COFEPRIS Food Supplements Regulations in Mexico

Food supplements are regulated by COFEPRIS in Mexico. The requirements can cover different areas, from product classification and ingredients to labeling and advertising.

The Mexican dietary supplements market is estimated at about US$2.8 billion in 2026 and is expected to continue growing in the coming years. This article looks at the main rules for food supplements in Mexico, and the steps companies need to consider before placing a product on the market.

What Are Food Supplements Under Article 215 in Mexico?

Under Article 215, Section V of Mexico’s General Health Law, food supplements are products intended to increase, complement, or replace part of the dietary intake. They may include herbal products, plant extracts, traditional foods, fruit concentrates, vitamins, or minerals and can be presented in pharmaceutical forms for oral use.

The nutrition supplements must be taken through oral route alone and the product presented as confectionery (candy, lollipops, chewing gum), patches, injectable solution, among others, are not allowed are not categorized as Food Supplements. The food supplements can be presented as oral dosage forms such as capsule, emulsion, suspension, syrup, powder, solutions and tablets.

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What Ingredients Can Be Used in Food Supplements in Mexico?

The food supplements may include vitamins, minerals or herbal substances. COFEPRIS do not consider products containing plants not allowed for infusions or tea as food supplements. The food supplements containing vitamins and minerals shall met the maximum daily limits established in Appendix XVII.1 of the Regulation.

COFEPRIS List of Accepted Food Additives

COFEPRIS maintains lists of additives and processing aids permitted for use in foods, beverages, and food supplements. The lists are organized into different annexes based on the function and type of additive. COFEPRIS also publishes positively evaluated additives and extensions of use that have not yet been incorporated into an update published in the Official Gazette of the Federation.

For food supplements, permitted additives must comply with the applicable Mexican requirements. COFEPRIS also states that vitamins and minerals may be included provided they remain within the permitted limits established in Appendix XVII 1.1 and 1.2 of the Regulation for Sanitary Control of Products and Services.

Certain substances are not permitted in products classified as food supplements. These include substances with recognized pharmacological action or those that may present a health risk, such as procaine, ephedrine, yohimbine, germanium, and animal or human hormones. Plants that are not permitted for use in teas or infusions are also excluded. COFEPRIS provides further guidance on prohibited or restricted ingredients in food supplements.

COFEPRIS Product Classification Consultation for Food Supplements

The product classification consultation is a crucial step in ensuring compliance with the legal framework for food supplements. This free procedure allows the health authority to assess your product’s formulation and labeling to determine if it meets the criteria for classification as a food supplement. It’s important to note that the consultation provides a technical opinion and does not constitute a health authorization. In case of imported products, the Product Classification Consultation shall be carried out before applying for an advertising permit for the food supplement.

Requirements for a Classification Consultation Request

To request a product classification consultation, an application on the company’s letterhead, signed by the owner, legal representative, or health responsible individual must be submitted. The application should be addressed to the Sanitary Operation Commission of COFEPRIS. The request must include the information about the food supplement –

Response Time and Possible Outcomes

Upon submission of the consultation request, COFEPRIS will provide a response within a maximum of 90 days. The possible outcomes may include:

COFEPRIS Food Supplements Regulations and Standards

The Food supplements are regulated under General Health Law. In addition to the Law, food supplements are also regulated under the Mexican Standards, Norma Official Mexicana.

• NOM-251-SSAI-2009: Hygienic practices for the processing foods, beverages, or food supplements
• NOM-051-SCFI/SSA1-2010 and its subsequent amendments : General labelling specifications for pre- packaged foods and non-alcoholic beverages-Commercial and sanitary information.

Claims Requirements for Food Supplements in Mexico

Claims assessment is the critical step in determining the product classification and the registration requirements. Claims are regulated under Articles 6.2 and 6.3 of NOM-051-SCFI/SSA1-2010. Disease reduction claims are not allowed. The claims made by the food supplements could be

• Conditional Claims
• Nutrition claims
• Health Claims

All the claims must be backed up with supportive data and scientific evidence.

COFEPRIS Requirements for Food Supplements in Mexico

Food supplements do not require sanitary registration to be sold in Mexico. However, companies must meet the applicable COFEPRIS requirements before placing them on the market, including product classification, ingredient review, labeling, and the relevant establishment notifications.

Classify the Product as Food Supplement:

• To sell a food supplement in Mexico, it is necessary that it classifies as Suplemento Alimenticio”.
• The food supplement should not have any therapeutic properties or claims; hence it will be categorized as medicinal product.

To categorize as food supplement, the product should abide to the following regulations:

1. General Health Law (Ley General de Salud)
2. NOM-051-SCFI/SSA1-2010
3. NOM-086-SSA1-1994

You can click here, to know more about the product classification as food supplement.

Verify the ingredients:

• All the ingredients used in the food supplement such as vitamins, minerals, etc. Should not be from the prohibited list of ingredients for nutraceuticals.
• To check your ingredients with the list, the manufacturer can request for the prohibited list to the COFEPRIS.

Prepare Spanish label with all the details:

In Mexico, it is mandatory to prepare a label in Spanish language.

This Spanish nutraceutical should comply with the NOM-051-SCFI/SSA1-2010 that outlines all the requirements for label preparation.

1. As per the Regulation for Sanitary Control of Products and Services, the label must include the following:
2. Name of the product both generic and specific
3. Complete list of ingredients according to the quantitative predominance.
4. For products that contain herbs the following must be included: whether in mixtures or not, common name and botanical name indicating the genus and species.
5. Components if any used that possess an immediate or mediate risk to the consumers health
6. Nutritional declaration
7. If manufacturer, importer, packer, maquiladora and national or foreign distributor: Name and address must be provided.
8. Instruction for use, storage, preparation (if any) and consumption
9. Identification of the lot, expiration date and warnings.

Prepare Documents:

The following is the list of documents that should be prepared before marketing a food supplement and should be submitted when requested:

• Name of each ingredient
• Scientific name for plants
• The monograph of uncommon substances
• Qualitative-quantitative formula
• Sample of the original label and information with which it is marketed
• Product technical specifications.
• Ingredient safety and quality data.
• Label artwork.
• Evidence of Good Manufacturing Practices (GMP).
• Proof of legal entity registration.
• Importation documents (if applicable).

If importing, submit Notice of Operation:

• Dietary supplements do not require registration to be sold in Mexico.
• However, if they are being imported, a Notice of Operation known as “Aviso de Funcionamiento” needs to be submitted 30 days before beginning the procedure.
• This is a free of cost procedure and involves review by the COFEPRIS.

Following information should be added into the Notice of Operation:

• Name and address of the individual or legal entity that owns the establishment (Company name and RFC).
• Complete address of the establishment.
• Processes used and product line(s) (product(s): trade name, distinctive name and type of product.
• Declaration and under penalty of perjury.

Submit Notification of Sanitary Responsible Person:

• The notification known as “Aviso de Responsable Sanitario” of the person or legal entity responsible for handling regulatory procedures in Mexico on behalf of the local or foreign nutraceutical company is required.
• It is necessary that the person should be well qualified.
• However, the product registration is not required but to submit this notification to the COFEPRIS is a mandatory step towards product compliance.

Maximum Daily Limits for Vitamins and Minerals in Food Supplements

Appendix XVII.1 establishes maximum daily limits for certain vitamins and minerals used in food supplements. Some of these limits are listed below.

COFEPRIS Advertising Permit for Food Supplements

Upon obtaining Prior Sanitary Import Permit (PSPI) or submitting Notice of Operations, an advertising permit from COFEPRIS, under NoM 251 NUMERAL 6.7, is mandatory for marketing food supplements. This is required for food supplements manufactured domestically or overseas. Failure to obtain this advertising permit exposes products to sanctions outlined in the General Health Law. Obtaining a food supplement advertising permit typically takes an estimated two months.

COFEPRIS Labeling Requirements for Food Supplements in Mexico

Entire information on the label must be in Spanish. The English information can appear on the label but must never substitute the information that should be in Spanish. If more than 1 language is used, the Spanish content should be in a font larger or equal to the other language used.

Warning Statements for Food Supplements in Mexico

While keeping warnings in the label for food supplements the following must be included. According to Article 216 of the General Law of Health, Ministry of Health, Mexico, if food supplements are provided to the public stating that they have therapeutic properties, then the package or container must have the words “This product is not a medicine”. Keep in mind that this statement must be written in contract colours and easily readable letters.

The label must also contain the following statement “The consumption of this product is the responsibility of the person recommending it and the person using it”. This must be in capital letters, easily readable letters, clear, bold and colour must be in contrast to the background. The font must be same as the font of the information in the information surface.

Conclusion

With an increase in the demand for dietary supplements, greater will be the risk for the entry of substandard products in the market. Dietary supplements can serve as a great advantage to health but only upon proper regulation. To implement this and to ensure their safe market entry and maintenance, COFEPRIS sets out certain regulations to bind with.

Artixio can help you with food and dietary supplement registration in Mexico. Our region based regulatory experts assure you with complete guidance from development to documentation and market entry. Contact Artixio at info@artixio.com for expert regulatory support in Mexico’s dynamic food industry.

FAQs

Do Food Supplements Require Sanitary Registration in Mexico?

No. Food supplements do not require sanitary registration in Mexico. However, companies must comply with the applicable COFEPRIS requirements, including those related to product classification, ingredients, labeling, and establishment notifications where applicable.

What Are Food Supplements Under Article 215 of Mexico’s General Health Law?

Article 215 defines food supplements as products intended to increase, complement, or replace part of the dietary intake. They may contain ingredients such as herbal products, plant extracts, traditional foods, fruit concentrates, vitamins, or minerals.

How Can I Check Whether a Food Supplement Is Approved by COFEPRIS?

Food supplements are not generally subject to sanitary registration in the same way as medicines. Compliance should instead be checked against the applicable COFEPRIS requirements, including product classification, permitted ingredients, labeling, and any relevant establishment or advertising requirements.

What Are the Labeling Requirements for Food Supplements in Mexico?

Food supplement labels must comply with the applicable Mexican requirements and provide the mandatory information in Spanish. Requirements may also apply to ingredient declarations, warning statements, claims, and other product information.

What must the nutritional declaration of the food supplement label contain?

The nutritional declaration of the food supplement label must have at least the following information: Energy content (Kcal), Proteins (g), Fats (lipids) (g), Carbohydrates (g), Sodium (g), Specific content of each mineral and vitamins in milligrams, any other component highlighted in the advertisement or label information or attachments.

Does food supplement imported into Mexico need a permit or just notification?

An import permit (“PERMISO Sanitario de Importación”) is required for the food supplements imported into Mexico. Notification is eligible for only energy drinks with low concentration of ingredients like ephedrine, glucuronolactone and taurin.

What is the major challenge to comply with COFEPRIS guidelines and regulations?

One of the major challenges is the language barrier. The regulations, laws or guidelines being written in Spanish language is an issue for foreign manufacturers and distributors. Due to this there will be the need to appoint a local agent. Apart from this the labels must be in Spanish and the documents submitted must be in Spanish or should have an equivalent Spanish translation.