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WARNING LETTER

April 27, 2023

298 E. Monterey Ave.
Pomona, CA 91767 USA

RE: 652780

Dear Ibrahim El Shahawy:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.voltcandy.com, between December 2022 and March 2023, where you took orders for “PrimeZEN Black 6000.”¹ In addition, we observed that your websites www.voltcandyonline.com and https://premierzen.com/, redirect to your website at www.voltcandy.com where you took orders for “PrimeZEN Black 6000.” We also reviewed your social media page at www.facebook.com/voltcandy1/ where you direct consumers to your website, www.voltcandy.com. Further, FDA has obtained a sample and labeling of your “PrimeZEN Black 6000” product. As described below, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “PrimeZEN Black 6000” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

FDA confirmed through laboratory analysis that a sample of your product contains undeclared pharmaceutical ingredients. Specifically, a sample of your “PrimeZEN Black 6000” product contains tadalafil and sildenafil. Tadalafil are sildenafil are phosphodiesterase type-5 (PDE-5) inhibitors and the active ingredients in the FDA-approved prescription drugs Cialis and Viagra, respectively, used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates.

Information on the label and labeling of your “PrimeZEN Black 6000” product demonstrates that it is marketed as a dietary supplement. However, 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 include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Cialis (containing tadalafil as the active ingredient) as a new drug on November 21, 2003, and approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that tadalafil and sildenafil were not marketed as dietary supplements or as food before Cialis and Viagra were approved, your “PrimeZen Black 6000” product is excluded from the definition of dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).

Unapproved New Drugs

Your “PrimeZEN Black 6000” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your website and social media page that establish the intended use of your “PrimeZEN Black 6000” product as a drug include, but are not limited to, the following:

From your product container/package label and product webpage for your “PrimeZEN Black 6000” product located at https://voltcandy.com/product/primezen-black-6000mg-male-sexual-performance-enhancement/:

• “Increases Time of INTERCOURSE”
• “Increases SIZE and ROCK HARD Grow Length, Width of Yours”
• “Increases STAMINA and SEX DRIVE”
• “FREE from PREMATURE EJACULATION”
• “100% Natural, Safe and Effective! Boost your Stamina & Endurance.”
• “Stimulates libido and supports normal hormone levels and the quality of sperm as well.”

From a July 17, 2022, post on your social media page, www.facebook.com/voltcandy1/:

• “Increases Time of INTERCOURSE”
• “Increases SIZE and ROCK HARD Grow Length, Width of Yours”
• “Increases STAMINA and SEX DRIVE”

Your “PrimeZEN Black 6000” is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There is no FDA-approved application in effect for “PrimeZEN Black 6000.” Introduction or delivery of this product into interstate commerce without an approved application violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Misbranded Drugs

Your “PrimeZEN Black 6000” product is also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. “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. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs. Your “PrimeZEN Black 6000” product, which contains undeclared tadalafil and sildenafil, is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. Prescription drugs can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs, including for your “PrimeZEN Black 6000” product. Your “PrimeZEN Black 6000” product is not exempt from the requirements that its labeling bears adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there is no FDA approved application in effect for this product. For these reasons, your “PrimeZEN Black 6000” product is misbranded under section 502(f)(1) of the FD&C Act.

Additionally, your “PrimeZEN Black 6000” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C 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 FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’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 for your “PrimeZEN Black 6000” product does not declare that the product contains PDE-5 inhibitors. 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 “PrimeZEN Black 6000” product 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 these ingredients in the product’s labeling renders your “PrimeZEN Black 6000” product misbranded under section 502(a) of the FD&C Act.

The undeclared active pharmaceutical ingredients in your product also cause this product to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because its labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for serious health risks associated with this product, particularly since anyone who takes your “PrimeZEN Black 6000” product would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.

The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. In addition to the violations discussed above, FDA observed that your website https://voltcandy.com/ offers for sale products that resemble products in previous FDA warnings about undeclared drug ingredients.² We also note that FDA previously issued a public warning to consumers not to use your “PremierZEN Gold 7000” product after FDA analysis confirmed the presence of undeclared PDE-5 inhibitors.³ You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that the product you distribute is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

CAPT Tina Smith
Acting Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_______________________

1 FDA issued a warning to consumers not to use your “PrimeZEN Black 6000” product (see PrimeZen Black 6000 contains hidden drug ingredients). Further, we acknowledge that you recalled “PrimeZEN Black 6000” in February 2023 and that you no longer offer this product for sale on your website at www.voltcandy.com (see Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and Tadalafil).

2 For example, you offer for sale “MV7 Days 2000,” “MV7 Days Gold 4500,” “MV7 Days Extreme 4500,” “MV7 Days Platinum 5000,” “MV9 Days Platinum 5000,” “MV9 Days Platinum 14000,” which resemble various “Rhino” male enhancement products that FDA has previously warned about and you offer for sale “Imperial Perfect Extreme 5000,” and “Imperial Perfect Gold 5000,” which resemble various “Imperial” male enhancement products that FDA previously warned about. See FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients. Also, see warnings for similarly labeled “Rhino” and “Imperial” products, by searching “Rhino” and “Imperial” in FDA’s Health Fraud Database.

3 See https://www.fda.gov/drugs/medication-health-fraud/public-notification-premierzen-gold-7000-contains-hidden-drug-ingredients.