Everything You Need to Know About What the FDA is Doing to Keep Covid-Related Claims Honest and Trustworthy
We are lucky to live in a country where you have the reasonable expectation that products do what they say they will do. This is particularly important during our current state of affairs with the Coronavirus pandemic. This is thanks to the FDA. Along with other federal, state, and local agencies and public health officials across the country, the FDA is protecting public health during the COVID-19 pandemic. This is because they stand in the way of less-than-reputable companies putting products on the market with bogus health claims. Consider the following facts:
#1 Gloves and masks don’t have FDA approval. Medical gloves and masks are intended to provide broad barrier protection. At this time, FDA has not cleared, approved, or authorized any medical gloves for specific protection against a COVID-19 infection. There are currently no FDA-approved face masks, surgical masks, or respirators. This is not to say that masks don’t work, simply that they haven’t been checked and approved by the FDA.
#2 The FDA for Covid is here to issue warnings about fraudulent products. The FDA and the FTC issued warning letters to several companies this year for selling fraudulent COVID-19 products. The FDA and Federal Trade Commission (FTC) are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The warning letters were the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19).
#3 The FDA says to wash your hands!
You may think the FDA would push a product like a certain hand sanitizer to keep us all germ-free. In fact, they tell us that one of the best ways to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
If you’re developing, manufacturing, or marketing a medical device that fights Covid or keeps people germ-free, you’ll need detailed knowledge of the FDA regulatory process. Everything from the way your device is classified to to how your product is cleared is complex. It is oftentimes confusing for business owners. If you have any further questions or want to go through the process of having your product FDA approved for effectiveness against COVID-19, we recommend reaching out to a proven team of FDA lawyers for Covid. These professionals are here to make everything easier to get to market! FDA lawyers for Covid will help you with label review, product clearance, and more.