FDA Warns Against Unapproved “Lipo Injections” Sold Online

23 December 2023

Popular spa treatments pose serious health risks due to unapproved products

The U.S. Food and Drug Administration (FDA) has issued a warning about the dangers of “lipo injections,” a popular spa treatment that claims to reduce fat deposits in problem areas. These injections, sold under various brand names such as Aqualyx, Lipodissolve, Lipo Lab, and Kabelline, are available for purchase on online platforms like Amazon. However, the FDA cautions that these products are not approved and can cause serious side effects. Reports have surfaced of individuals experiencing adverse reactions after receiving these unregulated injections at unlicensed beauty spas or self-administering them.

The Risks of Unapproved Injections

The FDA has received numerous reports of individuals suffering from severe side effects after using unapproved fat-dissolving injections. These side effects include permanent scars, serious infections, skin deformities, cysts, and painful knots in the injection sites. The use of unregulated injections poses a significant risk to individuals seeking non-invasive fat reduction treatments.

Krystal Roney-Smith, a master aesthetic nurse practitioner and owner of Lush RX Med Spa in Houston, emphasizes the importance of thorough research before considering these treatments. Roney-Smith advises individuals to seek reputable establishments with positive reviews, licensed practitioners, and proper credentials. The lack of regulation in the med spa industry has led to an increase in unqualified individuals offering potentially harmful treatments.

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FDA Approved Alternatives

Kybella, a deoxycholic acid injection, is the only FDA-approved treatment that effectively destroys fat cells. However, it is exclusively approved for treating submental fat, commonly known as a “double chin.” Roney-Smith explains that Kybella is sometimes used off-label for individuals at their ideal weight who wish to address imperfections like love handles. It is crucial to consult with a licensed professional who understands the proper administration of acid-based treatments.

The unapproved injections often contain ingredients such as phosphatidylcholine (PPC) and sodium deoxycholate (DC), which have not undergone evaluation by safety regulators. The lack of oversight and evaluation raises concerns about the potential risks associated with these substances. Roney-Smith urges individuals to exercise caution and avoid treatments that sound too good to be true.

The Importance of Regulation and Safety

The FDA advises against purchasing medical spa treatments online and encourages individuals to consult healthcare professionals before trying such products. The rise of online platforms has made it easier for unapproved products to reach consumers, putting their health at risk. The lax use of the term “med spa” has further complicated the issue, leading to a proliferation of unqualified practitioners offering unsafe treatments.


The FDA’s warning against unapproved “lipo injections” highlights the dangers of using non-regulated products for fat reduction treatments. The reported cases of severe side effects, including permanent scarring and serious infections, emphasize the need for stricter regulation in the med spa industry. Individuals seeking these treatments must exercise caution, conducting thorough research, and consulting with licensed professionals. The FDA’s recommendation to avoid purchasing medical spa treatments online serves as a reminder of the importance of prioritizing safety and seeking expert advice when considering cosmetic procedures.

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