July 30, 2020 -- Since the beginning of the coronavirus pandemic, the FDA has issued more than 90 warning letters about fraudulent products claiming to prevent or cure the disease. While the bulk of those letters are to companies, a handful are directed at health care professionals.
Some of the professionals the FDA -- sometimes working with the Federal Trade Commission (FTC) -- sent warning letters to include:
- A naturopath in Massachusetts whose website offered HealthMax Nano-silver Liquid, as well as silver lozenges and other ''silver products," to prevent, treat, or cure COVID-19. The FDA says the products are unapproved new drugs and sold in violation of the federal Food, Drug and Cosmetic Act.
- A doctor in California offered a COVID Supplement Protection pack, with thymosin-alpha and methylene blue capsules to prevent, treat, diagnose, mitigate, or cure COVID-19. The FDA site notes the doctor took “corrective action,” meaning the products are no longer for sale for that purpose.
- A chiropractor in Southern California offered an umbilical cord-derived stem cell product for COVID-19 prevention and treatment.
- Another Southern California doctor offered vitamin C and liquid silver for COVID-19 prevention or treatment. An employee says they have removed the COVID-19 claim.
The FDA and FTC are not the only ones fighting bogus product claims about COVID-19. The FBI began investigating Jennings Ryan Staley, MD, a San Diego doctor who operated the Skinny Beach Med Spa. In mid-April, he was charged with mail fraud in connection with the sale of a COVID-19 treatment pack he said would make users immune to the virus for at least 6 weeks. According to the U.S. Attorney's Office in the Southern District of California, Staley also offered Xanax (alprazolam) as part of the package without providing a required medical exam. The anti-anxiety drug is a Schedule IV controlled substance.
In an interview with the FBI, Staley denied saying the treatments are a 100% effective cure for COVID-19, according to the news release issued by the U.S. Attorney's Office.
Pandemics: Expect the Worst
It's no surprise that a crisis like the pandemic brings out outlandish claims, especially for dietary supplements, says Peter Lurie, MD, president and executive director of the Center for Science in the Public Interest and former FDA associate commissioner.
"Assume the worst," he says. "Anybody who is making a [COVID-19] claim that appears too good to be true probably is too good to be true. If a product is good, do you think someone wouldn't have applied to the FDA for approval? There's too much money to be made; why hide it?"
In recent testimony before a Senate subcommittee, CSPI Policy Director Laura MacCleery urged the FDA and FTC to bring enforcement proceedings against Joseph Mercola, DO, an osteopathic doctor. The website Mercola.com lists 22 vitamins, supplements, and other products for sale that claim to prevent, treat, or cure COVID-19 infections.
MacCleery noted during her testimony that the National Institutes of Health says there is no evidence for silver supplements to prevent or treat any condition. Mercola's site offers a variety of colloidal silver products, promoted as a way to support the immune system and respiratory health. She noted that the FDA and FTC also sent warning letters to The Jim BakkerShow earlier this year after experts on that show claimed people should use silver daily and that it is safe for babies. That’s not true, she said. Colloidal silver in large enough amounts can be hazardous to the kidneys and other organs.
"On a recent episode of Mercola's podcast, he actually advises consumers to take the immunity-boosting supplements he sells and then attempt to contract the COVID-19 virus deliberately because his supplements will allegedly reduce their symptoms. Even with all my experience investigating supplement scams, this reckless self-promotion and endangerment of the public took my breath away," MacCleery told the lawmakers.
On the podcast, Mercola says, ''The best thing you can do is get these infections naturally and stay healthy.''
Before requesting the enforcement action, Lurie says, "we did go through each and every one of the two dozen products they have made claims for. We went through the [medical] databases looking for substantiation. We didn't find it. In most cases, there were no studies. Others were inappropriately designed."
Steve Rye, CEO of Mercola Health Resources, says that the CSPI’s accusations are false. The statements that support nutritional benefits or foods use direct references from studies published by reputable journals, he said.
The articles on the company’s web site are separate from the advertisements offering supplements. "There is a clear separation between content and advertisements, yet CSPI has purposely lied about this distinguishment," the statement continues.
"Even [Dr. Anthony] Fauci has said this virus will not be eradicated, which leaves you with two options, optimize your metabolic function and immune system or trust a fast tracked coronavirus vaccine,” Rye said in an email. “It is inevitable, you will be exposed to coronavirus and now is the time to protect yourself."
Dangers of Bogus Claims
People who believe the supplements may help them prevent or treat COVID-19 could get lax about other preventive measures, says Arthur Caplan, PhD, a bioethicist at New York University. ''People taking vitamins [to prevent COVID-19] may not be wearing masks."
Medical boards should be tough on those promoting these silver bullets and unproven remedies, Caplan says. How tough? "Suspend their license, force them into an education program, and not allow them to practice until they show they understand."
In California, for instance, the Medical Board of California monitors and reviews FDA warning letters sent to California doctors and investigates them for possible violations of the Medical Practice Act if appropriate, says Carlos Villatoro, a spokesperson.
In late March, the Federation of State Medical Boards, in conjunction with the National Association of Boards of Pharmacy and the National Council of State Boards of Nursing, issued a joint statement about the dangers of inappropriate prescribing of medications to prevent or treat COVID-19.
"There is a lot of leeway for physicians to be able to prescribe medication for what is called off-label," says Humayun Chaudhry, DO, the federation's president and chief executive officer. Off-label refers to the legal practice of prescribing a drug for a condition it is not formally approved for, if the doctor believes that evidence suggests it will be of benefit and experts support its use in that way. But, he says, "physicians, pharmacists, and hospitals must exercise caution." That means following established guidance and clinical evidence, he says.
Because treatments and guidance on COVID-19 are fluid, Caplan suggests checking out a doctor's suggestion on an unusual COVID-19 prevention or treatment with others or a second opinion to see if he or she is the only one suggesting it. The National Institutes of Health posts COVID-19 Treatment Guidelines and updates them regularly.