FDA WARNING_LETTER - Jansen Enterprises, LLC - November 30, 2014

The FDA issued a Warning Letter to Jansen Enterprises, LLC dba HealthWorksUSA after reviewing their website, www.healthworksusa.net, in November 2014. The FDA determined that the company's products "Nutra Blast Natural Energy," "Ionic Silver Water," "Nutra Complete," and "Nutra Gel" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1).

The therapeutic claims on the website, such as "Heal yourself of any disease" for Nutra Blast Natural Energy, "When confronting an illness, take a capful every hour..." for Ionic Silver Water, and claims related to cancer cell communication for Nutra Complete, establish their intent for use in the cure, mitigation, treatment, or prevention of disease. Nutra Gel with Emu Oil also had claims like "Helps relieve insect bites and other skin problems" and "Helps relieve joint and muscle pain!"

These products are considered "new drugs" under section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for their promoted uses. Introducing or delivering these new drugs into interstate commerce without prior FDA approval violates section 5