On April 14, 2020, the Federal Trade Commission (FTC) announced that a new series of warning letters was sent to companies making claims that their products can prevent or treat the novel coronavirus causing COVID-19. The 10 FTC warning letters were sent to companies in the US and abroad. The letters informed the companies that they should stop making unsubstantiated claims about the ability of their products to treat COVID-19.
Some of the products are sold through the Internet. Other companies claimed that the treatments could be performed in a clinic or at the home of a consumer. According to the U.S. Food and Drug Administration (FDA), there are no scientifically proven treatments or preventive products for COVID-19.
The Director of the FTC’s Bureau of Consumer Protection said that there simply is no proof these products work.
The 10 warning letters were sent to
2) Face Vital LLC,
7) Resurgence Medical Spa, LLC
9) Suki Distribution Pte. Ltd.
10) Vita Activate
Manufacturers, sellers, distributors, and marketers of any drugs, medical devices, supplements, or other medical products should consult with an experienced healthcare lawyer before making claims about the efficacy of the products. A skilled lawyer will review the federal and state compliance laws, and help prepare a proactive compliance plan and respond to any agency enforcement actions (including warning letters).
The scope of the new round of FTC warning letters
FTC warning letters previously focused on supplement sellers. The supplements in the new set of FTC warning letters included essential oils, teas, colloidal silver, and other supplements. The new letters focus on a range of products including:
- “Corona Virus Immune System Boost COVID-19.” Ads described this product as giving users “Advanced Rife Healing Frequencies” and that the product was developed by “The Man Who Cured Cancer.” The product claimed to use sound frequencies to penetrate the cells “thousands of times more than chemical information.”
- The “Face Vital Sonic Silicone Facial Brush,” was marketed as able to “fight off Coronavirus” by “Ramping Up Your Beauty and Cleansing Regimen,” to keep your hands and face clean.
- Marketing for “PuraTHRIVE Liposomal Vitamin C,” claimed:
- “…Experts in the field are suggesting that regular dosing of Vitamin C could help to prevent the Coronavirus”
- “The Coronavirus can be dramatically slowed or stopped completely with the immediate widespread use of high doses of Vitamin C”; and
- Some intravenously (IV) administered solutions used names such as
- “Immunity Boost” IV drips
- The “Myers’ Cocktail IV package,”
- “High Dose Vitamin C Plus Immune Booster.” (This product was promoted on social media – Instagram and Facebook).
The FTC states in its letters that the claims are not supported by scientific evidence and therefore violate the FTC Act. The recipients of the letters were informed to immediately stop making false claims that the products can treat COVID-19.
Frequently Asked Questions about Telehealth and HIPAA during the COVID-19 emergency
The Department of Health and Human Services has created a list of frequently asked questions and answers about using telehealth during the COVID-19 emergency
The FTC further adds in the letters that if the companies don’t cease these unwarranted claims, the FTC:
- May request a federal court to issue an injunction to stop the claims
- May seek a court order requiring the companies to refund the money paid for these products back to the consumers.
The companies and people who received the FTC warning letters were told that they had just 48 hours to inform the FTC about what specific steps the company will be taking in response to the letters.
Additional FTC warning letters about coronavirus claims
The FTC and FDA previously sent warning letters to 7 entities that sold “teas, essential oils, and colloidal silver—as able to treat or prevent coronavirus.”
A set of FTC letters were sent to Voice over Internet Protocol (VoIP) service providers. The letters informed the recipients that “assisting and facilitating illegal telemarketing or robocalls related to the coronavirus or COVID-19 pandemic is against the law.”
The FTC’s duties include protecting and informing consumers and promoting fair competition.
An FTC warning letter to Bioenergy Wellness Miami
On April 3, 2020, the FTC sent a warning letter to Bioenergy Wellness Miami located in Miami Beach, Florida. The warning letter stated that the FTC had reviewed the company’s website and determined that the company is unlawfully advertising that its products treat or prevent COVID-19. Some of the unlawful claims on the website include:
“Corona Virus Immune System Boost Covid19. Advanced Rife Healing Frequencies To The Rescue. Rife Frequencies are named after Dr. Royal Raymond Rife who is referred to as ‘The Man Who Cured Cancer’ and found that certain frequencies destroyed cancer cells, viruses, parasites and bacteria.
… When a cell is resonated at its resonant frequency, the cell is destroyed. Cancer, parasites, viruses, bacteria and other organisms all have their own resonant frequencies.
… We have produced a set of programs with frequencies that target Coronavirus/SARS viral infections, and can be used either as homeoprophylaxis or at the onset of flu-like symptoms. . .. [S]ound is highly effective using frequencies for healing as it penetrates the cells thousands of times more than chemical information.”
-[from product webpage https://bioenergywellnessmiami.com/coronavirus]
The warning letter cited the FTC Act, 15 U.S.C. § 41 et seq., which makes it illegal to market a product as being able to prevent, treat, or cure a human disease unless the entity making the claim has competent scientific evidence to support the claims. Competent scientific evidence includes properly-controlled human clinical studies. The studies should be able to verify that the claims, when made, are true. The warning letter states that the claims by Bioenergy Wellness Miami cannot be true because there are no known studies for COVID-19.
The FTC warning letter told the company it should immediately stop making the unsubstantiated claims (remove the claims from the company website). The letter also advised Bioenergy Wellness Miami that it should also review all other product claims and remove any other claims that aren’t supported by competent medical evidence. The company was given just 48 hours to email the FTC about the specific steps the business was taking in response to the FTC warning letter.
An FTC warning letter to Face Vital LLC
In another FTC warning letter regarding unsubstantiated COVID-19 claims, the FTC informed Face Vital LLC on April 8, 2020 that an advertisement the company posted on Amazon.com illegally advertised that a company product could prevent users from developing COVID-19. Face Vital LLC is located in Miami Beach, Florida.
Some of the unlawful coronavirus prevention claims that were posted on Amazon included the following:
- “Face Vital Sonic Silicone Facial Brush, Fight off Coronavirus.”
- “RAMP UP YOUR BEAUTY AND CLEANSING REGIMEN, FIGHT OFF CORONA:… Take this lightweight brush with you, keep your hands and face clean everywhere you go – protect yourself from the coronavirus.”
The FTC, as it did in other letters, informed Face Vital LLC that:
- The claims violated the FTC Act because it’s illegal to state a product can prevent, treat, or cure a human disease unless the claim can be supported by reliable competent scientific evidence.
- Since there are no current studies that show that there is any product that can treat or prevent COVID-19, the claim is inherently false.
Face Vital LLC was informed, through the warning letter that it must:
- Cease the unlawful claims regarding the products mentioned in the letter
- Review any other product claims for a determination of the validity of the claims
- Contact the FTC within 48 hours about what corrective measures the company is taking to address the concerns in the warning letter
An FTC warning letter to New Performance Nutrition
In an April 7, 2020 letter, the FTC warned New Performance Nutrition, a California company, that claims made on its website were unlawful because they advertised the company products could treat or prevent COVID-19. The FTC provided the following example:
- “NPN ANTI-VIRUS KIT. NPN ANTI-VIRUS KIT is a bundle of immune defense supplements, hand-picked by NPN Owner/Founder Matt Mahowald, that will target and increase your immunity to help ward off the COVID-19 virus.”
The FTC, as it did in other similar warning letters, stated that since there is no known treatment or way to prevent COVID-19, any ads that make such claims are unlawful. The company was given 48 hours to respond to the warning letter by stating what efforts it was making to remove such claims and to review any other invalid COVID-19 claims.
AN FTC warning letter to Rocky Mountain IV Medics
On April 7, 2020, the FTC sent a warning letter to Rocky Mountain IV Medics in Frederick, Colorado, after reviewing the company’s website and Facebook account. The warning letter informed the company that the following claims that its products could prevent or treat COVID-19 were false because there is no current treatment or preventive product for the disease:
- Social media account. A March 12 post states, “Coronavirus Symptoms Treatment Tests are underway and IV Vitamin C treatments are starting to show promising results! If you’re looking for IV Vitamin C therapy, we have ASAP and prescheduled appointments available.”
- Website post. The website states that, “We have received an influx of calls for our Myers’ Cocktail IV package due to information being released about Vitamin C IVs potentially helping with the coronavirus…To learn more about this, we’ve compiled a few resources on the topic…[including a hyperlinked article,] Can Vitamin C Prevent and Treat Coronavirus?” When consumers click on the hyperlinked article, “Can Vitamin C Prevent and Treat Coronavirus?,” consumers are directed to an article on the website …which states, “the Shanghai Medical Association has released an expert consensus statement on the comprehensive treatment of COVID-19 where they endorse the use of high-dose IV vitamin c for the illness…the principle investigator of the first high-dose IV vitamin C trial in China has told [a doctor quoted in the article] that the preliminary results of the study are promising. The investigator said the administration of 24 grams per day to COVID-19 patients leads to significant reductions in inflammation…this is notable because massive inflation in the lungs and potentially other organs may be fatal in the illness.”
Rocky Mountain IV Medics was given 48 hours to respond with the steps the company would take to address the unlawful posts and to review any other possible unlawful posts.
The FTC and FDA are aggressively pursuing claims that products and treatments can treat, prevent, or cure COVID-19 because there are no current approved treatments or vaccines for the disease. In addition to joint letters, the FTC is also sending its own letters warning companies against making false claims on websites and social media accounts.
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.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
Contact Us
