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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Natural Wellness, LLC 10/5/10

  

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

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 

WARNING LETTER
FLA-11-02
 

October 5, 2010

Alexander Treynker
Chief Executive Officer
Natural Wellness, LLC
440 S. Federal Hwy., Ste 107
Deerfield Beach, FL 33441-4187

Dear Mr. Treynker:

This letter concerns your firm's distribution and marketing of the products "MasXtreme," "Passion Power for Men," and "Passion Power for Women" on your websites, www.staminamen.com and www.passionpowershot.com, on other websites, and via retail stores. As described below, these products are unapproved new drugs in violation of sections 505(a) and 301(d) of the Food, Drug and Cosmetic Act (the Act) (21 U.S.C. §§ 355(a) and 331(d)) and are misbranded drugs in violation of sections 502(f) and 502(a) (21 U.S.C. §§ 352(f) and 352(a)).

The United States Food and Drug Administration (FDA) inspected your firm between May 5, 2010, and June 30, 2010. Over the course of the inspection, the investigator collected samples and labeling associated with "MasXtreme," "Passion Power for Men," and "Passion Power for Women" that you market as dietary supplements. Laboratory analysis conducted by the FDA found that "MasXtreme," "Passion Power for Men," and "Passion Power for Women" contain phentolamine, a nonselective alpha-adrenergic antagonist, and the active ingredient in FDA approved drugs for the prevention or control of hypertensive episodes. Further, one lot of "MasXtreme," was found to contain sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor and the active ingredient in Viagra, an FDA-approved drug for the treatment of erectile dysfunction (ED).

Under section 201(ff)(3)(B) of the Act, (21 U.S.C. § 321(ff)(3)(B)), dietary supplements may not include an article approved as a new drug under section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Regitine as a new drug with the active ingredient phentolamine on January 30, 1952, and is not aware of any phentolamine containing products that were marketed as a dietary supplement or as a food before this date. FDA approved Viagra as a new drug with the active ingredient sildenafil on March 27, 1998, and is not aware of any sildenafil containing products that were marketed as a dietary supplement or as a food before this date. Therefore, "MasXtreme," "Passion Power for Men," and "Passion Power for Women" are excluded from the definition of a dietary supplement.

Statements on your products' labels and your firm's websites describe the intended use of the aforementioned products. These claims include, but are not limited to, the following:

"Passion Power for Men"

• "ENHANCE YOUR PERFORMANCE"

• "PASSION POWER"

• "It will enhance the frequency and duration of sensual arousal."

• "Passion Power provides energy, increases arousal, creates euphoria, enhances the sensations and lengthens the duration of sexual emotions and feelings."

• "The effects of Passion Power will promote a thrilling energy, more stamina, constant readiness, nasty thoughts, prolonged arousal, feelings of well being, romantic and sensual experience."

"Passion Power for Women"

• "ENHANCE YOUR PERFORMANCE"

• "PASSION POWER"

• "It will enhance the frequency and duration of sensual arousal."

• "Passion Power provides energy, increases arousal, creates euphoria, enhances the sensations and lengthens the duration of sexual emotions and feelings."

• "The effects of Passion Power will promote a thrilling energy, more stamina, constant readiness, nasty thoughts, prolonged arousal, feelings of well being, romantic and sensual experience."

"MasXtreme"

• ''MasXtreme™ will improve your sexual performance, libido, stamina and pleasure like you have never felt before."

• ''MasXtreme™ will enhance Sexual Pleasure and deliver Peak Sexual Experience."

• ''MasXtreme™ will improve your sexual performance, libido, stamina and pleasure like you have never felt before."

• "[Y]ou will experience as an increase in penis size, increased libido and firmness, longer more powerful erections, as well as additional sexual stamina."

• "[Y]ou will last longer and will have a better performance, MasXtreme™ gives a natural sex boost, will make your sex encounter more pleasurable, more intense and long lasting."

Under section 201(g)(1) of the Act, (21 U.S.C. § 321(g)(1)), products (other than foods) that are intended to affect the structure or function of the body, or for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are defined as drugs. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution (21 C.F.R. § 201.128). The statements listed above cause "MasXtreme," "Passion Power for Men," and "Passion Power for Women" to be drugs, as defined in section 201(g)(1) of the Act, (21 U.S.C. § 321(g)(1)).1

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. Your distribution or sale of these products without an approved application violates these provisions of the Act.

Furthermore, your products are "prescription drugs" as defined at section 503(b)(1)(A) of the Act, (21 U.S.C. § 353(b)(1)(A)), in that their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all PDE 5 inhibitors and nonselective alpha-adrenergic antagonists which have been approved for marketing by FDA are limited by an approved new drug application 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 C.F.R. § 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 which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there is no FDA approved application for your firm's "MasXtreme," "Passion Power for Men," and "Passion Power for Women" 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)).

Additionally, 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 "Passion Power for Men," and "Passion Power for Women" does not declare that these products contain phentolamine. Likewise, the labeling for "MasXtreme" does not declare that this product contains, depending on the lot, phentolamine, sildenafil, or other PDE5 inhibitors. The undeclared ingredients in your products may pose a serious health risks because patients with underlying medical issues may take one of your products without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. The failure to disclose the presence of phentolamine and/or sildenafil renders your products' labeling false and misleading. "MasXtreme," "Passion Power for Men," and "Passion Power for Women" are therefore
misbranded under Section 502(a) of the Act (21 U.S.C. § 352(a)).

"MasXtreme," "Passion Power for Men," and "Passion Power for Women" 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. There is potential for adverse events associated with the use of your products, particularly since someone who takes one of these products would be unaware of the presence of phentolamine and/or sildenafil. For example, because of its undeclared sildenafil content, patients who take nitrates and consume "MasXtreme" may be at risk of life threatening hypotension. Patients who take alpha blocker medications for treatment of either hypertension or benign prostate hypertrophy and consume "MasXtreme," "Passion Power for Men," or "Passion Power for Women" would have a significant risk of adverse cardiovascular events as a result of the additive alpha blocking activity of the products' undeclared phentolamine content.

The introduction or delivery for introduction into interstate commerce of these misbranded products, "MasXtreme," "Passion Power for Men," or "Passion Power for Women," violate section 301(a) of the Act (21 U.S.C. § 331(a)).

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 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 assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to ensure that you have knowledge of the ingredients in your products before you offer them for sale.

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. In addition, please provide evidence of the current status of the embargoed products and any necessary supporting documentary evidence. 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, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Norris at (407) 475-4730.

Sincerely,
/S/
Emma R. Singleton
Director, Florida District
 

____________________________________________________________

1 Furthermore, various lots of "MasXtreme" were also found to contain dimethylsildenafil, thiosildenafil, and ammotadfil. Such PDE5 inhibitors are synthetic active pharmaceutical ingredients and not dietary ingredients as defined in section 201(ff)(1) of the Act (21 U.S.C. § 321 (ff)(1)). Under section 201(g)(1) (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 claims quoted herein for "MasXtreme" do not describe the effects of nutrients or dietary ingredients in the products. Rather, the claims are made for the product as a whole and relate to its PDE5 inhibitor content. Since PDE5 inhibitors are not nutrients or dietary ingredients, but synthetic active pharmaceutical ingredients, 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, in lots that contain one or more of the six ingredient listed above, "MasXtreme" is a drug within the meaning of section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).