By V. Srini Srinivasan
As raw materials used in dietary supplements are sourced from around the world and global manufacturing of finished products accelerates, a new resource now available can help manufacturers, suppliers, laboratories and regulatory agencies ensure the quality of these ingredients and products. Published by the US Pharmacopeial Convention (USP), the 2012 USP Dietary Supplements Compendium (DSC) can assist dietary supplement manufacturers in developing quality specifications, testing new products, qualifying raw materials and protecting their overall supply chains. India has emerged as a leading source of supplements and their ingredients, paralleling its rise as a global pharmaceutical manufacturer. This is certainly the case for herbals and botanicals, as traditional Indian medicines have become more widely accepted around the world. Particularly for Indian manufacturers interested in exporting to the United States, the DSC can help establish the quality of supplements and ingredients to U.S. customers and regulators.
USP is a nearly 200-year-old, private, non-governmental organization that sets standards for the identity, quality, purity, and strength of dietary supplements, food ingredients, and medicines. Headquartered in the United States, USP has had a facility in Hyderabad since 2005, which was greatly expanded in 2011.
Praveen Tyle, Ph.D., USPs utive vice president and chief science officer, noted the DSCs value to manufacturers: While estimates vary, we know that many people consume one or more dietary supplement products as part of their overall health strategy. The quality of these products and the ingredients that go in to them should be paramount. The new USP Dietary Supplements Compendium offers international dietary supplement manufacturers of all size a comprehensive resource for finding suitable, unbiased and scientifically sound analytical methods, and specifications for the identity, quality and purity of ingredients and products.
In addition to analytical methods and specifications, the DSC includes essential information such as the U.S. regulatory framework for dietary supplements, industry guidance documents and tables of dietary intake levels. Other practical features for manufacturers, ingredient suppliers, contract laboratories and regulatory agencies include checklists for Good Manufacturing Practices audits used by the USP Dietary Supplement Verification Program (see below for a description of this program); Good Agricultural Practices from the American Herbal Products Association; and U.S. Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidelines on appropriate labeling for dietary supplements. Again, these are of special interest to Indian manufacturers that export ingredients or finished supplements to the United States. DSC standards also can be used as the basis for buyer-supplier relationships and contractual agreements regarding expected quality of dietary supplement components.
The USP Dietary Supplement Verification Program and a companion program for USP Verified Dietary Ingredients is another means by which manufacturers can assure their customers of product quality and distinguish themselves competitively.
USP Dietary Supplement Verification Program
Products that meet the program’s stringent criteria are awarded the distinctive USP Verified Mark for use on labels, packaging, and promotional materials. The Mark makes it easy for customers, healthcare practitioners, and retailers to identify USP Verified products. Seeing the USP Verified Mark on a label indicates that the dietary supplement product inside contains the ingredients listed on the label, in the declared potency and amounts; does not contain harmful levels of specified contaminants; will break down and release into the body within a specified amount of time; and has been made according to FDA current Good Manufacturing Practices using sanitary and well-controlled procedures.
USP Verified Dietary Ingredients Program
Manufacturers of dietary ingredients that pass USP Verification can display the USP Verified Ingredient Mark on containers of verified products, as well as on an accompanying Certificate of Analysis. When the manufacturers of dietary supplement finished products see this distinctive mark on the containers of ingredients they buy, they can feel confident that the ingredients are consistent in quality from batch to batch; the ingredients meet label or certificate of analysis claims for identity, strength, purity, and quality; and the ingredients are prepared in accordance with accepted manufacturing practices; the ingredients meet requirements for acceptable limits of contamination.
Taken together, USPs DSC and Verification programs offer manufacturers a comprehensive tool kit for helping to ensure product quality. As more people around the world turn to dietary supplements to enhance and maintain their health and as the supply chains for these supplements grow ever-more complex and transnational it is vitally important that quality be a top priority for manufacturers and regulators alike.
About the Author
The author is utive Vice President and Chief, International Sites and Standards, US Pharmacopeial Convention (USP).