12601 Twinbrook Pkwy.
Rockville, MD 20852-1790
Phone: (301) 881-0666; (800) 227-8772
Email: [email protected]
Website: www.usp.org

The Science Behind Ingredient Integrity

There’s an old adage—garbage in, garbage out. If you can’t verify the quality of your ingredients, you can’t verify the quality of your end product. As a manufacturer, you likely rely on a trusted supplier to provide quality ingredients. But is trust enough? Not anymore. In today’s world of increasingly complex global supply chains, it’s okay to trust, so long as you verify. Not only is this the right thing to do, it is also a regulatory requirement.

Establishing qualified supplier relationships is critical for success, and auditing suppliers is a business best practice. Independently verifying the authenticity, identity, content and purity of ingredients is essential for supplement manufacturers to minimize business risk. The FDA (U.S. Food and Drug Administration) current good manufacturing practices (cGMPs) in 21CFR111.75(a)(2)(ii)(A) require supplement manufacturers to qualify their suppliers, if they intend to rely on a supplier’s certification of analysis (CoA). Equally, if not more important, is the need to establish suitable specifications for ingredients and supplements, as required by the cGMPs in 21CFR111.70(b) and (e). The lack of appropriate specifications for ingredients and supplements is frequently cited as a cGMP violation by FDA.

Although more closely associated with the pharmaceutical industry, the United States Pharmacopeial Convention (USP) has a wealth of resources available for the nutrition industry to help ensure the quality of ingredients used in dietary supplements and foods. USP establishes science-based quality standards for dietary supplement ingredients and products, and offers supplier qualification and verification programs for the same.

News stories about tainted herbal supplements and adulterated foods have made consumers wary and have prompted them to seek reassurance that the products they use are of high quality. That’s why now more than ever, it’s important for supplement and food manufacturers to employ USP’s stringent quality standards to help ensure the quality of both the ingredients they purchase and the products they deliver to consumers.

Dietary Supplement Standards

The United States Pharmacopeia-National Formulary (USP-NF) contains quality standards for drugs and dietary supplements. The USP-NF is recognized as an “official compendium” in the Food Drug and Cosmetic Act (FDCA) for drugs, and in §403(s)(2)(D) of FDCA, as amended by DSHEA regarding misbranded dietary supplements.

The Dietary Supplement Compendium (DSC) is intended as a comprehensive resource specifically for the dietary supplement industry. In this single reference, the nutrition industry can find the all the unbiased, scientific-based specifications and information they need to develop, manufacture, and test new products; to qualify raw materials; to prepare for cGMP audits; to develop and validate test procedures; and to conduct in-process and batch-release tests. The DSC contains close to 500 monographs for dietary supplement raw materials (e.g., ginkgo), ingredients (e.g., powdered ginkgo extract) and finished products (e.g., ginkgo tablets). Monographs set forth an ingredient or product’s name, definition, specification and other requirements related to packaging, storage and labeling. The specification consists of tests, test procedures and acceptance criteria that help ensure the identity, strength, quality, purity and performance of the ingredient or product.

Verification Services

For supplement manufacturers that want to be reassured of the quality of the ingredients they purchase, or those that want to demonstrate the quality of the finished products they deliver to consumers, USP offers two third-party verification programs.

The USP Dietary Ingredient Verification Program is offered to ingredient manufacturers who want to reassure supplement manufactures that their dietary ingredients meet USP standards, and can serve as a means by which supplement manufacturers can qualify their suppliers. USP staff help ensure that quality is built into ingredients by conducting on-site facility GMP audits, reviewing product documentation, performing comprehensive laboratory testing, and conducting annual off-the-shelf testing of randomly selected samples to confirm that USP-verified ingredients continue to meet USP standards.

Similarly, the USP Dietary Supplement Verification Program is offered to supplement manufacturers who want a scientific, independent third-party verification of product quality to reassure retailers and consumers that their products meet USP’s stringent quality standards. When consumers see the USP Verified Mark on a dietary supplement label, they have assurance that the product contains the ingredients listed on its label, in the declared potency and amounts; it does not contain harmful levels of specified contaminants it will break down and release the ingredients into the body within a specified amount of time; and it has been made according to FDA and USP cGMPs.

In addition to dietary supplements, consumers increasingly turn to functional foods for the health benefits they desire. USP also engages in standards-setting activities for food ingredients that help support the quality and safety of food through a variety of resources.

For more on USP’s offerings for the food industry, visit www.usp.org.