FDA WARNING_LETTER - USA Golden Vision, Inc.

The FDA issued a Warning Letter to David Tan and Paul Brucato of Golden Vision, Inc., following a review of their website, www.alternative2cancer.com. The FDA determined that their products, "SunRecome in Packets" and "SunRecome in Capsules," are promoted with therapeutic claims that cause them to be unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. Claims such as "destroy the enzyme in DNA responsible for cancer cells," "anti-tumor product," and "minimize the toxic side effects of chemotherapy" establish the products as drugs intended for disease treatment, violating section 201(g)(1)(B). These products are not generally recognized as safe and effective, classifying them as "new drugs" under section 201(p), which cannot be legally marketed without prior FDA approval per section 505(a). Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use. The firm was also noted for promoting other products for disease treatment on www.goldvitamins.com. Golden Vision, Inc. must take prompt action to correct these violations, review all promotional materials, and respond to the FDA within fifteen working days detailing specific corrective steps and timelines. Failure to comply may result in enforcement actions, including product seizure and injunctions.