Vaping Ban and Digital Health Laws

On Jan. 15, 2026, the Mexican president published in the Federal Official Gazette a broad reform to Mexico’s Ley General de Salud (LGS, General Health Law), amending, adding, and repealing several provisions. The decree entered into force the following day, marking one of the most consequential health law reforms in decades.

While public debate has largely focused on the implementation of the Constitutional mandate to ban electronic cigarettes and vape devices (with a notable caveat that we’ll explain below), the reform addresses several other matters, such as the formal legal recognition of digital health, and additional capabilities to monitor pharmacovigilance and techno vigilance.

Expansion of Regulatory Oversight 

The reform seeks to strengthen governmental guidance on key health matters. The catalogue of subjects deemed relevant to public health is expanded, to include the National Master Plan for Health Infrastructure and High‑Technology Medical Equipment among other topics.  

Any public project involving the creation, replacement, or expansion of health infrastructure must now be registered and aligned with this plan, which will certainly impact the analyses done by market access teams.

Digital Health: From Practice to Legal Category

For the first time, digital health is expressly defined and regulated within Mexican federal law. The new Chapter VI Bis incorporates telemedicine, telehealth, electronic health records, mobile health applications, and wearable devices as legitimate modalities of care, subject to regulatory standards on data protection, patient consent, documentation, and professional responsibility.

This move provides long‑overdue legal certainty for providers and investors operating in a regulatory grey zone. At the same time, it places significant responsibility on the Ministry of Health to develop secondary regulations capable of balancing innovation with patient safety and privacy. The reform sets the architecture; the regulatory burden will now fall on implementation.

Extension on Renewals, Stricter Pharmacovigilance, Techno Vigilance

The approved amendments extend the validity of marketing authorizations for drugs and devices, with an initial five-year term, followed by 10-year renewal periods. This should allow for added regulatory predictability and life-cycle planning, particularly for advanced-technology manufacturers.

Simultaneously, the reform strengthens pharmacovigilance and techno vigilance, reinforcing post‑market surveillance obligations and expanding enforcement powers. The newly appointed general commissioner for COFEPRIS will have the task of overseeing compliance, through adequate staffing, technical expertise and procedural clarity.

The Ban on Vaping Devices: Is There an Alternative?

The reform’s most discussed component is the implementation of an absolute prohibition on the manufacture, importation, distribution, and commercialization of electronic cigarettes, vape devices, and analogous systems, backed by criminal sanctions.

However, the law defines e-cigarettes, vapes and other systems or analogous devices as any apparatus or mechanical, electronic system, or any other technology that is used to heat, vaporize or atomize liquid toxic substances, gels, salts, waxes, dry aerosols, resins, wax oils or other new synthetic formulations with or without nicotine, susceptible of being inhaled by a consumer.

This definition interestingly leaves out tobacco heating devices, which are already present in the Mexican market and allow the consumer to consume nicotine while mitigating the health risks associated with combustion.

This reform will face a substantial challenge in enforcement. Though vaping devices have been prohibited through law, decrees, and regulations for several years, they are currently widely — and openly — available to consumers.

It is likely that we will see a combination of informal market sales, with the associated health risks, in combination with an increase in use of the above-mentioned tobacco heating devices.

Institutional Strengthening, Conflict Resolution

Less discussed but structurally important is the reinforcement of the National Medical Arbitration Commission (CONAMED), now affirmed as a technically autonomous body with expanded authority in mediation, conciliation, and arbitration between patients and providers.

What’s Next?

Implementation of this reform lies ahead — in secondary regulations, enforcement activities, budgetary choices, institutional coordination, and day‑to‑day administrative practice. Several topics are open, and decisions moving forward by the public sector will determine its success.