FDA WARNING_LETTER - Gold Crown Natural Products - February 11, 2019

On February 5, 2019, the FDA issued a Warning Letter to Gold Crown Natural Products, following a review of their website (www.goldcrownnaturalproducts.com) in October 2018. The FDA determined that the products New Ultra Colostrum, Melatonin with Valerian, Anamu & Llanten, and Circulation Max are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], as they are intended for disease cure, mitigation, treatment, or prevention.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].

Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they fail to bear adequate