Overview of regulation requirements for food supplements and herbal products in Mexico

  

Very recently the health authorities in Mexico have taken strong actions against products that are commonly known as “Miracle Products”. The term refers to those products that claim NOT to be medicines or medical devices in order to avoid having to prove their efficacy and therefore not obtaining a registration number; which a is legal requirement for products that claim to cure or prevent or cure any disease or its symptoms.
Many of these products are masquerading as “food supplements”; and are equivalent to what is known in other countries as “Herbal supplements”; or are just multivitamins.  Others try to pass off as cosmetics and offer medicinal actions (such as reducing dress sizes),  which is not allowed for cosmetic products. Some of these argue they are “Health” products.
The current regulations in Mexico do not consider a category for “health” products”, “herbal products” or for “natural products”. Regulations basically consider two categories:
1. Products for general consumer use (foods, beverages, cosmetics, food supplements, amongst others)
2. Products to be used under medical supervision/advice/prescription (medication/drugs, herbal remedies, medical devices)
The basic differences between both categories are:
• General products are not registered, they are notified and depending on the sanitary risk for each product any specific category may have further requirements.
• All the other products DO REQUIRE registration by the sanitary authorities before they are labeled, imported, advertised, or put on sale.
Regarding some specific natural or health products and the classification they usually go into according to Mexico:
1.    Food supplements are products that are a subcategory within food; they are notified and require no registration. Food supplements must comply with the following:
a. The formulas and claims must be in accordance to the legal definition for the product: they must supply basic nutrients (protein, fats, carbohydrates) and may or not also contain vitamins and minerals, but cannot consist only of vitamins and/or minerals. Food supplements cannot alter metabolism, prevent/cure/treat or intervene in any way with disease/symptoms. They cannot be weight loss aids/products/etc.
b. Labeling must be done in accordance with Mexican regulations. Translation of English labels into Spanish is not adequate.
c. For import a prior import permit from the health authorities is required PER SHIPMENT.
2. All herbal products that have no nutritional value usually go into either the herbal medication category or the herbal remedy category. Both of these are categories requiring prior registration of the product.
a. Herbal medications are products based exclusively on herbs that have a known and standardized pharmacological active. As these are drugs, there must be proper clinical trials demonstrating the effectiveness of the drug contained. Their sale is restricted to drugstores, but they may or may not require a prescription, depending on the drug they contain.
b. Herbal remedies are products based exclusively on plants that have a traditional usage as treating symptoms, but for which there is no identified active drug in the herbs contained. They ALSO require registration, and are sold as OTC are sold in the US. Owner of the registration must be a manufacturing lab established within Mexico.
3. Homeopathic products (tinctures, for example) are classified as homeopathic medication in Mexico. They are considered as containing drugs (Pharmacologically active compunds), and must be registered and also must have the studies demonstrating the dinamization will provide the active ingredient required.
In order to avoid the problems derived from denied import permits or from product recalls from the authorities, we strongly suggest that before any new product is imported into Mexico or manufactured in Mexico, the legal requirements and correct classification are reviewed in order to make sure the product will be within the legal requirements.