alternative cancer protocol…”
  • “OncoBomb Cancer Support…is a[n]…alternative cancer protocol…treating a wide variety of cancers…This herb has been used clinically to treat lung, prostate, gastrointestinal, pancreatic, bladder and other cancers…”
On the product webpage for “Nano SilverStrap” under the heading, “Product Description” and the webpage on puredoseofnature.com where the product is sold:
  • “[B]road spectrum disinfectant, antibiotic, antimicrobial, antiviral, antifungal product…broad-spectrum antimicrobial product, shown to destroy bacteria, viruses, fungus, and simple pathogens…ability to disinfect and sterilize…Given the world of super-bacteria and a seemingly increasing array of potentially deadly or debilitating pathogens, Nano Silver Strap is a natural supplement you can use to protect you and your family…Silver Strap is a potent and proven broad-spectrum antimicrobial product, shown to destroy bacteria, viruses, fungus, and simple pathogens…Nano Silver Spheres and the Hydrosome Silver are ingested into bacterium, viruses, and other single-celled pathogens, disabling the pathogen’s oxygen metabolism enzyme, effectively suffocating pathogens…”
On the website, www.healthydoseofnature.com, on the product webpage for “Red Strap Hemp Extract Vape 100mg – 15 ML”:
  • “The natural health benefits and properties of CBD Cannabidiol are well-researched and well-publicized, including anti-anxiety, anti-cancer, anti-inflammation…anti-pain…among others.”
On the website, www.redstraphemp.com, on the webpage www.redstraphemp.com/products/, under the title, “Frequently Asked Questions regarding your RedStrap Hemp Extract products:
 
Under the heading, “Dosing Considerations”:
  • “Anxiety, Depression – 8mg/day”…
  • “Severe pain management – 32mg/day”
  • “Cancer with CBD as main protocol – 64mg/day”
On the website, www.cancerandcbd.com and www.doseofnature.info regarding your “Sweet CBD 250 mg – Water Soluble CBD,” also referred to as “RedStrap CBD in Glycerin” and “Sweet CBD Drops,” product:
 
On the homepage under the heading titled, “Why CBD?”
  • “Cannabidiol (CBD) has been at the forefront in the news lately in its application to treat…autism, cancer, pain, PTSD, brain injuries, anxiety, and various neurological conditions.”
  • “Research noted by the National Cancer Institute suggest that CBD may be a helpful and relatively safe supplemental treatment for cancer.”
  • “Anti-Tumor”
  • “Anti-Pain”
  • “Anti-Inflammatory”
In a video featured on the websites www.cancerandcbd.com and www.doseofnature.info:
  • (1:48) “It does appear that this [CBD] may also have anti-cancer properties”
  • (3:55) “[I]ncredible results in PTSD, in migraines, depression, arthritis, cancer, and heart disease…might have the capabilities of helping to stop the progression of Parkinson’s, Alzheimer’s, ALS, MS, and diabetes…”
On the website, www.cancerandcbd.com, on the webpage titled, “Blog”:
  • A January 15, 2015 post titled, “Cannabidiol is a potent inhibitor of cancer cell proliferation, metastasis, and tumor growth”
  • A January 15, 2015 post titled, “Research Articles – CBD (Cannabiol) With Various Types of Cancer”
o   “General Cannabidiol as potential anticancer drug (PubMed) Cannabidiol inhibits angiogenesis by multiple mechanisms (PubMed) The inhibitory effects of cannabidiol on systemic malignant tumors (PubMed) Cannabidiol inhibits cancer cell invasion via upregulation of tissue inhibitor of matrix metalloproteinases1 (PubMed) Marijuana fights cancer and helps manage side effects (Daily Beast) Lung Cannabidiol inhibits lung cancer cell invasion”
 
Further, claims made on your Facebook page, www.facebook.com/mydoseofnature, which includes a link to www.doseofnature.com where your products are sold, provide additional evidence that your CBD products are intended for use as drugs: 
  • A January 6, 2015 post titled, “CBD May Reverse Brain Deficits in Parkinson’s, Alzheimer’s”
Your products “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg“RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” “Red Strap Sweet Nectar – 250mg”, “Sweet CBD 250 mg – Water Soluble CBD,” “Red Strap Hemp Extract Vape 100mg – 15 ML” “OncoBomb Cancer Support,” and “Nano SilverStrap” 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 “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” “Red Strap Sweet Nectar – 250mg”, “Sweet CBD 250 mg – Water Soluble CBD,” “Red Strap Hemp Extract Vape 100mg – 15 ML,” “OncoBomb Cancer Support,”  and “Nano SilverStrap” 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, “Red Strap Hemp Extract Quick FX 1x - 288mg,” “Red Strap Hemp Extract Quick FX 4x – 1088mg,” “RedStrap 2000 mg Hemp Extract – Clinical Grade,” “RedStrap 250 mg Hemp Extract – Clinical Grade,” “RedStrap 500 mg Hemp Extract – Clinical Grade,” “RedStrap Hemp Extract in Organic Apricot Oil – 250 mg,” “RedStrap Extract in Organic Olive Oil – 250 mg,” “Red Strap Sweet Nectar – 250mg”, “Red Strap Hemp Extract Vape 100mg – 15 ML,” “OncoBomb Cancer Support,” and “Nano SilverStrap” 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)].
 
Additionally, review of www.RedDrop.com website determined that your firm manufactures the “Red Drop TK Blood Test.” Your website indicates that the Red Drop TK Blood Test is a diagnostic kit utilizing Thymidine Kinase (TK) cell marker which can be used in healthy individuals to predict the likelihood of cancer and can be used in patients with a variety of cancers (including breast cancer, renal cell carcinoma, lung cancer, and prostate cancer) as a screening test for cancer, as a prognostic marker, and as a marker of response to therapy. 
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale.
 
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, FDA has reviewed your website at www.RedDrop.com and determined that the Red Drop TK Blood Test is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
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 these 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 Compliance Officer Todd Maushart at U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions concerning this letter, please contact Mr. Maushart at FDAADVISORY@fda.hhs.gov.
 
Sincerely yours,
/S/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition
 

 
[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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