The health agency’s decision affects dietary supplements and energy drinks that use… ozone as an ingredient in its formulationThis reinforces the fact that the gas has not been proven safe for use in food and is only authorized in the country as a disinfectant in water treatment, which raises the level of regulatory alert for manufacturers and consumers.

The Brazilian National Health Surveillance Agency (ANVISA) has prohibited the manufacture, sale, distribution, advertising, and use of products from the company OZT Comércio Atacadista Especializado em Produtos Ozonizados, which added… Ozone in ready-to-drink food and energy supplements, with claims of health benefits lacking technical support.

The measure also includes the seizure of items considered irregular for using ozone outside of the permitted regulations. authorized scope and because they make therapeutic promises typical of medicines, not food.

What exactly did Anvisa prohibit in the case of ozone?

The decision covers all food and energy supplements from the company in question that contain ozone in their composition.

In practice, Anvisa (Brazilian Health Regulatory Agency) prevents these products from continuing to be produced, distributed, advertised, or sold in the national territory., ending the regular circulation of the company’s ozonized product portfolio in the market.

In addition to the ban, the agency ordered the seizure of available batches, precisely because the items incorporated ozone as part of the formulation intended for ingestion.

The gas was being used in supplements and ready-to-drink liquid compounds, which contradicts the current framework that allows the use of ozone only in another function and in another regulatory context.

Why ozone is not considered safe in food.

In its released statement, Anvisa was clear in stating that the Ozone has not been assessed for safety for use in food, dietary supplements, or ready-to-drink energy products..

This means that there is no approved safety dossier that proves, according to the required parameters, that ingesting the gas, under the conditions proposed by the products, is safe for the population.

Currently, the use of ozone is authorized exclusively as a disinfectant in water treatment.

In this context, Ozone acts as a sanitizer, not as an ingredient with functional or therapeutic claims., and its use is limited by specific water quality standards.

Any expansion of scope, including supplements and beverages, depends on formal technical evaluation and express approval, which does not currently exist for the food use of the gas.

Another key point for the ban was the content of the advertisements associated with the products.

According to Anvisa, the company advertised supplements containing ozone, attributing to them… unapproved therapeutic and health claims, as a promise to support the healthy functioning of the digestive, hepatic, ocular, and cardiovascular systems, among others.

In this context, the agency emphasized that the authorizations granted for dietary supplements pertain to specific metabolic roles of nutrients or substances in the body, within a balanced diet.…and not promises of treatment or prevention of diseases.

Claims of medicinal purpose are exclusive to pharmaceuticals, require robust clinical studies and their own regulatory evaluation, which makes it irregular to attempt to attribute this type of effect to food products containing ozone.

How supplement regulation and health claims work.

According to current regulations, dietary supplements must be formulated with recognized ingredients and within defined usage limits, always based on safety and efficacy compatible with daily consumption.

The approved claims are limited to general nutritional or physiological functions., without extrapolating into the therapeutic field.

When a company crosses that boundary, the regulatory line shifts from that of food to that of pharmaceuticals, with much more stringent requirements.

In the case of products containing ozone, Anvisa highlighted that None of the approved food claims are associated with medicinal or therapeutic purposes.…and that this type of message is incompatible with being classified as a food supplement.

By promising effects on specific organs and systems without approval, the company placed its products in violation of the regulatory framework, which contributed to the ban and seizure decision.

The measure against supplements and energy drinks containing ozone adds to another recent decision by Anvisa involving the same gas.

The previous month, the agency had already banned the sale and use of 69 ozone-based hair cosmetics from the Ozonteck brand.This is precisely because the manufacturer attributed pharmacological activity to these products, which is not permitted for items classified as cosmetics.

In that case, the problem was not just the use of ozone, but mainly the fact that Cosmetics cannot claim to have the typical actions of medicines., such as treatment for diseases or specific pharmacological effects.

The recurrence of cases involving ozone, now in different product categories, indicates that the agency is more rigorously monitoring the use of the gas and the claims associated with it in the Brazilian market.

Impacts on the supplements and energy drinks market

For the food and energy supplement segment, the ban has a direct effect on the company targeted by the measure, but it also serves as a regulatory signal to the rest of the market.

Manufacturers considering using ozone in ingestible formulas or associating the gas with health benefits. They now receive a clear warning that this type of strategy is not supported by current regulations.

From a competitive standpoint, removing these products from the market reduces the risk of asymmetry between companies that strictly adhere to safety and labeling standards and those that attempt to exploit unsubstantiated therapeutic claims.

The decision tends to reinforce an environment in which communication with the consumer needs to be aligned with what has actually been approved by Anvisa., both in terms of composition and marketing messages.

For the end consumer, the case of supplements and energy drinks with ozone highlights the importance of Check if health or performance claims are consistent with the product category..

Items classified as food or supplements cannot, as a general rule, promise to treat, cure, or prevent diseases, nor can they replace medications prescribed by healthcare professionals.

It is also important to follow official announcements from Anvisa (Brazilian Health Regulatory Agency) regarding banned products, recalls, and risk alerts.

When an ingredient like ozone lacks an approved safety assessment for use in food, consumption often exceeds what has been tested and validated., increasing uncertainty regarding possible adverse short- and long-term effects.

In situations like this, regulatory guidance serves as a central reference point for purchasing decisions.

Given a scenario where ozone is only authorized for specific uses, such as water disinfection, and remains without… proven safety In the food industry, the discussion about limits and responsibilities between industry, regulators, and consumers is gaining importance.

And you, when faced with health promises in supplements or energy drinks, do you usually check if they have approval from Anvisa (Brazilian Health Regulatory Agency), or do you still trust the advertising more than the available regulatory information?