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Selling food supplements in Mexico

In Mexico, food supplements (suplementos alimenticios) are defined in the General Health Law and regulated by COFEPRIS under the Reglamento de Control Sanitario de Productos y Servicios. They may not contain pharmacological substances or claim therapeutic effects, must stay within daily vitamin and mineral limits, and carry two mandatory legends in Spanish.

Updated · Each section links to the official source it comes from

Definition
Article 215, fracción V, General Health Law
Detailed rules
Title 19 and Appendix XVII of the Reglamento de Control Sanitario de Productos y Servicios
Regulator
COFEPRIS, for the Secretaría de Salud
Mandatory legends
"Este producto no es un medicamento" and the responsibility legend
Claims
No preventive, rehabilitative or therapeutic indications
Hygiene
NOM-251-SSA1-2009 applies to supplements

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a supplement, or a medicine or herbal remedy under other rules? Read more
  2. 2Does any ingredient fall on the banned list, or any vitamin or mineral exceed the daily limit? Read more
  3. 3Does the label carry the required particulars and both legends, at the right size? Read more
  4. 4Do the label and marketing avoid therapeutic claims and disease references? Read more
  5. 5How does it come into Mexico, and who answers for it there? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Advertising permit

Advertising food supplements needs a COFEPRIS permit.

  • Advertising of health-regulated products is governed by the Regulation of the General Health Law on Advertising (Reglamento de la Ley General de Salud en Materia de Publicidad), under articles 300 and 301 of the General Health Law.
  • COFEPRIS lists food supplements among the products whose advertising needs an advertising permit (Permiso de Publicidad, COFEPRIS-02-001).
  • The permit is filed in person on form FF-COFEPRIS-13, carries a fee under article 195 of the Federal Law of Duties, and COFEPRIS answers within seven working days.

How we help: Compliant Always keeps the advertising permit with the campaign and product it covers, dated, and sets the advertising copy beside it. Ask about this

What counts as a supplement

The legal definition, and where a product stops being a supplement.

  • COFEPRIS accepts the oral forms in the Mexican Pharmacopoeia, such as capsules, tablets, powders, syrups, solutions, suspensions and emulsions. Confectionery forms such as sweets, lollipops and gum, patches and injectables are not permitted.
  • COFEPRIS says supplements are not for treating, curing, preventing or relieving disease, not for weight loss or obesity, and not aphrodisiacs; products meant to treat disease are health inputs that need a sanitary registration.
  • A supplement is a product based on herbs, plant extracts, traditional foods, or dehydrated or concentrated fruit, with or without added vitamins or minerals, which may come in a pharmaceutical form, and whose purpose is to increase, complement or supply part of the total dietary intake (Article 215, fracción V, General Health Law).
  • Under the Regulation, supplements may consist of carbohydrates, proteins, amino acids, fatty acids, metabolites, plants, herbs, algae, dehydrated traditional foods or others the Secretaría sets, alone or combined, and their consumption must not be a risk to health (Article 168).
  • Products with added substances of recognised pharmacological action, or to which therapeutic, preventive or rehabilitative properties are attributed, may not be sold in Mexico unless they meet the rules for health inputs (insumos para la salud) (Article 171).

How we help: Compliant Always keeps the formula and the reasoning for the product's classification with the product, so the file shows why it is sold as a supplement. Ask about this

Banned substances and vitamin and mineral limits

What a supplement may not contain, and the most it may provide each day.

  • Supplements may not contain procaine, ephedrine, yohimbine, germanium, animal or human hormones, plants not allowed for infusions or tea, or any other recognised pharmacological substance or substance that is a risk to health (Article 169).
  • Where a supplement contains little-known substances that may be a risk, its processing and import are subject to showing their safety scientifically to the Secretaría (Article 169).
  • Appendix XVII of the Regulation sets the maximum daily amount for each vitamin and mineral.
  • Raw materials, especially dehydrated plants, are treated to reduce microbial load and harmful residues (Article 170); additives are those set in the Agreement on additives and processing aids (Article 168).

How we help: Compliant Always reads your formula and certificates of analysis against the banned list and the daily limits, with the clause beside each line. Ask about this

Labelling and legends

What the label shows, and the two legends every supplement carries.

  • Appendix XVII.3 lists the particulars: generic and specific name; the full list of ingredients in order of predominance, with the common and botanical name (genus and species) of herbs; components that may be a risk to health; the nutrition declaration; the name and address of the manufacturer or importer, packer and distributor; instructions for storage and use; the lot; and the expiry date.
  • The label carries the legend required by Article 216 of the General Health Law, "Este producto no es un medicamento", and "El consumo de este producto es responsabilidad de quien lo recomienda y de quien lo usa", in capitals, bold and contrasting colours.
  • The minimum height of the legends rises with the information panel: 0.5 mm up to 20.9 cm², 0.8 mm up to 40.9 cm², 2 mm up to 160.9 cm² and 3 mm above that.
  • The nutrition declaration gives at least energy, protein, fat, carbohydrates, sodium and each vitamin and mineral, per 100 g or mL or per serving (XVII.4).
  • Product information and labels are given in Spanish (Article 34, Federal Consumer Protection Law).

How we help: Compliant Always sets your label beside the particulars and legend sizes in Appendix XVII, so a missing botanical name or an undersized legend shows up before printing. Ask about this

Claims and advertising

What the label and marketing may and may not say.

  • Labels and marketing may not confuse, exaggerate or mislead about composition, origin, effects or properties, nor carry preventive, rehabilitative or therapeutic indications (Article 173).
  • They may not use names, figures or statements about diseases, symptoms, syndromes, anatomical data or physiological phenomena, nor claim that the product alone meets nutritional needs or can replace a meal (Article 174).
  • Supplements advertised or promoted as medicines, or presented as a definitive treatment for a condition, may be seized as a safety measure (Article 414 Bis, General Health Law).

How we help: Compliant Always sets your label copy and claims beside Articles 173 and 174, with the source for each line. Ask about this

Establishments, hygiene and import

The notice a business gives, the hygiene it keeps, and how supplements come into Mexico.

  • Supplements are under sanitary control for processing, import and export (Article 194, General Health Law).
  • Establishments that need no sanitary authorisation but are named by agreement give a notice of operation (aviso de funcionamiento) at least 30 days before starting (Article 200 Bis).
  • NOM-251-SSA1-2009 sets good hygiene practices for businesses that process supplements, including a recall plan.
  • The importer must be domiciled in Mexico, and COFEPRIS may sample imported products at random (Articles 285 and 286 Bis). The Secretaría may also ask for the ingredients, quantitative formula, directions and the original label (Article 172 of the Regulation).

How we help: Compliant Always keeps the formula, certificates and import documents with the product and lot, ready when COFEPRIS asks for them. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe formula, the label, both legends and the claims.Formula and label checked against the Regulation, with the evidence behind them.
ManufacturerHygiene under NOM-251, raw material treatment and the composition limits.Certificates of analysis kept by lot and read against the limits.
ImporterBeing domiciled in Mexico, the import documents and the information COFEPRIS may request.Supplier documents read and dated before the goods arrive.
Ingredient supplierIdentity, botanical names and specifications of what it supplies.Specifications collected once and shown to each customer that asks.

Federal rules and the states

Product rules in Mexico are federal: the General Health Law, the Federal Consumer Protection Law and the Normas Oficiales Mexicanas apply across the national territory.

Health surveillance is shared. Under the General Health Law, a notice of operation (aviso de funcionamiento) goes to the Secretaría de Salud or to the government of the state (entidad federativa), and several sanitary NOMs are enforced by COFEPRIS and the state governments together.

Questions businesses ask

How does Mexican law define a food supplement?
A product based on herbs, plant extracts, traditional foods or dehydrated or concentrated fruit, with or without vitamins or minerals, possibly in pharmaceutical form, meant to increase, complement or supply part of the diet (Article 215, General Health Law).
Do supplements need a sanitary registration in Mexico?
The General Health Law lists sanitary registration for medicines, devices, pesticides and toxic substances, not supplements. Supplements are under sanitary control, and the Secretaría may request the formula, directions and label (Article 172 of the Regulation).
Which legends must a supplement label carry in Mexico?
"Este producto no es un medicamento" and "El consumo de este producto es responsabilidad de quien lo recomienda y de quien lo usa", in capitals, bold and contrasting colours, at a minimum height set by the label area.
Which ingredients are banned in Mexican supplements?
Procaine, ephedrine, yohimbine, germanium, animal or human hormones, plants not allowed for infusions or tea, and any other recognised pharmacological substance or substance that is a risk to health (Article 169).
Are there maximum vitamin and mineral levels?
Yes. Appendix XVII of the Reglamento de Control Sanitario de Productos y Servicios sets a maximum daily amount for each vitamin and mineral a supplement may provide.
Can a supplement claim to treat or prevent a disease in Mexico?
No. Labels and marketing may not carry preventive, rehabilitative or therapeutic indications, nor refer to diseases, symptoms or syndromes (Articles 173 and 174).
Must herbs be named botanically on the label?
Yes. Where the formula includes herbs, the ingredients list gives both the common name and the botanical name, with genus and species (Appendix XVII.3.2).
What happens if a supplement is sold as a medicine?
Supplements advertised as medicines or as a definitive treatment for a condition may be seized as a safety measure, including stock held by distributors and retailers (Article 414 Bis, General Health Law).
Does the hygiene NOM apply to supplements?
Yes. NOM-251-SSA1-2009 sets minimum good hygiene practices for the processing of food, drinks and food supplements.
Must a supplement importer be based in Mexico?
Yes. The importer of products under sanitary control must be domiciled in Mexico (Article 285, General Health Law).
Can a food supplement in Mexico be a gummy or a patch?
COFEPRIS accepts oral forms in the Mexican Pharmacopoeia, such as capsules, tablets, powders and syrups. It does not permit confectionery forms such as sweets, lollipops and gum, or patches and injectables.
Can a supplement in Mexico be sold for weight loss?
No. COFEPRIS says food supplements are not for weight loss or obesity, not for treating or preventing disease, and not aphrodisiacs. A product meant to treat disease is a health input that needs a sanitary registration.
Do I need a permit to advertise supplements in Mexico?
Yes. COFEPRIS lists food supplements among the products whose advertising needs a permit (COFEPRIS-02-001), filed in person with a fee; COFEPRIS answers within seven working days.
How does Compliant Always help with selling in Mexico?
Our team reads the rules for the markets you sell in, including the Normas Oficiales Mexicanas and COFEPRIS requirements. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Mexico and what your paperwork needs to show.

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