How FDA Is Monitoring The COVID-19 Product Market

FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working with online marketplaces, domain name registrars, payment processors, and social media websites to remove unproven claims from their platforms.

To date, FDA has issued over 65 warning letters. In certain instances, FDA has followed those warning letters by asking DOJ to initiate formal legal proceedings against a product manufacturer. For some categories of products, FDA has used press announcements to effectively provide a generalized warning to all manufacturers in the space. Below we tabulate all of the enforcement efforts that FDA has been using to try to keep fraudulent COVID‑19 products off the market.

FDA and FTC sent their first round of warning letters three months ago. Now, FDA has issued at least 66 warning letters to firms selling fraudulent products with claims to prevent, diagnose, treat, mitigate, or cure COVID-19.

The products include (1) CBD products, (2) dietary supplements and vitamins, (3) essential oils, (4) herbal products, (5) homeopathic products, (6) sanitizer products, (7) products labeled to contain chlorine dioxide or colloidal silver, and (8) others. FDA has taken issue with various marketing claims—ranging from #coronavirus hashtags to statements made on pop-up windows. The below chart lists the warnings letters by product category and identifies some of the problematic statements that FDA has identified. This reference chart should be useful in helping to determine where FDA is focusing its enforcement efforts when it comes to COVID‑19 claims. Links to warning letters are also provided for each product.

Coronavirus Protocol (Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune System, and Elderberry Tincture)

“Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver

“Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free Toothpaste”

HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges with Vitamin C, and Silver Biotics Silver Gel Ultimate Skin & Body Care (collectively, “your silver products”)

Silver, CBD products, iodine, medicinal mushroom, selenium, zinc, vitamin C, vitamin D3, astragalus, and elderberry

“China Oral Nosode,” described as “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES”

FDA’s warning letters have escalated into legal action in at least two instances. As we previously reported, FDA warned a seller of chlorine dioxide products to remove its products from the market within 48 hours. After the seller “made clear that they had no intention of taking corrective action,” DOJ obtained a temporary restraining order against it.

Likewise, DOJ obtained a temporary restraining order against a seller of colloidal silver products who, despite “remov[ing] their COVID-19-related webpages for a time, . . . resumed marketing their colloidal silver products as a treatment for COVID-19 in violation of law.”

In both cases, FDA indicated there was a lack of adequate data to establish the safety and effectiveness of the products for “any use,” let alone for the novel coronavirus. The agency expressed concern that such claims could cause consumers to delay or stop appropriate medical treatment. Although it gave the product manufacturers an opportunity to take corrective action, it ultimately followed through on the threat of legal action.

FDA has also used daily press announcements to communicate with COVID-19 product manufacturers, most notably at-home test and serology test manufacturers.

In one such announcement, FDA warned that it had not authorized any test for self-collection—despite a wave of tests that were preparing to hit the market. It has recently signaled more openness to the concept, though. As we previously reported, it has granted emergency use authorizations (EUA) to an at-home collection kit, saliva-based at-home collection kit, and standalone at-home collection kit. It has even started providing a Home Specimen Collection Molecular Diagnostic EUA Template to further support the development of tests for self‑collection at home.

Similarly, FDA has published several press announcements like this one explaining its stance on serology tests. The agency previously maintained a fairly relaxed policy for serology tests, since mid-March, permitting commercial antibody tests to be marketed and used without FDA EUA review if they followed certain criteria. But FDA updated this policy last month, shortly after a congressional subcommittee criticized the agency for “fail[ing] to police” the coronavirus serological antibody test market.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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Post time: Jun-11-2020

How FDA Is Monitoring The COVID-19 Product Market | Morrison & Foerster LLP