'Blood Disorders' Supplement, More Bocchi Labs Hair Care Products Recalled
McDaniel Life-Line recalls its Indian Herb supplement after FDA determined it was marketed without an NDA for claims including "blood disorders." For third time in less than a year, John Paul Mitchell Systems brand and other shampoos recalled by manufacturer Bocchi Labs due to potential contamination; other health, beauty and wellness product recalls.
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Wellness Industry News: MacKay Leaving CRN; Another Life-Line Recall, Ginkgo Bioworks' Second Startup, More
Duffy MacKay is leaving CRN and Andrew Shao will return for an interim period; McDaniel Life-Line recalls all lots of its Life-Line Water due to contamination; Harvest One acquires LivRelief supplement firm; and Gingko Bioworks' second startup funded $90m.
Warning letter to Bocchi Laboratories details violations of FDA regulations agency inspectors found in an inspection of firm's facility from late March through early June 2018 "in response to an outbreak of Burkholderia cepacia associated with" a cleanser it manufactures. In addition to product adulteration due to microbial contamination, FDA found Bocchi in violation of drug GMPs because products were labeled with indications rendering them drugs under FDA regulations.
Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.