FDA WARNING_LETTER - Wholistic Herbs, Inc. - January 10, 2012

The FDA inspected Wholistic Herbs, Inc. from December 28, 2011, to January 10, 2012, finding significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, the website promoted "At Ease" as an unapproved new drug due to therapeutic claims for conditions like depression and arthritis, making it misbranded and an unapproved new drug under the Act. Several products (At-Ease, Aller-Ban, Stomach Flu, Morning Calm) were also misbranded for failing to include "dietary supplement" in the statement of identity, a domestic address/phone number for adverse event reporting, proper botanical ingredient listing, and capsule ingredients in the ingredient list.

Specific CGMP violations included failure to prepare and follow master manufacturing records (MMRs) and batch production records, establish written quality control procedures and designate personnel, establish required specifications for components, in-process, labels, packaging, finished products, and incoming materials, and conduct identity testing for dietary ingredients. The firm also lacked records and procedures for holding and distributing operations, failed to assign qualified personnel for supervision, and did not have written procedures for product complaint review, investigation, or handling returned dietary supplements. Furthermore, the company failed to collect and hold reserve samples. The FDA found the company's January 24, 2012, response inadequate for all