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.
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.
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).
Donald D. Ashley
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Unapproved New 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 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.
Additional claims observed on your social media site www.facebook.com/redpillmedical include, but are not limited to, the following:
On the homepage, under the heading “Discover NOW what Red Pill product is right for you”:
Drugs that are new cannot be introduced or delivered into interstate commerce unless the drugs are pre-approved by FDA. FDA approval requires a rigorous scientific review to confirm the products are safe and effective for patients. FDA noted that there are not currently any “FDA-approved applications in effect for any of the above-mentioned products.”
An experienced CBD product lawyer can help determine what other violations may apply and help manufacturers prepare compliance plans which include a thorough review of all company websites, social media platforms, offline marketing, and product labels. Compliance plans should address all federal laws including FDA rules and regulations.
This product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v) because the product 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.
Some of the many examples that FDA cites in support of the conclusion that many company products are indeed drugs are the following:
I would like a consult with a physician:
“82 percent of American adults take at least one prescription medication and 29 percent take five or more”
Get an in-depth understanding about CBD by reading Dr. Smith’s eBook.DOWNLOAD EBOOK
Apply to be part of the Red Pill Medical Provider Network (RPMPN)
Learn More about What CBD is and it’s benefits via our video libraryVIDEO LIBRARY