FDA WARNING_LETTER - GumRunner, LLC - June 30, 2013

The FDA issued a Warning Letter to GumRunners, LLC, following a June 2013 review of their website, www.joltgum.com. The FDA determined that the products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints are promoted with therapeutic claims, causing them to be unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The website's "Info" page and linked articles made numerous disease claims, including "Prevents Parkinson's disease," "Prevents skin cancer," "Prevents dry-eye syndrome," "Helps control ADHD," "Can help breathing in young babies," and "Curbs Depression." The "News" page also linked to an article claiming reduced risk of type-2 diabetes and oral/esophageal cancer. These claims establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs per section 201(g)(1)(B) of the Act.

Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) and require prior FDA approval, which they lack, violating section 505(a) and 301(d). Furthermore, the conditions addressed are not amenable to self-diagnosis, meaning adequate directions for layperson use cannot be provided