NatureAll-STF Holding, LLC – FDA Warning Letter, Jun 6, 2013

The FDA inspected NatureAll-STF Holding, LLC (Spinal Touch Formulas) from May 30 to June 6, 2013, uncovering serious violations of dietary supplement CGMP (21 CFR Part 111), unapproved new drug marketing, and misbranding. Several products, including Colostrum and Valerian-Plus, were promoted with therapeutic claims (e.g., "fight off viruses," "pain relief"), classifying them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act. Valerian-Plus, Lung-Plus, and Yucca-Plus were also misbranded for lacking adequate directions for use (section 502(f)(1)). CGMP deficiencies included failures to conduct identity testing for dietary ingredients (21 CFR 111.75(a)(1)(i)), verify finished product specifications (21 CFR 111.75(c)), establish quality control procedures (21 CFR 111.103), prepare Master Manufacturing Records (21 CFR 111.205(a)), maintain complete Batch Production Records (21 CFR 111.255(b), 111.260), and calibrate instruments (21 CFR 111.27(b)). Misbranding violations for Iron Plus, Black Walnut Plus, Myrrh, and Prostate-Plus involved failing to identify them as "dietary supplements" (section 403(s)(2)(B)), identify plant parts (section 403(s)(2)(C)), include adverse event reporting contact (section 403(y)), list capsule ingredients or quantitative mineral amounts (section 403(i)(2)), and declare iron warning statements (section 403(f)). The firm's corrective action response was deemed inadequate. Prompt action is required within fifteen working days to prevent legal action and potential reinspection fees. Additional concerns included unverified supplier COAs and discarded records.