FDA WARNING_LETTER - Nature's Health, LLC - March 31, 2015

On March 30-31, 2015, the FDA inspected Nature's Health, LLC, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The company's website, www.natureshealth.com, promotes products like Ginkgo & Rhodiola and Blood Sugar Balance IV with therapeutic claims, classifying them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and § 321(p)(1). These products are also misbranded under 21 U.S.C. § 352(f)(1) due to inadequate directions for layperson use.

Additionally, numerous products, including Bronchi Relaxer II and Liver-Kidney Balance, are adulterated dietary supplements under 21 U.S.C. § 342(g)(1) due to cGMP violations. Deficiencies include failure to establish product specifications (21 CFR 111.70(e)), verify finished product specifications (21 CFR 111.75(c)), establish and verify component identity specifications (21 CFR 111.70(b)(1), 111.75(a)(1)(i)), and maintain complete batch production records (21 CFR 111.255(b), 111.260