Proposed Product Quality Tests for Food Supplements

The USP proposed a new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests in the Pharmacopeial Forum (PF) 49(4). The chapter is intended as an informational chapter, not as a requirement for compliance. The comment deadline is 30 September 2023.

Background

The new chapter proposal is based on the previously issued draft chapter Multi-Ingredient Dietary Supplement Products—Development of Quality Tests, which was published in PF 47(5) [Sept.–Oct. 2021]. On the basis of comments received, that proposal has been canceled and is being replaced with a new proposal that revises the content of the chapter. The title of the draft chapter also has been changed to Multi-Ingredient Dietary Supplement Products—Product Quality Tests to better describe the revised content.

Multi-ingredient food supplement products are products containing two or more dietary ingredients. They can be formulated as capsules, tablets, oral powders, oral liquids, or chewable gels (marketed as "gummies"). The chapter focuses on the quality tests that are generally necessary to assess the quality of various dosage forms for which individual USP monographs are not available. It can be used for food supplements that contain a combination of herbal ingredients and ingredients other than vitamins and minerals.

Proposed Product Quality Tests

According to the USP, the product quality tests can be divided into three following categories:

• Universal tests
• Specific tests which should be considered depending on the finished dosage form
• Product performance tests such as disintegration or dissolution

Amongst others, these Universal Tests should be performed:

• Heavy Metals: Finished dosage forms should meet the requirements of Elemental Contaminants in Dietary Supplements <2232>. This USP chapter provides the analytical procedures and acceptance criteria for the four major elements of toxicological concern (i.e., As, Cd, Pb, and Hg). Additionally, other elemental contaminants identified as potential reasonably anticipated contaminants (RACs) should be evaluated.
• Residual Solvents <467>: Food supplements should contain levels of residual solvents no higher than can be supported by safety data.

More information is available in the USP's General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests after registration to the Pharmacopeial Forum.