FDA WARNING_LETTER - LifeHealth Science - December 11, 2019

The FDA inspected LifeHealth Science LLC (Twinsburg, OH) from November 25 to December 11, 2019, and reviewed its website, identifying serious violations for its ORËÁ product. The product is deemed an unapproved new drug under 21 USC § 321(p) due to website claims establishing its intent for disease treatment/prevention, making it a drug without FDA approval (21 USC §§ 331(d), 355(a)). It is also a misbranded drug under 21 USC § 352(f)(1) for lacking adequate directions for use, as it addresses conditions requiring professional supervision (21 USC § 331(a)). Even as a dietary supplement, ORËÁ is adulterated under 21 USC § 342(g)(1) due to Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111), including failures in establishing product/component specifications and maintaining complete batch production records. The firm's response to these CGMP issues was inadequate. Furthermore, ORËÁ is a misbranded dietary supplement under 21 USC § 343 due to numerous labeling non-compliances (21 CFR 101). These include the absence of adverse event reporting contact information, non-compliant nutrition information presentation, an unlinked and improperly formatted FDA disclaimer, missing unit declarations, incorrect ingredient list placement, and failure to state preservative functions. The firm must promptly correct all violations, investigate root causes, and submit a written response within 15 working days detailing corrective actions and prevention plans. Failure to comply may result in legal action (seizure, injunction) and potential FDA reinspection fees.