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The latest products and services the US Federal Trade Commission identified as making fraudulent claims to treat COVID-19 can be lawfully sold OTC, while direct-to-consumer sales were among the violations the Food and Drug Administration identified for some at-home tests recently appearing on its warnings list.

The agencies’ disclosures of additional warnings continue adding to the total each has made during the novel coronavirus pandemic. Other than a gel and a licorice product offered by two of the 30 businesses the FTC warned, though, all of the products and services are types that already have been identified in previous warnings.

The FDA’s Center for Devices and Radiological Health emphasized in its warnings to three businesses (see box below) published on 17 June and signed by Timothy Stenzel, director of the center’s Office of In Vitro Diagnostics and Radiological Health, that not only were their products offered as at-home serology tests for COVID-19 antibodies not approved for sale in the US with the indication, they also weren’t allowed to be distributed OTC.

CDRH also announced separately that currently it has not approved or authorized any diagnostic or antibody COVID-19 serology test kits to be used completely at home, a procedure that can present unique and potentially serious public health risks, including whether a consumer has the ability to collect his or her specimen, run the test and interpret results accurately.

Meanwhile, the center has authorized several at-home COVID-19 tests for collection of samples from the nose or mouth that can then be sent to a lab for processing and test reporting. But those tests also aren’t approved for OTC sales. (Also see "US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use" - HBW Insight, 22 Apr, 2020.)

“When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk,” said CDRH Director Jeff Shuren.


250 Warnings And Counting For FTC

The FTC announced its latest 30 COVID-19 fraud warnings on 18 June, noting that it has warned a total of 250 businesses about making various false and misleading claims about products available directly to consumers preventing or treating the disease caused by the coronavirus.

“Like the warning letters FTC staff has already sent to companies making COVID-19 claims, the latest stack reminds recipients that no study is currently known to exist to support the representations they’re making for their products and services,” said Lesley Fair, senior attorney with the FTC Bureau of Consumer Protection.

The seventh set of coronavirus-related warning letters from the FTC revisit product types including infrared saunas, intravenous drips of vitamin, mineral and supplement blends, pulsed electromagnetic field devices, oxygen/ozone therapies, collodial silver products, stem cell treatments and cannabidiol-containing products. Like the agency’s earlier warnings, the latest identify products and services that are allowed to be sold OTC but are not approved for the claims identified as fraudulent.

The latest warnings, though, show that FTC officials also found a hydrogen peroxide gel and supplements containing licorice fraudulently offered as COVID-19 treatments. In a 3 June warning, the FTC stated that San Francisco Dental Wellness sent email advertisements to consumers with claims including “now offering a peroxide gel that allows you to use [sic] for 15-20 minutes to help prevent the spread of Covid-19” and “offering Oral peroxide gel with custom fit trays for you. If you know you need to go out, when you return home, use the solution immediately to prevent the virus. Buy 5 solutions get 1 free for $100. Custom trays are $75 which can also be used for teeth whitening or non-custom standard trays are $25.”

The agency also warned Big Sky Compounding, of Kalispell, MT, in a 2 June letter about making claims found on its website on 14 May for its herbal and other supplements including “Licorice is anti-viral and provides adrenal support” under the heading “Anti-Viral (Envelope Virus) Prevention or Treatment Pick ONE or TWO to keep in your medicine cabinet.”

As it and the FDA have with all other businesses they’ve warned about fraudulent COVID-19 claims, the FTC instructed the San Francisco dental practice and the Montana business to respond within 48 hours via email describing specific actions the businesses have taken to address the regulatory concerns identified.

The FDA has submitted a total of 72 warnings on drugs, supplements and devices unlawfully promoted for COVID-19 prevention and treatment.

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