The Food and Drug Administration (FDA) is an organization within the U.S. Department of Health and Services. It protects the public health by assuring the safety, effectiveness, and security of human and veterinarian drugs, vaccines, and other biological products. The agency is also responsible for the safety and the security of food, dietary supplements, cosmetics, products that emit radiation, and also regulating tobacco products.
FDA Updates Show Reassuring Action In The Battle Against Covid-19
The Food and Drug Administration (FDA) 28 April, announced measures that have been taken in their effort to battle the covid-19 pandemic.
The first of these announcements was the issue of a video explaining Emergency Use Authorizations (EUAs) which is one of the tools that the FDA uses to ensure critical medical products are made available during public health emergencies such as the present Covid-19 pandemic.
The FDA, in its constant effort and vigil on fraudulent product being sold to consumers. along with the FDC (Federal Trade Commission) , issued warning letters to Hopewell Essential Oils for offering essential oils and Herbal Products in the US market with a misleading claim that these products are safe and effective for the prevention and treatment of Covid-19.
The Second warning letter was issued to Santiste Labs LLC for marketing DefendTMPatch which is a transdermal patch containing a patch of Botanical oils for sale in the United States with a misleading claim that these products are safe and effective for the prevention and treatment of Covid-19. The FDA pointed out in both the warning letters that there are presently no FDA-approved products for treating or preventing Covid-19. Both these companies have reportedly not yet responded to the letters issued to them.
The FDA also issued warning letters to food and dietary supplement companies including David Rosen Bakery Supplies Inc., Prime line Distributors Inc., Fatima Brothers, Promex Distributors LLC., Seasnax and Diamond Rock Food Imports Inc., and 12 other companies. These companies were issued warning letters for either failing or not applying for clearance under the FDA’s Foreign Supplier Verification Program (FSVP).
In addition to these actions on non-conforming companies, The FDA has also initiated action against more than 40 companies for manufacturing and marketing unapproved and misbranded products related co Covid-19. Another 6 companies have also been pulled up with warning letters for food packed or held under unsanitary conditions.
Another 3 companies including Macduff Shellfish and Smoked Salmon Unlimited received warning letters for violating HACCP (Hazard Analysis and critical control Point) and CGMP (Goods Manufacturing Practices) for manufacturing and marketing misbranded and adulterated products.
The FDA further announced that it has updated its Frequently Asked Questions (FAQ) page with information about smoking and covid-19. The update mentions that smoking makes people more vulnerable to respiratory illnesses such as Covid -19 and even cancer. The update added this is the best time to give up smoking for good.
In addition, the FDA has a “every Try Counts” campaign that provides supportive tips for smokers to give up this habit for good.
Another step taken by the FDA was to post information to help Pharmaceutical manufacturers submitting generic Drug applications along with bioequivalence study reports whose approvals are likely to be impacted during the Covid-19 crisis.
The FDA has issued Emergency Use Authorization to 50 test kit manufacturers and labs. 22 authorized tests have been added to EUA letter of authorization for complex molecular based lab developed tests (LDTs).
The FDA report mentioned that it has been informed that 230 testing labs across the United States have begun testing according to the procedures laid out in its Covid -19 policy.
Clearly, the FDA means business and all the actions are sure to bring about an improvement in the health of Americans and serve as a warning to companies intending to capitalize on the Covid-19 pandemic.