John Gray’s Mars Venus LLC – FDA Warning Letter, Feb 11, 2019

The FDA issued a Warning Letter to John Gray’s Mars Venus LLC and John Henderson Gray on February 5, 2018, following a September 2018 review of their websites, www.marsvenus.com and www.facebook.com/Mars.Venus.John.Gray. The FDA determined that products sold, including 2-AEP Membrane Complex, Ionic Silver Water, L-Glutathione, Liposomal DHA – Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, and Vectomega, are unapproved new drugs and misbranded.

The claims on their websites, such as those related to reducing Alzheimer's risk, treating infections, and supporting detoxification, establish these products as drugs intended for disease cure, mitigation, treatment, or prevention under section 201(g)(1)(B) of the Act. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) and require prior FDA approval, which they lack, violating sections 301(d) and 505(a).

Furthermore, products like 2-AEP Membrane Complex, Glutathione, Liposomal DHA, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, and Vectomega are intended for diseases not amenable to