FDA WARNING_LETTER - Absonutrix, LLC - May 31, 2017

The FDA issued a Warning Letter to Absonutrix following a May 2017 review of their website, www.absonutrix.com. The agency determined that numerous products, including Absonutrix Forskolin Pure X-treme Capsules, Absonutrix Fucoidan Max Strength, and Absonutrix Parasite Detox X-Treme, are illegally marketed as unapproved new drugs. Website claims, such as "aids in the inhibition of colon cancer cell growth" and "help fight the growth of tumors," establish these products as intended for the cure, mitigation, treatment, or prevention of disease, or to affect body structure/function, classifying them as drugs under 21 U.S.C. 321(g)(1)(B) and (C). Since these products are not generally recognized as safe and effective for their intended uses, they are "new drugs" under 21 U.S.C. 321(p) and cannot be introduced into interstate commerce without prior FDA approval, violating 21 U.S.C. 331(d) and 355(a). Furthermore, specific products like Absonutrix Forskolin Pure X-treme Capsules and Absonutrix Lavender Oil X-Treme are misbranded under 21 U.S.C. 352(f)(1) because they lack adequate directions for use, as they are intended for diseases requiring professional supervision. The introduction of these misbranded drugs violates 21 U.S.C. 331(a). The letter also cited the firm for improperly displaying the FDA logo on its website, which implies endorsement. Absonutrix must take prompt action to correct all violations and respond in writing within 15 working days, outlining corrective steps, timelines, and supporting documentation, to avoid potential legal action such as seizure or injunction.