The commercialization of products classified as food supplements is very common in Mexico. But what kind of products are classified as food supplements? What is required to comply in order to market them?
First, in Mexico, the General Health Law defines them as Products based on herbs, plant extracts, traditional foods, dehydrated fruits or fruit extracts, with or without added vitamins or minerals, that might be in a pharmaceutical dosage form; and the intention of use is to increase or supplement the total dietary intake, complement it or to replace any of its components.
The Regulations on the Sanitary Control of Products and Services (RCSPyS) states that food supplements can be made from carbohydrates, proteins, amino acids, fat oils, metabolites, plants, herbs, algae, dehydrated traditional foods, or anything else defined by the Ministry of Health, and they might be sold isolated or as a combination, with or without added vitamins or minerals and its consumption might not result in a health risk.
It is very important to highlight that RCSPyS states that food supplements MUST NOT contain substances with recognized pharmaceutical action, or claim therapeutic, preventive, or rehabilitative properties. Not to the product itself, nor functional claims of its ingredients, that are exclusive for pharmaceutical products.
Contrary to pharmaceutical products or medical devices, food supplements do not require a Cofepris Marketing Authorization (Registration) to be marketedd in Mexico. Nevertheless, a Product notification must be filed. This must be carried out by the company that is going to market the product since this company will be the one responsible for the product in Mexico. This notification also includes the activities that will be performed on the product (manufacturing, distribution, commercialization).
The labelling of food supplements must comply with RCSPyS requirements for labelling of food supplements, which is very specific for this kind of products and they are NOT covered by any Mexican Official Standard (NOM) on labeling.
The manufacturers or distributors of food supplements may also submit to Cofepris a classification inquiry confirmation, to confirm if a specific product is a food supplement or not.
To obtain the confirmation, the following must be submitted:
- Qualitative and quantitative formula (if it is a plant, the scientific name).
- Monograph for uncommon substances.
- Directions and recommendations of use.
- An original label sample and the information with which the product will be marketed, which must comply with RCSPyS requirements for the labelling of food supplements.
It is important to be awaare that Cofepris answer to the classification inquiry is NOT a product authorization, but it is required to request a food supplement advertising permit, and it is useful to avoid controversy while marketing the product.
Finally, it is important to consider that supplements labelling must not include information that may mislead, exaggerate, or deceive about a product’s composition, origin, effects, or any other property. It cannot claim that the product is useful to prevent or cure any discomfort, ailment, or desease. According to the Mexican regulation, a food supplement can only be used to increase or complement the total dietary intake or to replace any of its components.
On the other hand, as consumers, we must keep an eye on commercialized products and be aware of what we consume. In case of finding a product claiming properties not matching those of food supplements or not complying with what has been mentioned above, an individual, or a legal entity may fil an online report before the Health authorities at https://www.gob.mx/cofepris/acciones-y-programas/denuncias-sanitarias.
Should you need help with a food supplement, do not hesitate to contact us and we will be glad to help.
