Mihon Corp. d/b/a VitalityVita and Boulla, LLC

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://vitalityvita.com from August to December 2024 and your product listings on your Amazon storefronts at https://www.amazon.com/gp/product/B0CXTX9X8R/ref=ox_sc_act_title_1?smid=A2QN00MS00FLEE&psc=1 and https://www.amazon.com/ZoomMax-Nutrition-Maximize-Stamina-Vigorous/dp/B0D4SDCGZM/ref=sr_1_4_sspa?dib=eyJ2IjoiMSJ9.6CSIXY89VWyHbQ%E2%80%A6 in October 2024. The FDA has observed that your website and your Amazon storefronts offer the products “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” for sale in the United States. In addition, FDA has obtained samples of your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products. As described below, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce 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, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce 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 “VitalityXtra,”1 “PeakMax,”2 “ZapMax,”3 and “ZoomMax,”4 purchased from your before-noted websites, contain undeclared active pharmaceutical ingredient (API) sildenafil. Additionally, laboratory analyses identified the presence of undeclared API diclofenac in your “PeakMax,” “ZapMax, and “ZoomMax” products.

Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the FDA-approved prescription drug Viagra used to treat erectile dysfunction (ED). This undeclared API may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates.

Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Information on the labels and/or labeling of your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” demonstrate that the products are marketed as dietary supplements.5 Under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), if an article is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized.

FDA approved Viagra (containing sildenafil as the active pharmaceutical ingredient) as a new drug on March 27, 1998. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. Given that sildenafil and diclofenac were not marketed as dietary supplements or as foods before Viagra or Voltaren were FDA-approved, “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax,” which contain sildenafil or sildenafil and diclofenac, are excluded from the definition of “dietary supplement” under section 201(ff)(3)(B)(i) of the FD&C Act.

Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” 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 for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims from the labeling that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

From the product label:• “Strength”• “Stamina”• “Endurance”

From your product webpage https://www.vitalityvita.com/products/vitalityxtra-male-supplement-for-endurance-vitality-energy-stamina-and-strength-fast-acting-physical-performance-10-count-per-pack:• “VitalityXtra, Male Supplement for Endurance, Vitality, Energy, Stamina, and Strength”• “Boost your energy for higher vitality.”• “[I]ncrease your endurance, and enhance your over health.”• “Greater endurance and stamina”

From your product webpage https://www.vitalityvita.com/products/peak-max-male-supplement-for-endurance-vitality-energy-10-count-per-pack?variant=45112925454499:• “Male Supplement for Endurance, Vitality, Energy”• “Are you looking to boost your vitality, endurance, drive, and stamina when you need it the most? Well, look no further! Our amazing blue pill supplement is here to help.”

From your product listing at https://www.amazon.com/gp/product/B0CXTX9X8R/ref=ox_sc_act_title_1?smid=A2QN00MS00FLEE&psc=1• “[F]or Energy and Endurance”

From your product listing at https://www.amazon.com/ZoomMax-Nutrition-Maximize-Stamina-Vigorous/dp/B0D4SDCGZM/ref=sr_1_4_sspa?dib=eyJ2IjoiMSJ9.6CSIXY89VWyHbQ%E2%80%A6• “Our natural herbal blend helps maximize demands for sports and other physical activity. Our natural ingredients helps [sic] your body improve its endurance and stamina to perform longer at your peak performance. It also improves your energy by raising your body's vigor and energy. Lastly, feel the improved physical strength.”

“VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violate sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” 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 “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products do not declare that the products contain a PDE-5 inhibitor or diclofenac. The failure to disclose these ingredients in the product labeling renders your “VitalityXtra,” “PeakMax,” “ZapMax” and “ZoomMax” products misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” 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 (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. 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 “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products, which contain undeclared sildenafil, are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), and as such, 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 your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products such that a layperson can use the drugs safely for their intended uses. “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are not exempt from the requirements that their labeling bears adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there are no FDA approved applications in effect for these products. For these reasons, your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are misbranded under section 502(f)(1) of the FD&C Act.

The undeclared active pharmaceutical ingredients in your products also causes 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 “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” 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 drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

A list of tainted products discovered by FDA can be found at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.