FDA WARNING_LETTER - Health & Herbs - April 02, 2014

The FDA inspected Better Health Herbs' facility in Albany, Oregon, from March 10 to April 2, 2014, and reviewed their website in October 2014. The inspection revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) for products CORYDALIS and CVF BGONE, rendering them adulterated.

Additionally, several products sold on their website (e.g., Parasite Cleanse Kit, STRP-THRT, Depression Gone EFR) were promoted with therapeutic claims, classifying them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. These products are not generally recognized as safe and effective for their claimed uses and lack adequate directions for layperson use.

CGMP violations for CORYDALIS and CVF BGONE included failure to establish written master manufacturing records, prepare batch production records, implement production and process controls, establish component specifications (identity, purity, strength, composition, contamination limits), conduct identity testing for dietary ingredients, establish written procedures for equipment calibration and maintenance, and hold reserve samples.

Misbranding violations for CORYDALIS and CVF BGONE included failure to list quantitative amounts of dietary ingredients, include a statement of identity as a "dietary supplement," identify the plant part for botanical ingredients, and list the manufacturer's name and place of business.

The company's April