FDA WARNING_LETTER - Enhance Nutraceutical

The FDA issued a Warning Letter to Enhance Nutraceutical after reviewing their websites, including www.enhancenutraceutical.com, www.diaberex.com, and others. The agency determined that the company markets products such as "Diaberex," "Detorex," "Naeleens," "Angirx," "Hard Rod Plus," and "Vigarexx" as unapproved new drugs and misbranded drugs, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These products are considered drugs under section 201(g)(1) due to claims for treating serious conditions like type 2 diabetes, hypertension, heart disease, erectile dysfunction, and enlarged prostate. They are deemed "new drugs" under section 201(p) because they are not generally recognized as safe and effective, and are marketed without FDA-approved applications, violating sections 301(d) and 505(a). Furthermore, these products are misbranded under section 502(f)(1) because they address conditions not amenable to self-diagnosis and treatment, making adequate directions for laypersons impossible (21 CFR § 201.5). Introducing such misbranded drugs into interstate commerce violates section 301(a).

Additionally, FDA laboratories confirmed that other Enhance Nutraceutical products, "ZenMaxx," "Instant Hard Rod," and "RigiRx Plus," contained the undeclared drug ingredient aminotadalafil, an analog of tadalafil (Cialis), which is unlawful. The company must notify the FDA within fifteen working days of specific corrective actions taken, including steps to prevent recurrence, and provide supporting documentation. Failure to comply could lead to further regulatory action.