Better Health Lab, Inc – FDA Warning Letter, Sep 22, 2014

The FDA conducted an inspection of Better Health Lab, Inc. from September 10-22, 2014, and subsequently reviewed their websites (www.alkazone.com, www.antioxidantwater.com) in November 2014. The inspection and review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The products ALKAZONE® Alkaline Booster, ALKAZONE® Gout Reliever, and ALKAZONE® Premium Energy Booster are deemed "unapproved new drugs" because their labeling and websites make therapeutic claims (e.g., neutralizing acid buildup, preventing cancer, regulating blood pressure, reducing gout symptoms) that establish them as drugs intended for disease treatment or prevention. These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, they are misbranded because they are offered for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use.

Even if not unapproved drugs, ALKAZONE® Alkaline Booster with Antioxidant is an adulterated dietary supplement due to significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Deficiencies include: 1. Failure to establish required specifications for components and finished products (21 CFR 111.70). 2. Incomplete batch production records, missing information like equipment identification, unique component identifiers, actual/theoretical