# FDA WARNING_LETTER - Je Dois Lavoir LLC - August 11, 2021

Source: https://www.keypedia.com/records/warning_letter/je-dois-lavoir-llc/996ca43d-65b0-4428-b946-171e873beef1

> FDA WARNING_LETTER for Je Dois Lavoir LLC on August 11, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Je Dois Lavoir LLC
- Inspection Date: 2021-08-11
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA issued a Warning Letter to Ms. Orozco regarding the product "365 Skinny High Intensity" sold on jedoisavoir2020.com and associated social media. The FDA's June 2021 review and laboratory analysis confirmed the product contains undeclared sibutramine, a drug withdrawn from the market in 2010 due to increased risks of heart attack and stroke.

The product is deemed an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement. Claims on the website and social media, such as "excellent results in the loss of weight" and "anti obesity," establish its intended use as a drug. Since there is no FDA-approved application for this product, its introduction into interstate commerce is prohibited.

Furthermore, "365 Skinny High Intensity" is a misbranded drug under section 502 and 301(a) of the FD&C Act. It lacks adequate directions for use (502(f)(1)), is false or misleading due to undeclared sibutramine (502(a)), lacks adequate warnings (502(f)(2)), and is dangerous to health when used as recommended (502(j)).

The FDA acknowledges the voluntary recall

## Related Officers

- [Director - Compliance Branch](https://www.keypedia.com/people/lance-m-de-souza/8445cae5-3104-4159-89e9-e07fb7852270)

Company: https://www.keypedia.com/companies/je-dois-lavoir-llc/1f043c4c-42e9-483d-8912-a5fd4b828b30

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6