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  5. Red Pill Medical Inc. - 593389 - 11/22/2019
  1. Warning Letters

WARNING LETTER

Red Pill Medical Inc. MARCS-CMS 593389 —


Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. Gregory Smith
Recipient Title
President
Red Pill Medical Inc.

2321 West Royal Palm Road, Suite K
Phoenix, AZ 85021
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740-3835
United States


Dear Mr. Smith:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.redpillmedical.com and www.redpillwellness.com in September and October 2019 and has determined that you take orders there for the products “Red Pill Formula 1,” “Red Pill Nano I.P.R. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,”  “Relief,” and “Pet,”  all of which you promote as products containing cannabidiol (CBD).  We have also reviewed your social media websites at www.facebook.com/redpillmedical and www.instagram.com/redpillmed/; these websites direct consumers to your website, www.redpillmedical.com to purchase your products.  The claims on your websites and social media websites establish that your “Formula 1,” “Red Pill Nano I.P.R. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,” and “Relief” 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 “Red Pill CBD Pet” 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 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. You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

Dietary Supplement Labeling

It appears that you intend to market at least some of your CBD products as dietary supplements. For example, your “Formula 1 – Full Spectrum CBD,” “Gold CBD,” and “Crave CBD” products contain a Supplement Facts panel. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). 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.[1]  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. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary substance definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence bearing on this issue. 

Unapproved New Drugs

Based on our review of your websites, your “Formula 1,” “Red Pill Nano I.P.R. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,” and “Relief” 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 intended to affect the structure or any function of the body.   

Examples of claims observed on your websites www.redpillmedical.com and www.redpillwellness.com that establish the intended use of your products as drugs include, but may not be limited to, the following: 

On the webpage titled “Blog” under the heading “Cure for Cancer”:  

  • “There are numerous anecdotal accounts of CBD doing great things including curing cancer, stopping seizures, chronic pain, treating obesity…the list goes on and on.” 

On the homepage, under the heading “Discover NOW what Red Pill product is right for you": 

  • “Medical Grade CBD[:] If you are taking 1 or more prescription medication per day and suffer from:
      • Chronic Pain
      • Chronic Anxiety
      • Chronic Insomnia
      • Opioid Addiction
      • Clinical Depression
      • Any other Major Medical Illness” 

Additional claims observed on your social media site www.facebook.com/redpillmedical include, but are not limited to, the following:

  • A video posted May 8, 2018 titled “Healing Cancer in this Century” (also available on your website) – “We’ve seen CBD kill prostate cancer cells, kill colon cancer cells…there’s just thousands of anecdotal stories on the internet where people have cured themselves when they were told they had weeks or months to live using CBD…I’ve had success with CBD in patients that have attention deficit, had some Parkinson’s,  had dementia or Alzheimer’s…a lot of good success in some older children…with autism…”
  • A video posted May 8, 2018 titled “What Does CBD Do?” (also available on your website) –
    • “Relieves Pain
    • Reduces inflammation
    • Calming effect, helps reduce anxiety
    • Anti-depressive
    • Supports healthy sleep
    • Human lung cancer tumor regression
    • Neuroprotective
    • Antibacterial
    • Decreases nausea and vomiting
    • Blunts psychoactivity of THC
    • What Does Conditions May CBD Be Effective For? [sic]
      • IBS
      • Migraine headaches
      • Fibromyalgia
      • Seizure disorders
      • Diabetes
      • Chronic Pain
      • MRSA
      • Cancer
      • Depression
      • PTSD
      • Autism
      • Parkinson’s
      • Alzheimer’s”
  • August 7, 2019 posting – “Red Pill Medical CBD Formula 1 Full Spectrum 50 mg CBD with less than .3% THC was applied directly to a customer’s presumed skin cancer spot over 3 days.  Day 1 it was inflamed and painful. By day 3, with daily application, the redness and inflammation was drastically reduced and almost gone. And the pain was gone.”  

Your “Formula 1,” “Red Pill Nano I.P.R. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax ,” “Focus,” and “Relief” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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.  There are no FDA-approved applications in effect for any of the above-mentioned products. 

Misbranded Drugs

Your “Formula 1,” “Red Pill Nano I.P.R. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax ,” “Focus,” and “Relief” 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. (See 21 CFR 201.5.)  The aforementioned 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 that 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 Drugs

During our review of your websites, www.redpillmedical.com and www.redpillwellness.com, your “Pet” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal.  Further, as discussed below, this product is an unapproved new animal drug and marketing them violates the FD&C Act. 

Examples of claims observed on your firm’s websites, www.redpillmedical.com and www.redpillwellness.com, and social media sites, www.facebook.com/redpillmedical and www.instagram.com/redpillmed/, that show the intended uses of this product include, but are not limited to, the following: 

On your product webpage for “Pet” and your Facebook and Instagram posts from June 27, 2019: 

  • “This CBD is organically-grown and hemp-derived and interacts and supports your pet’s endocannabinoid system* resulting in:
    • Healthy sleep
    • Calmness (less excessive barking and nervousness)
    • Pain relief
    • Overall wellbeing” 

On your product webpage and product label displayed on your product webpage for “Pet”: 

  • “For acute pain…”

This product is a “new animal drug” under 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.
 
To be legally marketed, a new animal drug must have 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-l. This product is not approved or index listed by the FDA, and therefore this product is considered 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). Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
 
301(ll) and Adulterated Animal Foods
 
Moreover, to the extent that you market any of your products containing CBD as animal 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 animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, unless the drug was marketed in animal food before any substantial clinical investigations involving the drug were instituted.[2] There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act prohibits the introduction into interstate commerce of any animal food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.
 
You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[3]
 
There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
 
Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated animal food into interstate commerce is prohibited under 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, including 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. 
 
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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 Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or by email to FDAADVISORY@fda.hhs.gov.

Sincerely,

Donald D. Ashley
/S/
Director                                                      
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

William A. Correll Jr.
/S/
Director                                      
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Eric Nelson
/S/
Director of Compliance                                                   
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration 


[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 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.

[2] 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 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.

[3] Under section 201(s)(5) of the FD&C Act (21 U.S.C. 321(s)(5)), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.