ee

 

 
 
WARNING LETTER
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 5, 2019
 
John Gray’s Mars Venus LLC
John Henderson Gray
20 Sunnyside Ave
Ste A130
Mill Valley, CA 94941
 
13 Lyon Pl
Mill Valley CA 94941
 
RE: 564498
 
Dear Mr. Gray:           
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.marsvenus.com in September 2018 and has determined that you take orders there for the products 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.  FDA also reviewed your social media website at www.facebook.com/Mars.Venus.John.Gray, which provides a link to your website at www.marsvenus.com. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Examples of some of the claims observed on your website that provide evidence your products are intended for use as drugs include the following:
 
On the page of your website titled “Glutathione Is The Master Antioxidant”:
On the page of your website titled “The Link Between Diabetes, Dementia and Alzheimer’s Disease”:
“7. Take folate, vitamin B-6 and vitamin B-12. These three nutrients can … reduce the risk of Alzheimer’s by half.
 
“8 . Take a daily Omega-3 supplement.
“12. Take N-acetyl-cysteine, or NAC…
“17. Take one capsule of 2-AEP Membrane Complex three times daily before each meal.”
 
On the page of your website titled “Cholesterol-lowering Drugs Have A Dark Side”:
On the product page, “Ionic Silver Water – Superior Mouthwash for Infections, Digestions & Candida Control”
On the product page, “NAC – Liver Health & Glutathione for Detoxification”
The claims quoted above are supplemented by the metatag keywords used to bring consumers to your website through Internet searches. The metatag keywords include:
Furthermore, the following claims made on your Facebook page at https://www.facebook.com/Mars.Venus.John.Gray/, which provides a link to your website at www.marsvenus.com, provide additional evidence that your products are intended for use as drugs: 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products 2-AEP Membrane Complex, Glutathione, Liposomal DHA – Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, and Vectomega are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. 
 
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
 
cc:
John Gray's Mars Venus LLC John Henderson Gray
13 Lyon Pl
Mill Valley CA 94941

This page was posted on February 21, 2019.

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