Is Your Mask FDA Certified? How to Spot False Claims
Last week the FDA made headlines when they issued warnings to 25 companies that were falsely advertising their masks as “FDA Registered” or “FDA Certified”, some going so far as to include fake certificates indicating that the product had received FDA approval. These deceptive marketing practices have boomed, exploiting consumer concerns about COVID-19 and their desire to protect their health and the health of their families. Often the masks with these labels are no more effective than any other mask on the market, some with no better protection than a simple cloth mask. So how can consumers tell if a company is being dishonest about their FDA status and avoid being taken advantage of?
The FDA Never Issues Certificates
If a mask’s packaging claims to include a certificate of FDA approval or registration, it is false advertising. Many of the companies that received warning letters from the FDA have gone so far as to include the FDA logo on their fake certifications in an attempt to create an official appearance. This is in violation of the Federal Food, Drug, and Cosmetic Act and this kind of packaging should be reported to the FDA, not purchased. Even medical devices that have been approved by the FDA do not receive any sort of certificate.
Registration with the FDA is Not the Same as Approval
Companies that produce and sell medical devices, such as masks, are typically required to register with the FDA. The registration process does not involve the FDA assessing or approving their products, it only indicates that the company has completed the appropriate paperwork to conduct business in the United States. Companies can register with the FDA prior to receiving any sort of facility or product assessment by the FDA – registration alone does not suggest that any quality standards have been met.
Both manufacturing facilities and medical devices usually undergo extensive testing to receive FDA approval. The facilities of and the products made by a company could all be at different stages of this process. Companies advertising their products as “FDA registered” are engaging in misleading marketing.
Finding Approved, Cleared, or Authorized Products
There are three ways to determine if a product has received FDA authorization. First, medical devices that have gone through the FDA’s extensive testing and approval process will be listed in the Devices@FDA database with detailed information about the product. Low risk new products that do not qualify for standard approval pathways may also be found in the FDA’s De Novo database. Finally, under COVID-19 the FDA has authorized many products for emergency use, temporarily circumventing the usually lengthy approval process for products with strong potential to save lives. Products that have received this classification are listed on FDA’s Emergency Use Authorizations for Medical Devices page.
However a product is authorized for the market, it will never receive a certificate for use in marketing.
Identifying Quality Masks
While handling the COVID-19 pandemic, the FDA is focused on bigger concerns than offering a seal of approval to help mask manufacturers sell more masks. That said, there are measures of quality that manufacturers can obtain to identify their products as superior for protection against COVID-19. Look for masks that have been independently verified by a third-party laboratory to meet ASTM F2100-19 standards – masks with this qualifier filter out at least 95% of particles in the air. Another indicator of quality is the rating of the factory your mask was produced in – look for options that meet ISO 10993 manufacturing standards.
Blackbriar Regulatory Services manufactures masks that meet all of these criteria, in addition to working through the FDA’s emergency use authorization process. Reach out if you’re looking for high-quality, USA-made masks with honest advertising.
Article written by MARA UNKEFER – Director of Consumer Research at Blackbriar Regulatory Services