FDA WARNING_LETTER - Soothedrawal, Inc.

The FDA issued a Warning Letter to Soothedrawal, Inc. on January 11, 2018, following a December 2017 review of their websites (www.soothedrawal.com and www.facebook.com/Soothedrawal). The FDA determined that Soothedrawal Daytime Formula and Soothedrawal Nighttime Formula are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are deemed drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] due to claims on their websites and social media indicating intent for use in the cure, mitigation, treatment, or prevention of disease, specifically opiate withdrawal and addiction. Examples of such claims include "alleviate and soothe the symptoms of opiate withdrawal," "fights off acute withdrawal symptoms and long term cravings," and testimonials describing their use for getting off Suboxone or Oxy.

As "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)], they require prior FDA approval for interstate commerce introduction, which they lack. Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(