FDA WARNING_LETTER - Dherbs Health Emporium Inc. - June 24, 2015

The FDA issued a Warning Letter to Dherbs Health Emporium, Inc. on December 10, 2015, following a June 2015 inspection and review of product labeling and website. Serious violations of the Federal Food, Drug and Cosmetic Act were identified, and the firm's responses to the FDA 483 were largely inadequate. The letter cited two main violation categories. First, products like "10 Day Kidney Cleanse" were promoted with therapeutic claims (e.g., "soothe and heal genital tract inflammation"), classifying them as unapproved new drugs under Sections 201(g)(1)(B) and 201(p) of the Act. They were also misbranded under Section 502(f)(1) due to inadequate directions for use for laypersons, addressing conditions not amenable to self-diagnosis. Introducing these into interstate commerce violates Sections 301(d) and 301(a). Second, the products were deemed adulterated dietary supplements under Section 402(g)(1) due to Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies included failure to establish product specifications (21 CFR 111.70(e)), and failure to establish and follow written procedures for quality control (21 CFR 111.103), packaging/labeling (21 CFR 111.403), and holding/distributing operations (21 CFR 111.453). The firm's corrective action responses lacked evidence of implemented procedures. Dherbs was required to take prompt corrective action and respond within fifteen working days, detailing steps and providing documentation. Non-compliance could lead to legal action, including seizure, injunction, and reinspection fees.