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Nutraceutical & Dietary supplements regulations in Mexico

Mexico's nutritional supplements market is set to expand from $9.2 Mn in 2022 to $14.96 Mn by 2030, exhibiting a CAGR of 7.4%. The industry is driven by factors like an ageing population, rising disposable incomes, and growing health consciousness. The market for nutraceuticals and dietary supplements regulation in Mexico has witnessed significant growth in recent years due to increasing awareness of health and wellness. In Mexico, nutraceuticals and dietary supplements fall under the category of "Alimentos y Bebidas no Alcohólicas" (Foods and Non-Alcoholic Beverages). Examples of products falling under this category include vitamin and mineral supplements, herbal extracts, amino acids, probiotics, and other substances intended to supplement the diet. As the demand for these products rises, the Mexican government has implemented robust regulations to ensure consumer safety and product efficacy.

Nutraceutical & Dietary supplements regulations in Mexico

Mexican Health Authority and Legal Representation:

The Federal Commission for the Protection against Sanitary Risk or the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS) is the regulatory authority.

COFEPRIS defines supplements as:

Products based on herbs, plant extract, traditional food, dehydrated or concentrated fruits, added or not, of vitamins or minerals, that can be presented in a pharmaceutical form and whose purpose of use is to increase the total dietary intake, supplement it or supply some components.

Supplements can contain- carbohydrates, plants, algae, dehydrated traditional food, metabolites, fatty acids, amino acids, and protein.

Supplements cannot contain- procaine, ephedrine, substance with pharmacological action, germanium, animal or human hormones, and yohimbine.

Pre-registration requirement nutraceuticals in Mexico :

Before starting the registration process, companies must ensure that their products comply with all relevant regulations and have the necessary documentation ready for submission.

Registration process for nutraceuticals in Mexico :

The registration process for nutraceuticals and dietary supplements in Mexico involves the following steps:

  1. Review the list of ingredients in the product.

  2. Review the label and develop with a client Mexico-compliant label.

  3. Classify the product.

  4. Prepare pre-consultation submission to COFEPRIS.

  5. Pre-consultation submission to COFEPRIS.

  6. Wait for approval/rejection/queries from COFEPRIS.

  7. Submission to COFEPRIS.

  8. If final approval - the product may be distributed sold in Mexico.

List of documents required:

  1. Product Information: Name, composition, intended use, and packaging details.

  2. Safety Data: Toxicological and clinical safety data.

  3. Quality Control: Specifications and analytical methods used to ensure product quality.

  4. GMP Compliance: Evidence of adherence to Good Manufacturing Practices.

  5. Labeling Information: Draft label artwork and compliance with labeling requirements.

Labeling Requirements for nutraceuticals in Mexico:

COFEPRIS mandates strict labeling requirements to provide consumers with accurate information about the product. Labels must include the product's name, list of ingredients with their respective quantities, recommended dosage, usage instructions, and any contraindications or warnings. Health claims made on the label must be supported by scientific evidence and comply with COFEPRIS regulations.

Approval in EU/US and Progressing Registration Mexico:

If a product is already approved in the European Union (EU) or the United States (US), it can expedite the registration process in Mexico. The submission of relevant documentation and approval from COFEPRIS.

Import and Distribution Requirements nutraceuticals in Mexico:

Only registered products are allowed for import and distribution in Mexico. Importers and distributors must comply with all regulations and maintain records of the products they handle. National product registration is lenient. Where only the production facilities must be notified.

Timeline and associated fees nutraceuticals in Mexico:

The timeline for imported product registration can vary depending on the completeness of the application and the workload of COFEPRIS. Generally, it may take several months to a year or more. As per the fees associated, it might cost 215 USD.

Post-marketing Activities nutraceuticals in Mexico:

  • Pharmacovigilance: Monitoring and reporting adverse events related to the product's use.

  • Variations: Seeking approval for any changes to the product formulation, labeling, or manufacturing processes.

  • Renewal: Periodic renewal of product registration, typically every five years.

  • Audits: Companies may be subject to audits by COFEPRIS to assess compliance with regulations.


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