Inhalable Product Not Considered Dietary Supplement, Says FDA Warning Letter

March 19, 2012

A product designed for inhalation cannot be considered a dietary supplement, FDA stated in a March warning letter to Breathable Foods Inc.

A product designed for inhalation cannot be considered a dietary supplement, FDA stated in a March warning letter to Breathable Foods Inc. The agency questioned the company’s AeroShot, a mix containing caffeine and B vitamins that is described as “inhalable caffeine.”

However, wrote FDA, “By definition, dietary supplements must be intended for ingestion.”

FDA also requested additional evidence from the company to support its claims that the product, when inhaled through the lungs, is safe, as well as to support the firm’s claims that its powders are larger than 10 microns and that “[d]ecades of research have shown that particles above 10 microns in size, if inhaled, fall out in the mouth and do not penetrate the respiratory tract.”

Nutritional Outlook thanks the American Herbal Products Association for the tip.