Sharp Labs Inc – FDA Warning Letter

On July 9, 2008, the FDA issued a Warning Letter to Sharp Labs Inc., specifically addressing products promoted on their website, www.sharpweblabs.com. The FDA determined that numerous products, including "Acai Juice," "Alkaline Herb Drops," "Cesium Bladder Package," "Liquid CoQ10," and "Shark Cartilage," were promoted with therapeutic claims that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The letter cited specific claims, primarily related to the cure, mitigation, treatment, or prevention of various diseases, particularly cancer. Examples included claims that "Acai Juice" helps prevent cancer, "Alkaline Herb Drops" can make cancer cells dormant or die by raising pH levels, and "Cesium Chloride" raises the pH of cancer cells, causing them to die. Other products were marketed with claims for treating heart disease, infections, and various deficiencies.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval. Furthermore, they are deemed misbranded under section 502(f)(1) of the Act due to the absence of adequate directions for use.

Sharp Labs Inc. was instructed to take prompt action to correct these violations and prevent recurrence.