#anvisa

Resolution published after the death of a businessman who underwent peeling with the substance

Anvisa (National Health Surveillance Agency) published a resolution this Tuesday (25) that prohibits the importation, manufacture, manipulation, commercialization, advertisement, and use of products based on phenol (carbolic acid) in general health or aesthetic procedures. According to the entity, no studies have been presented to the agency proving the efficacy and safety of the product for use in these procedures. The determination is temporary and remains in effect while investigations into the potential damages associated with the use of this chemical substance, which has been used in various invasive procedures, are conducted.

The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of electronic cigarettes, known as e-cigarettes, vaporizers or “vapes.”

Manufacturing, selling, importing and advertising vapes has been banned in the country since 2009, but even so, e-cigarettes are easily found in small shops and online stores across Brazil. And consumption, especially among young people, is on the rise. 

According to a survey by the Brazilian Institute of Geography and Statistics (IBGE), a federal government agency that gathers population data, 16.8% of students aged 13 to 17 said they had tried vaping at least once in their lives.

Also, data from Covitel, which carries out surveys related to health matters, reveal that 4 million people have already used electronic cigarettes in Brazil, even though sales have not been authorized for 15 years.

Brazil’s federal health regulator Anvisa has approved injectable cabotegravir, a pre-exposure prophylaxis (PrEP) medication for HIV. The registration was published in the official gazette on June 5.

Injectable cabotegravir has been recommended as a preventative treatment for HIV by the European Medicines Agency (EMA) since October 2020. The U.S. Food and Drug Administration (FDA) approved it in late 2021 for use in at-risk adults and adolescents over at least 35 kilograms for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV. 

In 2022, the World Health Organization also recommended that member countries approve injectable cabotegravir as PrEP for HIV.

Brazilian federal health regulator Anvisa on Wednesday voted to keep the country’s ban on e-cigarettes, in force since 2009.

Board members agreed in maintaining the prohibition of the sale, import, and advertising of e-cigs. They also approved the future discussion of new regulations aimed at enforcing the ban and reducing demand.

The meeting was broadcast online and lasted for over four hours. Several experts, activists, and politicians spoke before the vote. Only one person was against the ban — a lawyer for Philip Morris.

In June 2022, Brazilian Health Regulatory Agency (“ANVISA”) approved the possibility of importing Cannabis ssp plant extract (“Product”) based on Resolution RDC 327/19 (“Resolution”). This means a victory for patients and the pharmaceutical industry, as well as the starting point for the creation of new business opportunities in Brazil. Now, Brazilian-based companies can import the Product as a starting material to manufacture Cannabidiol (“CBD”) active pharmaceutical ingredient.

ANVISA decision is highly positive to multiple stakeholders since it means:

reducing or completely cutting CBD importation needs and, therefore, reducing overall manufacturing costs and time;

the possibility of locally manufactured CBD as an active pharmaceutical ingredient, thus reducing time to supply CBD-based products and creating many new business possibilities; and

enabling Brazilian patients broad and ample access to CBD-based products, which currently can only be obtained by time-consuming, costly, and bureaucratic processes, which often involve seeking a favorable court decision to import and acquire such products.