FDA WARNING_LETTER - Aerosol Science Laboratories Inc.

The FDA issued a Warning Letter to Aerosol Science Laboratories Inc. on October 29, 2008, following a review of their website, www.aslrx.com. The letter states that the website contains false and misleading claims for compounded aerosolized medications used with the SINUS SCIENCE Aerosol Medication Delivery System, causing these drugs to be misbranded under Section 502(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The identified violations include: 1. **Unsubstantiated Efficacy Claims**: The website claims that aerosolized treatments for chronic sinusitis and allergic rhinitis should improve symptoms and that inhaled antibiotics, anti-fungals, anti-inflammatories, and mucolytics are "new treatment choices" for these conditions, sinus headaches, and loss of smell. The FDA states there is no substantial evidence (adequate and well-controlled clinical investigations) to support these claims, and the products are not approved for these indications. Additionally, the labeling lacks adequate directions for use. 2. **Unsubstantiated Superiority Claims**: The website claims the SINUS SCIENCE system produces fine particles (3.1 microns) that reach areas larger droplets from typical nasal sprays (up to 150 microns) cannot, implying superior therapeutic benefit. The FDA deems these claims false or misleading due to lack of substantial evidence. Furthermore, the FDA raises safety