State and federal offices seek to protect consumers by cracking down on false and misleading COVID-19 treatment claims
Earlier this month the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly issued warning letters to seven companies—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—for selling products that fraudulently claim to prevent, treat or cure COVID-19. The products cited in these warning letters are teas, essential oils, tinctures and colloidal silver, all of which FDA considers unapproved drugs that pose significant risks to patient health and violate federal law.
The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). The agencies are actively monitoring social media, online marketplaces and incoming complaints to help ensure consumer safety against fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. An FDA cross-agency task force has been established and dedicated to closely monitor for fraudulent products related to COVID-19.
The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. 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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
FTC Chairman Joe Simons stated that “[w]hat we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.” It is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease without having competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, to substantiate the truth of the claims at the time they are made.
State attorney general offices are also closely monitoring fraudulent activity regarding COVID-19. In addition to the joint FDA-FTC warning letter, the Jim Bakker Show also received a cease and desist order from New York Attorney General Letitia James and was sued by Missouri Attorney General Eric Schmitt over recent statements made on the show regarding use of the Silver Solution product, sold on the show’s website, in treating COVID-19. The letter from James stated that the “segment may mislead consumers as to the effectiveness of the Silver Solution product in protecting against the current outbreak” and that “any representation on the Jim Bakker Show that its Silver Solution products are effective at combating and/or treating the 2019 novel coronavirus violates New York law.”
Attorney General offices in Illinois, Minnesota, Massachusetts, Virginia, and the District of Columbia, among others, have all issued warnings that individuals to be cautious of any claims that a certain product can cure, treat or prevent COVID-19. Illinois Attorney General Kwame Raoul warned that products like chlorine dioxide, hydroxycholroquine, essential oils, silver, elderberry and garlic are being advertised as “cures” for COVID-19.
In view of FDA and FTC regulations and current positions on COVID-19, all product claims should be scrutinized. Unsubstantiated health claims, or any claims that a product treats, prevents or can cure COVID-19, for all dietary supplements and unapproved drugs, should be avoided.