In this file:
· Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
· FDA officials repeat message to remain calm about food safety during outbreak
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
Statement From: Commissioner of Food and Drugs - Food and Drug Administration (FDA), Stephen M. Hahn M.D.
For Immediate Release: March 18, 2020
Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration. As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic. Now more than ever, the American people are depending on us. We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.
In keeping with the White House Coronavirus Task Force and cross-government guidance, this week we directed all eligible FDA employees to begin teleworking. While this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, we will continue to adjust our approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.
Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.
Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.
I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.
Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.
In fact, inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen. Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products. For example, the medical product and food industries we regulate are subject to certain reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to, for example, operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate food safety hazards.
From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership. In fact, in last fiscal year, the overall domestic violation rate was only about 5%.
The FDA remains committed to using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers. As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed and we stand ready to resume any postponed inspections as soon as feasible.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA officials repeat message to remain calm about food safety during outbreak
By Coral Beach, Food Safety News by Marler Clark
March 18, 2020
Americans shouldn’t worry about the safety of their food during the coronavirus outbreak. They should watch the FDA website’s FAQ section for up-to-the-minute information, according to agency officials who spoke today.
Offering more generalities than specifics, three top administrators spoke to “stakeholders” during a half-hour session this afternoon “to discuss food safety and food supply questions related to Coronavirus Disease 2019 (COVID-19).” The moderator stressed that the conference call was not a media briefing and none of the questions from the audience were from news organizations.
Other topics discussed included postponing some food safety inspections and working with other departments on shortages of hand sanitizers and other supplies.
Two of the speakers specifically said there has been no evidence to date that the virus is foodborne or transmitted by food packaging. However, the Centers for Disease Control and Prevention has previously reported that COVID-19 can live on cardboard for hours and on hard surfaces such as stainless steel and plastic for up to three days.
“This is not a foodborne gastrointestinal virus,” said Frank Yiannas, Deputy Commissioner, Office of Food Policy and Response.
The deputy commissioner stressed that person-to-person transmission is the main route for the virus. He also said people can contract coronavirus by touching frequently touched surfaces and then touching their faces.
The top food safety administrator at the FDA, Yiannas, also repeatedly said there is no shortage of food in the United States and that the farm-to-fork supply system is working around the clock to stock grocery stores. Yiannas said he is on the White House team that is watching for supply chain issues.
Yiannas did not say everything is completely under control in the food industry or in government.
“There is more we can do and more we will do together,” Yiannas said.
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