Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

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).

Passage 3

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).

Passage 4

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.

Passage 5

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.

Passage 6

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.