- Delivery Method:
- Via Overnight Delivery
Food & Beverages
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
July 1, 2022
Dear Mr. Mousstaid,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) obtained a sample of your product Royal Honey for Him, purchased directly from your website at www.shopaax.com. Based on laboratory analysis of your product, 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 a sample of your Royal Honey for Him contains the undeclared active pharmaceutical ingredient sildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient 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.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 has been added.
Your Royal Honey for Him product is a food to which sildenafil has been added. Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(II) of the FD&C Act.
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 comment:
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 corrective actions 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 Kimberly Dutzek with the FDA via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied
Food and Drug Administration
1 FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. 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.