FDA WARNING_LETTER - Nature's Elements, Inc. - October 16, 2025

The FDA issued a warning letter to Nature’s Elements, Inc., following an inspection of its Bohemia, New York facility conducted between October 14 and 16, 2025. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act and related regulations regarding the manufacturing and labeling of dietary supplements. Primary violations involve the marketing of products—including He Shou Wu, Schizandra Berry extract, and DHT Blocker—with health claims that qualify them as unapproved new drugs. The FDA noted that these products are intended to treat or prevent medical conditions like high cholesterol, depression, and prostate issues, making them misbranded as they lack adequate directions for safe use by a layperson. Furthermore, the inspection identified critical failures in Current Good Manufacturing Practices (CGMP). The company failed to establish necessary product specifications for identity, purity, and strength, and neglected to maintain comprehensive master manufacturing and batch production records. To resolve these issues, Nature’s Elements, Inc. is required to submit a written response within 15 working days detailing specific corrective actions and providing documentation of their updated compliance procedures. Continued non-compliance may result in legal actions such as product seizures or injunctions.