FDA Postpones Most Foreign Inspections Due to COVID-19

The FDA is postponing most foreign inspections through April, effective immediately, due to the global COVID-19 outbreak,¹ and the agency is taking action against companies that claim to treat or prevent the virus.²

The FDA based their decision to postpone foreign inspections on a number of factors, including State Department Level 4 travel advisories, which states that travel is prohibited for United States government employees, CDC travel recommendations, access restrictions imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management, and the importance of the health and safety of agency employees.¹

In a statement released Tuesday, FDA Commissioner Stephen M. Hahn, MD said inspections outside the United States that are deemed mission-critical will still be considered on a case-by-case basis. His statement also noted that the FDA is confident in its ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.¹

“We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely, and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government,” Hahn said.¹

Officials with the FDA are temporarily not permitted to physically inspect foreign produced FDA-regulated products or manufacturers; however, as an interim measure, they will employ additional tools to ensure the safety of products imported to the United States. These tools include denying entry of unsafe products into the United States, physical examinations and/or product sampling at US borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records in advance of or in lieu of on-site drug inspections.¹

The agency will continue to work with US Customs and Border Protection to target products intended for importation into the United States that violate applicable legal requirements for FDA-regulated products. Its risk-based import screening tool, known as PREDICT, will be used to focus their examinations and sample collections based on heightened concerns of specific products entering into US commerce.¹

“Americans can rest assured the FDA is diligently monitoring this outbreak, and the impact on our operations. Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat, and prevent the disease; survey the medical product supply chain for potential shortages or disruptions, and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools, including enforcement tools to stop fraudulent COVID-19 activity,” Hahn said.¹

In addition, the FDA and the Federal Trade Commission announced Monday that warning letters were sent to 7 companies over products the agencies claim are being fraudulently marketed to treat or prevent COVID-19.²

According to Hahn, the FDA considers the sale and promotion of fraudulent products to be a threat to public health. “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,” said Hahn, in a prepared statement.² “We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”

The FDA and FTC jointly 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. The products cited in these warning letters are teas, essential oils, tinctures and colloidal silver.²

In a statement, FTC Chairman Joe Simons said the warning letters, the first related to COVID-19 products, are just the initial step in actions taken against these 7 companies. Enforcement actions may also be taken.²

“There already is a high level of anxiety over the potential spread of coronavirus,” said Simons.² “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.”

The FDA also has been monitoring the drug supply chain with an expectation that COVID-19 would likely impact pharmaceuticals. The agency recently announced that at least 1 drug manufacturer has reported shortage of a human drug due to a manufacturing site affected by COVID-19.³

The FDA will continue to assess and calibrate their approach as needed to help advance federal response efforts.¹

REFERENCES

• Coronavirus Disease 2019 (COVID-2019) Update: Foreign Inspections [news release]. Silver Spring, MD; March 10, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections. Accessed March 10, 2020.
• Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 [news release]. Silver Spring, MD; March 9, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or. Accessed March 10, 2020.
• Coronavirus (COVID-19) Supply Chain Update [news release]. Silver Spring, MD; February 27, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update. Accessed March 10, 2020.