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WARNING LETTER

 

 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

 

November 7, 2018

 

MA Labs LLC

Michael Eitutis

1860 Whitney Mesa Drive, Suite 120

Henderson, NV 89014

Re: 566831

 

 

Dear Mr. Eitutis:

 

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address masupps.com in October 2018 and has determined that you take orders there for your Vicaine product. The claims on your website establish that this product is a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].  Additionally, even if the labeling for your product did not bear claims that make it a drug, and assuming the products meets the definition of “dietary supplement” in section 201(ff) of the Act [21 U.S.C. § 321(ff)], the product would be an adulterated dietary supplement under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains an unsafe food additive.  As explained further below, introducing or delivering this product 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. 

 

Unapproved New Drugs and Misbranded Drugs

 

Examples of some of the website claims that provide evidence that your Vicaine product is intended for use as a drug include:

 

• “Prohedonic Opioid-Stimulant Complex”
• “Produces both Stimulatory and Opiate-like Effects”
• “Induces Euphoria…”
• “[P]ain-killer, … euphoriant, speed-ball in a bottle, stress-reducing agent…”
• “Vicaine possesses both stimulatory and opiate-like properties with a strong dopaminergic element…”
• “Containing potent dopaminergic-stimulants and a full-opioid agonist…”
• “Originally developed as a mood-brightening agent by The French Society of Medical Research, tianeptine was initially classified as a selective serotonin re-uptake enhancer, or S.S.R.E. (the first and only compound of its kind), and used as an anti-depressant with great success.” 
• “Tianeptine attaches to these receptors in the same way that traditional opiates do, displaying strong activity at the mu-receptor (primarily responsible for triggering euphoria), moderate activity at the delta-receptor (partially responsible for triggering euphoria)…”
• “Although the mechanisms through which tianeptine works have not yet been full elucidated, researchers believe that, in addition to activating the opioid receptor, it also possesses activity at the AMPA receptor, dopamine receptor, and NDMA receptor. This would account for (at least in part) its unique ability to provide mild stimulant-like effects in the face of opioid receptor activation. Basically, tianeptine provides all the positive effects of traditional opiates without causing the CNS depression (drowsiness, impaired motor skills, etc) of prescription opioids, thereby eliminating the one trait that could negatively impact exercise performance.”
• “Many have speculated that this may have long-term benefits in terms of degenerative brain disease prevention.”
• “Lastly, tianeptine tends to balance out the stimulant half of the product by alleviating any anxiety or restlessness that may transpire through stimulant use.”

 

Your Vicaine product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 CFR 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 Vicaine product is 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 product safely for its intended purposes. Accordingly, your Vicaine 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

 

Even if your Vicaine product did not have claims that make it an unapproved new drug and misbranded drug, Vicaine would be an adulterated dietary supplement under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains an unsafe food additive.  Your Vicaine product is labeled as a dietary supplement.  Given that you have declared your Vicaine product as a dietary supplement in the labeling of your products, we assume you have a basis to conclude that the product is a “dietary supplement” under section 201(ff) of the Act [21 U.S.C. § 321(ff)].

 

The Supplement Facts label for your Vicaine product declares tianeptine as a dietary ingredient. Under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Tianeptine is not a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Accordingly, tianeptine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)].

 

If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition,[1] it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)]. Adulterated foods cannot be legally imported or marketed in the United States.

 

Section 201(s) of the Act [21 U.S.C § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the tianeptine used in your dietary supplement product, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.

 

Tianeptine is not generally recognized as safe under its conditions of use in your dietary supplement product. Because tianeptine does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Vicaine product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains an unsafe food additive.

 

The violations cited in this letter are not intended to be an all-inclusive statement 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/or 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 [email protected].

 

Sincerely,

/S/                                                                       

William A. Correll

Director

Office of Compliance

Center for Food Safety

  and Applied Nutrition