Inspections, Compliance, Enforcement, and Criminal Investigations

Nova Products, Inc. 9/26/14

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597·4390 

 

WARNING LETTER
14-PHI-23
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
September 26, 2014
 
 Abramo Ruggieri, President and Owner
 Nova Products, Inc.
 5 Mount Pleasant Road
 Aston, PA 19014
 
 
Dear Mr. Ruggieri:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your distribution facility located at 5 Mount Pleasant Road, Aston, PA from January 13, 2014 to February 7, 2014, and March 21, 2014. FDA has determined that certain products you distribute, including but not limited to, “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are unapproved new drugs under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (“the FDCA) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)], as detailed below.
 
Unapproved New Drugs
 
FDA confirmed through laboratory analysis that your products identified below contain the following undeclared active pharmaceutical ingredients:
 

Product Name
Undeclared Active Pharmaceutical Ingredient(s)
Xzone 1200
sildenafil; tadalafil
Mojo Risen
sildenafil
Black Ant
sildenafil
African Black Ant 
sildenafil
Xzen 1200
sildenafil; tadalafil
Xzen Platinum
sildenafil; tadalafil
Xzen Gold
sildenafil; tadalafil
Xzone Gold
sildenafil; tadalafil

 
Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED). Tadalafil is also a PDE-5 inhibitor and is the active ingredient in Cialis™, another FDA-approved prescription drug used to treat ED.
 
Your “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are marketed as dietary supplements. According to section 201(ff)(3)(B)(i) of the FDCA [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement cannot contain an article that is approved as a new drug under section 505(a) of the FDCA [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 Viagra™ was approved, “XZONE 1200,” “MOJO Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum,” which all contain sildenafil, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FDCA [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 Cialis™ was approved, “Xzone 1200,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” 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) of the FDCA [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 “Xzone 1200,” “MOJO Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” include, but are not limited to the following:
 
Xzone 1200
 
  • “Sexual Performance Enhancer for Men”
  • “[M]aintaining optimal levels of testosterone and thyroid hormones”
 
Mojo Risen
 
  • “Go BIG & STRONG ***All Night Long!”
  • “Sexual Formula for Men . . . to support sexual stamina, performance, and pleasure.”
 
Black Ant
 
  • “[M]ale hormone active (sic), albumen assimilation and stimulating marrow making blood function effects (sic), can accelerate blood corpuscle growth and producing sperm (sic). It can effectively activate adrenal gland PDA sound ause factor, dilute and supplement sperms (sic), reach several ejaculation and many times orgasm (sic) . . ..”                                                
 
 
African Black Ant
 
  • “[S]ubstitute for American Viagra . . ..”
  • “It can quickly elongate, thicken and enlarge the penis to effectively rescue you from short sexual intercourse time, take good therapeutic effect on preventing impotence and premature ejaculation (sic). . ..”
  • “It is of good therapeutic effect on prostate disease.”
  • “Indications: impotence, premature ejaculation, spontaneous emission, weak ejaculation . . . myasthenia of the limbs . . . tinnitus . . . prostatitis, and symptoms caused by deficiency of the kidney.”
 
Xzen 1200
 
  • “Sexual Performance Enhancer for Men.”
  • “[M]aintaining optimal levels of testosterone and thyroid hormones”
 
Xzone Gold
 
  • “Male Sexual Performance Enhancement”
  • “Fast Reaction Rock Hard”
  • “Experience Rock Hard Erections”
  • “Increase in length, width, and stamina”
  • “Increase volume of ejaculate”
  • “Free from premature ejaculation”
 
Xzen 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”
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***”
Moreover, “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are new drugs under section 201(p) of the FDCA [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 FDCA [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 FDCA [21 U.S.C. § 355(b) or (j)] is in effect for it. There is no FDA-approved application on file for “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” or “Xzen Platinum.” The distribution or sale of these products without approved applications violates these provisions of the FDCA.
 
Misbranded Drugs
 
“Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” 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 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are prescription drugs as defined in section 503(b)(1)(A) of the FDCA [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 such drugs.
 
As such, “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)], because their labeling fails 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 FDCA [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 “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” fail to declare that the products contain the PDE-5 inhibitors 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 renders your products’ labeling false or misleading. Therefore, “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” are misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)]. 
 
The undeclared PDE-5 inhibitors in “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” also cause these products to be misbranded under section 502(f)(2) of the FDCA [21 U.S.C. § 352(f)(2)] in that the products’ labeling lacks 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 “Xzone 1200,” “Mojo Risen,” “Black Ant,” “African Black Ant,” “Xzen 1200,” “Xzen Gold,” “Xzone Gold,” and “Xzen Platinum” 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 drug products mentioned above violates section 301(a) of the FDCA [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.  
 
In addition to the noted unapproved new drug and misbranded drug violations, your firm is in violation of section 301(f) of the FDCA [21 U.S.C. § 331(f)] in that your firm made refusals to permit inspection as authorized by section 704 of the FDCA [21 U.S.C. § 374(a)(1)]. Our investigator displayed credentials and issued a written notice, FDA Form 482 that includes section 704 of the FDCA, to you on March 21, 2014. Section 704(a)(1)(B) of the FDCA identifies the authority the FDA has regarding performing inspections to enforce the FDCA.
 
Our investigator was refused required access to the complete inventory of all products previously sampled. The FDA regards this refusal as a serious violation because it hinders our investigators’ ability to thoroughly and completely evaluate your firm’s ability to market and distribute products that do not violate the FDCA. 
 
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 FDCA 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 implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
 
Further, Section 743 of the Act [21 U.S.C. § 379j-31], authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. § 379j-31(a)(2)(B)].  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
FDA acknowledges that you issued a voluntary nationwide recall of “African Black Ant,” “Black Ant,” “XZen Gold,” “Xzen Platinum,” “XZen 1200,” “XZone Gold,” “XZone 1200” and “Mojo Risen” on April 1, 2014.
 
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. 
 
Your response should be sent to Yvette Johnson, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Johnson can be reached at 215-717-3077 or Yvette.Johnson @ fda.hhs.gov.
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District

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