The increasing of health-conscious people has increased the demand of food supplements. Mexico has witnessed a steady growth of food supplement intake. According to the statistical calculations, the revenue from the vitamins and minerals market is considered to reach around US$344.99m in 2025. The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) is the regulatory authority in Mexico that regulates food supplements.
This blog aims to brief you about all the regulatory key requirements for food supplements in Mexico.
Food Supplements – COFEPRIS Point of View
Under Article 215, Section V of the Mexico’s COFEPRIS General Health Law, a food supplement is defined as a “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 of use is to increase the total dietary intake, complement it or replace any component”.
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.
What can be included in the Food Supplements?
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.
In case of food supplements containing the little known substances that may represent a risk or damage to health, scientific evidence to prove their safety should be submitted to the COFEPRIS. Food supplements containing substances such as procaine, ephedrine, yohimbine, germanium, animal or human hormones; or other pharmacological substance recognized or substances posing a health risk are also not considered as food supplements.
Steps For Food Supplement Registration and Notification Process In Mexico:
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:
- General Health Law (Ley General de Salud)
- NOM-051-SCFI/SSA1-2010
- 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.
- As per the Regulation for Sanitary Control of Products and Services, the label must include the following:
- Name of the product both generic and specific
- Complete list of ingredients according to the quantitative predominance.
- 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.
- Components if any used that possess an immediate or mediate risk to the consumers health
- Nutritional declaration
- If manufacturer, importer, packer, maquiladora and national or foreign distributor: Name and address must be provided.
- Instruction for use, storage, preparation (if any) and consumption
- 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.
COFEPRIS Daily Limit for Food Supplements
The daily limit for some vitamins and minerals are listed below:
| Vitamins/ Minerals | Per day limit |
| Vitamin A | 1000g |
| Beta carotene | 15 mg |
| Vitamin B1 | 15 mg |
| Vitamin B2 | 18 mg |
| Vitamin B3 | 25 mg |
| Vitamin B5 | 20 mg |
| Vitamin B6 | 10 mg |
| Vitamin B12 | 12 g |
| Folic acid | 400 g |
| Vitamin C | 300 mg |
| Vitamin D | 10 g |
| Vitamin E | 200 mg |
| Vitamin K | 30 g |
| Biotin | 300 g |
| Calcium | 1200 mg |
| Copper | 3 mg |
| Magnesium | 500 mg |
| Fluorine | 1 mg |
| Iron | 20 mg |
| Zinc | 20 mg |
| Selenium | 100 g |
| Manganese | 7.5 mg |
| Iodine | 200 g |
| Phosphorous | 1200 mg |
| Chrome | 200 g |
| Molybdenum | 250 g |
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 Assessment –
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
| Type of Claims | Claims made by the Food supplement |
| Conditional Claims | Enhanced nutritional value attributed to added nutrients; Specific nutritional attributes resulting from the reduction or exclusion of certain nutrients; Use of terms such as “natural,” “pure,” “fresh,” “home-made,” and “organically grown” is permissible when aligned with the applicable legal framework; Religious preparations (e.g., Halal, Kosher) are acceptable if they adhere to the specified requirements; Indicating that a food product possesses unique characteristics is allowed when it is evident in the declaration of properties and applies to all similar foods with such characteristics. |
| Nutrition Claims | Nutrition claims are permitted for caloric content, protein, carbohydrate, fat, fiber, sodium, and vitamins and minerals based on Daily Reference Values (DRV).
|
| Health Claims | A health claim refers to any representation that indicates, suggests, or implies a connection between a food or its components and health. Health claims encompass two categories: Nutrient Function Claims: These types of claims describe the physiological role a nutrient has in growth, development or normal body functions. Other Function Claims: This claim is about the beneficial effects it can produce on consumption of the product in the context of total diet, which contributes to the positive impact of health, improvement of normal physiological body function, modification or preservation of health. |
All the claims must be backed up with supportive data and scientific evidence.
Advertising Permit and Entry Approval:
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.
Mexico Food Supplements Labeling Requirements
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.
Mexico Food Supplement Label: Warnings
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 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.
FAQ’s
Q. 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.
Q. 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.
Q. What are the labelling options available for food supplements in Mexico?
The two options are: i) An English container can be used but a Spanish sticker satisfying all the labelling requirements must be attached. ii) Packing the product with a Spanish label for the local Mexican market.
Q. 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.
