CSPI urges federal enforcement action against supplement manufacturers making illegal antiviral claims

Investigation finds 46 such products on Amazon

The Center for Science in the Public Interest is asking the Food and Drug Administration and the Federal Trade Commission to take enforcement action against companies trying to exploit the COVID-19 pandemic by claiming dietary supplements fight viruses. In a market scan on May 29, 2020, the nonprofit watchdog group found 46 such products on Amazon. CSPI is now calling on the online retailer to delist such products and to work cooperatively with the FDA and FTC to protect consumers from unscrupulous supplement makers. These 46 listings represent just a small sampling of the illegal and potentially unsafe supplements currently sold on Amazon and other online retailers, according to CSPI.

It is illegal under federal law for dietary supplements to bear claims that they prevent, diagnose, or treat any disease, including COVID-19, which has claimed the lives of more than 107,000 Americans. Yet CSPI’s investigators found a wide variety of explicit or implied antiviral claims, such as “effective against an enormous array of disease causing…virus[es],” “virus protection,” “and fend off certain viruses.”

Some claims go even further. Biotica’s Immune Support Capsules, for instance, claim to “help your immune system fight viruses and bacteria in sinus, throat and respiratory tract.” Phytobiotic Capsules claim to “[P]romote normal immunity to bacterial and viral infections.” Another product, Virus Shield, claims to help with “flue [sic] infections and decreases incidence and symptoms of upper respiratory tract infections.”

Supplement makers may make statements about how supplement ingredients may affect the structure or function of the body, if they have substantiation for such claims. For example, a general claim that a multivitamin, say, “boosts immunity” would be permissible with substantiation. But disease prevention claims (such as “boosts immunity against viruses”) are impermissible since the FDA would consider these products to be unapproved and misbranded new drugs. In a 2002 guidance, the agency indicated that “[c]ertain product class names are so strongly associated with treating and preventing diseases that claiming membership in the product class constitutes a disease claim,”and went on to name “antivirals” specifically as such a product class.

The very names of the products often contribute to the problem, according to CSPI. Besides Virus Shield, CSPI found products such as Viracid, Anti-V formula, and Bronchial Virus Care for sale on Amazon; the FDA has held that the name of the product is relevant in considering whether a supplement is making a disease claim. And despite the efforts of Amazon, which has reportedly removed 6.5 million unauthorized coronavirus products from its platform since the start of the pandemic, these problems persist.

“The most important thing for consumers to know is that no supplement is FDA-approved to treat or prevent COVID,” said CSPI president Dr. Peter Lurie. “Besides being a waste of money, these products may harm consumers if they decide to opt for a supplement in favor of the things we know that actually help, like hand washing, maintaining social distance, wearing personal protective equipment, or seeking real medical treatment when sick.”

“Amazon, the FDA, and FTC have already acted against products that explicitly made claims about coronavirus,” said CSPI policy director Laura MacCleery. “This is the next assignment: to pursue claims made by supplement profiteers using broad anti-virus claims in the context of this pandemic. FDA policy is clear that such claims are illegal—and the importance of that policy is at its apex now.”

Illegal claims that supplements can help ward off the coronavirus that causes COVID-19 began emerging in the earliest days of the pandemic. In February, CSPI asked the FDA and FTC to take enforcement action against televangelist James Bakker for claims made on his show that a solution containing the element silver could kill the coronavirus “within 12 hours.” Bakker’s program had previously claimed the solution cured “all venereal diseases” and HIV. Bakker has since been sued by state attorneys general in New York and Missouri over the coronavirus claims.