• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Schindele Enterprises dba Midwest Wholesale 7/17/14

   

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

Public Health Service
Food and Drug Administration
  Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, KS 66214-1524
Telephone: (913) 495-5100

 

July 17, 2014
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING  LETTER
Ref.CMS# 418843
 
John G. Schindele
Owner
Schindele Enterprises, LLC
DBA Midwest Wholesale
617 N. Althea Avenue
Nixa, MO 65714 
 
 
Dear Mr. Schindele:
 
The United States  Food and Drug Administration (FDA) conducted an inspection at your distribution firm located  at 617 N. Althea  Ave., Nixa, Missouri, as well as at your firm's storage area located at 1710 N. CC Highway, Nixa, Missouri, from October 21 through  November 5, 2013.  FDA has determined  that your "Xzone Gold Male Sexual Performance Enhancement''  ("Xzone Gold"), "Triple MiracleZen Platinum  Male Sexual Performance Enhancement" ("MiracleZen"), "Xzen Platinum Male Sexual Performance Enhancement"  ("Xzen  Platinum"), "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra'' are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)], as detailed below.
 
Unapproved New Drugs
 
FDA confirmed through laboratory analyses that your products identified below contain the following undeclared active pharmaceutical ingredients:
 
 
Product Name
Undeclared Active Pharmaceutical Ingredient(s)
Xzone Gold
sildenafil; tadalafil
Miracle  Zen
sildenafil; tadalafil
Xzen Platinum
sildenafil; tadalafil
New Extenze
sildenafil
Magic for Men
sildenafil; sulfosildenafil
Sexy Monkey
sildenafil
Boost Ultra
sildenafil


 

Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved  prescription drug used to treat erectile dysfunction (EO).  Sulfosildenafil is a PDE-5 inhibitor and an analogue of sildenafil. Tadalafil is the active ingredient in Cialis, another FDA-approved prescription drug used to treat ED.
 
Your "Xzone Gold," "MiracleZen," "Xzen Platinum," "·New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra" are marketed as dietary supplements. Under section 201(ff)(3)(B)(i) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement may not contain an article that is approved as a new drug under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug.  FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27,1998. Given that sildenafil was not marketed as a dietary supplement or as a food before this date, "Xzone Gold ", "MiracleZen", "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra,"which all contain sildenafil, are excluded from the definition of a dietary supplement under section 201 (ff)(3)(B)(i) of the Act [21 U.S.C. § 321 (ff)(3)(B)(i)].  FDA approved Cialis (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. Given that tadalafil was not marketed as a dietary supplement or as a food before this date, "Xzone Gold," "MiracleZen," and "Xzen Platinum," which all contain tadalafil, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321 (ff)(3)(B)] on the basis of their tadalafil content as well.
 
Moreover, these products are drugs as defined by section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321 (g)(1)(C)]  because they are intended to prevent treat, or cure disease conditions and/or affect the structure or function of the body.1    Labeling statements documenting the intended use of "Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and
"Boost Ultra" include, but are not limited to the following:  
 

 

 
Xzone Gold
 
 
    "INCREASE VOLUME OF EJACULATE"
    "INCREASE IN LENGTH, WIDTH AND STAMINA"
     "INCREASES INTENSE, EXPLOSIVE ORGASMS"
    "FREE FROM PREMATURE EJACULATION"
    "AMAZING INCREASE  IN THICKNESS"
    "EXPERIENCE ROCK HARD ERECTIONS"
    "Stamina GAIN INTENSE ORGASMS, ROCK HARD & POWERFUL"
 
MiracleZen
 
 
    "Increase Volume of Ejaculate"
    "Increase in Length,Width, and Stamina"
    "Increase Intense, Explosive Orgasms"
    "FREE From PREMATURE EJACULATION"
    "Amazing Increase in Thickness"
    "Experience Rock Hard Erections"
    "Increases TIME of  INTERCOURSE"
    "Increases SIZE and ROCK HARD"
    "Increases STAMINA and SEX DRIVE"
 
Xzen Platinum
 
 
    "Gain Intense Orgasms, Rock Hard & Powerful"
    "INCREASE THE TIME OF INTERCOURSE"
    "INCREASE VOLUME OF EJACULATE"
    "INCREASE IN LENGTH, WIDTH AND STAMINA"
    "INCREASES INTENSE, EXPLOSIVE ORGASMS"
    "FREE FROM PREMATURE EJACULATION"
    "AMAZING INCREASE IN THICKNESS"
    "EXPERIENCE ROCK HARD ERECTIONS"
 
New Extenze
 
 
    "Male Sexual Enhancement"
    "Increase your size"
    "Maximum Strength Male Enhancement"
    "Enhance pleasure & performance"
    "Improve your sex life"
 
 
Magic for Men
 
 
    "[W]orks as quickly as 45 minutes and may help increase pleasure and performance."
 
 
Sexy Monkey
 
 
    "Increases size & rock hard erection"
    "Increases stamina  & sex drive"
    "Free From Premature Ejaculation"
    "Experience Powerful Erections"
    "Increase Intense, Explosive Orgasms"
 
 
Boost Ultra
 
 
    "ULTRA SEXUAL Enhancement Formula"
 
 
Moreover, "Xzone Gold", "MiracleZen," "Xzen Platinum," "New  Extenze," "Magic for Men," "Sexy Monkey, "and "Boost Ultra" are "new drugs" under section  201(p)  of the FD&C Act [21
U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and
505(a) of the FD&C 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 application approved by FDA under either section  505(b) or (j) of the FD&C Act [21 U.S.C. § 355(b) or (j)]  is in effect  for it. There are no FDA-approved applications on file for "Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze,""Magic for Men," "Sexy Monkey, "or "Boost Ultra.".  The distribution or sale of such products without approved applications violates these provisions of the FD&C Act.
 
Misbranded Drugs
 
"Xzone Gold," "MiracleZen," ''Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra" contain one or more PDE-5  inhibitors. All PDE-5  inhibitors that 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. Therefore, "Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra" are prescription drugs" as defined  in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. 
 
As such, "Xzone Gold," "MiracleZen," "Xzen  Platinum," "New Extenze," "Magic for Men,'' "Sexy Monkey,"and "Boost Ultra" are misbranded  under section 502(f)(1) of the FD&C  Act [21 U.S.C. §
352(f)(1)] because their labeling fail to bear adequate directions for their 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 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 201.15]. Because there are no FDA-approved applications for your firm's "Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra,'',  their labeling  fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C .§ 352(f)(1)).
 
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular.  According to section 201(n) of the FDCA [21 U.S.C. § 321(n)], in determining whether the labeling or advertising "is misleading, there shall be taken into account (among other things) not only representations made or suggested ...but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations ...."  The use of PDE-5 inhibitor scan be associated with significant safety issues and the risk of serious adverse events. The undeclared  PDE-5 inhibitors in your products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs  they may be taking.  For example, PDE-5 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, or heart disease often take nitrates. Accordingly, your "Xzone Gold", "MiracleZen," ''Xzen  Platinum," "New Extenze," "Magic for Men," "Sexy  Monkey," and "Boost Ultra'' products are misbranded under section  502(a) of the FDCA  because their labeling is false or misleading in that it fails to reveal material  facts with respect to consequences that may result from the use of these products.The undeclared sildenafil, tadalafil, and/or sulfosildenafil contained in these products may pose serious health risks to consumers.
 
"Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey,"and "Boost Ultra" are also misbranded  under section  502(f)(2) of the FD&C  Act [21 U.S.C. § 352(f)(2)] in that the products labeling lack adequate warnings for the protection of users.  As previously noted, there is potential  for adverse events associated with the use of PDE-5 inhibitors. Consumers who use these products would be unaware of the presence of the undeclared PDE-5 inhibitors and placed at risk for their associated adverse events.
 
Accordingly, the introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
A full list of all tainted products discovered by FDA can be found  at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.
 
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 ensure that your firm complies with all requirements of federal  law and FDA regulations, and to ensure that all products you manufacture or distribute are in compliance with the FD&C Act and all of its implementing regulations and all other requirements of federal Law.  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 seizure, injunction, and/or prosecution. Furthermore,FDA may reinspect  your facility to verify that corrective actions have been completed.
 
We acknowledge that your firm is cooperating with FDA by conducting a voluntary nationwide recall of certain lots of "Xzone Gold", "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy  Monkey," and "Boost Ultra." You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations.  In your response, please 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 all corrections before you respond,  you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections. If you no longer distribute these products, please indicate this in your response, including the reasons and the date on which you ceased to distribute them.
 
Your firm' sresponse should be sent to: Amy E. Devine, Compliance Officer, Food and Drug Administration, 8050 Marshall  Drive, Suite 205, Lenexa, KS 66214-1524. If you have any questions about the content  of this letter please contact  Ms. Devine at (913) 495-5147, or at the above address.
 
Sincerely,
 /S/
Cheryl A. Bigham
District Director
Kansas City District
 
 
1  As noted, in addition to sildenafil, "Magic for Men" contains sulfosildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor and a nanalogues of sildenafil.  Under section 201 (g)(1) of the FD&C Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the FD&C Act [21 U.S.C. § 343(r)(6)] or the product is subject to regulation as a drug.  Section 403(r)(6) of the FD&C Act 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 "Magic for Men" 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 sulfosildenafil content. Since sildenafil or sulfosildenafil are not a nutrients or dietary ingredients as defined in section 201 (ff)(i) of the FD&C Act [21 U.S.C. § 321 (ff)(1)), but instead a reactive 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 FD&C Act [21 U.S.C. § 343(r)(6)].  Therefore, "Magic for Men" is a drug within the meaning of section 201(g)(1)(C) of the FD&C Act (21 U.S.C. § 321 (g)(1)(C)].