FDA WARNING_LETTER - Center for New Medicine/Perfectly Healthy by Connealy MD - April 30, 2020

On May 6, 2020, the FDA and FTC issued a Warning Letter to the firm after reviewing their websites (www.perfectlyhealthy.com, www.cfnmedicine.com, www.cancercenterforhealing.com, www.shopcfnmedicine.com) and social media. The agencies found that the firm was offering products, including Camu Camu’s Vitamin C, Vitality C, Immunity Kit, Vitamin D3-K2, Liquid Silver, and Power Immune, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Consequently, their introduction into interstate commerce is prohibited under sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also found that the firm's coronavirus-related prevention or treatment claims for these products lacked competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.). The firm is required to immediately cease the sale of these unapproved and unauthorized COVID-19 related products and stop making unsubstantiated claims. Within 48 hours, the firm must email both the FDA and FTC, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, addition to FDA's public warning list, and potential orders to pay back consumers for FTC violations. Products may also be refused admission if imported.