FDA Flags Wipe Seller for COVID-19 Claims

The US Food & Drug Administration sent a warning letter to CAMA Wellness Center/IodoRios Company, LLC, Philadelphia, PA, for unapproved and misbranded products related to Coronavirus Disease 2019 (COVID-19). In the letter, dated March 5, 2021, the agency said it had reviewed the company’s website (www.cp.camacenter.com) on February 8, 2021, and March 2, 2021, respectively, and its social media accounts (www.facebook.com/IoWipe), where it was selling a hand wipe that was intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
 
Some examples of the claims on your websites and/or labeling that establish the intended use of the firm’s product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include: 
 
On a package insert that accompanies the  product, under “WHEN SHOULD I REPLACE MY WIPE”:
“However due to COVID-19 being a readily communicable disease, to be safe, we’d like you to replace it when it starts to fade from jet black or have any discoloration. This would be a sign that its iodine, the active ingredient, is beginning to be depleted (and why we say “You can see it working!). We are recommending this more conservative measure for the time being, while we pursue COVID-19 specific testing. Bear in mind that COVID-19 is an extremely easy virus to destroy outside the body, and the wipe has been tested on much tougher bugs.”
 
 “A Chestnut Hill family is producing a sanitizing wipe that lasts 30 days and can be used 600 times . . . Even at nearly 91 years old, inventor Solomon Rosenblatt is still figuring out new ways to wipe away bacteria, fungi, and viruses. His latest product is especially relevant during COVID-19. IoWipe is a reusable, iodine-based sponge that can be used to wipe hands.” [from your webpage www.cp.camacenter.com/iomedia, you also posted this with a parenthetical “(available at IoWipe.com)” on a September 2, 2020 post on your Social Media webpage https://www.facebook.com/IoWipe/] 
 
“Hill scientist, 90, invents ‘IoWipe’; combats pandemic . . . Though the invention was created years ago, an intensive need for it didn’t seem to exist until the COVID-19 global pandemic. The product came into existence in late 2019, just before the need materialized . . . ‘There is a definite need now for IoWipe in light of the global pandemic and future pandemics, which are likely to occur more frequently. It is a personal, convenient, reusable, cost-effective wipe that releases iodine in safe amounts. I believe it is a superior option, as compared to alcohol gels and disposable wipes.’” [from your webpage www.cp.camacenter.com/iomedia]
 
“After sending out our COVID-19 email about temporarily closing CAMA, our acupuncture center to our patients with a mention about IoWipes, our anti-viral wipes, we ended up with 30 orders, many of them local. So tonight we are driving around delivering anti-viral hand wipes and cell phone wipes in party bags two [sic] friends and patients!” You also replied to your post with “IoWipes – Reusable Hand Wipes available at iowipe.com [from a March 24, 2020 post on your Social Media webpage https://www.facebook.com/IoWipe/]
In addition, FDA’s letter to the company noted that it is unlawful under the FTC Act  to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. 
 
CBD Salve
Additionally, the FDA sent a warning letter to a CBD products company after reviewing the website of Scottsdale, AZ-based  Cannafyl in November 2020, as well as its  social media websites at www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd, found that the company was selling CBD-containing products intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. The claims on the company’s website and social media websites establish that various CBD products, including a Relief CBD Salve, are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, the CBD-containing products for humans are also misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). 
 
In the letter, FDA noted the company’s claim: “Cannafyl CBD Relief Salve – 500mg & 1000mg is a revolutionary full-spectrum CBD topical salve formulated to help relieve . . . neuropathy, psoriasis and much more!”
 
Hand Sanitizers
This latest release of warning letters included adulterated hand sanitizer products from several companies including: 
• Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, importer of Pristine Hand Sanitizer Gel; 
• Plasticos Las Palmas S.A. de C.V., importer of Medically Minded Hand Sanitizer Gel; and
• Rodriguez Fierro Marco Antonio , importer of Natural Gold Gel Alcohol Antiseptic 75% Topical Solution.