FDA WARNING_LETTER - Intelli Health Products, LLC

The FDA issued a Warning Letter to Intelli Health Products, LLC regarding their product "Duro Extend," marketed as a dietary supplement. Laboratory analyses revealed that "Duro Extend" contains undeclared phosphodiesterase type-5 (PDE-5) inhibitors, specifically sulfoaildenafil and/or aildenafil, which are analogues of sildenafil, the active ingredient in Viagra. Consequently, "Duro Extend" is deemed an unapproved new drug under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the Act), as it is not generally recognized as safe and effective and lacks an FDA-approved application. The product is also classified as a prescription drug due to its potential for harmful effects, requiring professional supervision. Furthermore, "Duro Extend" is misbranded under multiple sections of the Act: 502(f)(1) for failing to bear adequate directions for its intended use; 502(a) because its labeling is false and misleading by not disclosing the presence of PDE-5 inhibitors, which pose serious health risks, particularly interactions with nitrates; and 502(f)(2) for lacking adequate warnings for users. The introduction of this misbranded product into interstate commerce violates section 301(a) of the Act. The FDA requires the firm to respond within fifteen working days, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure or injunction. The letter emphasizes the firm's responsibility to know product ingredients and comply with federal law.