The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements from FDA and HHS relating to the life sciences industry, along with highlights on FDA’s intent to step up enforcement action against fraudulent and counterfeit COVID-19 tests on the market.
FDA recently issued warning letters to seven companies for selling fraudulent COVID-19 products. The FDA and Federal Trade Commission (FTC) issued joint 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. The products cited included teas, essential oils, tinctures and colloidal silver. The companies were asked to respond within 48 hours to describe the steps taken to correct the violations. Companies that sell products claiming to prevent, treat or cure COVID-19 could be subject to enforcement by the FDA and FTC, including legal action, seizure or injunction. An FDA cross-agency task force will monitor potentially fraudulent products related to COVID-19.
Despite the warning letters, expect to see more enforcement actions by FDA and FTC against companies intentionally or unintentionally making claims surrounding their products’ efficacy against COVID-19. To date, there is no approved treatment or vaccine for COVID-19, although clinical trials are underway.
On March 18, 2020, the FDA issued a statement regarding its new direction during the COVID-19 emergency, which includes postponing all domestic routine surveillance facility inspections. The FDA typically conducts in-person facility inspections every few years. Domestic for-cause inspections will be evaluated and will still proceed if critical. During this time, the FDA may use other routes for evaluating inspectional work that would not jeopardize public safety, such as evaluating records instead of conducting on-site inspections. Importantly this extends to all FDA-regulated industries, including food, devices, dietary supplements, cosmetics, drugs and biologics. In addition to suspension of domestic inspections, many of FDA’s public meetings have been canceled or moved to virtual settings.
With these changing enforcement trends, it is clear FDA is focusing on the most critical issues and violators, thereby responding to staffing issues that may arise and the limited agency resources available. So far, FDA seems to be reacting favorably to the needs of industry and the general public in its response to the crisis.
McGuireWoods has significant experience handling FDA inspections and enforcement issues. Please reach out to our team if you have questions.
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