Food Supplement Regulations In Mexico COFEPRIS

In today's world, taking into consideration the fact that people are too busy, busy to the point that having a proper balanced meal is a challenge. Many people even though busy, they are health conscious and a solution for them is food supplements. Latin America plays a pivotal role in the global food supplements market, constituting 7 percent of the industry. In Mexico, there is 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 by 2025.

The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) is the regulatory authority in Mexico that regulates food supplements. It is their duty and responsibility to make sure the food supplements entering into the Mexican market must and is in compliance with all the applicable laws and regulations. In this article, we will discuss what are food/dietary supplements? food supplement registration in Mexico, COFEPRIS regulations for food supplements, labelling requirements and more.

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. 

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). Nutrient Content Claims: It refers to the statement of nutritional property which describes the level of particular nutrient in the product. E.g. High fibre content, low in fat…. Comparative Nutrient Claim: Statement referring to nutrient comparisons. E.g. reduced, less than, less, increased and more than.
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.

Registration requirements for Food supplements in Mexico

Retailers dealing in food supplements in Mexico enjoy a streamlined process as they do not require prior approval or sanitary registration.

For domestically manufactured food supplements, regulatory requirements are comparatively lenient. Domestic manufacturers are obligated to notify COFEPRIS about their product facilities. A "Notice of Operation" must be submitted 30 days before commencing operations. It is free of cost. This notification serves as a proactive measure to inform COFEPRIS about the intended manufacturing activities.

Importation of Overseas Products: In contrast, overseas products face a more intricate process for market entry. The importer must submit a Notice of Operation to COFEPRIS as a pre-requisite. The food supplement must have a COFEPRIS Classification Consultation and Prior Sanitary Import Permit (PSPI) issued by COFEPRIS to import and market the food supplements in Mexico.

Manufacturers of overseas products must thoroughly check ingredients, labels, and claims, before submitting to COFEPRIS for correct classification. The submission of an application to COFEPRIS includes essential documentation such as a health certificate or certificate of free sales from the country of origin, original and translated labels, chemical and microbiological analyses for each batch, and proof of fee payment.

The fee for authorization of an import permit for food supplements is $3,811.74. Please note that this isn’t the exact or final amount as the fee is subjected to change. Refer to the COFEPRIS official website before proceeding with any payment.

The documents that are to be submitted to get an import permit are given below:

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.

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.

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.