An attorney who has represented the company asserts that Mercola's statements are protected speech under the First Amendment. And Steve A. Rye, CEO of Mercola Health Resources, had this to say: "Dr. Mercola does not advertise any products for COVID-19. This is a blatantly false statement."
FDA sent the letter on February 18 and made it public on its website last week. The letter references claims made by Mercola on his Twitter feed and in articles with his byline posted on his websites.
In an article posted on April 7, 2020, Mercola called Vitamin C a “vastly underutilized antiviral ‘drug.’” The title of the article is “Vitamins C and D Finally Adopted as Coronavirus Treatment.”
In the same article, Mercola notes that, “Vitamin C at extremely high doses acts as an antiviral drug, actually killing viruses.”
FDA cited two other articles posted on Mercola’s website with his byline. The second article cited in the warning letter, which was published on March 29, 2020, focuses on the effects of Vitamin C with similar claims to the article cited above.
FDA also focused on a third article, which delved into the effects of vitamin C in combination with the antioxidant compound quercitin which can be found in many natural sources. Among the claims made in that article, which was posted on October 8, 2020, are: “Quercetin was initially found to provide protection against SARS coronavirus in the aftermath of the SARS epidemic … Now, some doctors are advocating its use against SARS-CoV-2, in combination with vitamin C, noting that the two have synergistic effects.”
The overt nature of Mercola’s claims has gotten the attention of some critics of the dietary supplement industry. On July 21, 2020, Laura MacCleery, policy director for the Center for Science in the Public Interest, testified before a US Senate subcommittee urging that FDA and FTC take enforcement action against Mercola over the COVID-19 treatment advice he was allegedly dispensing.
Where do First Amendment protections end?
It has long been a matter of debate within the natural products industry and in constitutional law circles as to how much authority FDA or FTC might have to regulate claims made by experts in open forums. Over the years FDA has used as a determining factor the closeness of the link between the places on the Internet where claims are being made and where consumers can go to buy the products implicated in the claims.
The warning letter alleges that Mercola’s Twitter account has a direct link to a place to buy products. The site where the company posts the articles has a button at the top of page labeled 'Shop' was is qualified as an 'advertisement.'
Attorney: Statements are both true and protected
Todd Harrison, an attorney with the firm Venable LLC, was also copied in the letter as a result of having represented Mercola over the years. Harrison told NutraIngredients-USA that in his view Mercola’s statements are both true and are protected by the First Amendment.
“The statements referenced in the warning letter are not only truthful and well-documented, the statements are unequivocally protected speech and the allegations within the warning letter are without merit. We urge FDA to follow the science and immediately issue a well-crafted health claim that informs American consumers to work with their physician to determine their vitamin D levels and start a plan of Vitamin D supplementation to reduce their risk of developing a severe case of COVID-19,” he said.
“The science is clear on this issue and COVID-19 will likely be with us for a long time requiring constant vigilance. Thus, Americans should utilize everything in their arsenal to reduce their risk, including nutritional approaches that are often pennies a day to help stem the tide. These are simple inexpensive steps that will help reduce the risk of not only severe COVID-19 but other respiratory diseases. Indeed, we urge the federal government to make available vitamin D to disadvantage and underserved communities that have been hardest hit at no cost,” he added.
The other two warning letters addressed to supplement manfacturers and made public on the same day were sent to B4B Corp., a marketer of herbal teas, and SafaLab, Inc., which markets a set of supplemetns its calls the ‘Coronavirus 12 Pak.’