Opiate Freedom Center FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, www.opiate-freedom-center.com, in December 2017 and has determined that you take orders there for the product ''Opiate Freedom 5-Pack." FDA also reviewed your social media website at www.facebook.com/pg/OpiatefreedomCenter. The claims on your websites establish that this product is a drug under section 201(g)(1)(8) of the Federal Food,Drug, and Cosmetic Act (the Act) [21 U.S.C. 321 (g)(l)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through lin

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:

Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of Opiate Freedom 5-Pack for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Potential Health Risks

Consumers should be aware of potential risks associated with products from Opiate Freedom Center.

Regulatory Context

Your product "Opiate Freedom 5-Pack" is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)). FDA approves a new drug on the basis of scientific data and information demonstrating that the dtug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.