FDA WARNING_LETTER - Up Inya Gear - February 28, 2018

The FDA issued a Warning Letter to Up-Inya Beverages, LLC, for marketing "Crossroads Wellness Beverage" as an unapproved and misbranded drug. The FDA reviewed the company's websites (www.crossroads2freeedom.com and www.upinyabeverages.com) and product label in January and February 2018.

The product is deemed a drug under section 201(g)(1)(B) of the FD&C Act due to claims on its websites and label indicating intent for use in the cure, mitigation, treatment, or prevention of disease, specifically addiction withdrawal symptoms. Examples of such claims include "help the symptoms of addiction withdrawal," "addiction recovery beverage that helps detoxify, reduce withdrawals," and testimonials describing relief from withdrawal symptoms like leg cramps, upset stomach, and anxiety.

As a "new drug" under section 201(p) of the FD&C Act, "Crossroads Wellness Beverage" requires prior FDA approval, which it lacks, violating sections 301(d) and 505(a). Furthermore, the product is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as its intended uses (treating addiction) require supervision by a licensed practitioner. This also violates section 301(a).

The Federal Trade Commission (FTC) also reviewed the marketing claims for potential