Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has released a non-regulatory guide aimed at helping manufacturers and marketers determine whether their products qualify as dietary supplements under the country's stringent health laws. The guide establishes a four-part evaluation framework based on the General Health Law and related regulations, requiring that supplements be composed of herbs, extracts, or traditional foods; be free of pharmacological ingredients; avoid therapeutic or preventive claims; comply with additive and plant restrictions; and use only approved oral administration forms such as capsules, tablets, or powders while explicitly banning confectionery forms like gummies or candies. Products must clear all four sections of the classification form, and any "no" or "insufficient information" response automatically disqualifies the product—a critical distinction for companies as supplements do not require the same registration as pharmaceuticals but face severe penalties for making health claims or including prohibited substances.
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