Evaluation of Impermissible Claims and Marketing.
LegitScript’s Mask Review involves an evaluation of product claims and marketing, to ensure adherence to Google’s policies. Below is a list of examples of impermissible claims. Please note, this is not an exhaustive list.
Impermissible Marketing:
- Incorporation of the word “surgical” in the name of the product
- Inclusion of products under a “medical” tab
- Language regarding “FDA approval” or use of the FDA logo to imply FDA approval
- Falsified “Certificates” of FDA Registration or use of EUA certificates to imply FDA approval
Sample impermissible claims:
- “genuinly [sic] KN95 which meets all FDA requirements for medical and trade use”
- “Blocks 95.99% of bacteria, dust, chemicals, particles, pollen and smoke. Medical-grade mask: KN95…”
- “Blocks bacteria, virus, dust, chemicals, particles, pollen and smoke…”
- “Anti-COVID-19”
- “Prevent the Spread of Coronavirus”
- “PROTECTIVE MASK TAKE CARE OF YOU AND YOUR FAMILY…COVID-19…”
- “Multiple protection Against virus infection”
- “BEST FACE MASKS FOR BACTERIA AND VIRUSES”
- “anti-infection layer to help protect”
- “PFE [Particle FiltrationEfficiency] ≥ 95% BFE [Bacterial Filtration Efficiency] ≥ 95%”
- “Suitable for respiratory protection, filtering dust, haze, bacteria, droplets and other harmful particles in the air…The US Centers for Disease Control (CDC) now recommends that all Americans wear a fabric face mask outside their homes.”
- “Anti-droplets”
- “working primarily with medical distribution companies … to support those on the front lines”
Sources: FDA Warning Letters
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fixture-display-llc-615052-06282021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/professional-world-store-612406-04272021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bmhshop-612991-04262021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maskshellcom-611829-03112021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/world-packaging-solutions-llc-612824-06282021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/manhattan-stitching-company-inc-611719-04132021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natures-distributing-club-clean-incbuymedicalmasksnowcom-613952-05282021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irvin-inc-612738-05272021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-xichen-medical-technology-co-ltd-612946-06042021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fast-masks-usa-llc-612088-03262021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/captains-cloth-llc-613965-07022021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pairon-solutions-llc-616392-08092021
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/databazaarcom-617199-09032021