FDA WARNING_LETTER - Nobel Laboratories, LLC

The FDA issued a Warning Letter to Fasprin Health, LLC / Nobel Laboratories, LLC for marketing "FASPRIN?" as an unapproved new drug and for misbranding.

Fasprin, an OTC internal analgesic with aspirin (81mg), glucosamine, zinc salt, and magnesium salt, is deemed a "new drug" because its labeling claims extend beyond pain/fever relief to include cardiovascular disease prevention (heart attack, stroke, DVT), arthritis treatment, blood pressure reduction, and prevention of Alzheimer's, Parkinson's, colon cancer, periodontal disease, vision loss, and gallstones, as well as promoting longevity. These uses, the combination of active ingredients, and the 81mg dosage are not generally recognized as safe and effective, nor are they covered by the OTC Drug Review or an approved New Drug Application (NDA).

Furthermore, Fasprin's quick-dissolving, mouth-absorbed dosage form is not generally recognized as safe and effective, requiring an approved NDA.

The product is also misbranded due to: * Lack of adequate directions for its intended cardiovascular and arthritis uses, which require professional supervision. * Absence of a "Uses" section as required by 21 CFR § 201.66(c)(4). * Inadequate dosage for pain/fever relief compared to OTC Drug Review standards. * Misleading labeling ("Daily Aspirin Regimen") contradicting