Products for injection for fat removal are medicines – not cosmetics
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Changes
- : Added Hyalax Meso Body Slim to the list of products that are not approved medicines in Norway.
Products containing deoxycholic acid or other substances intended for injection to remove adipose tissue are prescription medicines in Norway and are regulated under the medicinal product regulations.
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The Norwegian Medical Products Agency (NOMA) has repeatedly discovered that Norwegian clinics offer injection treatments for fat removal using products that, according to the declaration, contain deoxycholic acid and similar or other active substances.
Covered by Medicinal Product Regulations
Clinics use products sold in vials intended for injection. These products may appear as cosmetics since they are labeled with "for use on the skin" or similar, but they must be injected to achieve the intended effect as claimed by the labeling and advertising.
When deoxycholic acid is injected, it affects physiological functions in the body. The substance is therefore classified as a prescription medicine in Norway and is covered by the medicinal product regulations. The products must have marketing authorisation (MA), and they must be prescribed by a doctor before they can be dispensed in a pharmacy and used in the healthcare system. These products are not considered cosmetics, even if they are labeled as such.
We have discovered that clinics offer injection treatments with products that are not approved medicines in Norway. Healthcare personnel or others are not allowed to import, market, or advertise medicines that are not approved in Norway.
We have received inquiries about LipoRem and Lemon Bottle, which are injected and used for fat removal. These products are also covered by the definition of medicinal products and the medicinal product regulations.
"Lemon Bottle" – dangerous to inject
"Lemon Bottle" is marketed on social media and by aesthetic clinics as a simple method to "melt" away fat. The treatment is not without risk and can lead to serious infections, allergic reactions, and/or permanent damage.
What is "Lemon Bottle"?
"Lemon Bottle" is an injection solution that some aesthetic clinics in Norway have started to offer to "melt" away fat in various areas of the body. The product is neither an approved medicine nor a medical device. Therefore, there are no requirements for the quality of the product's contents or how it is produced, and it is not safe to inject.
Do not use uncontrolled injections
"Lemon Bottle" is marketed as a natural extract of fruits and herbs. There is a completely different risk in injecting a product than in consuming it. NOMA strongly warns against injecting products that do not comply with regulations. There is a high risk that the result will not be as desired, and the patient may suffer serious injuries. It is important that injected products have safe contents and are sterile. It is also important that the product has instructions that clearly describe how it should be used safely.
Examples of such products that are not approved medicines in Norway:
- Celluform
- Celluform+
- Celluslim
- Desoface
- Desobody
- Hyalax Meso Body Slim
- LipoRem
- Lemon Bottle
- Pluryal Facecontour
- Pluryal Bodycontour
Mechanism of action of aeoxycholic acid
Deoxycholic acid is a cytolytic agent that physically destroys the cell membrane of adipocytes when injected into localized subcutaneous fat. The destruction of adipocytes triggers a tissue response where macrophages are attracted to the area to remove cell debris and lipids, which are then eliminated through natural processes. This is followed by the emergence of fibroblasts and an observed thickening of the fibrous septa, indicating an increase in total collagen (i.e., neocollagenesis).
Products containing deoxycholic acid are defined as medicines because they affect physiological functions through partially metabolic and partially immunological action.
One approved medicine
Belkyra is an approved prescription medicine that contains the active ingredient deoxycholic acid. The product is to be injected, and the indication is the treatment of moderate to severe convexity or fullness associated with submental fat in adults when the presence of submental fat has significant psychological importance to the patient. It is important to note that it is not allowed to advertise Belkyra or other prescription medicines to the general public.
Applicable Regulations
Medicinal Product Regulations (Legemiddelforskriften):
What is considered a medicine is defined in the regulation on medicines, cf. Regulation on Medicines § 1-3 a – medicine: any substance, drug, or preparation that:
1. is claimed to be suitable for preventing, curing, or alleviating disease, disease symptoms, or pain, or affecting physiological functions in humans or animals; or
2. can be used or given to humans or animals to restore, modify, or affect physiological functions through a pharmacological, immunological, or metabolic effect, or to detect disease.
The following applies to cosmetics:
Cosmetics Act (Kosmetikklova):
§ 2. Scope
The Act covers all aspects of the development, production, import, processing, distribution, export, and marketing of:
a. cosmetics and body care products, which are all substances or mixtures of substances intended to come into contact with the human body's surface, teeth, or mucous membranes in the mouth or nasal cavity for the sole or main purpose of cleaning or perfuming these parts of the body, changing their appearance, affecting body odors, protecting them, or keeping them in good condition.