CRITICALNutrition / SupplementsFDA Warning Letter · July 21, 2023

Gadget Island, Inc.

Atlas ID: 2023-07-fda-gadget-island-inc-j8gj43

FDA issued a warning letter to Gadget Island, Inc. (President/CEO Naeem Azizian) regarding three male sexual enhancement products — 'NUX Male Enhancement,' 'DYNAMITE Male Sexual Enhancement,' and 'ProPower Knight Plus 2550mg' — sold on www.gearisle.com. Laboratory analysis confirmed each product contained undeclared pharmaceutical ingredients tadalafil and sildenafil (active ingredients in FDA-approved prescription drugs Cialis and Viagra), rendering them unapproved new drugs and misbranded under the FD&C Act. The products were marketed as dietary supplements but cannot qualify as such under federal law because tadalafil and sildenafil were approved as drugs before being marketed as supplements. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Flagged claims (24)

Experience rock hard erections

Unsubstantiated efficacy · unapproved-drug-structure-function

Increase volume of ejaculate

Unsubstantiated efficacy · unapproved-drug-structure-function

13Days of Powerful Performance

Unsubstantiated efficacy · unapproved-drug-structure-function

Everlasting Stamina & Sex drive

Absolute language · unapproved-drug-structure-function

Amazing increase in THICKNESS and INCREASES in LENGTH, WIDTH and STAMINA!

Unsubstantiated efficacy · unapproved-drug-structure-function

No premature ejaculation

Cure claim · unapproved-drug-disease-claim

Prevents premature ejaculations

Cure claim · unapproved-drug-disease-claim

NO premature ejaculation

Cure claim · unapproved-drug-disease-claim

Increases intense, explosive orgasms

Unsubstantiated efficacy · unapproved-drug-structure-function

Be FREE from PREMATURE EJACULATION

Cure claim · unapproved-drug-disease-claim

Increase intense stamina & sex drive

Unsubstantiated efficacy · unapproved-drug-structure-function

Last up to 12 days

Unsubstantiated efficacy · unapproved-drug-structure-function

EXPLOSIVE orgasm

Unsubstantiated efficacy · unapproved-drug-structure-function

Bigger, harder, longer erections

Unsubstantiated efficacy · unapproved-drug-structure-function

Better ejaculation control, no limits

Unsubstantiated efficacy · unapproved-drug-structure-function

INCREASED Volume of Ejaculate!

Unsubstantiated efficacy · unapproved-drug-structure-function

missing-disclaimer

Missing disclaimer · undeclared-active-pharmaceutical-ingredient

Free from premature ejaculation

Cure claim · unapproved-drug-disease-claim

Larger & Harder Erection

Unsubstantiated efficacy · unapproved-drug-structure-function

Better ejaculation control

Unsubstantiated efficacy · unapproved-drug-structure-function

ROCK hard erection

Unsubstantiated efficacy · unapproved-drug-structure-function

ROCK hard erections

Unsubstantiated efficacy · unapproved-drug-structure-function

INCREASES Intense, Explosive Orgasms!

Unsubstantiated efficacy · unapproved-drug-structure-function

SIZE increase in thickness and in length

Unsubstantiated efficacy · unapproved-drug-structure-function

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.

Response required · 15 days

Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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