FDA WARNING_LETTER - Evenbetternow, LLC - October 12, 2010

This FDA Warning Letter, dated October 12, 2010, was issued to Evenbetternow, LLC, and its principals, Mr. Donald Nichols and Ms. Andrea Nichols, regarding the marketing of several products on their websites.

The FDA determined that products such as Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, and Natur-Leaf, marketed as dietary supplements, are unapproved new drugs. This is because their labeling claims, including testimonials, indicate intent to cure, mitigate, treat, or prevent diseases like heavy metal poisoning, autism, neuropathy, allergies, acid reflux, and interstitial cystitis. Similarly, Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay are also deemed unapproved new drugs due to claims of detoxifying the body of chemical toxins and heavy metals, and treating conditions like autism, migraines, and ALS. These products are considered "new drugs" under 21 U.S.C. § 321(p) as they are not generally recognized as safe and effective, and lack FDA-approved applications, violating 21 U.S.C. §§ 331(d) and 355(a). Furthermore, these products are misbranded under 21 U.S.C. § 352(f)(1) because they