FDA WARNING_LETTER - Hampshire Labs, Inc. - December 31, 2019

The FDA issued a Warning Letter to Hampshire Labs, Inc. following a December 2019 inspection and subsequent review of product labeling, catalogs, mailers, and social media for Antiiva, LungRenew, and LungRestore products. The agency determined that claims made for these products, such as prostate shrinking, relieving prostate problems, and helping with COPD, asthma, bronchitis, or emphysema, establish them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, these products are deemed misbranded under section 502(f)(1) of the Act because they lack adequate directions for use, as their intended purposes require supervision by a licensed practitioner, making self-diagnosis or treatment unsafe. The letter also cited dietary supplement labeling violations for Antiiva and Holy12 products, specifically the failure to declare all common or usual names of ingredients (21 CFR 101.36, 101.4) and, for Holy12, the failure to identify the plant part for botanical ingredients (21 CFR 101.4(h)(1)). Hampshire Labs, Inc. must respond within 15 working days with corrective actions and supporting documentation to prevent recurrence, or face potential legal action including seizure and injunction.