Do you have doubts about whether you are considering all the health regulations to be able to market and advertise your food supplement? Below we leave you the applicable regulatory framework.
The commercialization and advertising of food supplements in Mexico seems to be an easy task, however, there is a regulatory framework that establishes the minimum requirements related to the formulation, manufacture, storage, labeling and advertising of these, and that must be considered if we are manufacturers, distributors and/or importers to provide consumers with quality and safe products.
Below we leave you the current health regulations that regulate the commercialization of food supplements in Mexico and that will help us to introduce ourselves more in the field of this type of product.
We begin with the definition that is based on article 215, section V of the General Health Law (Ley General de Salud), which provides us with a clear idea of what Food Supplements are:
Food supplements: Herbal products, plant extracts, traditional foods, dehydrated or fruit concentrates, with or without added vitamins or minerals, which can be presented in pharmaceutical form and whose purpose is to increase the total dietary intake, complement it or supply any of its components.
We continue with the regulations applicable to the formulation of a Food Supplement, which serves as a guide for its development and/or analysis and determine if it can be marketed as a Food Supplement:
- Regulation of Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios): Title Nineteenth, Articles 168-174, Appendices of numerals from XVII.1 to XVII.4.
- Agreement that determines the prohibited or permitted plants for teas, infusions and edible vegetable oils
- Agreement that determines the additives and adjuvants in food, beverages and food supplements, their use and health provisions
- Herbal Pharmacopoeia, contains a list of plants with recognized therapeutic effects, which cannot be used in food supplements.
- CEMAR evaluation: Substances with recognized pharmacological action or that are considered risky based on a risk analysis carried out by CEMAR.
Well, if we already know that our product is a Food Supplement and we are about to market it, we leave you the name of the Official Mexican Standard that establishes the minimum requirements of Good Hygiene Practices that must be observed in the process of food, beverages or food supplements and its raw materials to avoid contamination throughout its process.
- NOM- 251-SSA1-2009 Prácticas de Higiene para el proceso de Alimentos, bebidas o suplementos alimenticios (Hygiene practices for the process of food, beverages, or food supplements)
It is important to know that prior to processing the Advertising License for a Food Supplement, you must have an Official Letter of Positive Response to the Food Supplement Classification Consultation issued by COFEPRIS, for this we leave you the link where you can find the requirements to carry perform the classification query and that will help you design the content of the label with which it should be marketed:
- https://www.gob.mx/cofepris/documentos/consulta-de-clasificacion-de-producto-como-suplemento-alimenticio-2?state=published
Finally, the advertising of Food Supplements is regulated by the Regulations of the General Health Law on Advertising (Reglamento de la Ley General de Salud en Materia de Publicidad), which aims to regulate the health control of the advertising of products, services, and activities, among which are the Food Supplements, here we can find the guidelines to follow to define the content of the advertising project that we must present to COFEPRIS, to obtain the Advertising License.
As we can see, the regulatory framework for Food Supplements is broad and complex but applying it will help us market our product safely and with the required quality, without putting the health of the population at risk, as well as obtaining our Advertising License issued by COFEPRIS in a timely manner.
If you have doubts in the application of the Sanitary Regulation of Food Supplements, we support you or we can provide you with the PDF of any of the regulations, norms or agreements mentioned above.
We also invite you to leave your comments on which regulations applied to Food Supplements you would like us to address.
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