FDA WARNING_LETTER - Nature's Rite

The FDA issued a Warning Letter to Nature's Rite, LLC, and KlearLabs, following a July 2011 review of their websites, www.mysleepapneacare.com and www.mynaturesrite.com. The FDA determined that products including Sinus Support™, Respiratory Relief™, Sinus Relief™, Sinus Trilogy™, Joint Relief™, Super Neti Juice™, Herpes Relief™, and Shingles Relief™ 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)(B)].

The websites make numerous disease claims, such as "kills fungus, bacteria, and virus" for Sinus Relief™, "effective treatment for Sinusitis!" for Sinus Trilogy™, and "treat the cause of joint pain" for Joint Relief™. These claims, along with personal testimonials and metatags like "sleep apnea treatment" and "herpes," establish the products' intent for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Because these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and require prior FDA approval, which they