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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Evol Nutrition Associates, Inc. 7/10/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309

 July 10, 2012

VIA UPS

Jeremy E. Nickels, Owner/CEO
Evol Nutrition Associates, Inc.
1075 Cobb International Place, Suite F
Kennesaw, GA 30152
 

WARNING LETTER
(12-ATL-14)

Dear Mr. Nickels:

On July 13-29, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing and distribution facility located at 1075 Cobb International Place in Kennesaw, GA. As part of the inspection, FDA collected product labels and samples of several of your products. We have also reviewed your firm's website, www.reddawnparty.com, and other Evol Nutrition Associates, Inc. websites where your products are marketed, including www.reddawndrink.com and www.evolnutrition.com. Your products "Sandman Party Powder Euphoric Drink Mix," "Sleep Walker Euphoria Awareness Enhancer," "Spark 4D Happy Caps," "GHRelease," "Zan-X Extra Relaxation," "Red Dawn Liquid," and "Mojo Nights" are unapproved new drugs under Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 331(d) and 355(a)]. In addition, "GHRelease," "Zan-X Extra Relaxation," and "Mojo Nights" are also misbranded under section 502 of the Act (21 U.S.C. § 352].

"Mojo Nights" Contains Undeclared PDE-5 Inhibitor Ingredient

Your firm distributes the sexual enhancement product "Mojo Nights." FDA confirmed through laboratory analysis that your "Mojo Nights" product contains undeclared tadalafil and sildenafil, the active pharmaceutical ingredients in Cialis and Viagra, respectively, both FDA-approved drugs used to treat erectile dysfunction (ED). According to section 201(ff)(3)(B) [21 U.S.C. § 321 (ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra as a new drug on March 27, 1998, and approved Cialis as a new drug on November 21, 2003. Sildenafil and tadalafil were not marketed as dietary supplements or as foods before these dates. As such, "Mojo Nights" is not considered a dietary supplement. This lot of your "Mojo Nights" also contained sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, all of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogs of sildenafil or tadalafil, and none of which were declared on the product label for "Mojo Nights."

Your firm's sexual enhancement product "Mojo Nights" is labeled with claims that include, but are not limited to, the following:

"Jump start your sex drive"
"Give you powrful (sic) erections"
"stop pre-mature ejaculations"
"MojoNights increases the STRENGTH and POWER of your ERECTION."

These statements make clear that "Mojo Nights" is intended to affect the structure or any function of the body. Accordingly, this product is a drug, under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)]1 Moreover, "Mojo Nights" is a new drug as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. There is not an FDA approved application for "Mojo Nights." Your sale of this product without an approved application violates these provisions of the Act.

Furthermore, "Mojo Nights" is a prescription drug as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or potentiality for harmful effect, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. "Mojo Nights" is a prescription drug because it contains several PDE-5 inhibitors; all PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer them.

According to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write "adequate directions for use" for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for your firm's "Mojo Nights," its labeling fails to bear adequate directions for its intended use, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

"Mojo Nights" is also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the product's labeling lacks adequate warnings for the protection of users. As noted, there is a potential for adverse events associated with this product, particularly since someone who takes it would be unaware of the presence of sildenafil, tadalafil, sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil in your "Mojo Nights" product. The undeclared ingredients may interact with nitrates found in some prescription drugs, such.as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)] provides that in determining whether an article's labeling or advertising "is misleading there shall be taken into account ... not only representations made or suggested ... but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ... " Your product, "Mojo Nights" is misbranded under section 502(a) of the Act because its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of this product. Sildenafil, tadalafil, sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, contained in your "Mojo Nights," may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the product's label.

Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products mentioned above violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Street Drug Alternatives

In addition, several of your products, labeled as dietary supplements, are marketed as alternatives to illicit street drugs. These products include "Sandman Party Powder Euphoric Drink Mix," "Red Dawn Liquid," "Sleep Walker Euphoria Awareness Enhancer," and "Spark 4D Happy Caps." The following statements on your product containers or firm websites demonstrate that these products are intended as alternatives to illicit street drugs:

Sandman Party Powder Euphoric Drink Mix

"Euphoric Drink Mix"
"Sandman Party Powder is designed to heighten euphoric pleasure .... "
"I think the one little packet made me super "euphoric" for a total 8 hours."

Red Dawn Liquid

"It Gives you,
Energy,
Euphoria,
Happy
VERY social ... ! "

SleepWalker Euphoria Awareness Enhancer

"GREAT euphoria that last (sic) ALL day .... "
"Euphoria Awareness Enhancer"
"Dream on, enjoy having your head in the clouds"

Spark 4D Happy Caps

" 'Un'ergy' has never felt so Bliss."
"Forget about the 'Red' pill or the 'Blue' pill. Take the Green pill and enjoy the 4th Dimension."

Under section 201(ff) of the Act [21 U.S.C. § 321(ff)], dietary supplements are products that must be intended to supplement the diet. Street drug alternatives, i.e., products that claim to mimic the effects of recreational drugs, are not intended to supplement the diet and, as a result, cannot lawfully be marketed as dietary supplements. 2 See United States v. Undetermined Quantities of Articles of Drugs, 145 F. Supp. 2d 692 (D. Md. 2001). Accordingly, your products, "Sandman Party Powder Euphoric Drink Mix," "Red Dawn Liquid," and "SleepWalker Euphoria Awareness Enhancer," and "Spark 4D Happy Caps" as currently labeled are not dietary supplements under the Act.

"Sandman Party Powder Euphoric Drink Mix," "Red Dawn Liquid," "SleepWalker Euphoria. Awareness Enhancer," and "Spark 4D Happy Caps" are drugs, as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended to affect the structure or any function of the body of man or other animals. Moreover, these products are new drugs, as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of "Sandman Party Powder Euphoric Drink Mix," "Red Dawn Liquid," "SleepWalker Euphoria Awareness Enhancer," and "Spark 4D Happy Caps" without approved applications violates these provisions of the Act.

Even if these products did not include street drug alternative claims, your products "Sandman Party Powder Euphoric Drink Mix," "Sleep Walker Euphoria Awareness Enhancer," and "Spark 4D Happy Caps" also cannot be dietary supplements because they contain 2-oxo-1-pyrrolidine acetamine, also known as piracetam. Your firm markets these piracetam-containing products as dietary supplements. However, these products are excluded from the definition of"dietary supplement" under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Piracetam is an article that has been authorized as an investigational new drug (IND) for which substantial clinical investigations have been instituted in the United States and the existence of such investigations have been made public. The results of at least two clinical studies conducted under authorized INDs were published in peer reviewed journals3,4.  In addition, there is no evidence that piracetam was marketed as a dietary supplement or a food prior to the authorization to investigate piracetam as a new drug. Therefore, a piracetam-containing product cannot be a dietary supplement under the Act. 5

Moreover, your "Spark 4-D Happy Caps" contains the directions for use, "[L]et dissolve in mouth for quicker absorption." Your firm markets this product as a dietary supplement. However, the Act defines the term "dietary supplement" in section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)], as a product that is "intended for ingestion." Because your product is intended to enter the body directly through the mucosal tissues, it is not a dietary supplement or food. Therefore, in addition to the street drug alternative claims and piracetam content mentioned above, as currently marketed, "Spark 4-D Happy Caps" cannot be a dietary supplement because it is not "intended for ingestion."

Other Unapproved New Drugs and Misbranded Drugs

Your firm promotes several other products including "GHRelease" and "Zan-X Extra Relaxation" with various disease claims that cause these products to be unapproved new drugs and misbranded drugs under the Act. The following statements on your website www.reddawnparty.com and product labels demonstrate that "GHRelease" and "Zan-X Extra Relaxation" are intended to treat or prevent certain diseases:

GHRelease

"This revolutionary product is formulated to help with insomnia .... "

Zan-X Extra Relaxation

"NO MORE INSOMNIA FOR ME!"

The product name "Zan-X" closely resembles, "Xanax," a well known prescription drug product to treat anxiety and panic disorders.

Your products "GHRelease" and "Zan-X Extra Relaxation" are intended for use in the cure, mitigation, treatment, or prevention of disease. Accordingly, these products are drugs under Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(C)]. Moreover, these products are new drugs as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.

Under sections 301(d) and 505(a) of the' Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. There are no approved applications for "GHRelease" and "Zan-X Extra Relaxation." Your sale of these products without approved applications violates these provisions of the Act.

In addition, because your products, including "GHRelease" and "Zan-X Extra Relaxation" are offered for conditions, such as insomnia, anxiety, and depression that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, the labeling for "GHRelease" and "Zan-X Extra Relaxation" fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Accordingly, the introduction or delivery for introduction into interstate commerce of"GHRelease" and "Zan-X Extra Relaxation" violates section 301(a) of the Act [21 U.S.C. § 331(a)].

* * * *

We note that you appear to no longer market your "Vector Extra Party Enhancer" (hereinafter "Vector Pill"). However, FDA laboratory analysis of this product revealed that it contains, among other ingredients, 1-( a, a, a-trifluoro-m-tolyl)piperazine [trifluoromethylphenylpiperazine, TFMPP]. The product label, labeling, and your website www.reddawnparty.cornlnroductsNector-Pill.html included statements indicating that "Vector Pill" is intended as an alternative to an illicit street drug, such as "6-8 hours of ... rushes and euphoria." Continued sale of this product would cause it to be an unapproved new drug in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 33l(d) and 355(a)] and a misbranded drug under section 502 of the Act [21 U.S.C. § 352].

This letter is not intended to be an all-inclusive list of violations that may exist at your facility. It does not indicate that FDA conducted an all-inclusive review of all the products you manufacture and/or distribute. In particular, you need to ensure that all products you are selling do not contain undeclared ingredients. It is your responsibility to ensure that the products you market are safe. Likewise, you are responsible for ensuring that your firm is operating in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement regulations (21 CFR Part 111 ). You may find copies of the Act and pertinent regulations through links on FDA's homepage at www.fda.gov.

We acknowledge receipt of the August 2, 2011, letter from (b)(4) representatives responding on your behalf. The response indicates that your firm is no longer manufacturing Red X Dawn "Dream Weaver Sleep Enhancer," and that the remaining product has been destroyed. The response, however, did not include documentation of the products' destruction nor does not indicate whether your firm initiated a recall of the "Dream Weaver Sleep Enhancer" product that been distributed to your customers.

You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.

Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.

Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer., at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.

Sincerely,

/S/

John R. Gridley
District Director
Atlanta District Office

 

1 As noted, in addition to sildenafil and tadalafil, "Mojo Nights" also contains sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, all of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil or tadalafil. Under section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. However, the structure/function claims quoted above for "Mojo Nights" do not describe the effects of nutrients or dietary ingredients in the product. Rather, the claims are made for the product as a whole and relate to its sildenafil, tadalafil, sulfosildenafil, sulfotadalafil, and/or hydroxythiohomosildenafil content. Since sildenafil, tadalafil, sulfosildenafil, sulfotadalafil, or hydroxythiohomosildenafil are not nutrients or dietary ingredients as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but instead are active pharmaceutical ingredients or analogues of active pharmaceutical ingredients, the claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Accordingly, "Mojo Nights" is a drug within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321 (g)(1)(C)].

2 In March of 2000, FDA made available a guidance for industry on street drug alternatives.  This document contains additional information and is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070343.pdf.

3 Pranzatelli, M.R., Tate, E.D., Galvin, I., and Wheeler, A. (2001). Controlled Pilot Study of Piracetam for Pediatric Osoclonus-Myoclonus. Clinical Neuropharmacology, 24(6), 352-357.
4 Kampman, K.M., et al. (2003). A pilot trial of piracetam and ginkgo biloba for the treatment of cocaine dependence. Addictive Behaviors, 28(3), 437-448.
5 In addition, piracetam does not meet the definition of a dietary ingredient under section 201(ff)(1)(A-F) of the Act [21 U.S.C. § 321(ff)(1)(A-F)] in that it is not a vitamin, a mineral, an herb or other botanical, an amino acid, or a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Additionally, piracetam is not a concentrate, metabolite, constituent, extract, or combination of a dietary ingredient.