Saudi Arabia: SFDA amends certain herbal products to being health products subject to registration

Effective 19 March 2020, the Saudi Food and Drug Authority (“SFDA”) issued a publication detailing that certain health products that were previously required to be “listed” at SFDA are now required to be “registered” as a health product in order to be marketed in Saudi Arabia. This update details these changes.

Herbal products to be registered as Health products:

Health products classified as “subject for listing” are submitted to the SFDA under a simplified listing scheme. To classify a product as health product subject for listing, it must meet a series of criteria and/or be of a specific type of products.

SFDA has reclassified some of these types of products from being “subject for listing” to requiring “registration”, and changed the thresholds for registration in other instances.

This group of products includes the following:

1. Alcohol hand sanitizers composed of ethanol 60-80% or isopropanol 60-75%;
2. Throat lozenges that consist only of volatile oils, ascorbic acid (or its salts), and at least menthol with no unacceptable claim and at a concentration of 5 mg or higher. The concentration of the individual ingredients (menthol, eucalyptus oil and ascorbic acid) must not exceed the maximum value as follows:
   1. Menthol 5-20 mg;
   2. Eucalyptus oil 0.5-15 mg; and
   3. Ascorbic acid 100 mg.
3. Topical products containing organic acids (alpha-hydroxy acids (AHAs)) where the total concentration of organic acids is higher than 10%;
4. Skin care products containing urea in a concentration greater than the amount recommended by the GSO standards for cosmetic products;
5. Aromatic and medicinal herbal oils that contain one or more of the oils that are extracted from medicinal plants, that have non nutritional claims, and are used internally;
6. Products containing medicinal herbs that are not in their natural form and have gone through any manufacturing processes such as grinding, extraction, packaging, or any other manufacturing process;
7. Insect repellents in direct contact with human skin; and
8. Topical patches, creams, ointments, and gels containing counterirritant ingredient as an externally applied substance that causes irritation or mild inflammation of the skin for the temporary relieve of pain in muscles or joints by reducing inflammation in deeper adjacent structures (these products should comply with the Canadian Counterirritant monograph).

Applicable guidelines and rules:

Key SFDA guidelines for the registration of herbal and health products include:

• Guidance for Presenting PIL and Labelling Information of Herbal and Health Products;
• General Rules for Products containing Vitamins and Minerals;
• SFDA’s Products Classification Guidance; and
• Guidance for submission

The SFDA is responsible for putting in place regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed in the Kingdom of Saudi Arabia. Please join our healthcare email list to receive more healthcare and life sciences legal and regulatory updates impacting the industry across the Middle East here.