FDA WARNING_LETTER - cholrem pty ltd - May 09, 2024

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