Without a specific regulatory category that clearly defines what a dietary supplement is, based on its nature, confusion arises in Peru about whether it should be treated as food or medicine (despite being distinct products). This impacts the regulatory treatment given to it, which constitutes a barrier to the development of this industry in the country.
Therefore, it is imperative that Peruvian legislation clearly differentiate dietary supplements from pharmaceutical products and from the food category. Having an autonomous classification would allow for the establishment of technical and health criteria appropriate to their nature, guarantee oversight of their characteristics, and provide greater legal certainty for all involved. This regulatory differentiation would not only strengthen the protection of public health but would also promote the development of a more dynamic, safe, and competitive supplement market. Currently, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID in Spanish) has the authority to regulate and establish the procedures applicable to dietary supplements, pursuant to Law 29459, the Law on Pharmaceutical Products, Medical Devices, and Health Products. This law defines pharmaceutical products as preparations intended to prevent, diagnose, treat, or cure diseases, a classification that includes the category of dietary products, even though the latter do not have a therapeutic purpose.
However, Article 17 of Decision No. 9 of the Free Trade Commission of the Additional Protocol to the Pacific Alliance Framework Agreement (the decision applicable to Peru) establishes that the competent authority to regulate the category of dietary supplements should be the General Directorate of Environmental Health and Food Safety (DIGESA in Spanish).