Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Life Sciences newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (March 4, 2021, 9:46 PM EST) -- The U.S. Food and Drug Administration sent a warning letter on Thursday to an alternative medicine proponent with instructions to stop peddling unapproved Vitamin C supplements as treatments or cures for the novel coronavirus.
Joseph Mercola, an osteopath and internet salesman, has been selling non-FDA approved "Liposomal Vitamin C," "Liposomal Vitamin D3," and "Quercetin and Pterostilbene Advanced" dietary supplements that claim to prevent, treat or cure COVID-19, in violation of the Food, Drug and Cosmetic Act, according to the FDA's letter.
On his website, Mercola says that "Vitamin C at extremely high doses acts as an antiviral drug, actually killing viruses," and that "there's no reason to ignore vitamins C and D for the prevention and treatment of COVID-19 and other respiratory infections," according to the letter.
The FDA said that Mercola also has made claims that the Shanghai government officially recommends the use of Vitamin C to treat the virus and that the supplement has also been used to treat sepsis.
In its letter, the agency said that Mercola is misleadingly representing the supplements as safe and effective treatments for COVID-19, instructing the salesman to remove any product labels or promotional materials that make those false claims.
"FDA is advising consumers not to purchase 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 letter states.
The FDA said that the Vitamin C and Vitamin D products referenced in the letter are unapproved and cannot be legally sold in the U.S.
In a statement to Law360 on Friday, a representative for Mercola and his company said the osteopath has been published in "peer reviewed medical literature demonstrating the clear link between Vitamin D deficiency and severe cases of COVID-19."
The spokesperson said the FDA's letter provides evidence of scientifically referenced articles without any commercial advertising and that Mercola will continue to express his professional opinions.
In response to the letter, Mercola and his company have told the FDA that it "can't stop speech it does not like," according to the statement.
In a statement on Thursday, Dr. Peter G. Lurie, the president of the Center for Science in the Public Interest, applauded the FDA's letter, saying Mercola has been in trouble with the FDA before, including when he claimed that thermography — or thermal imaging — can be used to screen for breast cancer.
"Americans are justifiably concerned about becoming infected with the coronavirus and contracting COVID-19," Lurie said. "Being misled to believe that supplements could prevent or treat COVID-19 could cause consumers to fail to take protective measures such as mask-wearing, putting themselves and others at risk, or fail to seek actual medical treatment if sick."
The FDA and the Federal Trade Commission have issued a slew of warnings over COVID-19 claims since the start of the pandemic.
Back in April, the federal agencies told far-right conspiracy theorist Alex Jones and his online InfoWars store to stop selling products falsely touted as cures or treatments for the novel coronavirus, following a similar directive from the New York attorney general. The FDA said that it had checked the InfoWars website on April 6 and viewed videos boosting SuperSilver and Superblue products, such as toothpaste, as cures and treatments for COVID-19.
More recently, the FDA issued letters in November targeting stem cell products and dental rinses.
And last month, the agency fired off warning letters to three online sellers of malaria drug hydroxychloroquine over unfounded claims that it can treat or prevent COVID-19. Early in the pandemic, former President Donald Trump touted without evidence that hydroxychloroquine was a "game changer" in treating the coronavirus. After Trump boosted the drug in April, the FDA warned later that month that the malaria drug had been reported as causing life-threatening heart rhythm problems.
At the time, hydroxychloroquine and another malaria drug were being used as a treatment in limited circumstances under an emergency use authorization, or EUA, for adolescent and adult patients. Two months later, the agency revoked the EUA, warning that the drugs are probably not effective against COVID-19 and may even interfere with a coronavirus drug sold by Gilead Sciences Inc.
--Additional reporting by Emily Field, Mike Curley and Adam Lidgett. Editing by Steven Edelstone.
Update: This story has been updated with comment from Mercola.
For a reprint of this article, please contact reprints@law360.com.
