The U.S. Food and Drug Administration is putting a halt to the sale of alleged treatments for COVID-19 due to concerns about the safety risks these products could have to the public.
The U.S. Food and Drug Administration (FDA) is putting a halt to the sale of alleged treatments for COVID-19 due to concerns about the safety risks these products could have to the public.
On Monday, the FDA and the U.S. Federal Trade Commission issued warning letters to seven different companies for the sale of fraudulent products aimed at the coronavirus. The two federal agencies said the products are unapproved and pose a potential safety risk for patients. The warning letters are the first issued by the regulatory agency for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19), the FDA said.
FDA Commissioner Stephen M. Hahn said the sale of these fraudulent treatments is a threat to the public health. The products being sold as purported treatments are teas, essential oils, tinctures and colloidal silver. The FDA has previously warned that colloidal silver is not safe or effective for treating any disease or condition.
“We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” Hahn said in a statement. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
The FDA and FTC issued warning letters to Vital Silver; Quinessence Aromatherapy Ltd.; Xephyr, LLC doing business as N-Ergetics; GuruNanda, LLC; Vivify Holistic Clinic; Herbal Amy LLC; and The Jim Bakker Show. In the jointly-issued letters, the FDA and FTC requested companies respond in 48 hours describing the specific steps they have taken to correct the violations. If no steps are taken, they could be subject to legal action that includes seizing of the products in question and/or an injunction.
In addition to following up with companies that fail to make adequate corrections, the FDA and FTC said they will continue to monitor social media, online marketplaces and incoming complaints to help ensure that the companies do not continue to sell fraudulent products under a different company name or on another website. An FDA cross-agency task force has been established and dedicated to closely monitor for fraudulent products related to COVID-19. The agencies said fraudulent COVID-19 products may come in many varieties, including dietary supplements and other foods, as well as products purporting to be drugs, medical devices or vaccines.
FTC Chairman Joe Simons noted that the government is prepared to take enforcement actions against those selling untested products that pose a health risk. He added that there are high levels of anxiety about the spread of the coronavirus in the United States and the agencies are trying to prevent unscrupulous actors from “preying on consumers by promoting products with fraudulent prevention and treatment claims.”
There are currently no vaccines or drugs approved to treat or prevent COVID-19. There are some investigational products under development by various companies and universities, but they are in the early stages of development and have not been tested for safety and efficacy.
