Nutraceuticals in Colombia

“Nutraceuticals”, a term commonly employed in the marketplace, is usually used to identify products derived from food sources exhibiting extra health benefits in addition to the nutritional value of foods. These products are not specifically defined by law in the US but are regulated by FDA as well as Dietary Supplements.

The situation is similar in Colombia since there is no regulation explicitly directed to “nutraceuticals”, nor a legal definition for these products is in place. Accordingly, before any attempt of commercializing of such a product in Colombia, it is highly recommended to analyze which regulation is to be met according to the specific composition and use of the product. It is to be mentioned that many products fall in different regulatory categories than those
whereby they were registered in the country of origin, sometimes requiring additional technical documentation for its sanitary registration (Marketing Authorization-MA).

Furthermore, it is to be understood that although a trademark used to identify a product may be registered before the Colombian Trademark Office – SIC, it may eventually be objected by the local Sanitary Authority – INVIMA, during the marketing authorization process, if said authority considers that the brand could: i) mislead about the true nature of the product or, ii) lead to irrational consumption of the same.

The SIC during its trademark registrability evaluation does not analyze the same criteria that INVIMA assesses. Consequently, a trademark or distinctive sign that can be perfectly registrable before the SIC, can be objected by the Sanitary Authority and according to the highest judicial authority for these cases, the Council of State 1 , INVIMA is empowered to make such pronouncements when it legitimately considers the trademark may threaten the health or deceive the general public.

The trademark registration is not a mandatory requirement for the Marketing Authorization of all the products supervised by INVIMA. However, Medicines, Phytotherapeutics and Spirits require a certificate or trademark application as part of the MA requirements. Other products, such as Foods, Dietary Supplements, or Medical Devices, do not need to show prior trademark registration, but if they are used, they can be thoroughly evaluated.

Given this, those interested in entering the Colombian market with these products, must consider not only the criteria of the Trademark Office – SIC when choosing a brand, but also the criteria handled by the local Sanitary Authority – INVIMA and thus guarantee that the protected brand can be effectively used.

1. Sentence 2004-00883 of June 7, 2018.

By

María Alejandra Pava

María Alejandra Pava
Trademarks Director

Gina A. Arias

Gina A. Arias
Regulatory Affairs Manager