FDA WARNING_LETTER - Healthy Healing Enterprises, Inc.

The FDA issued a Warning Letter to Healthy Healing, LLC dba Crystal Star after reviewing their website and product label for "Withdrawal Support" in December 2017. The FDA determined that the product is an unapproved new drug because its claims establish it as intended for the cure, mitigation, treatment, or prevention of disease, making it a drug under 21 U.S.C. § 321(g)(1)(B). As it is not generally recognized as safe and effective for these uses, it is a "new drug" under 21 U.S.C. § 321(p). Introducing such a drug without FDA approval violates 21 U.S.C. §§ 331(d) and 355(a). Furthermore, "Withdrawal Support" is misbranded under 21 U.S.C. § 352(f)(1) because it lacks adequate directions for use, as its intended purposes are not amenable to self-diagnosis or treatment. Introducing this misbranded drug into interstate commerce violates 21 U.S.C. § 331(a). The Federal Trade Commission (FTC) also reviewed the product's marketing claims for unsubstantiated advertising related to opiate withdrawal/addiction, citing potential violations of the FTC Act. The company must take prompt action to correct all violations, notifying both FDA and FTC within fifteen working days with documentation of corrective steps. Failure to comply could result in legal action, including seizure, injunction, and monetary penalties.