WARNING LETTER
Gadget Island, Inc.
MARCS-CMS 658733 —
July 21, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Naeem Azizian
Recipient Title
President/CEO
Gadget Island, Inc.
PO Box 981630
West Sacramento
,
CA
95798
United States
info@gearisle.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
July 21, 2023
PO Box 1156
Newark, CA 94560
RE: 658733
Dear Naeem Azizian:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, www.gearisle.com, between January and July 2023, where you took orders for “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg.”
1
In addition, FDA has obtained samples and labeling of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products. As described below, these products are unapproved new drugs 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are misbranded drugs 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 analyses that samples of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products each contain the undeclared pharmaceutical ingredients tadalafil and sildenafil. Tadalafil and 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/or labeling of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products demonstrates that these products are marketed as dietary supplements. 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are drugs as defined by section 201(g)(1) of the FD&C Act 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. Examples of claims observed on your website and product labels that establish the intended use of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products as drugs include, but are not limited to, the following:
On the “NUX Male Enhancement” label:
“SIZE increase in thickness and in length”
“NO premature ejaculation”
“EXPLOSIVE orgasm”
“ROCK hard erections”
On your webpage, www.gearisle.com/nux-male-enhancement-blue-pill for “NUX Male Enhancement”:
“No premature ejaculation”
“Better ejaculation control”
“ROCK hard erection”
On the “DYNAMITE Male Sexual Enhancement” label:
“Be FREE from PREMATURE EJACULATION”
“INCREASED Volume of Ejaculate!”
“Amazing increase in THICKNESS and INCREASES in LENGTH, WIDTH and STAMINA!”
“INCREASES Intense, Explosive Orgasms!”
On your webpage www.gearisle.com/dynamite-super-58000mg-male-enhancement-red-pill for “DYNAMITE Male Sexual Enhancement”:
“Free from premature ejaculation”
“Better ejaculation control, no limits”
“Increase volume of ejaculate”
“Experience rock hard erections”
“Increases intense, explosive orgasms”
On the “ProPower Knight Plus 2550mg” label:
“13Days of Powerful Performance”
“Larger & Harder Erection”
“Everlasting Stamina & Sex drive”
On your webpage www.gearisle.com/pro-power-knight-plus-2500mg-sexual-performance-enhancement-1-pill for “ProPower Knight Plus 2550mg”:
“Last up to 12 days”
“Bigger, harder, longer erections”
“Prevents premature ejaculations”
“Increase intense stamina & sex drive”
Your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are not generally recognized as safe and effective for their above referenced uses and, therefore, each 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” or “ProPower Knight Plus 2550mg.” Introduction or delivery of these products 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their 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. Each of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products, which contain undeclared tadalafil and sildenafil, are also prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products. “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are not exempt from the requirements that their labeling bear 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 these products. For these reasons, your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352.
Additionally, your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products do not declare that the products contain 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” 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 these ingredients in the product labeling renders your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products misbranded under section 502(a) of the FD&C Act.
The undeclared active pharmaceutical ingredients in your products also cause these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for serious health risks associated with these products, particularly since anyone who takes your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products 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 these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
We also documented that your websites www.gearisle.com, www.smokewrap.com, and www.ultimamax.com offer for sale variations of “Titanium 18k,” “Hard AF!,” and/or various Rhino products for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your websites revealed these products contain the undeclared ingredients sildenafil and/or tadalafil.
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We also note that you offer for sale the product “Royal Honey” on your website at www.smokewrap.com. A variation of this product with the same name has been the subject of previous FDA warnings after FDA analysis confirmed the presence of an undeclared PDE-5 inhibitor.
3
While the Agency has not sampled and tested these product variations from your inventory to date, this letter is to express our serious concern about the safety of these products and emphasize that it is your legal responsibility under federal law to ensure that they do not contain any undeclared and potentially harmful ingredients.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with the products you distribute. 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 products you distribute are 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 “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and ProPower Knight Plus 2550mg” products (see: https://www.fda.gov/drugs/medication-healthfraud/nux-male-enhancement-contains-hidden-drug-ingredients, https://www.fda.gov/drugs/medication-healthfraud/dynamite-male-sexual-enhancement-contains-hidden-drug-ingredients and https://www.fda.gov/drugs/medication-health-fraud/pro-power-knight-plus--contains-hidden-drug-ingredients). Further, we acknowledge that you recalled your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and ProPower Knight Plus 2550mg” products in April 2023 and that you no longer offer these products for sale on your website at www.gearisle.com (see https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/gear-isle-issues-voluntary-nationwide-recall-pro-power-knight-plus-nux-male-enhancement-anddynamite).
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For example, you offer for sale “Titanium 18K Male Sexual Enhancement Black Silver” and “Hard AF Black 3500mg Male Sexual Dietary Supplement Pill” on www.gearisle.com that appear similar to products that have been the subject of previous FDA warnings (see: https://www.fda.gov/drugs/medication-health-fraud/public-notification-titanium-18k-contains-hidden-drugingredients and https://www.fda.gov/drugs/medication-health-fraud/public-notification-hard-af-contains-hidden-drug-ingredients). Additionally, you offer various Rhino products for sale on your websites www.gearisle.com, www.smokewrap.com, ultimamax.com, and www.gearadult.com. FDA warned consumers to avoid Rhino products in 2018 (see: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-rhino-male-enhancement-products-found-retailers-because-undeclared-and).
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See https://www.fda.gov/drugs/medication-health-fraud/public-notification-kingdom-honey-royal-honey-vip-contains-hidden-drugingredient and https://www.fda.gov/news-events/press-announcements/fda-warns-four-companies-selling-tainted-honey-basedproducts-hidden-active-drug-ingredients.
Content current as of:
07/25/2023
Regulated Product(s)
Drugs