USANA Supplement Manufacturing Standards
USANA Health Sciences operates in numerous countries around the world. So, USANA must meet the manufacturing and regulatory standards of each country to sell products there. Examples of these include the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
The FDA requires dietary supplement manufacturers to follow Good Manufacturing Practices (GMP) for dietary supplements (21 CFR, part 111). USANA meets and exceeds these standards by voluntarily using the more stringent GMP for pharmaceuticals (21 CFR, part 211) as the model for its quality-assurance program. This model regulates virtually every aspect of manufacturing, including facility design and maintenance, raw material specification and control, supplier validation, product design, product testing, and more.
Here are just a few of the ways USANA meets or exceeds the dietary-supplement requirements:
- Raw-material-supplier quality is reviewed by USANA’s Quality Assurance before suppliers are approved to provide ingredients for use.
- Samples incoming raw materials in-house by a statistically sound sampling plan. This ensures tests are representative of the entire lot of material received.
- Has a state-of-the-art laboratory on-site. It’s staffed by qualified scientists, who ensure the identity, purity, and potency of each ingredient and finished product, as well as the absence of contamination.
- Keeps an extensive library of product records and standard operating procedures to ensure quality is guaranteed for every batch.
- Coordinates a robust stability program to ensure products meet label claims throughout the product shelf life.
Since 2018, USANA’s Salt Lake City, Utah, manufacturing facility has been certified by United States Pharmacopeia (USP) to meet the applicable GMP requirements (set forth in the 21 Code of Federal Regulations, Part 111, and in USP General Chapter 2750). And, where applicable, USANA tests its supplements to make sure they meet USP standards and specifications for potency, uniformity, and disintegration.
As an Australian supplier, USANA is regularly inspected and audited by the TGA to ensure their GMP standards are met. TGA mandates that manufacturers follow a set of GMP similar to pharmaceutical GMP in the United States.
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 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.