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WARNING LETTER
•God Quest, Inc. d/b/a Creation Today•April 30, 2017

God Quest, Inc. d/b/a Creation Today – FDA Warning Letter, Apr 30, 2017

Record Details

The FDA issued a Warning Letter to God Quest, Inc. d/b/a Creation Today following an April 2017 review of their website, www.creationtoday.org. The FDA determined that the firm's products, B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power, along with the accompanying book "World Without Cancer: The Story of Vitamin B17," are marketed with claims establishing them as unapproved new drugs. These claims, found on the website and in the book, indicate the products are intended for the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act. Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p). Introducing such unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed misbranded under section 502(f)(1) because they lack adequate directions for use, as their intended purposes require supervision by a licensed practitioner, making self-treatment impossible. The introduction of these misbranded drugs also violates section 301(a). The FDA requires the firm to take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to address the violations and prevent recurrence. Failure to comply may lead to legal action, including seizure and injunction.

Company
God Quest, Inc. d/b/a Creation Today
Inspection date
April 30, 2017
Product type
Drugs
Office
San Juan District Office
Person
  • Maridalia Torres-Irizarry ( District Director )
View Company Profile

ID · bfd7f81e-043f-4451-9ccd-8cd1fdd21a6a

Violation Codes9
21 U.S.C. 321(g)(1)(B)21 U.S.C. 321(p)21 U.S.C. 331(d)21.U.S.C. 355(a)21 U.S.C. 352(f)(1)21 U.S.C. 353(b)(1)(A)21 CFR 201.12821 CFR 201.521 U.S.C. 331(a)

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