US FDA Emergency Use Authorization Masks Marketing Data

(Ellie Lockhart, Ph.D.)

During the COVID-19 crisis, the United States FDA has issued a series of emergency authorizations for masks of both domestic and import origin. These masks conform to various sets of safety standards established by the FDA during this time as defined in Emergency Use Authorizations (EUAs), and can have their use authorizations revoked if they fail to meet standards. There are a number of regulatory standards and burdens, and it has become fairly simple for companies to have compliant products added to the FDA's list. Despite this, masks are still sold in the United States which do not meet the FDA's EUA standards, or whose manufacturers/importers/sellers have not taken the steps to verify that they meet these standards. This is not a violation of the law, as masks which are registered with the FDA may also be sold; however, as a mask consumer, I was disappointed to learn the difference between a product being "FDA registered," which simply means that the company is not violating FDA regulations and having an EUA meant that the US FDA had been doing no particular testing on a brand of KF95 (Korean Filter 95) masks which I and my family have been using.

As these products were listed on Amazon.com (and likely elsewhere) as being "FDA registered," I believe a large number of online distributors may be exploiting the difference between having FDA authorization and simply having registered. Utilizing ScrapeHero Cloud to quickly obtain all masks that appeared in search results for "FDA mask" on Amazon.com on February 8, 2021, I then manually compiled the brand names of all FDA-authorized masks that have been authorized as a result of the COVID crisis under EUAs from the FDA list linked in this document, as well as their list of masks which are no longer authorized for various reasons (such as having been decontaminated). Using PostgreSQL to quickly link together tables and compile them as .csv files, I then created this data set, with two tables: all_authorized_masks.csv and unauthorized_masks.csv - NOTE: the data set does not go down to the level of specific authorized products, which means uncertainty exists for manufacturers who have both authorized masks and masks which were authorized but are no longer authorized. The goal of this project is to use standard notebook data analysis methods and fuzzy language recognition to compile some statistics and visuals on the extent to which "FDA masks" being sold online are in fact FDA EUA authorized masks.

Some caveats:

1. I am not asserting any manufacturer in particular is committing misconduct, but rather attempting to determine the extent to which terminology confusion may be leading US consumers to purchase masks which have not been tested by the US FDA. (I, personally, am fine with using KFDA aka Korean FDA approved masks, but the lack of clarity is still less than ideal for consumers.)
2. Many manufacturers produce some EUA approved masks and some unapproved masks. This list is only able to determine definite negatives in terms of comparing who has an EUA and has "FDA mask" as part of their Amazon search results; it can also be used to suggest cases where the approval status of masks is unclear.
3. The dataset of all registered masks is extremely large. A seller is likely operating legally and not doing anything wrong as long as they are registered, and collecting the full dataset of registered FDA masks is not feasible as the current publicly available bulk dataset on this topic is from before the outbreak of COVID-19 and I am not comfortable engaging in scraping of government websites.
4. Nothing about this dataset is to imply specific products may be unsafe, but simply to make US mask consumers aware of the rate at which given masks have been granted US FDA Emergency Use Authorization when they use the term "FDA" in their marketing on (in this case, as the largest US online retailer) Amazon's US website.

Wearing any mask is better than wearing none. However, the use of "FDA" to simply indicate that a product can be legally sold in the US is misleading; customers expect that "FDA" in a product description includes some form of approval. The analysis that comes out of this dataset should show an approximate estimate, as of February 8, 2021, of how many masks claiming FDA compliance are indeed EUA authorized.