ARCSA reforms the sanitary control of dietary supplements in Ecuador

The National Agency for Regulation, Control and Sanitary Surveillance (ARCSA), Doctor Leopoldo Izquieta Pérez, issued Resolution ARCSA-DE-2026-021-DASP, which partially reforms the Sanitary Technical Regulations for obtaining sanitary notification and the control of dietary supplements. The measure was published in the Official Registry Third Supplement No. 381, on Thursday, October 1, 2026, and will enter into force six months after that date.

The reform replaces and expands Resolution ARCSA-DE-028-2016-YMIH, published in the Official Registry Supplement No. 937 on February 3, 2017, and last modified on January 26, 2023. The text was electronically signed by executive director Daniel Antonio Sánchez Procel, in Guayaquil, and applies to establishments where these products are manufactured, stored, distributed, imported, and marketed.

The decision is based on several technical and legal reports from the agency itself:

• Technical Report No. ARCSA-INF-DTRSNSOYA-AL-2025-013, dated April 1, 2025.
• Technical Report No. ARCSA-INF-DTBPYP-2025-008, dated April 24, 2025.
• Legal Report No. ARCSA-INF-DAJ-2025-079, dated October 27, 2025.
• Official Letter No. MPCEI-DGEC-2026-0006-O, from the Ministry of Production, Foreign Trade and Investments, dated January 13, 2026, with the methodological approval of the Regulatory Impact Analysis regarding the sanitary risk of supplements that do not meet their quality, safety, and innocence specifications.

Deadlines and procedures for sanitary notification

The resolution sets maximum times for each stage of the process before ARCSA:

• Documentary and technical review: forty (40) days.
• Correction of observations: twenty (20) days for national products and thirty (30) days for foreign products.
• Review of corrections: twenty (20) days, with a maximum of two rectifications.
• Payment of the fee: ten (10) days; otherwise, the application is definitively canceled.
• Re-registration: within one hundred and twenty (120) days prior to the expiration of the notification.
• Modifications: review in fifteen (15) days, corrections in fifteen and twenty (20) days, and up to eight (8) modifications with a cost per application.
• Exhaustion of label stocks: up to twelve (12) months, with an extension of one (1) calendar year.

Imported supplements must obtain sanitary notification or registration via a GMP certified line as a foreign product; if they are subsequently conditioned or packaged in the country, they will require the process as a national product.

Requirements, prohibitions, and labeling

Health notification will not be granted to supplements containing components prohibited nationally or internationally, ingredients in concentrations with therapeutic activity, unproven therapeutic properties or intentional benefits, nor to those that fail to comply with the regulations. Substances such as procaine, ephedrine, yohimbine, and germanium are expressly prohibited, and supplements for infants under 1 year old, as well as hormones or anabolic compounds in products for athletes, will not be permitted.

Labeling requires the Spanish language, the health notification code or the GMP code, nutritional information in accordance with NTE INEN 2983 and NTE INEN 1334-2, and mandatory legends such as “Keep out of reach of children” and “The product is not suitable for consumption as a sole source of food.” Advertising may not include claims of relief, treatment, or cure of diseases, nor images that are misleading or idealize the product.

GMP Certification and Costs

Establishments that produce dietary supplements may be certified in Good Manufacturing Practices (GMP) through Inspection Bodies Accredited (OIA) by the SAE and registered with ARCSA. Those with a current registered certificate shall not be required to obtain an operating permit or health notification, but must register their products in the VUE.

Registration or recertification costs are set by category: Industry 5 SBU, Medium Industry 4 SBU, Small Industry 3 SBU, Microenterprise 2 SBU, and Artisans 1 SBU; homologation for foreign companies also equals 5 SBU. Additionally, each plant must undergo an annual follow-up audit and have a technical representative with a recognized degree and a current operating permit.

The impact falls on the entire dietary supplement chain: manufacturers, contract manufacturers, importers, distributors, and retailers must adjust labels, procedures, and certifications in the coming months, while consumers gain access to stricter control over the composition, advertising, and safety of these products.

Source: Official Registry Third Supplement No. 381, Thursday, October 1, 2026, Executive Function – Resolutions, pág. 2 (official reference: Resolution ARCSA-DE-2026-021-DASP).