Gulla, Jennifer – FDA Warning Letter

The FDA issued a Warning Letter to Jennifer Gulla regarding the marketing of "Blow" on www.iloveblow.com. The product is marketed as an alternative to illicit street drugs, specifically cocaine, and is intended to affect the body's structure or function.

The FDA identified several indicators that "Blow" is marketed as a street drug alternative: the product name "Blow" (street terminology for cocaine), the appearance of the product name spelled out in a white granular substance resembling cocaine, multiple images of a white granular substance resembling cocaine powder, images showing the powder "cut" into "lines" for insufflation, packaging in a vial suggestive of street drug paraphernalia, use of illicit drug-related terminology in product names (e.g., "The Stash Box Sampler Pack"), and photographs implying illicit cocaine production, storage, and transport.

The FDA states that "Blow" is a drug under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) because it affects the body's structure or function. Furthermore, it is an unapproved new drug under Section 201(p) of the Act, as it is not generally recognized as safe and effective for its labeled uses. The sale of "Blow" without an FDA-approved application violates Sections 301(d) and 505(a) of the Act.

The letter requires prompt corrective action within fifteen working days