FDA WARNING_LETTER - Spa 35

The FDA reviewed Spa35's website, www.spa35.com, and found that its LipoDissolve products are misbranded, violating the Federal Food, Drug, and Cosmetic Act (FDCA) sections 352(a), 352(n), and 321(n), and FDA regulations 202.1(e)(5)(i) and (e)(6)(i).

The LipoDissolve products, containing phosphatidylcholine deoxycholate (PCDC) administered via microinjections to dissolve fat, are considered drugs under FDCA section 321(g)(1) because they are intended to affect the body's structure or function. As their use is not safe without practitioner supervision, they are also prescription drugs under FDCA section 353(b)(1).

The website contains false or misleading claims, causing misbranding under FDCA sections 352(a) and 352(n). Specifically, the FDA identified unsubstantiated efficacy claims, such as "permanently dissolve fat" and "with GREAT results," and unsubstantiated safety claims, including "no serious side effects ever being reported" and that PCDC use is "widely used for its safety profile, much like the use of Botox." The FDA stated there is no approved injectable PCDC in the U.S., making "off-label" claims false.

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