FDA WARNING_LETTER - Yoder's Good Health Products - September 18, 2017

An FDA inspection of Yoder’s Good Health Products from September 13-18, 2017, revealed serious violations across its dietary supplement, conventional food, and drug manufacturing operations. The firm's dietary supplement products are adulterated under 21 CFR Part 111 due to numerous Current Good Manufacturing Practice (CGMP) deficiencies. These include failures to confirm component identity, establish quality control procedures, prepare master manufacturing records, maintain complete batch production records, establish product specifications, implement lot traceability, collect reserve samples, establish equipment cleaning/sanitizing procedures, calibrate instruments, and develop procedures for components, packaging, and labels. The firm's responses to these observations were deemed insufficient, lacking supporting documentation.

Additionally, products like Yoder’s brand Respiratory & Cough Formula and Life Drops are considered unapproved new drugs under sections 201(g)(1)(B) and 201(p)(1) of the Act due to therapeutic claims. The Yoder’s Good Health Recipe conventional food product is adulterated under section 402(a)(2)(C)(i) because it contains unapproved food additives, Goldenseal and Black Cohosh, which lack GRAS status or regulatory approval. Several dietary supplements are also misbranded under section 403 of the Act and 21 CFR Part 101 for failing to identify as “dietary supplement,” incorrect serving sizes, and missing quantitative ingredient amounts. Furthermore, the Yoder’s Stress & Anxiety Support product's sublingual absorption instructions mean it does not meet the definition of a dietary supplement. The FDA requires prompt corrective actions, including establishing and implementing procedures, with a 15-working-day response, warning of potential legal action and reinspection fees for non-compliance.