Inspections, Compliance, Enforcement, and Criminal Investigations

Advanced Spine and Pain, LLC (d/b/a Relievus) 3/28/19

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DEPARTMENT OF HEALTH 
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
SILVER SPRING, MD 20993
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580

 

WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
March 28, 2019
 
Young J. Lee, MD, President
Advanced Spine and Pain, LLC (d/b/a Relievus)
813 East Gate Dr. Suite B
Mount Laurel, NJ 08054-1238
 
RE: 565256
 
Dear Dr. Young J. Lee:                                                                                 
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.relievuscbdoil.com in February 2019 and has determined that you take orders there for the products “CBD Salve,” “CBD Oil” (in 5 different flavors), and “CBD for Dogs,” which you promote as products containing cannabidiol (CBD). We have also reviewed your website at the internet address www.relievus.com, and your social media websites at www.facebook.com/Relievus/ and https://twitter.com/Relievus; these websites direct consumers to your website, www.relievuscbdoil.com, to purchase your products. FDA has determined that your “CBD Salve” and “CBD Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).  FDA has also determined that your “CBD for Dogs” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). 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.      
 
Unapproved New and Misbranded Human Drug Products
 
Based on our review of your websites, your “CBD Salve” and “CBD Oil” 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 “CBD Oil” products are not labeled as dietary supplements, but we note that the directions for use begin with the phrase “[a]s a hemp supplement….” Based on this language, it appears you may intend to market your product as a dietary supplement.  However, it cannot be a dietary supplement, because it does not meet the definition of a dietary supplement under sections 201(ff)(3)(B)(i), 201(ff)(3)(B)(ii), and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), 321(ff)(3)(B)(ii), and 321(ff)(2)(A)(i).
 
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. 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. [1]  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.
 
Furthermore, your product labeling states that your “CBD Oil” products are intended to be taken sublingually. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not intended for ingestion. Therefore, this is an additional reason why your “CBD Oil” products do not meet the definition of a dietary supplement under the FD&C Act.
 
Moreover, your “CBD Oil” product label has a nutrition facts panel. To the extent that your “CBD Oil” product label suggests that it is a food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless the drug was marketed in food before any substantial clinical investigations involving the drug were instituted. The existence of substantial clinical investigations regarding CBD has been made public. Based on available evidence, FDA has concluded that section 301(ll) prohibits the introduction into interstate commerce of any food to which CBD has been added.
 
Examples of claims observed on your websites and social media websites that establish the intended use of your products as drugs include, but may not be limited to, the following:
 
On your website www.relievuscbdoil.com: Webpage titled – “Home”
  • “We carry cannabinoid oil and CBD salve for treating your conditions. If you have any of the indications listed below, please consider trying our cannabis treatment products! . . . Anxiety . . . Chronic Inflammation . . . Cancer Pain . . . Depression . . . Chronic Pain . . .”
On your website www.relievuscbdoil.com: Webpage titled – “Indications”
  • “Here you can find a list of indications that we can treat with our hemp oil products . . . Anxiety . . . Chronic Inflammation . . . Cancer Pain . . . Depression . . . Chronic Pain . . .”
  • “Other indications . . . Alzheimer’s disease . . . Amyotrophic Lateral Sclerosis (ALS) . . . Anxiety . . . Autoimmune Disorders . . . Cancer . . . Chronic inflammation . . . Chronic Pain . . . Crohn’s Disease . . . Depression . . . Diabetes . . . Inflammatory Bowel Disease . . . Obsessive compulsive disorder (OCD) . . . Panic disorder . . . Parkinson’s disease . . . Post-traumatic stress disorder (PTSD) . . . Rheumatoid arthritis . . . Schizophrenia . . . Substance Use Disorders”
On your website www.relievuscbdoil.com: Webpage titled – “Health Benefits”
  • “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
  • “CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
  • “CBD may also protect brain cells from beta-amyloid toxicity, making it a potential therapeutic agent in Alzheimer’s and Parkinson’s disease.”
  • “CBD, due to its anti-inflammatory and antioxidant properties, may be a promising agent to treat and prolong survival in Amyotrophic Lateral Sclerosis (ALS) patients.”
  • “CBD is a potential treatment for psychosis.”
  • “CBD improves the symptoms of schizophrenia.”
  • “Cannabidiol May Treat Depression”
  • “Researchers suggest that it may be effective for panic disorder, obsessive compulsive disorder and post-traumatic stress disorder”
  • “Studies suggest that cannabinoids may be a new class of drugs for the treatment of chronic pain.”
  • “Cannabidiol May Provide Treatment for Alzheimer’s disease”
  • “Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression.”
  • “CBD . . . can possibly be used as a therapeutic agent for treatment of type 1 diabetes at an early stage of the disease.”
  • “Cannabidiol May Help with Inflammatory Bowel Disease”
  • “Cannabidiol May be Effective for Treating Substance Use Disorders”
  • “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin”
  • “CBD may be a promising substance for people who abuse opioids.”
  • “CBD may be used to avoid or reduce withdrawal symptoms.”
On your website www.relievus.com: Webpage titled – “Common Pain Conditions and Symptoms”
  • “CBD Hemp Oil for Pain . . . It can also aid in the treatment of . . . depression, reduce anxiety, and relieve chronic pain and inflammation.”
  • “Here is a list of indications that CBD oil can help . . . Alzheimer’s disease . . . Amyotrophic Lateral Sclerosis (ALS) . . . Anxiety . . . Autoimmune Disorders . . . Cancer . . . Chronic inflammation . . . Chronic Pain . . . Crohn’s Disease . . . Depression . . . Diabetes . . . Inflammatory Bowel Disease . . . Obsessive compulsive disorder (OCD) . . . Panic disorder . . . Parkinson’s disease . . . Post-traumatic stress disorder (PTSD) . . . Rheumatoid arthritis . . . Schizophrenia . . . Substance Use Disorders”
On your Facebook (www.facebook.com/Relievus/) and Twitter (https://twitter.com/Relievus) websites:
  • September 14, 2018 post – “Cannabidiol Fights Against Cancer CBD and other chemicals found in Cannabis have an anti tumor effect and could be used to improve standard treatments. Please visit our website for more information! Relievuscbdoil.com. #cbd #cannabiscommunity #cannaboid . . . #relievus #pain”
Your “CBD Salve” and “CBD Oil” products 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. 
 
Your “CBD Salve” and “CBD Oil” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “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. Your “CBD Salve” and “CBD Oil” products are 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 these drugs safely for their intended purposes. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson, however, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. 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).
 
 
Unapproved New Animal Drug
 
Based on our review of your websites, your “CBD for Dogs” product is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.  
 
Examples of claims observed on your website that show the intended uses of your “CBD for Dogs” product include, but may not be limited to, the following:
 
On your website www.relievuscbdoil.com: Webpage titled – “Indications”
  • “Here you can find a list of indications that we can treat with our hemp oil products . . . Anxiety . . . Chronic Inflammation . . . Cancer Pain . . . Chronic Pain . . .”
On your website www.relievuscbdoil.com: Webpage titled – “Health Benefits”
 
“Cannabidiol Fights Against Cancer
  • CBD and other chemicals found in Cannabis have an antitumor effect and could be used to improve standard treatments.
  • CBD successfully stopped cancer cells in multiple different cervical cancer varieties.
  • CBD decreased the ability of the cancer cells to produce energy, leading to their death.
  • CBD treatment helps lymphokine-activated killer (LAK) cells kill cancer cells better.
  • CBD increased tumor cell death in leukemia and colon cancer.”
“Cannabidiol Relieves Pain
  • CBD significantly decreased chronic inflammatory and neuropathic pain.
  • Cannabidiol shows promising results for the treatment of postoperative pain, chronic pain associated with . . . cancer, rheumatoid arthritis and neuropathic pain.” 
“Cannabidiol May Be Beneficial in Rheumatoid Arthritis
  • Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression.
  • Administration of CBD protected joints against severe damage, decreased progression and produced improvement of arthritis in animal models.”
Because your “CBD for Dogs” product is intended to cure, mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B).  Moreover, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1.  Therefore, this product is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). The introduction or delivery for introduction into interstate commerce of this adulterated drug 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. 
 
With regard to the advertising claims discussed above, please notify Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.
 
With regard to the FDA-related violations described in this letter, please notify FDA in writing, within fifteen (15) working days of receipt of this letter, 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  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, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to FDAADVISORY@fda.hhs.gov.
 
 
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
 
 
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
  
 
cc:
Relievus
904 Chicago Drive
Jenison, MI 49428


[1] 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. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). 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.

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