Anvisa issues ALERT on ban on injectable cosmetics; understand

A Anvisa, National Health Surveillance Agency, recently released a technical note in which it warns about the ban on cosmetics intended for injectable use. The Agency revealed that it has received information about serious cases of adverse events, such as pulmonary embolism, associated with unregulated products.

Adverse events

Adverse events were recognized through local health surveillance bodies, which identified the health risks related to the use of these products in aesthetic procedures. Furthermore, alarming cases of patients suffering serious complications after using these injectable products have been highlighted by the media.

These events were identified by local Health Surveillance bodies and highlighted in media reports.

“The Agency became aware of these adverse events through local health surveillance, which identified the health risks associated with the use of these products in aesthetic procedures.” – Anvisa

Particular Case

One particular case caught the attention of Anvisa, where a 29-year-old woman suffered a pulmonary embolism and hemorrhage after a butt filling procedure with a biostimulator. The patient needed to be admitted to an Intensive Care Unit (ICU) and was intubated.

Anvisa shares

Since it began monitoring the situation more rigorously, Anvisa has already banned a series of products from the companies Bio Essencialli, PHD Cosméticos and Biometik. According to Anvisa, these were cosmetics whose packaging and advertising induced professionals and consumers to use injectables, which goes against regulations.

Anvisa verification

After investigations, the Anvisa found that some notified products had several characteristics in their packaging and labeling that, when combined, could confuse the professional or end consumer regarding the correct destination of the product. For example, some products carry the claim of “sterile product” and packaging that allows needles to be attached.

Current Rules

Anvisa explains that, in general, items regulated as “cosmetics” in Brazil cannot be injectable, as they are intended for external use. To be applied injectable form, they need to be registered with the health authority as a “medicine” or “health product”.

To be applied in this way, it needs to be registered with the health authority as a “medicine” or “health product”.

Product Example

As an example, injectable hyaluronic acid for intradermotherapy (injection of medicines into the skin) or aesthetic medicine must be registered as a health product, according to Anvisa.

New Alert

In the new alert, the Anvisa states that companies, in addition to carrying out correct regulation, must inform users, in the labeling, packaging and form of use, that cosmetic products are for external use only.

Consumers should be careful not to inject items with the description of “External Use” on the label, as they “were not developed for this purpose and, therefore, do not have the quality and safety necessary to be used injectable form”.

Guidance for the Population

Anvisa’s guidance is that the population must be careful not to inject items with the description of “External Use” on the label. This is because they “were not developed for this purpose and, therefore, do not have the necessary quality and safety to be used injectable form”.

You injectable cosmetics represent a significant health risk, and the Anvisa is taking measures to combat its use in Brazil. It is important for consumers to be aware of these risks and take appropriate precautions when choosing their beauty products.

The Agency remains vigilant in monitoring and regulating cosmetic products to ensure the safety and health of the Brazilian population. The agency reinforces the importance of always paying attention to the product label and following the instructions for use.