FDA Issues Warning to Unauthorized COVID Drug Makers

The U.S. Food and Drug Administration (FDA) has issued two warning letters to manufacturers that claim to make drugs that cure Covid-19. The companies, Iodine Products Inc. and Applied Biological Laboratories Inc., have marketed non-FDA-approved drugs on social media and on their respective websites.

The FDA warning letter to Iodine Products Inc., sent on March 28, focused on two products offered by the company: “Liquid Mask Spray Anti-Viral” and “The COVID-Killer.” According to the FDA, “these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act.”

Since the drugs advertised themselves as products designed to “mitigate, prevent, treat, diagnose, or cure COVID-19,” they were treated by the FDA as novel drugs requiring pre-approval from the agency before sale or marketing. Additionally, because Iodine Products’ drugs were marketed in this way, they also ran afoul of the Federal Food, Drug & Cosmetic Act (FD&C Act) section on drug branding.

In their accusations, the FDA included a non-exhaustive list of examples of the unauthorized claims being made by Iodine Products Inc. The manufacturer claimed that “once you use [the Anti-Viral Liquid Mask], you’re protected.” The company also claimed that its product was used “worldwide” by doctors to prevent the spread of Covid-19.

A snippet from the company’s webpage also claimed that the active ingredient in their liquid mask product could “CURE COVID-19 patients and simultaneously PREVENT transmission as they kill COVID-19 virus particles.” Youtube videos by the company also said that the liquid mask was needed “to truly prevent the transmission of this disease organism,” referring to the SARS CoV-2 virus.

The FDA warning letter states that these statements are evidence that Iodine Products Inc. is “misleadingly representing” their products as safe and effective when the FDA has not certified that the drug is either safe or effective.

The second warning letter that the FDA sent out on March 28 was addressed to Applied Biological Laboratories Inc. This manufacturer was accused of advertising their “Biovanta Dual Action Throat Spray” and “Biovanta Triple Action Lozenges” as similarly misleading new drugs intended to treat or cure Covid-19 and likewise in violation of both the FD&C Act’s sections on novel drugs and proper branding.

The key statements cited in the FDA warning letter also included claims that the Biovanta drug could stop Covid-19 symptoms, and prevent or even cure the virus. The FDA cited testimonials from the company’s Amazon product page, YouTube videos, and social media posts on LinkedIn and Twitter. Notably, the FDA also came down on Biovanta’s misrepresentation of a study that the company cited: “Rational drug design for sore throat — An aspirin-based treatment that addresses bradykinin-induced inflammation.”

Applied Biological Laboratories cites the study on its site stating “the scientific studies demonstrate that the active ingredients in Biovanta help reduce the inflammation that causes upper respiratory infections, including COVID-19, while leading brands, which are designed to mask symptoms, do more harm than good,” as well as referring to it in a PR Newswire press release.

The study was first uploaded to a preprint biology server called BioRXiv. The site itself discloses “bioRxiv posts many COVID19-related papers. A reminder: they have not been formally peer-reviewed and should not guide health-related behavior or be reported in the press as conclusive.”

Additionally, the FDA comments on the study in the letter to Applied Biological Laboratories calling it “your firm’s study.” This statement is supported by the competing interest statement of the study which mentions that “This study was funded entirely by Applied Biological Laboratories, . . . [a]ll of the authors were employees of Applied Biological Laboratories at the time the experiments were performed.”

The FDA informed both companies that they had 48 hours to review their products and sites and describe the specific steps that have been taken to amend the violations. Failure to do so may result in the FDA pursuing an injunction or other legal action.

The FDA is also advising not to purchase or use these or any other products that have not been FDA approved for safety and effectiveness in treating Covid-19.

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