The Mexico Ministry of Health (COFEPRIS) have published a non-regulatory guide to the classification of food supplements.
A food supplement must satisfy each of four separate legal requirements in order to be marketed, otherwise it must fall into a different regulatory catetory.
- The General Health Law, which states that supplements must be based on herbs, plant extracts or traditional foods, aimed at complementing the diet, and free of restricted ingredients.
- The Regulation on the Sanitary Control of Products and Services, which incorporates criteria on composition, exclusion of substances with pharmacological action and, especially, strict rules on labelling, prohibiting therapeutic indications or misleading information. The guide prohibits the marketing of substances with a pharmacological or therapeutic action as food supplements.
- The Decree determining additives and adjuvants in food, beverages and food supplements, their use and sanitary provisions, published in the Official Gazette of the Federation (DOF) on December 15, 1999, and its amendments published on September 5, 2013 and May 16, 2016, and the Decree determining the prohibited or permitted plants for teas, infusions and edible vegetable oils, published in the DOF on December 15, 1999, which delimit the substances that can be used and the specific conditions applicable, including labeling requirements in the case of certain ingredients.
This guide establishes the possibility of using the Herbal Pharmacopoeia of the United Mexican States as a reference in the development of food supplements, since it lists plants and their derivatives that can cause unwanted effects, have interactions with other plants and medications,or can be toxic or allergenic.
This aligns Mexico’s marketing approval regulation more closely with that of Europe, but is a reminder that manufacturers and sellers (particularly online sellers) of supplements and botanicals must be highly cognisant of the specific regulations in each country of sale.
