WARNING LETTER
Thirsty Run LLC / US Royal Honey LLC MARCS-CMS 623359 —
- Delivery Method:
- Via Overnight Delivery
- Product:
- Drugs
Food & Beverages
- Recipient:
-
Recipient NameWaleed/Wail Gaafar
- Thirsty Run LLC / US Royal Honey LLC
6841 Ternes St.
Dearborn, MI 48126
United States-
- support@thirstyrun.com
- support@USRoyalHoney.com
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
July 1, 2022
10365 Haggerty St
Suite 100
Dearborn, MI 48126
RE: 623359
Dear Mr. Gaafar,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) obtained samples of your products Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her, purchased directly from your websites www.thirstyrun.com and www.usroyalhoney.com. FDA also reviewed your websites in June 2022. Based on our review of your websites and laboratory analysis of your products, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Prohibited Act under Section 301(ll)
FDA confirmed through laboratory analysis that samples of your products, Etumax Royal Honey for Him and Dose Vital Honey for Men, contain the undeclared active pharmaceutical ingredient tadalafil, and your product, Secret Miracle Royal Honey for Her, contains the undeclared active pharmaceutical ingredient sildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors. Tadalafil and sildenafil are 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.
Subject to a limited exception, it is a prohibited act under section 301(ll) of the FD&C Act [21 U.S.C. 331(II)] to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act [21 U.S.C. 355] or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to sildenafil and tadalafil.1 FDA is not aware of any evidence that would call into question its conclusion that section 301(ll) of the FD&C Act prohibits the introduction into interstate commerce of any food to which sildenafil or tadalafil has been added. Your Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her products are foods to which sildenafil or tadalafil has been added. Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(II) of the FD&C Act.
Unapproved New Drugs
FDA reviewed your websites at www.thirstyrun.com and www.usroyalhoney.com in June 2022 and determined you take orders there for the products Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her. In addition to being foods of which the introduction or delivery for introduction into interstate commerce is prohibited under section 301(ll) of the FD&C Act, these products are drugs under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Etumax Royal Honey for Him and Dose Vital Honey for Men products:
- “Reproductive System Health - Being a product of nature, royal honey possesses nutrients that decrease the risk of prostate illness and other reproductive system conditions.”
Secret Miracle Royal Honey for Her product:
- “Reduces vaginal discharge and protects against bacterial infection”
Your Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Dietary Supplement Labeling
You market Secret Miracle Royal Honey for Her as a dietary supplement. For example, the webpages for this product on your websites display a product label image with “dietary supplement” on them. However, this product cannot be a dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act [21 U.S.C. 321(ff)]. FDA has concluded, based on available evidence, that sildenafil products are excluded from the dietary supplement definition 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)]. Under those provisions, if an article (such as sildenafil) 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; however, based on available evidence, FDA has concluded that this is not the case for sildenafil. FDA is not aware of any evidence that would call into question its current conclusion that sildenafil products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
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.
Additionally, we have the following comments:
Your websites www.thirstyrun.com and www.usroyalhoney.com offer the product Pink Pussycat for Her for sale to consumers in the United States. Previous FDA laboratory analyses confirmed that Pink Pussycat contains the undeclared ingredient sildenafil (December 8, 2021 Public Notification: Pink Pussycat contains hidden drug ingredient, https://www.fda.gov/drugs/medication-health-fraud/public-notification-pink-pussycat-contains-hidden-drug-ingredient). While the Agency has not tested and sampled the above-mentioned product from your inventory since issuance of this public notification, this letter is to express our serious concern about the safety of this product and emphasize that it is your legal responsibility under federal law to ensure that it does not contain any undeclared and potentially harmful ingredients.
FDA has not conducted a complete review of your inventory. It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law. A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder. We recommend that you subscribe to our email service at https://public.govdelivery.com/accounts/USFDA/subscriber/new to receive regular notices about tainted products discovered by FDA.
Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of 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 cannot complete all corrections within fifteen (15) working days, state the reason for the delay and the time within which you will do so. 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.
Your written reply to the above violations should be directed to Mr. Quyen Tien with the FDA via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
________________________
1 FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. FDA approved Cialis™ (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for sildenafil or tadalafil.