FDA WARNING_LETTER - Try Nova - August 01, 2025

On September 9, 2025, the FDA issued a Warning Letter to the company Try Nova following an August 2025 review of its website. The agency determined that the company is marketing compounded drug products, specifically semaglutide, in a manner that violates federal regulations. The primary issue identified is the use of false and misleading advertising claims, such as stating their products contain the "Same active ingredient as Wegovy & Ozempic." Because compounded drugs are not FDA-approved, the agency asserts that implying these products are identical to approved brand-name drugs is deceptive. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections 502(a) and 502(bb), these products are considered misbranded. Introducing such misbranded drugs into interstate commerce is a violation of section 301(a) of the Act. The FDA requires Try Nova to take immediate action to correct these violations, which includes removing the misleading language from its promotional materials. The company must submit a written response within 15 working days detailing the steps taken to address the issues and prevent their recurrence. Failure to comply may result in legal actions, including product seizure or injunctions.