New USP Chapter for Food Supplements

The USP published the new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests. The chapter is intended as an informational chapter and will become official on 1 December 2024.

Background

The USP proposed the new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests last year in the Pharmacopeial Forum (PF) 49(4). Multi-ingredient food supplements products contain two or more dietary ingredients (e.g., finished dosage forms that contain a combination of botanical ingredients and ingredients other than vitamins and minerals). They can be formulated as capsules, tablets, oral powders, oral liquids, or chewable gels (marketed as "gummies"). 

According to the USP, food supplement quality tests can be divided into three categories:

• Universal tests that are applicable to all dietary supplement products, regardless of the dosage form type;
• Specific tests that should be considered for inclusion for specific types of finished products;
• Product performance tests such as disintegration or dissolution to estimate the ability of the finished products to release dietary ingredients for potential absorption and ensure consistent product quality from batch to batch.

The quality tests listed in the chapter can be used by manufacturers to develop appropriate specifications to assure the quality of multi-ingredient dietary supplement products. Available monographs for individual dietary ingredients and finished food supplements can serve as a supportive starting point for considering quality tests for products containing the same ingredients. Quality tests and acceptance criteria listed in individual monographs also can be helpful in establishing specifications for finished products containing different combinations of multiple ingredients.

More information is available in the USP-NF.