To read the full letter to the Food and Drug Administration, Environmental Protection Agency and U.S. Consumer Product Safety Commission, please click here.
Dear Dr. Woodcock, Mr. Regan and Dr. Thomas,
We write to urge you to use your authorities and competencies to ban the import and sale of medical masks and civilian equivalents in the United States and its territories that incorporate certain nanoscale materials. Furthermore, you should recall any such masks presently in the United States and its territories and strongly advise against the continued use of such masks because wholesale and retail recalls will not prevent the use of these masks by individuals unaware that regular use of the masks, e.g., by teachers and school children, will result in inhaling these nanomaterials at occupational exposure levels.
Jim Thomas, of the ETC Group in Canada, has aggregated Department of Commerce Harmonized System data on U.S. imports of Shengquan Group masks. Shengquan is a prominent global manufacturer of medical and civilian use masks incorporating biomass derived nanographene. Mr. Thomas estimates that companies including Shengquan USA, SQ Medical, Shengquan Canada, Aussino, Dolbec International, BP Exploration and others have imported into the U.S. over 600 million masks from Shengquan New Materials company since the beginning of the pandemic. We attach an Excel spreadsheet with Mr. Thomas’s Harmonized System data and his aggregation calculations. (Attachment 1) Shengquan masks incorporating nanographene “heal fiber” are not always advertised as such, so it is impossible to determine what percentage of the masks incorporate nanographene. The certificate of registration by one importer of the Shengquan masks explicitly notes that the certificate does not constitute Food and Drug Administration approval of the mask. However, Shengquan states in its marketing materials that its nanographene masks provides “equivalent protection” to that of National Institute for Occupational Safety and Health (NIOSH) certified masks and implies its imported masks are FDA approved.
We make this request in the full recognition that mask wearing continues to be a public health measure of critical importance as we enter the fourth wave of COVID-19. However, recent events concerning masks that incorporate antimicrobial nanomaterials provide evidence of the urgent need for you to take precautionary actions for imported masks that have not undergone pre-market safety reviews and post-market surveillance.
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