| Public Health Service Food and Drug Administration |
Denver District Office |
Department of Health and Human ServicesDecember 28, 2010
WARNING LETTER
Via UPS
Kelly D. Harvey, President
NovaCare, LLC (TSN Labs, Inc.)
330 West 6100 South
Salt Lake City, UT 84047
Ref: # DEN-11-06-WL
Dear Mr. Harvey:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above from March 8, 2010 through March 22, 2010. During the inspection samples were collected of your firm’s (b)(4) an ingredient used by your firm in the manufacture of products marketed as dietary supplements, and of the Master Manufacturing Records for products manufactured by your firm, which show (b)(4) as a component in their production. Laboratory analyses conducted by the FDA concluded that your firm’s (b)(4) contains sulfoaildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED). Following this finding, FDA obtained samples of products manufactured by your firm and marketed as dietary supplement including, but not limited to, “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex.”1 For the reasons stated below, these products are unapproved drugs in violation of section 505(a) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)] and misbranded drugs in violation of sections 502(f)(1) [21 U.S.C. § 352(f)(1)], 502(f)(2) [21 U.S.C. § 352(f)(2)] and 502(a) [21 U.S.C. § 352(a)]. In addition, [(b)(4) is a drug within the meaning of section 201(g)(1)(D) [21 U.S.C. § 321(g)(1)(D)] of the Act and is misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] of the Act.
Your firm’s sexual enhancement products “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” are labeled with claims such as the following:
“Aziffa”
• “Male Sexual Stimulant”
• “Sexual Stimulation Blend”
“MONSTER EXCYTE”
• “INCREASED SEX DRIVE, STAMINA AND VIRILITY FOR MEN”
• “MALE SEXUAL VITALITY ENHANCER”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity”
“Natural WOW! Ultra Perform for MEN”
• “SEXUAL BOOSTER!”
• “INCREASES STAMINA”
• “BOOSTS SEXUAL APPETITE”
• “INCREASES SEXUAL VITALITY”
• “take one capsules 30-45 minutes before sexual activity”
“Natural WOW! Ultra Perform for WOMEN”
• “SEXUAL BOOSTER!”
• “BOOSTS SEXUAL APPETITE”
• “INCREASES FEMALE SEXUAL VITALITY”
• “take one capsules 30-45 minutes before sexual activity”
“OMG”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity”
• “OMG Vitality Formula”
“ProLatis’”
• “All-Natural Male Performance Pill”
• “Take 1-2 capsules 1-2 hours before sexual activity.”
“Stiff Nights”
• “Male Sexual Stimulant”
• “Regain the Thunder”
• “Erection Booster BlendTM”
“Verect”
• “Male Sexual Vitality”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity.”
• “Zotrex Vitality Formula”
“XaitriX”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity”
“Zilex”
• “Female Sexual Vitality”
• “Zilex Vitality Formula”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water.”
“Zotrex”
• “Male Sexual Vitality”
• “Zotrex Vitality Formula”
• “As a dietary supplement, take 1-2 capsules 45 minutes before sexual activity with a large glass of water”
These statements make clear that the above mentioned products are drugs under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or function of the human body. Your firm’s “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” sexual enhancement products are labeled as dietary supplements. However, these products contain sulfoaildenafil, a phosphodiesterase type 5 (PDE5) inhibitor and an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED). Sulfoaildenafil is a synthetic active pharmaceutical ingredient and is not a dietary ingredient as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)].
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 do not describe the effects of nutrients or dietary ingredients in the products. Rather, the claims are made for the products as a whole and relate to their sulfoaildenafil content. Since sulfoaildenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but a synthetic active pharmaceutical ingredient, 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, “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” are drugs within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].
Furthermore, under section 201(g)(1)(D) of the Act [21 U.S.C. § 321(g)(1)(D)], an article intended for use as a component of a drug is also a drug. Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. See Title 21 of the Code of Federal Regulations, Part 210.3(b)(3) [21 CFR 210.3(b)(3)]. Master Manufacturing Records obtained from your firm indicate that (b)(4) is an ingredient used in the manufacture of drugs, including, but not limited to “Zotrex.” Accordingly, your firm’s (b)(4) is a drug within the meaning of section 201(g)(1)(D) of the Act [21 U.S.C. § 321(g)(1)(D)].
Moreover, “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” 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. Your distribution or sale of these products without an approved application violates these provisions of the Act.
“Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” are “prescription drugs” as defined at section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all FDA approvals of PDE5 inhibitors are limited to use under the professional supervision of a practitioner licensed by law to administer such drugs.
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 only be used safely 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 drugs that bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson [21 U.S.C. §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex,” their labeling fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
In addition, a drug in bulk package form intended for use in the manufacture of a new drug is only exempt from section 502(f)(1) of the Act [21 CFR § 352(f)(1)] if it satisfies the specific conditions set forth in 21 CFR § 201.122. Your bulk package drug (b)(4) does not satisfy the conditions of the exemption. Thus, your firm’s (b)(4) is also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
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 a drug’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 . . . .” The labeling of the above mentioned products does not declare that they contain sulfoaildenafil. Sulfaoaildenafil is an analogue of sildenafil, and, like sildenafil, is a PDE5 inhibitor. Because it is an analogue of sildenafil, sulfoaildenafil likely exhibits similar pharmacological action to sildenafil. The use of PDE5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE5 inhibitor in the above mentioned products may pose a serious health risks because patients with underlying medical issues may take these products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Further, patients who have been advised against taking PDE5 inhibitors because of comorbidities or potential drug interactions may seek products like “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” because they are marketed as not containing the active ingredients in approved ED drugs. The failure to disclose the presence of sulfoaildenafil renders your products’ labeling false and misleading. “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” are therefore misbranded under Section 502(a) of the Act [21 U.S.C. § 352(a)].
“Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” are also misbranded under Section 502(f)(2) of the Act, [21 U.S.C. § 352(f)(2)] in that their labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes them would be unaware of the presence of sulfoaildenafil. For example, because sulfoaildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume “Aziffa,” “MONSTER EXCYTE,” “Natural WOW! Ultra Perform for MEN,” “Natural WOW! Ultra Perform for WOMEN,” “OMG,” “ProLatis’,” “Stiff Nights,” “Verect,” “XaitriX,” “Zilex,” and “Zotrex” may be at risk of life-threatening hypotension.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act (21 U.S.C. § 331).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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 assure that your firm complies with all requirements of federal law and 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, injunction, and/or prosecution.
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 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 reply should be sent to the Food & Drug Administration, Denver District Office, Denver Federal Center – Building 20, 6th Avenue and Kipling Street, P.O. Box 25087, Denver, CO 80225-0087, to the attention of Thomas R. Berry, Compliance Officer. If you have any questions regarding the content of this letter, please contact Mr. Berry at (303) 236 -3028.
Sincerely,
/s/
H. Thomas Warwick, Jr.
Denver District Director
________________________
1 In August 2010, your firm conducted a voluntary nationwide recall of all lots of certain products sold prior to June 17, 2010, including the products listed above, after FDA informed you that the products appeared to contain sulfoaildenafil. FDA subsequently confirmed that the products above contain sulfoaildenafil.
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