Mexican regulations establish fundamental principles governing claims for cosmetic products and dietary supplements. The main objective is to ensure that these products are safe, effective, and not misleading to consumers.
This framework also serves to clearly differentiate them from so-called “miracle products.”
General Principles and Prohibitions
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the authority responsible for regulating cosmetics and dietary supplements in Mexico. It sets the requirements that must be met, including the review of claims made on product labeling and in advertising.
Veracity and Verification: All information presented to consumers must be truthful and verifiable. Manufacturers, importers, and marketers are required to have safety and efficacy studies to substantiate their product claims. COFEPRIS may request these studies for review at any time.
Therapeutic and Rehabilitative Claims: Regulations prohibit cosmetic and dietary supplement products from making claims typically associated with medications. This includes claims to cure diseases, regulate weight, combat obesity, or reference specific syndromes, signs, or symptom relief. If a cosmetic or dietary supplement makes such claims, it may be reclassified and required to comply with the corresponding drug regulations.
False or Unverifiable Claims: Products must not be attributed with characteristics or properties that cannot be substantiated, whether expressed through text, images, trademarks, or any other symbol. Likewise, claims must not mislead, exaggerate, or create confusion regarding a product’s properties, composition, or effects when used or consumed.
Specific Claims for Certain Products
In addition to the general rules, some product categories are subject to specific requirements:
Sunscreens: It is prohibited to claim 100% protection (e.g., “total blocker”) or to state that the product does not require reapplication. Labels must indicate the Sun Protection Factor (SPF), specify protection against both UVB and UVA radiation, and include a warning about the risks of excessive sun exposure.
Dietary Supplements: Product names must not reference a specific body part or medical condition. They should also avoid comparisons to natural foods that suggest superior value or promote the supplement as a substitute for complete meals.
Recommendations
When classifying a product and designing its labeling, it is essential to ensure that all claims comply with the applicable regulations. This is the only way to properly substantiate the information provided to consumers.
To learn more about classification queries, we invite you to read our article: “Classification query: A regulatory tool for marketing your cosmetics and dietary supplements.”. Additionally, for labeling matters, we invite you to read “Keys to the labeling of dietary supplements in Mexico” and “Cosmetic product labeling in Mexico: Essential requirements”.
Conclusion
Compliance with regulations in Mexico is essential for successful product commercialization. All claims made on labeling and in advertising must be truthful, verifiable, and aligned with current regulations, ensuring both transparency and consumer safety.
Written By:
Tania Ramírez
about ips
Mexico’s regulatory framework for cosmetics and dietary supplements requires more than just understanding the rules—it demands strategic application and proactive compliance. At IPS, we specialize in guiding companies through COFEPRIS requirements.
Let our team of regulatory experts help you avoid costly setbacks and ensure your products meet all labeling and safety requirements.
For tailored support, contact us at info@insumosparasalud.com