FDA WARNING_LETTER - Health King Enterprise & Balanceuticals Group, Inc. - June 30, 2013

The FDA issued a Warning Letter to Health King Enterprise & Balanceuticals Group, Inc. after reviewing their websites, www.healthkingenterprise.com and www.balanceuticals.com, in June 2013. The FDA determined that five products—"Sugar Balancer," "Blood Pressure Balance," "Bio-Defender," "AlcohLiver Fix," and "Super Reishi Essence"—were promoted for conditions that cause them to be unapproved new drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The websites made claims indicating the products were intended for the cure, mitigation, treatment, or prevention of disease, such as "Sugar Balancer" for diabetes, "Blood Pressure Balance" for hypertension and coronary disease, "Bio-Defender" for viral, bacterial, and fungal infections including HIV and anthrax, "AlcohLiver Fix" for hepatitis and liver damage, and "Super Reishi Essence" for cancer and neurasthenia.

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 claimed uses and lack prior FDA approval, violating Section 505(a) and 301(d). Furthermore, the products are misbranded under Section 502(f)(1) because they address conditions not amenable to self-diagnosis and treatment, meaning