June Roundup of FDA and FTC Warning Letters To Healthcare Companies Claiming COVID 19 Treatments and Cures

The Federal Drug Administration (FDA) and Federal Trade Commission (FTC) continued sending warning letters to companies making unapproved statements that their products, treatments, and services can be used to prevent or cure the novel coronavirus. The warning letters emphasize again and again that there are no known treatments or cures for the disease which has caused more than 125,000 deaths in the U.S. through June 2020.

The FDA warning letters regularly state that the promotion of unproven treatments is a “misbranding” of the products. The FDA warning letters also state that the products are “unapproved new drugs” because the companies make medical statements about prevention, treatment, and cures – without evidence of scientific studies to support their claims.

The warning letters generally require that the companies cease making the unauthorized statements and cease selling the products. The letters demand that these healthcare companies also review all other statements, online and in print, that improperly promote their unproven cures. Any other improper statements should also be removed.

The warning letters continue by informing the recipients if the businesses fail to respond within the time limits set forth in the letter, the health companies may be subject to civil action which could result in fines, seizure, and a court injunction to cease marketing and selling the products and services.

Warning letter to Out of the Box Remedies

On June 10, 2020, FDA and the FTC sent a joint warning letter to Out of the Box Remedies based on a review of the company websites and company social media sites. The social media sites direct consumers to the company’s main website. FDA stated that the iodine products offered for sale violated the Federal, Drug, and Cosmetic Act (FD&C Act) because the products “are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.” This makes the iodine products “unapproved new drugs.” The products are also “misbranded drugs” because of these false claims.

The US Department of Health and Human Services has issued a public emergency in response to “severe acute respiratory syndrome” also called COVID-19.

Examples of improper website claims that FDA maintains are misleading and improperly represented as effective treatments or prevention include the following [Emphasis in bold added]:

• “Coronavirus Terminator . . . ‘I have suggested that people put iodine into a nebulizer for aerosol treatment for transdermal effect into the lung tissues in the case of lung cancer, emphysema, asthma, and tuberculosis. . . So effective is iodine that aerosols can be effective in sterilizing a room at levels not even detectable by humans.’ . . . To which I would add viruses of any type, including mutated viruses and corona COVID-19. Adding Lugol’s iodine to ‘Ciggy Juice’ ramps up the application of antiviral iodine to sensitive lung tissue. . . . More information on this wonderful product can be found on my blog at www.outoftheboxremedies.net.
• “Coronavirus Terminator Refill (100 ml, 3.4 oz) . . . The Coronavirus Terminator Refill contains Lugol’s iodine, a known antiviral. This antiviral, antibacterial medicine is ideal for killing any alien microbes in the lungs.”
• “Iodine Kills ALL Viruses . . . ‘I have suggested that people put iodine into a nebulizer for aerosol treatment for transdermal effect into the lung tissues in the case of lung cancer, emphysema, asthma, and tuberculosis.’ To which I would add viruses of any type, including mutated viruses and corona COVID-19. Ways to Apply Iodine to Kill Coronavirus (COVID19) or Any Other Virus . . . The highly contagious Coronavirus can enter the body through the nose, mouth, eyes, and ears. Yes, even the ears can receive viruses. Taking iodine in the form of Lugol’s iodine is a good first step, but one must start with a small dosage and work up to larger doses over a period of weeks to avoid severe itching, especially in people over 50. . . . Be sure to visit Out of the Box Remedies to order anti-COVID19 iodine products.”

The company was given 48 hours to review all their promotional materials and representations. The healthcare company was given the same 48 hours to describe what corrective measures the company took to correct the violations including “an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.”

In addition, FDA’s warning letter stated the company would be added to an FDA list (published on the FDA’s website) advising consumers not to buy or use “certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19.” The list identifies all companies that have received FDA warning letters. The list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. The company was informed that if corrective steps were taken the list would reflect that fact.

The warning letter continued by discussing the FTC’s concerns. The FTC Act, 15 U.S.C. 41 et seq., makes it illegal to:

“advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

Since there are no known studies for COVID-19, any claims about effective cures or scientific support are presumed to be invalid. Out of the Box Remedies was given 48 hours to provide the FTC with evidence of its corrective measures. The company was informed that failure to take corrective steps could result in an injunction and the requirement to pay back any money received from consumers for the products.

Warning letter to MustHaveMom, an Amazon Associates Program participant

One May 26, 2020, FDA sent a warning letter to this healthcare company based on improper statements on its website. The warning letter also noted that, as an Amazon associate, MustHaveMom earned commissions

“by promoting the sale of colloidal silver, vitamins, minerals, herb oils and a homeopathic drug product” – with claims that implied or represented that the products could “mitigate, prevent, treat, diagnose, or cure COVID-19.”

FDA asserted that the claims result in Amazon products being purchased in violation of the FD&C Act because the products are “unapproved new drugs” and because the products are “misbranded.” Introducing the products into interstate commerce of unapproved new drugs and misbranded products is illegal.

The FDA warning letter noted the following improper claims on its website [Emphasis in bold added]:

• “Coronavirus | Prevention, Treatment, Plan . . .The coronavirus, aka COVID-19, has caused quite a scare here in the US. . . Here’s what you need to know about Coronavirus, how to prevent Coronavirus, natural remedies to treat Coronavirus and how to have a plan so you don’t have to live in fear.”
• “CORONAVIRUS TREATMENT . . . There are no approved treatments and very few effective antiviral medications to treat it. All the more reason to arm yourself with knowledge on who to treat Coronavirus naturally. . . Luckily, natural remedies don’t come with side effects and toxic ingredients like pharmaceuticals and vaccines do so it is also my preferred way to treat any virus.”
• “HOW TO PREVENT CORONAVIRUS. . . Have common immune boosters on hand – There is nothing worse than feeling a virus coming on and not having any natural immune support or remedies on hand. Stock up on . . . colloidal silver [Amazon associates link], Oscillococcinum [Amazon associates link], Vitamin C etc.”
• “NATURAL REMEDIES FOR CORONAVIRUS. . .There are plenty of things you can do to boost your immune system and fight off any virus including coronavirus. Here are a few!”
  • “1. “Vitamin C – This vitamin is essential to immune system support. There have been studies that have shown Vitamin C to be effective against some of the most awful viruses . . . I recommend starting with this powdered form of Vitamin C [Amazon associates link].”
  • “2. Vitamin D . . . This important vitamin plays a crucial role in immune health. Being deficient in Vitamin D can increase your risk of infection. I recommend this brand of Vitamin D [Amazon associates link] and starting at a minimum dose of 5,000 IU.”
  • “8. Colloidal Silver – Colloidal silver has been shown to kill viruses . . . It’s a potent remedy for any infection. You can drink the silver and even nebulize it to get it directly in the lungs and at the site of the virus. . . You can buy it though and I recommend this brand [Amazon associates link] if you buy it.”
• “There are several other things you can and should do to strengthen your immune system. These can help you prevent coronavirus and other illnesses as well. These things include:
  • “8. Take Trace Minerals – our food is lacking in mineral content. Add a trace mineral supplement like Concentrace [Amazon associates link] to your diet to replace the minerals missing in your diet. . .”
  • “11. Zinc . . . Zinc [Amazon associates link]. . .”
  • “12. Garlic . . .Experiments have shown that garlic . . . is highly effective at killing countless microorganisms responsible for some of the most common and rarest infections. . .This supplement form of garlic [Amazon associates link] . . .”
• Stock up on immune boosters and take steps to strengthen your immune system so you are prepared if you should be exposed to coronavirus. Your body is capable of great things, including overcoming coronavirus!”

The company was given the standard 48 hours to respond and notice that the warning letter information would be posted to FDA’s consumer website. The improper COVID-19 claims also caused the FTC to join in the warning letter.

COVID-19 warning letters from the FTC for deceptive COVID-19 claims

On June 5, 2020, the FTC announced the agency had sent another six warning letters to companies for deceptive coronavirus claims. The warning letters were sent to multi-level marketing companies (MLMs) based on posts in social media and video posts – including claims made in Spanish. The claims involved COVID-10 claims and also claims about the ability to earn in income.

The FTC found that the following claims were improper:

• Vivri USA, LLA, made a Spanish-langue social media post which stated,

“Take care of your health, your body, avoid many diseases many viruses, since this virus and many others are here to stay, coronavirus, influenza, flu, we should nourish our cells, our immune systems, reinforce it with the best nutrition system in the world …”

• Another social media post said,

“#VIRUS_CORONA Worried? I’ve been boosting my immune system for several years with high-quality Plexus supplements. You can too! #Plexus provides excellent all-natural supplements that truly work. Be sensible –not fearful. Scientifically formulated & doctor-approved! Ask me!”

The Health related claims (involving COVID-19) were sent to:

• Isagenix International LLC
• The Juice Plus+ Company
• Youngevity International, Inc. (this company was warned about claims in Spanish and English)
• Vivri USA, LLC (this company was warned about Spanish-language claims)
• Plexus Worldwide, LLC

The FTC warning letters assert the claims were not substantiated with scientific evidence – and thus violate the FTC Act. The lack of scientific evidence assert was based on the current status of COVID-19 research. There is no current scientific evidence that any products or services help prevent, treat, or cure the disease. Without scientific evidence, the claims are misleading and deceptive. The health companies were given 48 hours to take corrective measures

There is no known treatment, cure, or vaccine for COVID-19. There is no known way to prevent COVID-19 by boosting your immunity or through other means. Assertions on websites and social media to the contrary will be reviewed. The FTC considers all claims that there are treatments, cures, and preventive methods to be misleading. The assertions of treatments, cures, and preventive methods for COVID-19 will likely lead to warning letters that products are unapproved new drugs and that they’re misbranded under the FD&C Act.

Contact Cohen Healthcare Law Group for legal advice on website, social media, packaging, and other forms of online and offline marketing. Our experienced FTC and FDA healthcare lawyers are adept at explaining federal and state-level marketing compliance issues and helping healthcare clients take proactive measures.