What reports or FDA actions exist regarding unapproved fat‑dissolving injections in the past five years?
Executive summary
A cluster of FDA communications and news reports in December 2023 warns that unapproved “fat‑dissolving” or lipolysis injections — often sold under names like Aqualyx, Lipodissolve, Lipo Lab and Kabelline — have been linked to serious harms including infections, scarring, cysts and painful nodules, and the agency has urged consumers to avoid these products and report adverse events [1] [2] [3]. The FDA’s formal messaging stresses that only one injectable fat‑dissolving drug, Kybella, is FDA‑approved for submental fat and that commonly used ingredients in the unapproved products (phosphatidylcholine and sodium deoxycholate) have not been evaluated for safety or effectiveness by the agency [1] [2].
1. The FDA’s official warning: what it said and why it landed
In late December 2023 the FDA issued a public warning that it had received reports of consumers harmed by unauthorized fat‑dissolving injections and published an advisory outlining specific risks — including permanent scars, serious infections, skin deformities, cysts and deep, painful knots at injection sites — and provided photographic examples of infected nodules in at least one case [1] [3]. The agency framed the danger not only as chemical uncertainty (these products contain unapproved ingredients the FDA has not evaluated) but also as procedural risk: incorrect dosing, improper injection placement and unlicensed personnel administering injections can all magnify harm [1] [4].
2. Which products and ingredients are implicated
Reporting and the FDA identified a set of marketed names circulating online and in med spas — Aqualyx, Lipodissolve, Lipo Lab, Kabelline among them — and called out phosphatidylcholine (PPC) and sodium deoxycholate (DC), sometimes used together as “PCDC injections,” as common, unapproved constituents that pose safety risks because they have not undergone FDA evaluation for these uses [2] [1] [4].
3. Context: the lone FDA‑approved comparator and recommended safeguards
The FDA reiterated that Kybella (deoxycholic acid) is the only injectable drug approved for reducing submental fat (the “double chin”) and emphasized that approved products undergo evaluation for safety and efficacy and should be administered by trained health professionals, advice it contrasted with reports of people receiving unapproved shots from potentially unlicensed personnel or self‑injecting products bought online [2] [1] [5].
4. Media amplification and clinical community response
Major outlets and specialty sites quickly amplified the FDA advisory, characterizing patients as “maimed” or “left with deformities” in their headlines while stressing the agency’s call to seek medical care and report adverse events through MedWatch; surgical and aesthetic clinics echoed the FDA’s warning and urged patients to avoid online purchases and unregulated providers [6] [7] [4]. That alignment between the FDA and clinical reporters strengthened the reach of the message but also created sensational frames in some headlines that emphasized worst‑case imagery [6] [8].
5. Gaps, limitations and competing narratives
The available reporting documents the FDA’s warning and compiled adverse‑event descriptions but does not, in these sources, detail large‑scale enforcement actions such as seizures, injunctions, or criminal prosecutions tied to these specific products within the past five years; the primary documented FDA action in this set is the public health warning and guidance to consumers and clinicians [1] [9]. Industry and some aesthetic practitioners question whether a blanket warning might conflate varied product chemistries and techniques, and some clinics argue for harm‑reduction approaches rather than prohibition — perspectives present in trade‑oriented coverage though not detailed in the FDA release itself [4] [10].
6. What consumers and clinicians were asked to do
The FDA advised people to avoid purchasing or self‑administering unapproved fat‑dissolving products, to seek prompt medical care for complications, and to report adverse events via the FDA’s MedWatch program so the agency can better track harms; clinicians and accredited providers were urged to use only FDA‑approved therapies and proper sterile injection techniques [1] [3] [5].