FDA WARNING_LETTER - Alternative Health Supplements

The FDA issued a Warning Letter to Alternative Health Supplements for marketing and selling unapproved and misbranded drugs on their website. The product "Regenerect," marketed as a male enhancement dietary supplement, was found to contain tadalafil, a PDE-5 inhibitor and active ingredient in the prescription drug Cialis. This renders "Regenerect" an unapproved new drug and a prescription drug requiring medical supervision. It is also misbranded due to its introduction into interstate commerce without an approved application, lack of adequate directions for use, false/misleading labeling from undeclared tadalafil, and inadequate warnings. Eight other products—"Alligin," "Astaxanthin Advantage," "HDL Cholesterol Management," "Coral Calcium Supreme," "Resveratrol," "Shark Liver Oil," "Blood Sugar Imbalance," and "Supreme Immune Booster"—are similarly deemed unapproved and misbranded new drugs. These products are marketed with disease treatment/prevention claims (e.g., for cancer, neurodegenerative conditions, diabetes), making them unapproved and introduced without FDA-approved applications. They are also misbranded due to lacking adequate directions for use for conditions not amenable to self-diagnosis. The FDA requires prompt corrective action, investigation of causes, and prevention of recurrence. A written response detailing steps taken and supporting documentation is due within fifteen working days. Non-compliance may result in legal action, including seizure or injunction.