Health

Cosmetics

Nutritional Supplements

Medical Divices

Generics

New Molecule

Vitamin Drugs

Biologic /

Bio-technological

NUTRITIONAL SUPPLEMENTS

This process is usually detailed and specialized. While in many countries the food supplement category is very extensive and consumer friendly, in our country it is very limited regarding labeling, amount per ingredient, advertisement and promotion.

In Mexico a food supplement is a product based on herbs, vegetable extracts, traditional food, dehydrated fruit or fruit concentrates added or not, vitamins or minerals that may be presented as a drug and which purpose is to increase the total dietary ingestion, to complement it or to supply some of its components.

Any supplement exceeding the limits per ingredient or daily ingestion is considered a drug.

Stage 1

Review of the formula in order to define if the product may be listed as supplement.

Stage 2

Put together the dossier of the product:

Supplements may consist of carbohydrates, proteins, amino acids, fatty acids, metabolites, plants, herbs, algae, traditional dehydrated food or the mixture of these.
Prohibited: procaine, ephedrine, yohimbine, germanium, animal or human hormones, plants not permitted for teas. In case of unknown substances, it must be scientifically proven that they are harmless.
An analysis of the raw material must be presented.
Pharmacological study if so required by the substance.
Name and monograph of each ingredient.
Quantitative formula.
How to use.
Sample of the original label.

Stage 3

Labeling. The following must be considered:

Eliminate therapeutic information, composition, effects, properties and indications of the product.
Eliminate pictures or figures related to effects.
Complete list of ingredients ordered from higher to lower amount.
Mention allergenic components.
Nutritional statement.
Lot number.
Instructions for use, precaution and consumption.
Warning legend.
Comply with the text size proportion.
Expiration date.
Nutrimental information.

Stage 4

Product registration.

Stage 5

Import permit if foreign.

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