Nutra Pure Releases CBD Oil as a Natural Alternative to Pain Medication
Nutra Pure has recently released CBDPure to provide a safe and 100% certified organic CBD oil to help users manage pain and increase quality of life.
CBDPure organic CBD oil comes in 100mg, 300mg and 600mg.
Vancouver, WA (PRWEB) December 02, 2016
Many studies have been commissioned to determine the safety and efficacy of CBD. Studies have measured the effects of cannabidiol oil intake on pain management and the results suggest the use of CBD in chronic pain management is very useful in allowing an increase in quality of life and ability to significantly decrease pain.
As a result from these studies, Nutra Pure has recently released their own CBD products such as CBDPure to provide a safe and 100% certified organic CBD oil to users.
CBDPure is CO2 extracted from organic hemp that is high in CBD and low in THC which provides numerous benefits to users, yet is nonpsychoactive. CBD is also legal in all 50 states, yet remains a banned substance in some pro sports leagues.
Former star quarterback Jake Plummer and other pro football players want cannabidiol, or CBD, to be used as an alternative painkiller in the league.
These players know first-hand that CBD is an effective alternative to the potent painkillers they receive while in the league and that players should be allowed to use it. Five ex-pro football players, including Plummer, are currently raising money for more research to find out if CBD is also a viable treatment for symptoms of concussions and chronic traumatic encephalopathy.
Researchers at John Hopkins University and the University of Pennsylvania will join forces to survey about 20 current and 20 former pro football players regarding whether they’ve used CBD, as well as their injury and medical history.
This is all part of a historic campaign called “When the Bright Lights Fade” – to implement a more expansive clinical study on CBD and its potential in treating symptoms of concussions and chronic traumatic encephalopathy.
It’s not just football players that have reaped the pain management benefits of CBD. In fact, there are countless testimonials of people improving their quality of life by using CBD.
Teresa Klevey from Clackamas, Oregon said this about CBDPure, “I tried CBDPure for the first time when I was experiencing sciatic nerve pain and within 5 minutes it really made a difference. I have FSH Muscular Dystrophy as well as Degenerative Arthritis. I love the therapeutic effects I get from using it and wholeheartedly recommend adding it to your daily regimen.”
CBDPure’s organic hemp oil is enriched with cannabidiol (CBD) and is available in three concentrations: 100 mg, 300 mg and 600 mg. CBDPure is third party tested to be free of any contaminants, including harmful pesticides and herbicides.
Independent studies on CBD extract continue to show very positive results in assisting with a number of health issues, including: anxiety, depression, joint pain, autoimmune deficiency, injury recovery, and nausea.
CBDPure spokesperson, David Kingston, said CBDPure “continues to provide the highest quality CBD product available on the market. You deserve the best for your health and CBDPure meets the quality our customers demand.”
Considering CBD is safe to use and non-psychoactive, meaning it cannot make you feel “high,” it is becoming a top alternative to prescription medication for those suffering with pain.
CBDPure is now available for purchase directly on their website at http://www.cbdpure.com.
About Nutra Pure
Nutra Pure is a leader in all-natural supplements formulated in a state-of-the-art licensed facility using only the highest quality natural ingredients. Using a holistic approach, all Nutra Pure products are designed to stimulate healthy, long-term well-being. Nutra Pure’s ingredients include organic and patented plant extracts from raw material suppliers to ensure stringent quality control standards are met at every level of the development process, from farm to shelf.
Nutra Pure LLC MARCS-CMS 567714 — March 28, 2019
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address https://www.cbdpure.com/ in February 2019 and has determined that you take orders there for the products “Hemp Oil” (100mg, 300mg, and 600mg) and “CBD Softgels” which you promote as products containing cannabidiol (CBD). The claims on your website establish that the products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (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 because they are intended to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses 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 . In addition, the Federal Trade Commission (FTC) has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. 45(a) and 52.
Although you market “Hemp Oil” and “CBD Softgels” as dietary supplements, 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. 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.
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  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 sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue. 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.
Examples of claims observed on your website https://www.cbdpure.com/ that establish the intended use of your products as drugs include, but may not be limited to, the following:
On the webpage titled “CBD: Alzheimer’s”:
- “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- “Science also shows that CBD has anti-emetic, anti-convulsive, anti-inflammatory and analgesic properties. Because all of these come into play with Alzheimer’s, particularly brain inflammation, CBD is a viable option for minimizing these effects within the brain.”
On a webpage titled “CBD: Anxiety”:
- “Cannabidiol (CBD) Treats Neuropsychiatric Disorders”
- “…evidence that the therapeutic efficacy of CBD in the treatment of anxiety-related disorders was pronounced, particularly in the areas of conditioned fear responses, stress, generalized anxiety disorder, social phobia, panic disorder, PTSD, and OCD.
- “CBD can be effective as a treatment in and of itself, or in combination with other treatments.”
On the webpage titled “CBD: Depression”:
- “For many, CBD holds the answers to treating depression.”
- “CBD is a very broad treatment options that targets multiple symptoms and ranges present with depression.” [sic]
On the webpage titled “CBD: Fibromyalgia”:
- “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
On the webpage titled “CBD: Skin Conditions”:
- “The compounds present in CBD are found to have anti-inflammatory effects . . . Psoriasis is an inflammatory disease”
- “In the study referenced here, CBD was tested specifically in the treatment of psoriasis and found be effective in both stopping the spread of the disease and in alleviating symptoms.”
- “…CBD provides a safe, long term option for those suffering from skin disorders.”
On your webpage titled “CBD: Inflammation”:
- “‘Chronic inflammation’ [is] when the body is unable to shut off the inflammatory response. This category of inflammation encompasses the following disorders: Rheumatoid arthritis, Psoriatic arthritis, Chron’s disease and other inflammatory bowel diseases, Fibromyalgia, Atherosclerosis, Grave’s disease, Diabetes, Lupus, Celiac disease . . .”
- “Cannabidiol (CBD) . . . is building a reputation as an effective and safe treatment alternative in the battle against chronic inflammation.”
The claims on your websites establish that the 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 because they are intended to affect the structure or any function of the body.
Your products “Hemp Oil” and “CBD Softgels” 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 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.
A drug is misbranded under section 502(f)(1) of the FD&C 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 FD&C 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 “Hemp Oil” and “CBD Softgels” 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, “Hemp Oil” and “CBD Softgels” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the FD&C 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 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 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.
Unsubstantiated Advertising Claims
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See POM Wonderful LLC v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015); FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), aff’d, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat’l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff’d, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75, 866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See Daniel Chapter One, FTC Dkt. No. 9239, 2009 WL 516000 at *17-19 (F.T.C. Dec. 24, 2009), aff’d, 405 Fed. Appx. 505 (D.C. Cir. 2010).
The FTC is concerned that one or more of the efficacy claims cited above may not be substantiated by competent and reliable scientific evidence. The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers.