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Anvisa bans injection plant extracts without registration

10/10/2012

This article was translated by an automatic translation system, and was therefore not reviewed by people.



 


Anvisa ordered the suspension of manufacturing, handling, distribution, trading and use of any injectable drug to plant extracts, alone or in combination with other herbal ingredients or synthetic, that has not adopted the Agency.

The ban affects only the injectable products that have not proven their effectiveness and safety. Any plant extract that has no scientific evidence to be used as injectable product can bring health risks, if administered by this route.

We identified advertisements on the internet that suggest the use injectable (parenteral) substances such as green tea for weight loss and combating localized fat. However, no studies to prove the safety and effectiveness of the application of injectable medicines containing green tea or other herbal extracts.

There is no fence to the use and sale of herbal medicines for oral use containing green tea and have registration at ANVISA. Since food Green tea is exempt from registration and can be used normally.

The suspension lasts the time needed to stabilize the products with the Agency and is effective immediately upon publication in the Official Gazette of the measure.

See RE 4.302/2012, published in Official Gazette


Source: ANVISA

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