President Luis Inacio Lula da Silva on Monday approved a law (14.648/2023) authorizing ozone therapy. The text was published in The official diary of the Union. 
According to the new law, ozone therapy can only be performed by medical professionals with higher education levels who are registered with the Professional Oversight Board.
Another requirement of the standard is that the technology can only be applied using medical ozone generators that are duly regulated by the National Health Surveillance Agency (Anvisa). Use of this equipment for purposes other than those permitted by the regulatory authority constitutes a sanitary violation and is subject to penalties as set forth in Law No. 6437 of 1977.
The federal government has also determined that before applying ozone therapy, responsible professionals must inform patients that the treatment is complementary to other treatments.
use
Ozone therapy applies a mixture of ozone and oxygen to the patient. Some health experts recommend using this technique to improve tissue oxygenation and strengthen the immune system.
This is the case of the Brazilian Ozone Therapy Association (Aboz), an association representing professionals in this field. The association said on its website that ozone therapy has been found to be therapeutic and that it is “closely monitoring the progress of research in Brazil and other countries.”
Anvisa classifies ozone as “a gas with strong oxidizing and disinfecting power”.Recruiting by notification Brazil distributor, Anvisa announced that it issued a press release this Monday. In it, the regulatory agency approved that devices using regulatory-approved ozone therapy are indicated only for use in the treatment of dental caries. Periodontics; Endodontics; According to a technical note published in December 2022, in addition to cosmetic applications to help cleanse and sterilize the skin, it can also be applied in dental surgery.
The statement also notes that scientific evidence regarding its efficacy and safety has yet to be established for other medical indications in Brazil. Nevertheless, new work on this technology may be approved by government agencies.
“While there are no ozone generators approved by the agency for use in medical indications in Brazil, new indications for the use of ozone therapy have emerged as scientific evidence demonstrating its efficacy and safety has not yet been presented. If a new Ozone Generator Normalization Request is to be submitted, the responsible company, as set out in University Council Resolution – RDC No. 546/2021, shall It is conditional on presenting the studies necessary to prove efficacy and safety, in the resolution of the University Council – RDC No. 548/2021.
announced by the Ministry of Health. Brazil distributor, that the services provided by the Unified Health System (SUS) are licensed by Anvisa; “Other inclusions will only be analyzed if the new device and application of ozone therapy has been approved by Anvisa with proven efficacy and safety,” he concludes.
Other arrangements
The use of ozone therapy technology is controversial. Some groups understand that the procedure has not been scientifically proven to be effective and oppose the disclosure of this technique. The practice was already being used in 2020 to treat Sars-Cov-2 infected people and to treat other ailments without scientific verification, raising questions about its effectiveness.
In July 2018, the Federal Medical Council (CFM) announced: Union official diaryResolution No. 2,181/2018 defines this technology as a domestic experimental practice.
Reply to Brazil distributorThis Monday, the CFM sent a memo, in which “the authorization of Law No. 14.648/23 by the President of the Republic is not inconsistent with the provisions of Resolution No. 2.181/2018 of the University itself. Valid”. The government has also clarified that it maintains a specific working group to evaluate the efficacy and safety of using ozone therapy.
“The approval of Law No. 14.648/23 by the President of the Republic is not inconsistent with the provisions of the Federal Medical Council (CFM) Resolution No. A working group to evaluate the efficacy and safety of the use of ozone therapy,” informed the CFM.
In a memo, the Brazilian Medical Association (AMB) opposed licensing practice in Brazil. “To date, there is no high-quality scientific evidence to justify the revision of Resolution CFM No. 2.181/2018, so ozone therapy is no longer considered an experimental treatment, much less a law in this sense. No.” AMB understands that ozone therapy should continue as an experimental treatment until high-quality scientific evidence can change this situation.
“Ozone therapy must continue as an experimental treatment until high-quality scientific evidence can change this situation. This must be done by the Federal Medical Council. Federal Medicine The Council is responsible for “editing regulations defining the experimental nature of medicine and permitting or banning ozone therapy.” Physician care,” the memo from the Brazilian Medical Association said.
Note from Ministry of Health
In view of the approval of Law No. 14,648 of 4 August 2023 authorizing ozone therapy in the country, Anvisa has sent a memorandum stating that, so far, the devices approved by the agency only have the following indications: said repeatedly. “Dentistry: Caries treatment – antibacterial action; Periodontal disease: Prevention and treatment of inflammation/infection; Endodontics: Strengthening of the hygienic phase of the root canal system; According to Supplementary Technical Note No. 43, “and skin sterility”.
“While there are no ozone generators approved by the agency for use in medical indications in Brazil, new indications for the use of ozone therapy have emerged as scientific evidence demonstrating its efficacy and safety has not yet been presented. If a new Ozone Generator Normalization Request is to be submitted, the responsible company, as set out in University Council Resolution – RDC No. 546/2021, shall It is conditional on presenting the studies necessary to prove efficacy and safety, in the resolution of the University Council – RDC No. 548/2021.