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
Quinessence Aromatherapy Ltd
Xephyr, LLC doing business as N-Ergetics,
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
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
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.
McGuireWoods’ COVID-19 Response Team helps clients navigate urgent and
evolving legal and business issues arising from the novel coronavirus pandemic.
Lawyers in our 21 offices are ready to assist quickly on questions involving
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