COVID-19 impact on supplements and foods
The COVID-19 pandemic is likely the most significant public health emergency we have ever faced, both individually and as the health-promoting herbal products industry. As we all try to adapt to rapid changes, please note that the services AHPA provides and the commitment we share with you to our mission to support responsible commerce in herbal products will not change. AHPA is taking precautions in response to this current emergency and encourage you to do the same. We have compiled the following information and resources to help you stay up to date and take any necessary steps to mitigate the risks associated with COVID-19.
AHPA has created this WebCenter to provide its members with information on the novel coronavirus and COVID-19 pandemic as well as possible impacts on the herbal products industry. AHPA intends to update the WebCenter on a timely basis as new information becomes available. However, especially given the quickly evolving nature of these issues, AHPA cannot guarantee the completeness, currentness, or accuracy of information included on or linked from the WebCenter. AHPA recommends that members use the WebCenter as just one resource for relevant information on these issues and, as needed, consult their own legal and regulatory experts.
The CDC states that COVID-19 is thought to spread primarily between people who are in close contact (within about 6 feet) through respiratory droplets produced when an infected person coughs or sneezes. These droplets can transmit the virus when they are absorbed through the mouth or nose, or inhaled into the lungs. It may be possible that COVID-19 can be transmitted by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads.
Low risk of transmission through food and packaging
FDA has stated that it is “not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging.” CDC states that there is low risk of spreading the virus from products or packaging that are shipped over a period of days or weeks at ambient temperatures. The Food Industry Association (FMI) has additional information on the COVID-19, including information from the CDC that products and packages shipped to the U.S. from China pose a very low risk of spreading the virus as COVID-19 is most likely to be spread via respiratory droplets.
FDA postpones cGMP inspections, provides AER flexibility
The FDA is postponing most foreign inspections through April, effective immediately, due to ongoing concerns about the COVID-19. FDA is confident it can maintain oversight over international manufacturers and imported products using alternative tools and methods. FDA will use other tools at its disposal, including denying entry of unsafe products into the U.S., physical examinations and/or product sampling at borders, reviewing a firm’s previous compliance history, and using information sharing from foreign governments as part of mutual recognition and confidentiality agreements. FDA will resume foreign inspections as soon as feasible.
The FDA has provided guidance with recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.
Businesses practices to mitigate the impact
The CDC has an active resource guide for businesses. The CDC stresses that employers must consider how to decrease the spread of any illness in order to lower the impact in their workplace in the event of an outbreak. Employers should consider how to:
- reduce transmission among staff;
- protect those at higher risk for adverse health complications;
- maintain business operations; and
- minimize adverse effects on other entities in their supply chains.
The U.S. Occupational Health and Safety Administration (OSHA) provides resources to help companies protect workers during a pandemic.
Nations around the world have imposed travel restrictions to hamper the spread of COVID-19. CDC does not generally issue advisories or restrictions for travel within the United States. However, cases of COVID-19 have been reported in many states, and some areas are experiencing community spread of the disease. Crowded travel settings, like airports, may increase chances of getting COVID-19, if there are other travelers with COVID-19 infection. CDC provides recommendations for international travel, including guidance on when to consider postponing or canceling travel. The U.S. and Canada mutually agreed to temporarily close the border and the U.S. has barred the entry of all foreign nationals who had visited China, Iran and a group of European countries during the previous 14 days. All Americans who have been in high-risk areas and return to the U.S. are required to fly to one of 13 airports. The U.S. State Department provides travel information for U.S. citizens and maintains a list of travel advisories (sortable by date and country) from around the world.