What happened
Original notice title
Formulife, Inc. 5/12/17
From the archived source record
During this inspection, our investigators found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplements manufactured at your firm to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet cGMP regulations for dietary supplements. Based on our review, we have concluded that your Organ Shield product is in violation of Sections 505(a) and 502(f)(1) of the Act [21 U.S.C. §§ 355(a) and 352(f)(1)]. Based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Unapproved New Drug This is to advise you that FDA reviewed your website at the Internet address www.puruslabs.net in January 2017 and has determined that you take orders there for the product Organ Shield. 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). Accordingly, your Organ Shield product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Your (b)(4) , D-Pol, Condense Crisp Apple, and Noxygen dietary supplements are adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] as are other dietary supplement products that you manufacture, in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, 21 CFR Part 111.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 03f84e8d2e6a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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