WARNING LETTER
1am USA Incorporated dba Pleasure Products USA
MARCS-CMS 627006 —
July 01, 2022
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Brent Lawson
1am USA Incorporated dba Pleasure Products USA
6603 Crimson Lane
Barnhart
,
MO
63012
United States
sales@pleasureproductsusa.com
IAMDOLLUSA@yahoo.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
July 1, 2022
RE: 627006
Dear Mr. Lawson,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) obtained samples of your product X RATED HONEY FOR MEN, purchased directly from your website www.pleasureproductsusa.com. FDA also reviewed your website in June 2022. Based on our review of your website and 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 samples of your X RATED HONEY FOR MEN contains the undeclared active pharmaceutical ingredient tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, 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(ll)] 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 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 tadalafil has been added.
Your X RATED HONEY FOR MEN product is a food to which tadalafil has been added. Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(ll) of the FD&C Act.
Dietary Supplement Labeling
You market X RATED HONEY FOR MEN as a dietary supplement. For example, the product webpage describes the product as a supplement and displays a product label image with “Supplement Facts.” However, this product cannot be 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 tadalafil 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 tadalafil) 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 tadalafil. FDA is not aware of any evidence that would call into question its current conclusion that tadalafil 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 comment:
FDA has not conducted a complete review of your inventory. It is your responsibility under the Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. 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 product is 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 Jamie Bumpas 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
____________________________
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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 tadalafil.
Content current as of:
07/12/2022
Regulated Product(s)
Drugs
Food & Beverages