Anvisa bans cosmetics used irregularly as injectables after serious adverse events

Anvisa bans cosmetics used irregularly as injectables after serious adverse events


Injectable products with aesthetic purposes must be regulated as medicines or health products with Anvisa, not as cosmetics

The National Health Surveillance Agency (Anvis) ordered the interdiction of batches of two of the company’s products Bio Essencialli Industry and Commerce of Cosmetics. According to Anvisa, although registered as cosmetics, have been used irregularly and sold as injectables. The ban came after reports of “serious adverse events”.

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The agency verified that the company was advertising the products Dermo Biostimulator and Filler Cosmobeauty AND Cosmobeauty Ultraconcentrated Toning Fluid in the form of injectable use. The Civil Police and the Health Surveillance are investigating the events. OR Stadium I have contacted the company via email but have yet to receive a response.

All injectable products for aesthetic purposes must be regularized as medicines or health products with Anvisa. The agency cautions that products regulated as cosmetics and with the description “External Use” “may not be injected into any part of the body.” “Because they were not developed for this purpose and, therefore, do not have the necessary quality and safety to be used in an injectable form.”

The agency communicated that the cosmetic products bear on the label the number of the regularization procedure and the number of the Business Authorization (AFE). They appear as follows:

  • Product regularization process number: 25351.XXXXXX/XXXX-XX.
  • AFE number (this number starts with 2 or 4): 2.XXXXX-X or 4.XXXXX-X

Anvisa warns against the incorrect use of cosmetics

Source: Terra

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