FDA WARNING_LETTER - Herbalist and Alchemist, Inc. - November 16, 2012

On October 22, 2012, the FDA inspected Herbalist and Alchemist, Inc.'s dietary supplement manufacturing facility, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. These violations render their dietary supplement products adulterated under 21 U.S.C. 342(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 111).

Key violations include: 1. **Failure to verify component identity and establish specifications (21 CFR 111.75(a)(1)(i), 21 CFR 111.70(b)(2)):** The company used ingredients like Celery Seed Extract, Parsley Extract, Buchu Extract, Corn Silk Extract, Pipsissewa Extract, (b)(4) Extract, Motherwort, Bugleweed, and (b)(4) without adequate identity testing or establishing proper specifications for purity, strength, and composition. Organoleptic tests were deemed insufficient for extracts. The company's proposed specifications for purity and identity were inadequate, and heavy metal limits were incorrectly stated as maximum daily consumption. 2. **Failure to establish finished product specifications (21 CFR 111.70(e)):** The company did not establish product specifications for purity, strength, and composition for finished batches of products such as (b)(4)