FDA WARNING_LETTER - Nenningers Naturals, LLC

The FDA issued a Warning Letter to Nenningers Naturals, LLC, regarding its product "Triple Flu Defense," promoted on www.triplefludefense.com. The FDA determined the product is an unapproved new drug and biologic under the FD&C Act and PHS Act, respectively, due to therapeutic claims establishing its intended use as a drug.

The product, containing Influenzinum 30C, is considered misbranded under sections 502(a), 502(f)(1), and 201(n) of the FD&C Act. Violations include false or misleading information, lack of adequate risk descriptions, and marketing without FDA approval. Examples of claims cited from the website, promotional material, Facebook, and Twitter include "Seasonal Defense," "Relieves Flu Symptoms," "Eases Flu Vaccine Side Effects," and testimonials asserting prevention and mitigation of influenza.

The FDA states the product is not generally recognized as safe and effective for its claimed uses, making it a "new drug" requiring prior FDA approval. Furthermore, it is misbranded because it addresses conditions not amenable to self-diagnosis, and adequate directions for layperson use cannot be provided. The introduction of this misbranded drug into interstate commerce violates section 301(a) of the Act.

Nenningers Naturals, LLC, must take prompt action to correct these violations. Failure to do so may result in regulatory action, including seizure or