Supplement Manufacturing Standards
USANA Health Sciences operates in numerous countries around the world. USANA must meet the manufacturing and regulatory standards of each of these countries in order to sell products there. Examples of these, include the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
The FDA requires that dietary supplement manufacturers follow Good Manufacturing Practices (GMP) for dietary supplements (21 CFR, part 111). USANA, however, voluntarily follows the more stringent GMP for pharmaceuticals as the basis for its quality assurance program, which regulates virtually every aspect of manufacturing, including facility design and maintenance, raw material specification and control, supplier validation, product design, product testing, and more. This voluntary adherence to GMP for pharmaceuticals means that USANA treats nutritional supplements with the same care that goes into the manufacturing of over-the-counter medications. Also, where applicable, USANA voluntarily tests its supplements to make sure they meet trusted United States Pharmacopeia (USP) standards and specifications for potency, uniformity, and disintegration. In addition, USANA has acquired Drug Establishment Registration with the U.S. Food and Drug Administration. This means USANA operates an FDA-registered facility, following the FDA’s highest possible standard for manufacturers.
The TGA mandates that manufacturers follow a set of GMP identical to pharmaceutical GMP in the United States. As an Australian supplier, USANA is regularly inspected and audited by the TGA to ensure that their GMP standards are met.
Aside from meeting the criteria of regular TGA audits, USANA has voluntarily obtained additional third-party verification of GMP status. Since 2006, USANA’s Salt Lake City, Utah, manufacturing facility has been certified to be in compliance with NSF/ANSI Dietary Supplement GMP requirements set forth by NSF International. According to NSF, “GMP registration reflects [a] continued commitment to ensuring quality and satisfaction and gives companies confidence that their organization operates in conformance to established GMP.” In addition, a number of USANA supplements have been evaluated and approved by ConsumerLab.com, a leading provider of independent test results and information.
USANA is also a member of the United Natural Products Alliance (UNPA)—an association of dietary supplement and functional food companies that share a commitment to provide consumers with natural health products of superior quality, benefit, and reliability.
It is USANA’s mission to develop and provide the highest-quality, science-based products. Because poor manufacturing can destroy great science, USANA is one of the few companies to manufacture most of its products in its own state-of-the-art facility. To ensure that the formulas developed in USANA’s laboratories are produced consistently, the same process is followed each time manufacturing begins. By rigorously testing each product for potency and purity and by following pharmaceutical GMP, USANA has set the standard for excellence in dietary supplement manufacturing.