Description of Event or Problem · 0
URGENT CONCERN: MISLEADING MARKETING OF 2SAN COLORECTAL CANCER SELF TEST. DEAR FDA REPRESENTATIVE OR APPROPRIATE CONTACT, I AM WRITING TO FORMALLY REPORT CONCERNS REGARDING THE MARKETING AND SALE OF THE 2SAN COLORECTAL CANCER SELF TEST IN THE UNITED STATES. IT HAS COME TO MY ATTENTION THAT THE FDA DOES NOT APPROVE THE USE OF VERBIAGE THAT REFERENCES 'CANCER' IN ASSOCIATION WITH THESE TYPES OF TESTS. HOWEVER, THIS PRODUCT IS CURRENTLY BEING MARKETED AS A TEST FOR THE EARLY DETECTION OF COLORECTAL CANCER, WHICH IS MISLEADING AND POTENTIALLY HARMFUL TO CONSUMERS. THE 2SAN COLORECTAL CANCER SELF TEST IS A FECAL OCCULT BLOOD (FOB) TEST, WHICH DETECTS HIDDEN BLOOD IN STOOL. THIS IS NOT A DIAGNOSTIC TEST FOR COLORECTAL CANCER, AND THE LANGUAGE USED ON THE PACKAGING AND MARKETING MATERIALS FALSELY SUGGESTS OTHERWISE. THIS COULD LEAD CONSUMERS TO INCORRECTLY ASSUME THAT A POSITIVE RESULT CONFIRMS A DIAGNOSIS OF COLORECTAL CANCER, CAUSING UNDUE DISTRESS OR MISINTERPRETATION OF MEDICAL RISK. ADDITIONALLY, THE DESCRIPTION ON THE BACK OF THE PACKAGING ONLY LISTS COLORECTAL CANCER AND GROWTHS IN CONNECTION WITH BLOOD IN STOOL, OMITTING THE FACT THAT MANY OTHER CONDITIONS. THIS LACK OF DISCLOSURE IS MISLEADING, AS IT FAILS TO INFORM CONSUMERS THAT A POSITIVE RESULT DOES NOT NECESSARILY INDICATE CANCER OR PRECANCEROUS CONDITIONS. THE ABSENCE OF THIS CRITICAL INFORMATION COULD LEAD TO UNNECESSARY ANXIETY OR MISINFORMED MEDICAL DECISIONS. THIS TEST IS CURRENTLY AVAILABLE THROUGH MAJOR RETAILERS, INCLUDING: WALMART: HTTPS://WWW.WALMART.COM/IP/2SAN-COLORECTAL-CANCER-SCREENING-TEST/5106585015, MCKESSON: HTTPS://MMS.MCKESSON.COM/PRODUCT/1254004/2SAN-LLC-USFO1WO-1, KROGER: HTTPS://WWW.KROGER.COM/P/2SAN-COLORECTAL-CANCER-SCREENING-TEST/0085005233505, WALGREENS: HTTPS://WWW.WALGREENS.COM/STORE/C/2SAN-COLORECTAL-CANCERSCREEN- TEST/ID=300447054-PRODUCT, DILLONS: HTTPS://WWW.DILLONS.COM/P/2SAN-COLORECTAL-CANCER-SCREENING-TEST/0085005233505?FULFILLMENT=PICKUP, FRED MEYER: HTTPS://WWW.FREDMEYER.COM/P/2SAN-COLORECTAL-CANCER-SCREENINGTEST/ 0085005233505, AMAZON: HTTPS://WWW.AMAZON.COM/2SAN-COLORECTAL-CANCER-SCREENING-EASY/DP/B0CX4MFFC8. GIVEN THE SERIOUS NATURE OF THIS ISSUE AND THE POTENTIAL FOR CONSUMER HARM, I URGE THE FDA TO TAKE IMMEDIATE ACTION TO EVALUATE THIS PRODUCT'S MARKETING CLAIMS AND ENSURE COMPLIANCE WITH REGULATORY STANDARDS. WITHOUT ACTION, THIS IS UNDERMINING THE FDA REGULATIONS, AND THE PRODUCT IS BEING UNLAWFULLY TRADED ON THE MARKET. PLEASE CONFIRM RECEIPT OF THIS EMAIL AND ADVISE ON THE NEXT STEPS REGARDING THIS MATTER. I APPRECIATE YOUR PROMPT ATTENTION TO THIS URGENT CONCERN.