Warning letter · FDA Warning Letters, Historical Archive

John Gray's Mars Venus LLC: FDA Warning Letter 564498 (Feb 5, 2019)

Agency action: Feb 5, 2019Record ID: fda_warning_-1a43b15d61fcd1be
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What happened

Original notice title

John Gray’s Mars Venus LLC MARCS-CMS 564498, February 05, 2019

From the archived source record

These three nutrients can … reduce the risk of Alzheimer’s by half. There are much better ways to avoid a heart attack, including fish oil…” Below this claim, there is a link that says, “CLICK HERE to learn more about the products discussed in this video.” This link goes to the website [see original source] which list several products, including Vectomega. 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, 2-AEP Membrane Complex, Black Seed, Glutathione, Liposomal DHA – Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, and Vectomega 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)]. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. 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 injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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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
390eb98a4b59

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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What is affected

Product
17. Take one capsule of 2-AEP Membrane Complex three times daily before each meal; CLICK HERE to learn more about the products discussed in this video; Ionic Silver Water – Superior Mouthwash for Infections, Digestions & Candida Control; NAC – Liver Health & Glutathione for Detoxification; Liposomal DHA, Omega-3 for … Dementia, Alzheimers; 2-AEP Membrane Complex; Ionic Silver Water; L-Glutathione; Liposomal Methyl B12/Folate; NAC N-Acetyl-L-Cysteine; Ionic Silver Water – Superior Mouthwash for Infections; and January 8; Glutathione
Company
John Gray's Mars Venus LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.