Registering injectable products as cosmetics: is it legal?
On September 22, 2023, FDA published an article on the official page https://oryor.com regarding a raid carried out together with the central investigative police and the public health office.
The purpose of the control was to verify the use of cosmetics packaged in vials/ampoule containers used improperly in beauty clinics, aimed to maintain, revitalize the skin, reduce imperfections, freckles, dark spots and wrinkles, stimulate the production of collagen in the skin, etc.. Such claims are typical of medicinal products and not permitted in cosmetics. The products were injected into the body even though they were not sterile, effectively creating a serious health hazard for the clinics’ clients.
Following this discovery, 4 more beauty clinics in Bangkok were inspected and nurses and doctors at the clinics were questioned. They all testified that products registered as cosmetics were routinely injected, although the containers for the products were vials, typically used for medicines. The declared claims were similar for all products: maintenance, revitalization of the skin, reduction of imperfections, freckles, dark spots and wrinkles, stimulation of collagen production in the skin, etc.
A total of 943 items were seized during the inspection, including 779 items of injectable cosmetics, 109 items of unregistered medicines and 55 incorrectly labeled cosmetic items. All items were turned over to investigators from the 4th Division. The NCPO will continue to prosecute those involved. If it is found that all 4 beauty clinics actually committed crimes the defendants involved will be found guilty.
These are the facts as reported by Thai FDA (see source here). Let’s now consider in regulatory terms.
Injectable products as cosmetics are illegal
Cosmetics are products for external use, whose indications cannot refer to changes in the structure of the body (of the skin in this case) or to therapeutic effects (the treatment of skin blemishes or acne). The manufacturer who registers non-cosmetic products as cosmetics through the Thai distributor is subject to reporting to Customs and a permanent import ban.
If the products are actually cosmetics but are used as medicines (injected into the body) the problem lies with the clinic and the distributor, who will be called to justify themselves in court. If judged in bad faith, the penalties are both fine and jail.
In recent months we have been receiving many requests for the registration of cosmetic products in vials or ampoules, which, precisely because they are typical containers for injectable medicines, are carefully evaluated and in most cases rejected by the Thai FDA.
Further to all such requests, and even more so following what happened, we believe that the FDA will no longer accept as cosmetics products that can be injected or confused with medicines, therefore vials of Botox, hyaluronic acid, exosomes, and similars won’t be considered anymore as comsetics, even if declared for external use.
Injectable products must be sterile, therefore they can be registered as class 4 medical devices or as medicines. Sterilization is not a process included in Quality Standard of Cosmetics (GMP/ISO22716).
If you want to register injectable products as medical device you can contact us for an analysis of the product and verify its requirements as a medical device.
