# FDA WARNING_LETTER - Spa 35 - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/spa-35/7b03101f-ba74-4213-9ed7-f71d169141ad

> FDA WARNING_LETTER for Spa 35 on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Spa 35
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

Spa3

## Related Officers

- [Michael M. Levy](https://www.globalkeysolutions.net/people/michael-m-levy/3e0fdd21-e691-406d-81cf-4fe2460a6309)

Company: https://www.globalkeysolutions.net/companies/spa-35/4878d146-a2c0-48ac-a15e-484ab36dec8f

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