The Federal Trade Commission (FTC) announced on May 7, 2020 that the agency sent 45 more warning letters to companies that are making unsubstantiated claims that their therapies can prevent, cure, or treat COVID-19. Researchers and companies throughout the world are continuing to find effective treatments and to develop vaccines but as of May 2020, there are no known cure-alls or vaccines.
The FTC’s recent mailing of the 45 letters is the fourth set of COVID-19 warning letters the agency has sent in recent months. Another 100 warning letters were sent previously. The letters were sent to companies that make, distribute, market, or sell the following products and treatments:
- General Therapy Products, Supplements, Drugs, and Chinese Herbal Treatments
- Intravenous (IV) Therapy and Vitamin C Therapy
- Air Purifiers/Sanitizers and Water Filters
- Chiropractic Therapy
- EMF Radiation Protection
- Homeopathic Treatments
- Music Therapy
- Ozone Therapy
- Chinese herbal medications
Warning letters were even sent to companies making shields who claimed their products could “boost the immune system by protecting the wearer from electromagnetic fields”
Prior letters were sent to individuals and companies that sold “vitamins, herbs, colloidal silver, teas, essential oils,” ozone therapies, and other substances that were marketed as being scientifically proven to treat or prevent the novel coronavirus.
Possible FTC actions
The FTC warning letters state that efficacy claims aren’t substantiated because claims that aren’t backed by scientific evidence violate the FTC Act. The letters generally warn the individuals and companies to immediately stop making these false and deceptive claims about the ability of their products or treatments to prevent or treat COVID-19. The recipients are given 48 hours to inform the FTC about the specific ways the company will come into compliance with the FDA warnings.
The letters follow up the need to comply within 48 hours by stating if the false claims continue, the FTC may seek an injunction in federal court and a court order than any funds received because of the claims be returned to the consumers.
The FTC has also sent warning letters to:
- Voice over Internet Protocol (VoIP) providers who transmit pre-recorded telemarketing robocalls – that promote COVID-19 services and products
- Multi-level marketers boasting of earnings claims about coronavirus cures and treatments that are no substantiated.
The aims of the FTC are to:
- Promote fair competition
- Protect consumers
- Educate consumers
The FTC sends out warning letters under its own authority. The FTC also has been sending warning letters about COVID-19 in conjunction with the Federal Drug Administration (FDA).
Experienced healthcare compliance lawyers understand the FTC Act and the corresponding rules and regulations that govern what claims are permissible and which ones are not. They work proactively with makers of supplements, drugs, and other healthcare products to assess and respond to possible FTC violations. Compliance review includes a review of online marketing materials such as websites and social media accounts, print marketing, and package marketing. Skilled lawyers also provide advice on how to respond to FTC warning letters.
Federal Drug Administration continues to send warning letters to companies that boast products can treat, diagnose, prevent, or cure COVID-19 or boost immunity.
Sample warning letters – General therapy products, supplements, drugs, and Chinese herbal treatments
The warning letters indicate what types of statements about COVID-19 cures and treatments will raise suspicions with the FTC. A few examples follow:
A Center for Natural Healing. Website and marketing materials. A warning letter was sent to A Center for Natural Healing, based in Santa Clara, California on April 28, 2020 for unsubstantiated COVID-19 prevention and treatment claims. The FTC announced that the agency reviewed the company website and found the following examples of unsubstantiated claims about the ability coronavirus treatment and prevention claims:
- Website sales page claim. “Treatment with Chinese Medicine has already proven in China to strongly support recovery from COVID-19. We’ll be available to do virtual assessments to prescribe specific herbal and nutritional remedies and essential oil blends that target your symptom patterns and support you both in prevention and recovery.”
- Marketing materials titled “Did Chinese Medicine Rescue China from COVID19?” The company falsely claims that:
- “Chinese Medicine is a Highly Beneficial Treatment for COVID-19.”
- “Western treatments have no actual benefit in reducing viral replication within the body; a role that Chinese herbal medicine has proven to provide to a great extent.”
- “Chinese herbal formulas, on the other hand, combine potent antiviral agents with anti-inflammatory herbs to reduce fever, pain and dilate respiratory airways along with herbs that can break-up mucus accumulation in the bronchioles to benefit those suffering with pneumonia. Repeatedly over the course of this viral epidemic throughout China, these types of herbal formulations have proven to be highly effective in helping people recover and reducing the mortality rate of COVID-19.”
- “Many Chinese herbs have been extremely useful in the treatment and prevention of COVID-19. These include two common medicinal mushrooms which have been found to inhibit SARS-Coronavirus . . . In addition, ginsenoside-Rb1 isolated from Panax Ginseng has also been found to inhibit SARS Coronavirus. These medicinal agents are considered immune tonic herbs used to prevent disease and therefore it’s best to begin using them prior to contracting infection as a preventative. These tonic herbs would also be useful following recovery of symptoms to prevent relapse.”
- “In the U.S. we have access to most of the Chinese herbs and herbal formulas used to fight and overcome this infection as presented in this article. Herbal formulas can be cooked at home into a decocted tea or taken as pre-made patent medicines in the form of granular powders, pills, tablets and tinctures. Through these means we can support patients with an active COVID-19 infection to a great extent with Chinese Medicine.”
The FTC warning letter cites the FTC ACT, 15 U.S.C. § 41 et seq., which makes it illegal to advertise that products have the ability to prevent, treat, or cure a human diseases – unless there is reliable scientific evidence to support the claims. Scientific evidence generally requires “appropriate, well-controlled human clinical studies, which can verify that the claims are true at the time the claims are made.” Since there is now known current study, any COVID-19 claims about prevention or treatment are inherently – not supported by reliable scientific evidence.
The FTC warned the company that the company should stop making the claims and also review all other product claims to determine if the claims are false for the same reason – the claims are not supported by reliable scientific evidence.
Natural Herbal Life, Inc.
On May 1, 2020, the FTC sent a warning letter to Natural Herbal Life, Inc. about the unsubstantiated claims made about the ability of its products and services to prevent or to treat COVID-19.
The warning letter cited the following false claims about the company’s dietary supplements and herbs:
- Website claim. Below the headings “Natural Remedy for Corona Virus” and “Prevention of the Corona Virus is the maximum utilization of the ability that you have” is the claim:
- “Natural Anti-Viral Dietary Supplement… With coronavirus and Sars flu-like viruses floating around the world, you need to know that there are natural anti-viral herbs and supplements. Whether it’s a cold, flu, mumps, or something more serious, the rules for kicking a virus are the same.”
- Under the title “What Are Anti-viral Herbs,? is the claim that
- “anti-viral herbs boost the immune system, allowing the body’s natural defense to attack viral pathogens, using the body’s own defense systems.
- The section also claims that Bitter Leaf Tea (Vernonia Amygdalina) has been revered by African and Asians [sic] for centuries as an anti-inflammatory, antibacterial, antiviral, and anti-fungal. Bitter Leaf has anti-viral properties…”
An FTC warning letter was sent on April 29, 2020 regarding unsubstantiated claims about coronavirus treatments based on a review of the company website and Facebook social media postings. Examples of unlawful advertising found by the FTC about COVID-19 include:
- Marketing materials titled “How to Protect Yourself From the Coronavirus” claimed that:
- Powdered Black Seeds (Nigella Sativa) the company sells
- “increase the power of your immune system by at least 70% with regular consumption, Ingesting these powdered seeds will literally make you invulnerable you [sic] contagious pathogens.” The materials stated where consumers could obtain “Organic Powdered Black seeds.”
- A claim that an oregano oil for which you are an affiliate marketer can cure COVID-19: The claims includes assertions by the author that there are hundreds of PubMed research articles on coronavirus protection and that the author has seen how a couple of days usage of Wild Harvested Oil of Oregano defeats the “cold or flu, or anything bacterial or viral.”
- Powdered Black Seeds (Nigella Sativa) the company sells
- Marketing materials titled “Recent Study Finds Compounds in Black Seeds (Nigella Sativa) to Act as COVID-19 Treatment,” claim there is a study the shows that the ingredient, nigella sativa, in Powdered Black Seeds prevents or treats COVID-19.
- The website improperly links to the marketing claims (made in Facebook) and includes promotional images.
The FTC warning letter then continued with its standard summary explaining why claims about curing or treating human diseases must be supported by reliable scientific evidence – and that the company must come into compliance with the FTC Act immediately.
FTC warning letters were also sent to the follow California companies that sell general therapy products, supplements, drugs, and Chinese herbal treatments:
- ActiveHerb Technology, Inc. (San Diego, California)
- Golden Road Kratom (Huntington Beach, California)
- Golden Sunrise Pharmaceutical (Portersville, California)
- Holtorf Medical Group (El Segundo, California)
- Infuze MD (Pleasant Hill, California)
- Natural Herbal Life, Inc. (Manhattan Beach, California)
- Pacific Acupuncture (Manhattan Beach, California)
- Proactive Health (Tustin, California)
The FTC is aggressively reviewing claims by makers and sellers of dietary supplements, herbs, and other products – that their products boost the immune system’s ability to fight COVID-19 or that their products can prevent or treat COVID-19. The claims are considered violations of the FTC Act because there is no current scientific evidence to support the claims. Failure to discontinue the claims and respond to the FTC warning letters can result in substantial fines and court filings.
Contact Cohen Healthcare Law Group, PC for legal counsel on website, social media, and other forms of online and offline marketing. Our experienced healthcare attorneys and FTC lawyers understand compliance issues and advise clients on responding to FTC complaints and preparing compliance plans.