US FDA Sends Warning Letter to Red Pill Medical That Its CBD Dietary Supplements Violate FDA Rules

On November 22, 2019 the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) sent a warning letter to the President of Red Pill Medical Inc. in College Park, Maryland. The letter advised the president of the company the FDA takes orders for the following products that contain cannabidiol CBD:

  • “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,”
  • “Pet,” 

The FDA stated that the agency reviewed the company’s website and the company’s social media websites. The claims, according to the FDA, for the products are not approved for new drugs and violate the Food, Drug, and Cosmetic Act (FD&C Act). Additionally, FDA determined that “Red Pill CBD Pet” is an unsafe unapproved animal drug and is also adulterated. FDA states that introducing these products or delivering these products into interstate commerce violates the FD&A Act.

FDA warning letters require prompt attention. Failure to respond to the compliance issues can result in forceful legal action by FDA which can include seizure of property, injunctions to discontinue business, and the closure of the business. CBD product manufactures should consult with experienced FDA counsel before beginning a marketing program and if the company has received an FDA warning letter.

Dietary Supplement Labeling

FDA began its review by stating that it is clear that Red Pill Medical seeks to market some of its CBD products as dietary supplements. Examples include several products identified as dietary supplements on a “Supplemental Facts” panel. FDA states the products cannot be classified as dietary supplements because the products do not meet the FD&C Act definition under Section 201 (ff). This is because FDA has already determined that CBD products do not fall within the definition of dietary supplements under the FD&C Act.

“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 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.

While there is an exception if the article was “marketed” as a dietary supplement or as a conventional food BEFORE the authorization of new drug investigations (NDIs), FDA has determined that this exception does not apply for CBD. FDA review also concludes that there is no evidence to change this view – though Red Pill Medical is welcome to present new evidence.

Unapproved New Drugs

FDA concluded, based on studying the company websites, that many of the CBD products should be classified as drugs because the CBD products 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.”

Some of the many examples that FDA cites in support of the conclusion that many company products are indeed drugs are 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….
  • 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”

Claims on the company Facebook page claim that suggest the products being advertised are drugs include:

  • A video posted May 8, 2018 titled “Healing Cancer in this Century”“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?”
    • “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 Conditions May CBD Be Effective For?
      • 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 were drastically reduced and almost gone. And the pain was gone.” 

These products are, according to FDA, “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.

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.”

FDA considers a substance to be “authorized for investigation as a new drug” if the substance is the subject of an Investigational New Drug application (IND) that has gone into effect.  With limited exception, all products subject to FD&C Act, section 505, require an IND for all clinical investigations.

CBD has been approved as an active ingredient for just the drug product Epidiolex.

Misbranded Drugs

FDA continued its summary of FD&C Act violations in the FDA warning letter by identifying the drugs from the list that were “misbranded” within the definition of section 502(f)(1) of the FD&C Act because the labeling did not include adequate use directions.

“’Adequate directions for use’ mean directions under which a layperson can use a drug safely and for the purposes for which it is intended.”

In a fairly standard analysis for FDA, the agency states that products which are promoted as being able to treat conditions that cannot be self-diagnosed or treated by non-physicians are not capable of having “adequate directions” because instructions cannot be written so a layperson (nonphysician) can understand the directions and use safely for the intended purposes.

In another fairly standard analysis, FDA states that FDA-approved prescription drugs that include FDA-approved labeling are exempt from the “adequate directions for use by a layperson” requirements. The products offered by Red Pill Medical do not meet this exemption “because no FDA-approved applications are in effect for them.” This means introducing these “drugs” into interstate commerce violated the FD&C Act.

Unapproved New Animal Drugs

One of CBD products, named “Pet” was classified by FDA as an animal drug under section 201(g)(1) of the FD&C Act “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.”

The Pet CBD product is not an approved new animal drug and marketing the product is also a violation of the FD&C Act.

FDA focused on the following claims on the company website, the company Facebook page and the company Instagram accounts:

  • “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”

The product webpage and product state that the CBD product “Pet” is “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 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.

The FD&C Act requires that for new animal drugs to be marketed, the product:

“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.”

FDA noted that the Pet product is not so approved or index listed. Therefore, the Pet product is deemed to be unsafe and adulterated. Bringing the product into interstate commerce is thus illegal under the FD&C Act.

FDA continued its warning letter by stating the marketing any products containing CBD as animal foods are also prohibited. FDA continued by analyzing why CBD is an illegal “food additive.”

Warning letter requirements

As is standard protocol in FDA warning letters, FDA informed Red Pill Medical that there may be other violations and that the manufacturer is responsible for investigating and determining the causes of the identified violations and other violations. Additionally, the manufacturer is responsible for preventing any future violations.

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.

Companies that fail to comply with FDA warning letters can be the subject of additional legal actions including formal complaints, injunction requests, and seizure of company products and manufacturing tools and equipment.

Companies who receive an FDA warning letter are given 15 working days to prepare a reply detailing what corrective measures have been taken and the steps taken to prevent future violations from occurring. Manufacturers do have the right to explain why the manufacturers may not be in violation of the FD&C Act. Companies that need more time to take corrective measures can ask for more time provided the company explains the reason for the delay – and provides an estimated time frame for compliance.

Company websites for CBD products that claim an ability to cure cancer, treat Alzheimer’s, manage chronic pain, and help treat other diseases and disorders will be examined by FDA officials. FDA has the authority to regulate CBD products that FDA considers new drugs. The products may violate FD&C Act adulteration and misbranding rules. Products for animals may be considered animal drugs. FDA enforcement usually begins with an FDA warning letter. The consequences can escalate from there.

Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law.  Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.

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