FDA Import Regulations Loosened for Personal Protective Equipment, Not Botox

May 21, 2020

A glaring byproduct of the pandemic has been the national shortage of personal protective equipment (PPE). Pandemic headlines run concurrent to those lamenting the lack of PPE for those on the frontline. The emerging celebrity in all the hype is the now famous N95 mask. Unfortunately, the demand outweighs the stockpile. In response to the need, the FDA began softening PPE regulations beginning in late March, now permitting the import of the similar KN95 mask from China. For non-pandemic essential medical workers and med spas, it is important to be aware that relaxed importation requirements on PPE do not translate to other elective medical products.

Over the past few weeks, the FDA parameters have evolved swiftly to meet demand. A quick timeline of the shifting regulations reads as follows:

  • On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing certain N95 respirators not approved by the National Institute for Occupational Safety and Health (NIOSH). Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who all have similar standards to NIOSH. However, not listed at this point were KN95 masks due to concerns of fraudulence.
  • On March 28, 2020, the FDA issued an additional statement regarding steps taken to expedite the importation of PPE, and that products meeting EUA authorization would be allowed to enter the US more quickly, adding that the benefits of such imports, at this point, outweigh any known risks.
  • On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which, in effect, makes the KN95 masks eligible for authorization as long as certain criteria are met, including evidence/documentation of authenticity.

While nearly identical in performance to the N95 mask, the KN95 is regulated by the Chinese government and has only slight differences. The FDA’s main concern over the KN95 has been, and remains, the risk of counterfeiting. However, the risk of potential liability over bogus product may be better than the alternative: no mask. And yet, buyers beware. The FDA permitting the KN95 for import does not mean the KN95 is FDA-approved, meaning those who use it do so without legal protection.

Although some importation requirements have been relaxed due to COVID-19, the FDA’s COVID response does not spill over to any other medical devices, equipment, or products not specifically listed in their recent statements, such as drugs and injectables. The FDA has long since banned the importation of aesthetic medical products, such as Botox, from foreign countries, and the new EUA regulations do not loosen those restrictions. The FDA continues to monitor the quality of all drugs shipped to the US, while also working to potentially import drugs that may promise to treat COVID-19. As of this posting, however, the FDA has not cleared any one drug to be imported for this purpose.

As always, be aware that the situation regarding COVID-19 is subject to change daily. For more information on new FDA guidelines or for a consult, contact us at info@byrdadatto.com.

ByrdAdatto attorney Jay Reyero

Jay D. Reyero

Jay has mastered the art of communication, leaving clients with both an understanding of their business risk and the path to solution.