The Brazilian Health Regulatory Agency (Anvisa) has issued a crucial clarification regarding the use of phosphoethanolamine for cancer treatment. Despite widespread discussions and misinformation, phosphoethanolamine is not authorized or registered for use as a dietary supplement or medication in Brazil. The commercial distribution of this substance without proper approval from Anvisa is strictly prohibited, as mandated by Brazilian legislation and international standards.
Risks of Using Unregistered Products
Using unregistered products like phosphoethanolamine for cancer treatment poses significant risks. These products can interfere with conventional cancer treatments and may carry the danger of contamination. Patients are strongly advised against abandoning established medical treatments in favor of unauthorized therapies with unproven efficacy, such as phosphoethanolamine.
Importance of Clinical Research
For any substance to be deemed safe and effective for cancer treatment, it must undergo rigorous clinical research and obtain proper registration. Medical science is grounded in stringent data and evidence, and the criteria for approving new treatments are designed to protect patient health. Without adequate clinical trials and regulatory approval, phosphoethanolamine cannot be considered a viable option for cancer therapy.
Regulations for Dietary Supplements
Phosphoethanolamine also lacks approval from Anvisa as a dietary supplement. According to Article 56 of Decree-Law 986/1969, supplements containing this substance cannot make therapeutic or medicinal claims. This regulation aims to prevent consumers from being misled by products that promise cures without scientific proof.
Issues with Irregular Advertising
Promotional content on social media platforms that suggests phosphoethanolamine can combat cancer or any other diseases is illegal and deceptive. Such advertisements falsely attribute health benefits to the substance, misleading the public and potentially endangering lives.
Commitment to Public Health
Anvisa actively participates in discussions about the approval of substances without proper authorization, aligning with international practices and Brazil’s efforts to maintain a modern and safe regulatory environment. Since its establishment by Law 9.782 in 1999, Anvisa has prioritized the protection of public health.
The Correct Path for Commercialization
Anvisa supports innovation and the introduction of new products but emphasizes that protecting public health remains its primary mission. For phosphoethanolamine to be legally marketed in Brazil, manufacturers must submit a registration application, including quality, safety, and efficacy tests for Anvisa’s evaluation.
Ongoing Surveillance
Given that phosphoethanolamine is not a regulated product, it is included in Anvisa’s Epinet (Exclusion of Irregular Products from the Internet) search list. Since the inception of this tool in 2021, there have been 57 incidents involving phosphoethanolamine, with a successful removal rate of 97.73% from online platforms, according to Anvisa.
Conclusion
Anvisa’s clear stance on phosphoethanolamine underscores the importance of adhering to regulatory processes and ensuring that all medications and supplements meet the necessary safety and efficacy standards. Patients should rely on approved treatments and consult healthcare professionals for medical advice. The unauthorized use of substances like phosphoethanolamine not only jeopardizes individual health but also undermines the integrity of medical treatments.