Introduction
Given the recent significant increase in dietary supplements’ consumption and the debate surrounding their classification; this document presents an overview on the current categorisation & regulatory framework of the same in Egypt.
Definition
A dietary supplement (“Supplement”) is mainly defined as a product that:
Background
The Ministry of Health and Population used to be responsible for Supplements’ licensing and registration in Egypt, until the establishment of the National Food Safety Authority (“NFSA”); which assumed this responsibility ever since 2018.
However, in 2022, the Egyptian Drug Authority (“EDA”) introduced a new category of pharmaceuticals called “complementary pharmaceuticals.” These products contain an active ingredient or groups of active ingredients with a complementary medical impact used to help treat, prevent, restore, or adjust physiological functions.
It is worth highlighting that certain types of dietary supplements are designed to improve overall health or assist in managing specific health conditions. Such types would fall under the previously mentioned category of complementary pharmaceuticals. As a result, these supplements are now subject to the EDA’s authority.
Categorisation and Governance
In March 2023, the EDA and the NFSA established the “White List” mechanism, which categorises dietary supplements based on their concentration level. The said concentration level determines whether a Supplement falls under the licensing jurisdiction of the NFSA or the EDA. Hence, the lists set forth the maximum concentration levels for a Supplement to qualify as a food supplement with the NFSA, while exceeding these levels requires registration with the EDA.
Perspective
Although Supplements are processed foods intended to help individuals obtain adequate amounts of essential nutrients when they are unable to consume a varied and nutritious diet, many Supplements contain active ingredients that can have strong effects on the human body (e.g., increasing the risk of bleeding or potentially alerting the response to anesthesia if taken before surgery). The risk is increased by taking multiple Supplements simultaneously, or at high doses, or in combination with contradicting medicines.
Needless to mention the various victims who have been harmed by the unsupervised and excessive use of Supplements, particularly since 2020, with cases including liver damage and bone weakness. Ultimately, Supplements cannot replace the diverse range of foods necessary for maintaining a healthy body and a strong immune system.
Therefore, the high risks associated with the public’s insufficient awareness of these aforementioned issues provide a strong rationale for the EDA’s involvement in protecting public wellbeing and preventing having more lives at stake.
Lastly, it is worth noting that due to the strict regulations governing pharmaceuticals’ licensing and registration in Egypt (including compulsory pricing and exclusive availability through pharmaceutical institutions), Supplement manufacturers will often be more inclined to register their products with the NFSA over the EDA. This explains why, back in 2022, some Supplements’ manufacturers expressed dissatisfaction with the EDA’s sudden involvement in the Supplements’ industry, which could potentially impact investment. Nonetheless, the EDA remains a key player through the White List mechanism, as safeguarding public health remains the ultimate priority.
Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of ADSERO. This article is intended for general information purposes only and should not be considered or relied on as legal advice. Readers are encouraged to consult with a qualified attorney for specific legal guidance. ADSERO does not guarantee or warrant the accuracy, completeness, or adequacy of the information provided and accepts no liability or responsibility for any errors or omissions in the content.
