FDA WARNING_LETTER - Goodlife Juices - January 02, 2014

An FDA inspection (Dec 2013 - Jan 2014) and website review revealed serious violations at Goodlife Juices, LLC. Several products (Essential, Immunity, PAM Juice, ReBeet) are deemed unapproved new drugs under 201(g)(1)(B) and 201(p) due to therapeutic claims on the website. PAM Juice is also misbranded under 502(f)(1) for inadequate directions for use. All juice products are adulterated under 402(a)(4) due to insanitary conditions and Juice HACCP violations (21 CFR Part 120). The HACCP plan lacked control measures for a 5-log reduction of microorganisms (21 CFR 120.24(a)) and failed to list reasonably likely food safety hazards (21 CFR 120.8(a) and (b)(1)). Additionally, products (Essential, Immunity, ReBeet, Innergy, Brazil Milk) are misbranded foods under Section 403. Website labeling included unauthorized nutrient content claims (e.g., "excellent source") not meeting 21 CFR 101.54(b) or for substances like chlorophyll lacking established DVs (403(r)(1)(A)). Product labels were misbranded for lacking a statement of identity (403(i)(1), 21 CFR 101.3), failing to declare total percentage of juice (403(i)(2), 21 CFR 101.30), inaccurately listing ingredients (403(i)(2), 21 CFR 101.4), failing to provide nutrition information (403(q), 21 CFR 101.9), and omitting manufacturer details (403(e)(1), 21 CFR 101.5(a)). Goodlife Juices must promptly correct all violations. A written response with revised HACCP, labels, and website labeling is required within fifteen working days. Non-compliance may lead to regulatory actions like seizure, injunction, and reinspection fees.