Fat-dissolving injections in the Philippines: what regulators say

What are fat-dissolving injections?

Fat-dissolving injections are products injected into fat under the skin with the aim of shrinking it. They are sold under many brand names, and their ingredients differ.

The US FDA says the common ingredients in unapproved fat-dissolving injections are phosphatidylcholine (PPC) and sodium deoxycholate (DC). These are sometimes called "PCDC injections". The procedure is also called injection lipolysis.

Only the first row is an approved drug. The others are different products, and the approval of Kybella does not apply to them.

Is any fat-dissolving injection approved?

Yes, one. The US FDA says Kybella (deoxycholic acid) "is the only fat-dissolving injectable drug that is FDA approved to reduce the amount of fat under the chin, or 'double chin,' in adults." FDA adds that it "has only evaluated this drug for use under the chin; it is not approved for use in any other areas of the body."

• US approval: the FDA approval letter for Kybella (NDA 206333) is dated 29 April 2015. It covers "improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults". Submental fat is fat under the chin.
• Status in the US: Drugs@FDA lists it as a new molecular entity with the marketing status "Prescription". The current application holder is AbbVie.
• Canada: Health Canada lists the same medicine as Belkyra, a prescription human drug, marketed since 27 January 2016.
• Who gives it: the US FDA notes that the label says it should be given only by a health care professional.

The Kybella label describes it as "a cytolytic drug, which when injected into submental fat ... physically destroys the cell membrane causing lysis." In other words, it destroys fat cells.

What the Kybella trials found

The US approval rests on two randomized, double-blind, placebo-controlled trials of the same design. They enrolled adults aged 19 to 65 with moderate or severe fat under the chin. Combined, 514 people received Kybella and 508 received placebo.

Results were measured 12 weeks after the last treatment.

These results are for Kybella under the chin only. They do not apply to Aqualyx, Lemon Bottle or any other product.

Kybella label warnings

The Kybella label (revised 09/2026) lists these warnings:

• marginal mandibular nerve injury, which can cause an uneven smile or facial muscle weakness;
• difficulty swallowing;
• bruising at the injection site, seen in 72% of treated people in trials;
• hair loss at the injection site;
• ulcers, skin necrosis, nodules, lumps and infection at the injection site.

The label also says "serious adverse reactions have been reported following unapproved administration of KYBELLA outside the submental region", including blurred or reduced vision when used near the eye. Reactions reported in more than 20% of people were swelling, hematoma, pain, numbness, redness and hardening at the injection site.

Which fat-dissolving products has FDA Philippines warned against?

FDA Philippines has issued advisories against these unregistered products. In each one, FDA verified the product had no Certificate of Product Registration (CPR).

Advisory 2023-0164 is the only one in this table that names Aqualyx. The 2026 advisories are about other products. No FDA Philippines advisory naming Lemon Bottle was found.

In Advisory 2023-0164, FDA said it cannot vouch for the products' "quality, safety and efficacy" and that using them "may pose potential danger or injury to health". It warned establishments not to distribute them, and asked local governments and law enforcement to make sure they are not sold in their areas.

These advisories cover specific products. A product missing from this table is not necessarily registered.

What happened in the NBI operation?

On 22 May 2026, the National Bureau of Investigation (NBI) ran an enforcement operation in Pasig City, supported by FDA Philippines. FDA posted the notice on 11 June 2026.

According to FDA, "authorities reportedly apprehended a medical practitioner administering unregistered injectable products, including those marketed as weight loss injectables, glutathione, and fat-dissolving products". The products were not named.

FDA said these products "have not undergone the necessary FDA evaluation and authorization to establish their safety, quality, and efficacy". It added that "the use, promotion, distribution, and administration of unregistered health products are prohibited under Republic Act No. 9711".

What did regulators abroad find about Lemon Bottle?

Lemon Bottle is a branded "fat dissolving" solution promoted online and on social media. Swissmedic has warned against Lemon Bottle, and the UK General Pharmaceutical Council has raised concerns about it.

Swissmedic (Switzerland), 26 March 2024:

• Its official laboratory tested samples from various sources and "found that the ingredients do not match the declaration and even vary greatly from one pack to another." In one sample the only substance found was caffeine. In another, none of the listed ingredients was found. Swissmedic says the products "can therefore be regarded as falsifications."
• It states: "No medicinal effect has been scientifically proven, the quality of the ingredients has not been tested and using the product may therefore pose a health risk."
• It classes Lemon Bottle lipolysis solution as a medicinal product, because of its composition and because it is injected. As it is not authorised in Switzerland, it "may not be sold, dispensed or used" there.
• It "expressly warns against using" the product.

General Pharmaceutical Council (GPhC, UK), 9 April 2025: the UK pharmacy regulator said it had received concerns about pharmacies supplying unregulated, unlicensed products, including Lemon Bottle, which "claims to dissolve fat". In an email to pharmacy professionals, it said it had received concerns "suggesting these products have potentially caused serious harm."

What does the US FDA warn about?

The US FDA has a consumer page on fat-dissolving injections that are not FDA approved. It says they are sold online under several brand names, and it names Aqualyx among them.

FDA says it "has received reports about consumers who experienced adverse reactions such as permanent scars, serious infections, skin deformities, cysts, and deep, painful knots after receiving unapproved fat-dissolving injections."

• Where people got them: some at clinics or med spas from staff who might not have been properly licensed; some bought products online and injected themselves.
• Why FDA is concerned: the ingredients are unapproved, so FDA has not evaluated them.
• FDA's advice: "Do not purchase fat-dissolving products from websites and attempt to inject them yourself."

What case reports describe

Published case reports describe serious complications after injection lipolysis. Except for the last row, these reports do not name Aqualyx or Lemon Bottle.

What UK regulators say about phosphatidylcholine

The Joint Council for Cosmetic Practitioners (JCCP) in the UK says: "The MHRA has advised that phosphatidyl choline is a medicinal substance that is currently not authorised for use in the UK. Further, it must not be used for any cosmetic purposes." The JCCP has asked its registrants to stop using these products for cosmetic purposes.

Are fat-dissolving injections a weight-loss treatment?

No. These products are aimed at small areas of fat, not body weight.

• Kybella is approved in the US only for fat under the chin.
• A 2016 multicentre report on Aqualyx excluded 488 of 1,832 patients because their body weight changed by more than 5%.

Medicines studied for weight are covered in our guide to GLP-1 medicines.

How to check a product

FDA Philippines tells the public to check a product's registration on its verification portal.

• Verification portal: verification.fda.gov.ph. FDA advises the public to rely solely on it when confirming the regulatory status of FDA-regulated products and establishments.
• Establishments too: FDA says the portal can be used to check licensed establishments as well as products.
• Unregistered list: FDA also publishes a list of verified unregistered health products.
• Limits: FDA says portal information is for verification only and is not regulatory advice.

A search of the portal on 7 October 2026 showed:

A cosmetic notification is not a drug registration.

How to report a product

FDA Philippines asks the public to report suspected unregistered or counterfeit health products and unlicensed establishments.