Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club
FDA issued a warning letter to Tager Online, Inc. DBA Volt Candy regarding its 'PrimeZEN Black 6000' product, which was marketed as a dietary supplement but found through laboratory analysis to contain undeclared pharmaceutical ingredients tadalafil and sildenafil — the active ingredients in FDA-approved prescription drugs Cialis and Viagra. The product was deemed an unapproved new drug and misbranded drug under the FD&C Act due to its drug-intent marketing claims, failure to declare PDE-5 inhibitor ingredients, and lack of adequate directions for use or safety warnings. The company had already voluntarily recalled the product in February 2023, but FDA warned that failure to adequately address violations could result in seizure and/or injunction.
Flagged claims (7)
Increases SIZE and ROCK HARD Grow Length, Width of Yours
Increases Time of INTERCOURSE
Stimulates libido and supports normal hormone levels and the quality of sperm as well.
100% Natural, Safe and Effective! Boost your Stamina & Endurance.
Information on the label and labeling of your "PrimeZEN Black 6000" product demonstrates that it is marketed as a dietary supplement.
FREE from PREMATURE EJACULATION
Increases STAMINA and SEX DRIVE
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker