Interest in food supplements keeps growing in Mexico, and so does the number of companies trying to get their products onto shelves there. The good news is that supplements don’t need a sanitary registration. Classification, formulation, labeling, import paperwork and advertising, on the other hand, each come with their own set of COFEPRIS rules.
The regulator you’ll be dealing with is COFEPRIS, short for Comisión Federal para la Protección contra Riesgos Sanitarios (the Federal Commission for Protection against Sanitary Risk). We’ve laid out its requirements below in the order most manufacturers and importers hit them.
Key Points at a Glance
- Sanitary registration: not required. Your product and your establishment still have to comply with COFEPRIS rules before you start operating.
- Classification comes first. Check the product against the suplemento alimenticio definition in Article 215 of the General Health Law.
- Ingredients are restricted. Appendix XVII caps vitamins and minerals per day, and a handful of substances can’t be used at all.
- File the Aviso de Funcionamiento no later than 30 days before you begin operations.
- Labels go in Spanish, with two warning statements that every supplement has to carry.
- Ads need a COFEPRIS permit, one per advertisement, and none of them can claim the product prevents, treats or cures disease.
What Are Food Supplements Under Article 215 in Mexico?
Article 215, Section V of the General Health Law is the starting point. It describes products based on herbs, plant extracts, traditional foods, dehydrated foods or fruit concentrates. Vitamins or minerals can be added, but don’t have to be. The point of taking one is to increase or complement your total dietary intake, or to supply one part of it.
That purpose matters. If a product is pitched at treating, curing, preventing or relieving a disease or its symptoms, it has moved out of supplement territory, and COFEPRIS is unlikely to classify it as one.
Accepted and excluded dosage forms
The format of the product also counts. COFEPRIS accepts oral forms such as:
- capsules and tablets
- powders
- syrups, solutions, emulsions and suspensions
- other forms contemplated in the Mexican Pharmacopoeia
A few formats won’t pass, whatever is inside them: confectionery such as candies, lollipops or chewing gum, patches, and injectable solutions.
Permitted Ingredients in Food Supplements
The base of a supplement can be built from one or more of these:
- carbohydrates, proteins, amino acids
- fatty acids
- metabolites
- plants and algae
- dehydrated traditional foods
- anything else the Ministry of Health establishes
Vitamins and minerals can be added too, as long as they stay within the limits in Appendix XVII of the Regulation for Sanitary Control of Products and Services (see the table below). Permitted food additives may be used in line with the applicable additives agreement.
Prohibited ingredients
Article 169 of the Regulation rules out ingredients with recognised pharmacological action and anything that may pose a health risk. COFEPRIS specifically names these as prohibited:
- procaine
- ephedrine
- yohimbine
- germanium
- animal or human hormones
Plants have their own exclusions. If a plant isn’t allowed in teas or infusions, leave it out. The same applies to species the Mexican Herbal Pharmacopoeia lists for known toxicity.
For uncommon substances, COFEPRIS may request a monograph as part of the product information.
Food additives: checking COFEPRIS’s 2026 updates
The official list of additives and processing aids for foods, beverages and food supplements is maintained by COFEPRIS. Not everything reaches the Official Gazette right away, though. Newly evaluated additives and extensions of use are also posted by COFEPRIS as updates before any formal amendment is published.
In practice, this means the Gazette alone may not give you the full picture. Look at COFEPRIS’s most recent additives updates too, before any formulation is signed off.
Daily maximums for vitamins and minerals
Appendix XVII, sections 1.1 and 1.2, set the maximum amounts for the listed vitamins and minerals. COFEPRIS’s 2026 guidance continues to refer manufacturers to these sections. These limits apply to the total daily intake from the product, rather than to a single serving, and the recommended daily use should remain within the applicable maximum limit.
| Vitamin / Mineral |
Maximum daily amount
|
| Vitamin A / Retinol | 1000 µg |
| Folic Acid | 400 µg |
| Beta Carotene | 15 mg |
| Biotin | 300 µg |
| Vitamin B1 / Thiamine | 15 mg |
| Vitamin B2 / Riboflavin | 18 mg |
| Vitamin B3 / Niacin | 25 mg |
| Vitamin B5 / Pantothenic Acid | 20 mg |
| Vitamin B6 / Pyridoxine | 10 mg |
| Vitamin B12 / Cyanocobalamin | 12 µg |
| Vitamin C / Ascorbic Acid | 300 mg |
| Vitamin D | 10 µg |
| Vitamin E / d-α-tocopherol | 200 mg |
| Vitamin K | 30 µg |
| Calcium | 1200 mg |
| Copper | 3 mg |
| Chromium | 200 µg |
| Fluoride | 1 mg |
| Phosphorus | 1200 mg |
| Iron | 20 mg |
| Magnesium | 500 mg |
| Manganese | 7.5 mg |
| Molybdenum | 250 µg |
| Selenium | 100 µg |
| Iodine | 200 µg |
| Zinc | 20 mg |
COFEPRIS Product Classification Consultation for Food Supplements
Not sure whether your product counts as a suplemento alimenticio? You don’t have to guess. Manufacturers and importers can ask COFEPRIS for a product-classification consultation.
The consultation is free. What you get back is a technical opinion on whether the product complies with the current rules for food supplements. Be clear about what it isn’t, though: it is not a sanitary authorization, and COFEPRIS does not assess the product’s quality, safety or efficacy as part of it.
Requests are made per product and per flavour, so a range of four flavours means four requests. Each should follow Article 172 of the Regulation for Sanitary Control of Products and Services.
What to include in the request
COFEPRIS currently asks for a signed request on company letterhead, addressed to the Comisión de Autorización Sanitaria. Among other details, it should include:
- the product name and the generic denomination “Suplemento Alimenticio”
- a specific product description, covering dosage form, characteristic ingredients and flavour
- the intended use, which must be consistent with the purpose of a food supplement
- the qualitative and quantitative formula
- details of any vitamins, minerals and botanical ingredients
- directions for use
- a sample of the label and commercial information
- for imported products, the original label and, if a secondary label will be used, how it will be placed on the original
The full, current list of submission requirements is in COFEPRIS’s product-classification consultation guidance for food supplements.
Response time and possible outcomes
COFEPRIS gives itself a maximum of 90 days to respond. The answer will be one of three:
- It is a food supplement.
- Request for information, meaning COFEPRIS needs more from you before deciding.
- It is not a food supplement.
COFEPRIS Food Supplement Regulations and Standards
Two instruments do most of the work:
- the General Health Law (Ley General de Salud)
- the Regulation for Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios), whose Articles 168–179 deal specifically with food supplements
Two NOMs commonly come up in this context: NOM-251 and NOM-051. Their application is different.
NOM-251-SSA1-2009 applies. It sets minimum hygiene requirements for processing foods, beverages and food supplements, with the aim of preventing contamination during processing.
NOM-051-SCFI/SSA1-2010 does not apply. This is a common mix-up, because NOM-051 is the well-known labeling standard for pre-packaged foods. COFEPRIS states expressly, in its official legal framework for suplementos alimenticios, that it does not cover food supplements. Supplement labels follow the General Health Law, the Regulation for Sanitary Control of Products and Services (including Appendix XVII) and other applicable requirements instead.
COFEPRIS Requirements for Bringing Food Supplements to Market
Selling a food supplement in Mexico doesn’t require a sanitary registration. There’s still a checklist to clear before operations begin, though, and it applies to the product as well as to the establishment making or selling it:
- the product must meet the Mexican definition of a suplemento alimenticio
- the formula must use permitted ingredients and stay within the applicable limits
- the label and commercial information must meet food-supplement requirements
- the establishment must file the applicable operating notice
- imported products must meet the applicable import requirements
Aviso de Funcionamiento
Whoever manufactures and/or sells the supplements in Mexico has to file an Aviso de Funcionamiento, and the deadline is at least 30 days before operations start.
Don’t confuse it with an approval. COFEPRIS is clear that the Aviso is not a sanitary registration or a product authorization. It simply tells the authority that the establishment exists and what it does.
For establishments handling products and services, the procedure is COFEPRIS-05-018, Aviso de funcionamiento, modificación o baja del establecimiento de productos y servicios. COFEPRIS currently uses the FF-COFEPRIS-02 format for Aviso-related procedures.
Requirements for imported food supplements
Imported supplements are subject to the applicable COFEPRIS import procedure, which depends on the purpose and conditions of the import. COFEPRIS-01-002 covers commercial importation and certain modalities such as samples, personal consumption, research, laboratory testing and exhibition. Imports by return are handled separately under COFEPRIS-01-016. Other import procedures may apply depending on the product and circumstances.
COFEPRIS-01-002 itself has different modalities, depending on whether the import is for:
- commercialisation or distribution
- samples
- personal consumption
- scientific research or laboratory testing
- exhibition
Which route applies comes down to the purpose and conditions of the import, so pin down the procedure and paperwork before anything ships.
Food Supplement Labeling Requirements Under COFEPRIS
Label information has to be in Spanish for every food supplement on the Mexican market. For imported products, that information must be translated into Spanish in line with the Regulation for Sanitary Control of Products and Services.
Minimum label information
COFEPRIS lists the following as part of the minimum labeling requirements:
- the generic name “SUPLEMENTO ALIMENTICIO” on the front of the label
- a specific product description
- a complete ingredient list, in descending order by quantity
- any ingredient that may pose an immediate or delayed health risk
- a nutritional declaration
- the name and address of the manufacturer, importer, packer, contract manufacturer or distributor, as applicable
- instructions for storage, use, preparation and consumption
- lot identification
- expiration date
- applicable warning statements
Name each botanical clearly, using its common name and, where applicable, its botanical name too.
Inside the nutritional declaration
The minimum is energy, protein, fat, carbohydrates and sodium. Add the specific amount of each vitamin and mineral in the product. And if your label, accompanying information or ads make a point of any other nutrient or component, that one has to be declared as well, where required.
For the full detail, see COFEPRIS’s guidance on food-supplement labeling.
Mandatory warning statements
Two warnings must appear on every food-supplement label:
- “EL CONSUMO DE ESTE PRODUCTO ES RESPONSABILIDAD DE QUIEN LO RECOMIENDA Y DE QUIEN LO USA.”
- “ESTE PRODUCTO NO ES UN MEDICAMENTO.”
Both must be displayed according to the formatting requirements set for food-supplement labels.
Claims and Advertising: What COFEPRIS Allows
Claims get the closest scrutiny. Anything you say on the pack or in an ad has to fit a product whose job is to complement the diet.
What labels and commercial information can’t say
Articles 173 and 174 of the Regulation for Sanitary Control of Products and Services set the baseline. Nothing on the label or in commercial material may mislead about, or exaggerate, the product’s composition, origin, effects or properties. Saying it prevents, treats or cures a disease or health condition is also out.
Images count as much as words. Think of a label showing a heart or a joint next to the product name. If a picture or statement like that, tied to a disease, symptom, syndrome, body part or physiological function, could give the product a therapeutic meaning, it isn’t allowed. The same goes for presenting a supplement as meeting all of someone’s nutritional needs, or as something that replaces a meal.
COFEPRIS advertising permit
You need COFEPRIS’s authorization before a food-supplement ad goes out. That requirement sits in Article 79 of the Regulation of the General Health Law on Advertising, and the procedure is COFEPRIS-02-001-A (Permiso de Publicidad, Productos y Servicios), which explicitly includes food supplements.
One permit, one advertisement. It does not cover a whole campaign, a group of products or a set of ads for the same product.
Among other restrictions, supplement advertising must not:
- claim the product prevents, relieves, treats or cures a disease, disorder or physiological condition
- make claims that can’t be substantiated
- suggest the product gives extraordinary abilities or characteristics
- imply the supplement alone meets a person’s nutritional requirements
- encourage unhealthy eating habits
Where the authorization calls for a precautionary statement or specific wording, the ad has to include it.
Conclusion
With no sanitary registration to file, Mexico can look like an easy market. It isn’t quite. You still have classification, ingredients, labeling, the establishment notice, importation and advertising to get right, though how many of those apply depends on the product and how it comes into the country.
Begin with the Article 215 test: is this a suplemento alimenticio? If yes, move on to the formula and check it against the ingredient rules and daily limits. Then a compliant Spanish label, and then whichever COFEPRIS procedures apply, all before the product goes on sale.
Artixio helps companies with classification, labeling, import requirements and other food-supplement compliance work in Mexico. Explore our food supplement regulatory services in Mexico.
FAQs
1. What should the nutritional declaration on a food supplement label include?
Five items at minimum: energy, protein, fat, carbohydrates and sodium. Then the exact amount of each vitamin and mineral in the product. If the label, accompanying information or advertising singles out any other nutrient or component, it gets declared too, where applicable.
2. Do imported food supplements require a permit in Mexico?
Imported food supplements are subject to the applicable COFEPRIS import procedure. COFEPRIS-01-002 covers food supplements for several import purposes, but the applicable modality and requirements depend on the purpose and conditions of the import.
3. What labeling options are available for imported food supplements?
The required label information must be in Spanish. You can use a Spanish-language label prepared for the Mexican market or, where appropriate, apply compliant Spanish information to the imported product. Either way, the final presentation must meet Mexican labeling requirements.
4. Do food supplements require sanitary registration in Mexico?
No. COFEPRIS states that food supplements do not need sanitary registration. Manufacturers and/or those selling them in Mexico must still meet the applicable establishment, product, labeling, import and advertising requirements.
5. Is a local representative mandatory for food supplements in Mexico?
COFEPRIS doesn’t say that every food supplement needs its own local representative just because it is a food supplement. Some procedures, however, may have to be carried out by the interested party or a legal representative, and companies operating in Mexico must meet the applicable establishment and commercialisation requirements.
6. Does COFEPRIS publish a list of approved food supplements?
Food supplements aren’t subject to sanitary registration the way medicines are, so there’s no registration-based approval list to check. Instead, make sure the product meets the requirements for classification, ingredients, labeling, establishment notification, importation and advertising.
