# FDA WARNING_LETTER - Thirsty Run LLC / US Royal Honey LLC - July 12, 2022

Source: https://www.keypedia.com/records/warning_letter/thirsty-run-llc-us-royal-honey-llc/e73bd01d-fd48-4996-b91e-9d95e206f443

> FDA WARNING_LETTER for Thirsty Run LLC / US Royal Honey LLC on July 12, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Thirsty Run LLC / US Royal Honey LLC
- Inspection Date: 2022-07-12
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to the company at 10365 Haggerty St Suite 100, Dearborn, MI 48126, following the purchase and laboratory analysis of products Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her from their websites www.thirstyrun.com and www.usroyalhoney.com in June 2022.

The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Laboratory analysis confirmed that Etumax Royal Honey for Him and Dose Vital Honey for Men contain undeclared tadalafil, and Secret Miracle Royal Honey for Her contains undeclared sildenafil. Both are PDE-5 inhibitors, active ingredients in FDA-approved prescription drugs Cialis and Viagra, respectively, used for erectile dysfunction. The introduction of these products into interstate commerce is a prohibited act under Section 301(ll) of the FD&C Act [21 U.S.C. 331(II)] because they are foods to which approved drugs have been added.

Furthermore, these products are considered unapproved new drugs under Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] due to drug claims on the websites, such as "enhance male vitality" and "increase female libido." They

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- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.keypedia.com/companies/thirsty-run-llc-us-royal-honey-llc/bf6a8f9b-0df0-4bfb-bae6-e8edd989febd

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2