What happened
Original notice title
Phi Sciences MARCS-CMS 566043, January 30, 2019
From the archived source record
Based on the inspectional findings, a review of the product labels collected during the inspection, and a review of your website at www.phisciences.com , we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at the Internet address www.phisciences.com in September 2018 and has determined that you take orders there for the following products: Mega Hydrate Powder, Mega Hydrate Capsules, and Crystal Energy. Examples of such testimonials include: “I suffered from Classic Migraine headaches since age 13… I learned about your products through a Chiropractor friend who was literally snatched from the jaws of death after she became afflicted with Typhoid fever…She was so dehydrated the doctors could not get an IV into her, so went home to die. The blood has thickened to the point that a migraine saves the person from death by opening up the blood vessels in the brain. 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 Mega Hydrate products fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Dietary Supplement CGMP Violations Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations 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
- 36156939caf7
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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