In late July and early August 2018, the National Health Surveillance Agency, Anvisa, regulated the production and distribution of food supplement information and updated the regulation for dynamized medicines, which include homeopathic and anthroposophical drugs.
According to the institution’s website, the measures aim to “quickly modernize the standardization of therapeutic indications, without compromising the safety of the use of medicines, maintaining a scenario of product development and innovation” .
In the case of supplements, the Agency argues that the new regulation brings more clarity and security to the consumer, as explained by Anvisa’s CEO, Jarbas Barbosa, in an interview with Folha de S. Paulo:
“Food supplements are a trend worldwide, with new products being launched every day. In Brazil, we did not have a specific standard and this was a subcategory. From now on, we have a regulatory framework. ”
What has changed?
There are new rules for both categories, dynamic medicines and dietary supplements. Understand:
As a rule, when we talk about dynamized drugs, we are referring to homeopathic, anthroposophical and antihomotoxic.
Such drugs are prepared from substances that are subjected to successive shredding, dilutions followed or another form of rhythmic agitation, always with a preventive, palliative or curative purpose. The updating of the regulatory framework, however, targets only industrialized drugs.
As the PhD in pharmacology, Francielle Tatiana Mathias, explains, “these products will now follow specific legislation, similar to allopathic medicines . They start, for example, to have standardization of the package insert, with therapeutic indication, dosage and, in some cases, to have studies that prove the efficacy and safety ”
The main target of the changes are injectable drugs, which now have a stricter control so that they offer the lowest possible level of risk to its users.
In addition, those drugs that do not yet have, will now be able to adopt trade names, which makes life easier for the consumer at the time of purchase. They will also be able to receive the addition of sweeteners, a type of sweetener that was previously prohibited.
When does it come into force?
The new rules will take effect from September 25, 2018.
According to Anvisa, food supplements are considered “all products presented in pharmaceutical forms and intended to supplement the diet of healthy people with nutrients, bioactive substances, enzymes or probiotics” .
That is, the category of supplements is broad, containing products such as Whey Protein , multivitamins or isolated substances, such as omega 3.
In addition to defining which nutrients are considered supplements and to which public they are destined, the regulatory agency has defined maximum and minimum limits for each product. As explained by the pharmacist Dr. Francielle, the measure “can facilitate, for example, the comparison between products at the time of purchase” .
To improve the consumer’s life, Anvisa also authorized a set of 189 claims that may appear on the packaging according to the performance of the supplement in tests.
The same rule that regulates supplements ended up also serving for probiotics – supplements that rely on the presence of microorganisms, such as yogurt and fermented milk.
This issue generated surveys on the part of the industrial sector. In an interview with Folha de S. Paulo, Ubirajara Marques, from the Brazilian Association of Manufacturers of Nutritional Supplements, BrasNutri, found that “some ingredients and additives were not considered, despite their established use” .
In response to these complaints, Anvisa argues that the list is only a start and that they intend to carry out periodic updates to the standard.
When does it come into force?
Anvisa has established a period of 5 years for products that are already on the market today to adapt to the new rules. For new supplements, that is, which have not yet been approved by Anvisa, the new rules are already in effect.
How do these changes affect the consumer’s life?
The end consumer may not feel much of a difference now that these rules have come into effect, but in fact, these changes end up interfering with the whole game.
For the pharmacology doctor, Francielle Tatiana Mathias, the new rules represent a major advance, because “consumers will be purchasing these products with more security and information”.
Ultimately, they help the end consumer to better understand what exactly he is consuming and in what quantities. This makes it even easier for the doctor to prescribe this or that product.
In addition, with these new manufacturing rules, products are subject to a stricter quality control, which will bring more security to the consumer when choosing a product that is more affordable.
Our friends at Consulta Remédios have a portal where you can compare prices of medicines, supplements and more.
There you can also find all the information related to the products you need, such as the composition, ingredients and the package insert.