FDA WARNING_LETTER - Borinquen Natural, Inc.

The FDA issued a Warning Letter to Borinquen Natural after reviewing their website and Facebook page, which promoted products like "HCG Premium," "Moringa Premium," "Veggie Collagen Concentrado," and "Veggie Collagen Ultra Concentrado" with therapeutic claims. These claims, such as reducing cancer risk, preventing obesity, treating diabetes, cardiac problems, HIV/AIDS, depression, Alzheimer's, anti-aging, relieving pain, and anti-tumor effects, cause the products to be classified as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act. Introducing unapproved new drugs into interstate commerce violates sections 505(a) and 301(d). Additionally, the products are misbranded under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis and treatment by laypersons, thus lacking adequate directions for use. The introduction of misbranded drugs into interstate commerce violates section 301(a). The FDA had previously notified the firm of similar issues in an Untitled Letter in September 2013. Borinquen Natural must take prompt action to correct these violations and prevent reoccurrence, responding in writing within fifteen working days with specific steps and documentation. Failure to comply may result in legal action, including seizure or injunction.