FDA WARNING_LETTER - Hello Life, Inc - March 10, 2017

From March 7-10, 2017, the FDA inspected Hello Life, Inc.'s facility in Kentwood, Michigan, and collected labels and a sample of their "Diamaxol" dietary supplement. The FDA's review and sample analysis revealed that the "Diamaxol" product is misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(a)]. Laboratory analysis showed that the product's magnesium, manganese, and zinc levels were significantly below the declared label values (62%, 25.5%, and 51.5% of declared, respectively). As these are Class I nutrients, 21 CFR 101.9(g)(4)(i) mandates that nutrient content must at least equal the declared label value. The product's failure to meet these declared levels constitutes misbranding, and its introduction into interstate commerce is prohibited by section 301(a) of the Act. Hello Life, Inc. must promptly correct this violation and respond in writing within fifteen working days, detailing specific corrective actions, including documentation and a timetable if necessary, to prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.