Numerous warning letters were sent in March and April by Federal Drug Administration (FDA) to companies regarding unauthorized claims that company products could be used to prevent, treat, cure, or diagnose COVID-19. Letters are being sent to makers and sellers of dietary supplements, drugs, medical devices, and other products.
FDA is keenly aware that as of April 2020, there are no known treatments, preventive products, cures, or vaccines for the novel coronavirus. In some cases, the agency is working with the Federal Trade Commission to target companies making false claims about COVID-19. FDA is also sending its own warning letters when companies misbrand products, products are adulterated, or there are other violations of the Food, Drug, and Cosmetic Act and of FDA regulations.
Skilled FDA healthcare lawyers help medical companies understand which federal and state laws apply to businesses. They help review existing practices and procedures that may violate these laws and help the companies develop protocols and compliance plans to reduce the risk of charges being brought for alleged violations. They also help advise companies when warning letters are sent or other enforcement measures are brought in regard to the COVID-19 pandemic.
FDA response to the coronavirus pandemic
On April 8, 2020, FDA issued a press release that the agency is taking the actions in its ongoing response effort to the COVID-19 pandemic.
FDA is sending warning letters to help protect consumers and animals from entities making false or misleading claims about unapproved COVID-19 products. Three sellers were warned as follows:
- Chlorine dioxide products. Genesis II Church of Health and Healing was warned that it is selling fraudulent and dangerous chlorine dioxide products known as ‘Miracle Mineral Solution’ for prevention and treatment of COVID-19. FDA previously warned consumers that the FDA does not know of any scientific evidence which supports the safety or effectiveness of drinking chlorine dioxide products as medical treatments. FDA asserts drinking chlorine dioxide products poses a serious patient health risk.
- CBD products. The third seller that was warned, CBD Online Store, “offers unapproved and misbranded CBD products with misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19 in people.”
- Savvy Holistic Health, doing business as Holistic Healthy Pet, was warned that it “sells fraudulent products with misleading claims about the prevention or treatment of COVID-19 in people and pets.”
FDA also issued guidance on “the administration and study of convalescent plasma to patients currently seriously ill with COVID-19. Convalescent plasma is plasma collected from individuals who have recovered from COVID-19, and is referred to as COVID-19 convalescent plasma.”
The FDA is also keeping its COVID-19 Diagnostics FAQ up to date.
Warning letter to The Art of Cure
On April 15, 2020, FDA sent a warning to The Art of Cure, a Vancouver Washington company regarding products that were unapproved and misbranded regarding the coronavirus disease 2019 (COVID-19).
The letter advised the company that FDA and the FTC examined the company website and company Facebook account. FDA determined that The Art of Cure offers homeopathic drug products for sale in America – and that the products “are intended to mitigate, prevent, treat, diagnose, or cure COVID-19“ in humans. The violations included the following:
- FDA determined that these products are “unapproved new drugs” which are being sold “in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
- FDA also determined the drugs are misbranded under section 502 of the FD&C Act. Further, placing the products into interstate commerce violates sections 301(a) and (d) of the FD&C Act.
FDA is working aggressively to protect consumers following the declaration of a public health emergency, due to COVID-19, by the US Department of Health and Human Services and a national emergency declared by the President.
The warning letter advised The Art of Cure to cease the sale of these unapproved products.
Examples of misleading claims about the safety and efficacy of The Art of Cure products included the following statements:
- “BOOST NATURAL IMMUNITY HOMEOPATHICALLY FOR CIRCULATING VIRUSES, INCLUDING COVID-19”
- “Top Compiled HOMEOPATHIC Remedies for Coronavirus: … what remedies to use to lessen the chance of contraction and treat the virus…
- Homeopathic Coronavirus – a homeopathic made out of actual coronavirus . . . that you can take to lessen the chance of contraction. . . . PURCHASE HERE to purchase . . .
- Petasites hybridus . . . key to helping with the cough and lung symptoms produced by this coronavirus. to purchase . . .
- Arsenicum album . . . excellent remedy to treat respiratory distress . . . pneumonia . . . PURCHASE HERE to purchase . . .
- Gelsemium sempervirens . . . Homeopaths have treated individuals with coronavirus using Gelsemium in China with success . . . to purchase . . .
- 7 other remedies making false claims were identified
- “NEW CORONAVIRUS: ALL EYES ON INDIA… what does India know about the new coronavirus and COVID-19 disease… India reports that it has 23,531 people under observation, with no current infections or deaths… How is this possible … Could India’s dependence on homeopathy be one reason for the difference…
- The [Central Council for Research in Homeopathy] recommended that homeopathy medicine Arsenicum album 30 could be taken as a prophylactic medicine against Coronavirus infections…
- “CORONA-KIT & CONSULTATION . . . THIS IS OUR CORONA-KIT . . . THIS KIT CONTAINS GENUS EPIDEMICUS REMEDIES FOR COVID19” [
- “Read, share, and stock up . . . Boost Natural Immunity Homeopathically for Circulating Viruses, Including COVID-19”
The warning letter advised the company that there may be other violations. The company was instructed to review other marketing claims made on its websites, product labels, and other marketing materials to ensure that no other products that haven’t been approved by FDA are being wrongly promoted as being safe and effective treatments for COVID-19.
If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.
The warning letter gave the Washington company 48 hours to detail the specific actions it was taking to address the violations – including explaining how future violations can be prevented. Otherwise, FDA stated the agency would consider seeking an injunction, a seizure of business assts, and other legal action. Companies that don’t meet the 48-hour deadline must state the reasons for the delay and the anticipated reply date.
FDA also advised the company that it will be added to the FDA’s list of companies that have received warning letters with regard to products that are being sold or distributed for COVID-19 in violation of the FD&C Act. The list is being updated. Companies that take corrective actions have the corrected action updated to the list.
FDA warning letter to Botanix LRD DBA CanaBD
On April 16, FDA sent a warning to this UK company advising it that its coronavirus products were unapproved and misbranded based on FDA and FTC review of the company website and social media websites. FDA stated the agency saw that these sites offer CBD products for sale in the US and that the websites claim the products are “intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”
FDA violations include allegations the products:
- Are not approved new drugs – in violation of the FD&C Act
- Are misbranded in violation of the FD&C Act
- That introducing or the delivery to introduce such products into interstate commerce is prohibited by the FD&C Act
Based on the concerns about the COVID-19 pandemic, FDA is prioritizing protecting consumers from products that aren’t FDA approved or authorized. Most of the statements claimed that CBD products could improve the immune system of people who consumed the products – thus increasing the ability of the person to fight the disease – contrary to existing evidence about the COVID-19 immunity response.
FDA noted the following misleading claims about the safety and/or effectiveness of the CBD products:
- “5 ways CBD can Boost Your Immune System during the virus”
- “It’s never too late to start taking really good care of yourself during this unfortunate virus we are facing [sic] with. Whether or not you are choosing to self-quarantine so as to minimize the risk and spread of the virus, the time is now to start ramping up your immune system. Keeping your immune system in good working order is key to helping curb the stay healthy.
- Especially those of us with autoimmune disease, taking CBD (in various forms) can be especially good during this time.”
- “Here are several ways CBD can help you with your immune system in the current crisis . . . CBD Helps Fight Inflammation . . . In short, CBD can calm a hyperactive immune system, and strengthen a compromised one. And if you find yourself with a chronic cough, that’s your bronchial pathways being inflamed. Yes, CBD can help with that, too.”
- “With the global virus, wreaking havoc across the globe, finding relief from an incurable virus is just within reach in the form of CBD oil.”
- “CBD oil may help to prevent getting infected by strengthening your immune system. It has also been proven to offer relief to some of the symptoms.”
- “By using CBD oil, you can keep inflammation at bay, retain a healthy or even higher than average white blood cell count, stay calm and relaxed (which is best for a strong immune system), and prevent catching a virus or infection beforehand.”
- “In the wake of the current epidemic, it is now more important than ever to keep your immune system as healthy as can be . . . Here are 5 key ways to strengthen your immune system during the outbreak . . . Take supplements such as CBD . . .”
“In the wake of the current #Coronavirus epidemic, known as #COVID19, it is now more important than ever to keep your immune system as healthy as it can be. #HealthyLiving”
Both the FTC and FDA are reviewing your web and print marketing materials. If you make unsupported medical and treatment claims about your CBD promotions, you will receive a warning letter.
FDA advised the UK company that it had 48 hours to come into compliance with the FD&C Act or explain why it needed more time and to give FDA a timeline for corrective measures. FDA informed the company that if it failed to make a timely reply, FDA would consider filing a lawsuit in federal court to enjoin the company from making the statements and selling or distributing the products. The court case would also demand a return of all consumer payments for the CBD products.
The warning letter also indicated FDA would take other steps such as adding the company’s name to COVID-19 list of companies making false COVID-19 claims.
FDA warning letters are being sent to companies that claim products and treatments are effective against COVID-19. The letters are being mailed because there are currently no known treatments or cures for the disease. FDA is reviewing company websites and social media accounts for any evidence a maker, seller, or marketer of these products is making claims that suggest the products are unapproved drugs. The letters are targeting makers of supplements, medical devices, and any type of medical product.
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.