Inspections, Compliance, Enforcement, and Criminal Investigations

Black International Enterprise, LLC dba Puba Store 7/10/14

  

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

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
 
WARNING LETTER
FLA-14-16
July 10, 2014
 
Lenard W. deMontagnac, CEO
Black International Enterprises LLC dba Puba Store
3207 Little Oak Way
Orlando, FL 32812
 
Dear Mr. deMontagnac:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement distribution facility located at 3207 Little Oak Way, Orlando, FL 32812, from August 14, 2013 through August 19, 2013. We have also reviewed your website at www.pubastore.com.
 
FDA has determined that your “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “Xzen XPress,” and “Xzone Premium” are unapproved new drugs sold in violation of Sections 505(a) and 301(d) of the the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of Sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)],
 
Unapproved New Drugs
 
FDA confirmed through laboratory analyses that your “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “Xzen XPress,” and “Xzone Premium” contained the following undeclared phosphodiesterase type-5 inhibitors (PDE-5 inhibitors) and other active pharmaceutical ingredients (APIs):
 

Product
Undeclared Active Pharmaceutical Ingredient(s)
Xzone Premium
tadalafil, sildenafil and dapoxetine
Mojo Risen
noracetildenafil
Xzen Xpress
sildenafil and tadalafil
XZen Gold
sildenafil and tadalafil
Xzen 1200
tadalafil
Xzen Platinum
sildenafil and tadalafil

Sildenafil, found in your “Xzone Premium,” “Xzen Xpress,” “Xzen Gold,” and “Xzen Platinum,” is the active ingredient in Viagra, which is an FDA-approved drug for the treatment of erectile dysfunction (ED). Noracetildenafil, found in your product, “Mojo Risen,” is a PDE-5 inhibitor and an analogue of sildenafil. Tadalafil, found in your “XZone Premium,” “Xzen Xpress,” “Xzen Gold,” “Xzen 1200,” and “Xzen Platinum,” is the active ingredient in Cialis, which is also an FDA-approved drug for the treatment of ED. Dapoxetine, contained in your “Xzone Premium,” is a selective serotonin reuptake inhibitor (SSRI) authorized for investigation to prevent premature ejaculation. Your marketing and distribution of “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “Xzen XPress,” and “Xzone Premium” violates the FD&C Act as described below.
 
“Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “Xzen XPress,” and “Xzone Premium” are marketed as dietary supplements. According to Section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321 (ff)(3)(B)], a dietary supplement may not include 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, “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “Xzen XPress,” and “Xzone Premium” are not considered dietary supplements. Likewise, “Mojo Risen,” which contains a sildenafil analogue, is subject to regulation as a drug because the structure/function claims made for this product do not conform to Section 403(r)(6) of the FDCA [21 U.S.C. § 343(r)(6)], as detailed below.[1]
 
Moreover, these products are drugs as defined by Section 201(g)(1) of the Act, [21 U.S.C. § 321(g)(1)] because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Labeling statements documenting the intended uses of your products include, but are not limited to, the following:
 
Mojo Risen
 
  •  “Go Big & Strong***All Night Long!”
  • “Male Sexual Performance Enhancement . . ..”
  •  “Experience rock hard erections”
  • “Free from premature ejaculation”
  • “Increase volume of ejaculator (sic)
 
Xzen Platinum
 
  • “Male Sexual Performance Enhancement”
  • “Rock hard erection”
  • “Gain Intense Orgasms, Rock Hard & Powerful”
  • “Increase volume of ejaculate”
  • “Free from premature ejaculation”
  • “Experience rock hard erections”
 
Xzen Gold
 
  • Fast Reaction Rock Hard”
  • “Increase in length, width and stamina”
  • “Male Sexual Performance Enhancement”
  • “Experience Rock Hard Erections”
  • “Free from premature ejaculation”
 
Xzen 1200
 
  • “[M]aintaining optimal levels of testosterone and thyroid hormones”
  • “Sexual Performance Enhancer for Men”
 
Xzen Press
 
  • “Male Sexual Performance Enhancement”
  • “Increase In Length, Width and Stamina”
  • “Experience Rock Hard Erections”
  • “Increase volume of ejaculate”
  • “Amazing increase in thickness”
 
Xzen Premium
 
  • “Male Sexual Performance Enhancement”
  • “Experience Rock Hard Erections”
  • “Maximize volume of ejaculate”
  • “Free from premature ejaculation”
  • “Grow Length, Width . . .”
 
“Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” 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 FDA-approved application is in effect for it. No approved applications are in effect for your “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium.” Consequently, your marketing and distribution of these products without such an approved application violates these provisions of the FD&C Act.
 
Misbranded Drugs
 
“Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” contain one or more PDE-5 inhibitors, and “Xzone Premium” also contains an SSRI. All PDE-5 inhibitors and SSRIs 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, “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” 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 potential 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 such drugs.
 
As such, “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” 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 uses. “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 201.115]. Because no FDA-approved applications are in effect for your products, their labeling fails to bear adequate directions for their intended uses, 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 labeling for your “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” fail to declare that the products contain the PDE-5 inhibitors and/or other ingredients listed in the table above. The use of PDE-5 inhibitors can 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. The failure to disclose the presence of the PDE-5 inhibitors and/or dapoxetine renders your products’ labeling false or misleading. Therefore, “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” are misbranded under Section 502(a) of the Act [21 U.S.C. § 352(a)].
 
The undeclared PDE-5 inhibitors and/or SSRI in “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” also cause these products to be misbranded under Section 502(f)(2) of the FDCA [21 U.S.C. § 352(f)(2)], because their 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 and SSRIs. Consumers who use “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.
 
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products mentioned above 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. Furthermore, 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 seizure, injunction, and/or prosecution. Furthermore, FDA may re-inspect your facility to verify that corrective actions have been completed. 
 
FDA acknowledges that you initiated a voluntary nationwide recall of “XZen Gold,” “Xzen 1200,” “Xzen Xpress,” and “Xzone Premium” on January 1, 2014. On January 13, 2014, you initiated an expanded voluntary nationwide recall to include “Mojo Risen” and “Xzen Platinum.” In addition, we acknowledge that you have removed some products from your website. However, a recent review of your website revealed that it appears your firm continues to distribute products in violation of the FDCA.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Your response should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. Also, include the current status of the “Mojo Risen,” “Xzen Platinum,” “Xzen Gold,” “Xzen 1200,” “Xzen XPress,” and “Xzone Premium” recalls, and the current disposition of any and all violative products, as well as copies of related documentation. 
 
If you no longer market these products, please indicate this in your response, including the reasons and the date on which you ceased to market them. If you cannot complete the corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
 
Please send your response to the attention of Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, you may contact Mr. Morris via telephone at (407) 475-4728 or via email at Randall.Morris@FDA.HHS.GOV.
 
Sincerely,
/S/
Elizabeth W. Ormond
Acting Director, Florida District
________________________________________________________________

[1] As noted, in addition to sildenafil and/or tadalafil, contained in your “Xzen Platinum,” “Xzen Gold,” “Xzen 1200” “XzenPress,” and “Xzone Premium,” your “Mojo Risen” contains noracetildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitors and an analogue of sildenafil. 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. The male enhancement structure/function claims made for “Mojo Risen” do not describe the effects of a nutrient or dietary ingredient in this product. Rather, the structure/function claims quoted above for “Mojo Risen” relate to its noracetildenafil content. Noracetildenafil 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 is a synthetic 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)]. For these reasons, “Mojo Risen” is a drug within the meaning of Section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)].

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