Anvisa suspends sale of sublingual melatonin due to irregular composition

Agência Nacional of Vigilância Sanitária (Anvisa) recently ordered the suspension of sales and recall throughout the national territory of the product Fabricada by the company Vita BE

The decision was mainly motivated by flaws in the composition of the supplement. Identificou The sublingual melatonin formulation included an ingredient that had not been subjected to specific safety assessments for this route of administration. The sublingual method allows direct absorption of the substance through the oral mucosa, bypassing the initial digestive system, which requires strict safety and purity criteria.

In addition to the technical irregularities in the composition, Anvisa also pointed out issues related to the product’s advertising. The advertisement presented unapproved therapeutic claims, such as the promise of sleep regulation, insomnia prevention and body balance, which is prohibited for dietary supplements.

The agency emphasizes that dietary supplements have different regulations than medicines, and cannot promise cures or treatments without due scientific proof and registration as a drug. The sale of products with misleading promises can mislead consumers and compromise their health.

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Irregularities detected and consumer safety

Anvisa’s main concern lies in the safety of using substances that have not undergone a complete evaluation for the sublingual form. Diferentemente of other types of supplements, sublingual absorption occurs quickly and directly into the bloodstream, which can amplify the risks if the composition is not suitable or contains impurities.

The lack of specific evaluation for the ingredient used raises questions about possible adverse effects and the actual effectiveness of the product under the tongue. Anvisa supervision aims to ensure that all products available on the market meet minimum quality and safety standards, preventing consumers from being exposed to unnecessary risks.

Anvisa’s regulatory role

Anvisa plays a fundamental role in protecting the health of the Brazilian population, acting in the regulation and inspection of a wide range of products and services. Sua operations are based on scientific evidence and international standards, aiming to ensure that only safe and effective items reach the consumer.

In the case of dietary supplements, the agency establishes composition limits, quality standards and clear rules for labeling and advertising. Essa Continuous supervision is essential to curb practices that could deceive the public or put health at risk, such as the sale of unregistered products or products with false claims.

The suspension of sublingual melatonin by Vita BE Cosméticos LTDA is a direct example of the application of these standards. The measure demonstrates the rigor of Anvisa in ensuring that companies comply with health regulations, especially in a market with growing demand for supplements.

Understand melatonin and its use in Brazil

Melatonin is a hormone naturally produced by the pineal gland in the brain and is essential for regulating the circadian cycle, which controls sleep and wakefulness. Sua production is stimulated by darkness and inhibited by light, directly influencing the quality of sleep.

In Brasil, the sale of melatonin as a food supplement has been permitted by Anvisa since 2021, but with well-defined rules. Entre the main requirements are the maximum dose of 0.21 mg per day and the prohibition of therapeutic claims that classify it as a medicine.

The substance can be used by people with primary insomnia, circadian rhythm disorders (such as jet lag) and some neurological conditions, but always under professional guidance. The Anvisa decision reaffirms the need for even popular supplements to strictly follow guidelines to ensure user safety.

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Brazilian regulation on melatonin seeks to balance access to the product for those who really need it with the prevention of inappropriate use and protection against products that do not meet quality requirements.

The importance of supplement regulation

The proliferation of dietary supplements on the global market has been accompanied by an increase in the need for effective regulation. The difference between a supplement and a medicine is crucial and determines the approval processes and types of claims allowed.

Supplements are intended to supplement the diet and not to diagnose, treat, cure or prevent disease. Anvisa, when overseeing sublingual melatonin, reiterates that any product that makes therapeutic claims must be classified as a medicine and undergo much more rigorous testing and registration.

This distinction protects consumers from products that may not be as effective as promised or that may interact negatively with other medications, in addition to preventing serious health problems from being overlooked by relying on an unproven supplement. Regulation ensures that advertising is honest and that ingredients are safe.

Consumer protection measures

In view of the determination of Anvisa, consumers who purchased Melatonina Sublingual in Gotas Sabor Maracujá from Vita BE Cosméticos LTDA must immediately stop using the product. Recomenda-look for the place of purchase to check the possibilities of exchange or return, according to the establishment’s policies.

If you have any doubts about the use of melatonin or any other supplement, it is always recommended to consult a healthcare professional, such as a doctor or nutritionist. Esses experts can provide safe and personalized information, assessing the need and appropriateness of using supplements for each individual.

Consumer: rights and safety guidelines

Código of Defesa of Consumidor ensures the right to clear and accurate information about products and services, as well as safety against health risks. Anvisa’s action reinforces these rights, removing from the market a product that does not comply with regulatory requirements and that could potentially represent a danger.

To avoid purchasing irregular products, consumers must always check the Anvisa record on the label of supplements and medicines. Além Furthermore, it is important to be wary of miraculous or exaggerated promises in advertising, which often indicate products without due scientific proof.

Health surveillance warns about the dangers of self-medication and the use of supplements without professional guidance, especially for risk groups such as pregnant women, breastfeeding women, children and people with chronic illnesses. Searching for information from official sources and consulting health professionals are essential attitudes to ensure safety.

Continuous monitoring actions

The inspection of dietary supplements and other products subject to health surveillance is an ongoing activity of Anvisa. The agency monitors the market, receives complaints and carries out inspections to ensure products comply with current standards, adapting to new technologies and consumer trends.

This constant vigilance is vital to maintain the integrity of the healthcare system and ensure that the population has access to safe, quality products. Anvisa reinforces the commitment to act proactively to protect public health against health risks.