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Anvisa publishes a technical statement offering guidelines on the regularization of cosmetics intended for aesthetic treatments.

Cosmetics cannot be legalized as injectables. Furthermore, packaging and labels must not mislead consumers. Find out more.

This Monday (11/13), Anvisa published Technical Note 33/2023, which provides guidelines for companies on the regularization of cosmetic products. The main objective of the note is specifically that products intended for invasive aesthetic treatments cannot be regularized in the cosmetics category.

In addition to correct regulation, companies must include information on labels, packaging, and user instructions, making it clear that cosmetic products are exclusively for external use. Both professionals and consumers need to be alerted to avoid the improper use of these injectable products.

Anvisa has received reports of serious adverse events related to injectable products used for aesthetic purposes, mistakenly classified as “cosmetic products”. These adverse events were identified by local health surveillance authorities, which detect health risks associated with the use of these products in invasive aesthetic procedures.

After the complaints, Anvisa found that some notified products had packaging and labeling characteristics capable of misleading the professional or end consumer into an error regarding the correct destination of the product. For example, some packages claim to be a “sterile product” and allow immediate attachment of needles.

Including information and recommendations on packaging and labeling that could mislead is considered a health irregularity, by articles 5 and 59 of Law 6,360/1976. In addition to the technical note, Anvisa has already canceled the notification of several products regulated in alternative ways and prohibited the distribution, distribution, and manufacture of other products used in injectable ways.