Global Regulations: IADSA Creates a Global Guide for Good Manufacturing Practices for Dietary Supplements

When the global dietary supplement market is considered in its entirety, the number of products causing negative alerts is actually very small, with products often produced by companies who are not affiliated with a supplement trade association and who thus receive little or no guidance and support in Good Manufacturing Practices (GMPs) and regulatory compliance. However, these small number of products have created a large degree of distrust by regulators across the globe in the safety and quality of supplements.

The International Alliance of Dietary/Food Supplement Associations (IADSA) was formed in 1998 as an international body uniting the supplement sector. It now represents more than 50 associations and 20,000 companies over six continents. In addition to its other areas of speciality, IADSA has a technical program that is focused on continuing to build quality in the manufacture of supplements. At IADSA’s annual general meeting in February of last year, a great deal of discussion took place on the need for a global guide to GMPs for supplements. This followed a presentation on the international issues challenging the safety and quality of supplements and the frequent negative media stories that occur around the world.

In many regions of the world, supplements fall under the classification of food. In others, they exist in a grey area between food and pharmaceuticals. Although there have been a number of GMP guides produced for both these sectors, current GMP guides that have been produced for food or pharmaceuticals in general do not always encompass the areas that are essential to supplement manufacture.

In order to increase the awareness of supplement manufacturers around the world of the need for GMPs, and to raise the standard of all supplements to the level of quality expected by both regulators and consumers, IADSA members recognized that a specific global guide to GMPs for supplements was an important requirement. Thus, the decision to produce such a guide was adopted at the annual general meeting.
 

The Global Guide

A working group of GMP and quality experts from across the globe was created during the weeks following the 2010 annual general meeting. Its dedicated members worked electronically throughout the year, with regular discussions held via conference calls. The group’s goal was to produce a nonprescriptive but comprehensive guidance document, which would cover the essential requirements of GMPs for supplements and satisfy all regions of the world, while allowing for the substantial variations in the capabilities and financial circumstances of these different regions.

A detailed review was initially undertaken of all available national GMP guidelines and laws, including those for both food and pharmaceuticals. This review confirmed that the basic principles of GMPs were the same throughout all the documents, which differed mainly in the amount of detail incorporated in some sections and the degree of prescriptiveness in the legal requirements. While working on the preliminary chapters of the IADSA guide, the biggest issue was found to be that many specific words or phrases have different meanings between countries or regions. Considerable discussion was required in some cases before appropriate terms that would suit all regions were agreed on. For instance, the very first hurdle was what to call the products concerned, as the terminology varies around the globe: health supplements, dietary supplements, food supplements, etc. The decision was finally made to use the all-embracing term supplements.

The final draft of the IADSA Guide to GMP for Supplements was adopted for publication at IADSA’s annual general meeting this March. It provides advice on all aspects of GMPs, in a nonprescriptive framework format that allows for flexibility in application within any region. The Guide is suitable for use by every supplement manufacturer around the globe, from the smallest independent business to the largest corporation, within the poorest region to the wealthiest.

The Guide, which was due for publication at the end of May, will be freely distributed and is available for download from the IADSA website (www.iadsa.org). The intention is for the document to be utilized by as many supplement manufacturers around the globe as possible, including those who are not affiliated with a supplement trade association, and as a model for countries developing GMP regulations. The initial Guide will be published in English, but straightforward translation into national languages should be relatively easy. Discussions are already ongoing regarding translation of the guide into Japanese.

If manufacturers work to the IADSA GMP guidelines, the safety and quality of supplements across the world should be raised to a far higher standard.