# FDA WARNING_LETTER - cholrem pty ltd  - May 09, 2024

Source: https://www.keypedia.com/records/warning_letter/cholrem-pty-ltd/2bca0cc0-d719-4ec1-a787-df69f34000a6

> FDA WARNING_LETTER for cholrem pty ltd  on May 09, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: cholrem pty ltd 
- Inspection Date: 2024-05-09
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Kyle Hodgetts regarding the sale of "RemChol," "RemChol Saver Set," "RemChol Starter Pack," and "RemChol Ultra Set" products in the U.S. The FDA reviewed the firm's websites (www.cavadex.com, www.cholrem.com, www.cholrem.com.au, www.cholrem-cavadex.com, www.remchol.com, www.cavadextrin.com) and social media in May 2024.

The FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and their introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). The products are considered drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims indicating intended use for disease diagnosis, cure, mitigation, treatment, or prevention, and/or to affect body structure or function. Examples of such claims include reversing heart disease, clearing arteries, extending lifespan, reducing angina

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- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/cholrem-pty-ltd/1ab57035-a617-41de-981a-c4b1d39722a7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c