United States Pharmacopeia (USP)
www.usp.org
[email protected]
(301) 881-0666

Ed Wyszumiala is the director of market development at the United States Pharmacopeia (USP), where he manages the verification programs and new program development. For more than 20 years, Wyszumiala has worked in the dietary supplement industry, where he has been involved in quality, regulatory affairs and corporate management.

Question: As more Americans turn to dietary supplements to boost their health, retailers are under more pressure than ever to act as gatekeepers and ensure the dietary supplements they carry on their shelves are authentic and safe. Many retailers, big and small, have implemented their own rules for dietary supplements, creating a patchwork of requirements that can be burdensome on manufacturers.

How does USP’s Verification Program help manufacturers check all the boxes required by multiple retailers, while helping consumers trust the quality of their products?

Answer: Product quality is the No. 1 buying consideration for consumers when purchasing dietary supplements, and over 71 percent look for a quality mark or seal when purchasing. The USP Verified Mark not only tells consumers that they can trust the quality of the product, but it can be used to help meet retailer requirements.

Many retailers have implemented their own rules for dietary supplements. For example, in December 2020, Amazon.com launched its own set of rules for products sold as dietary supplements on its site. Amazon specifies that companies listing products on Amazon must comply with all federal, state and local laws related to dietary supplements, including 21 CFR 101.36 (nutritional labeling of dietary supplements) and 21 CFR Part 111 (good manufacturing practices, or GMPs, for dietary supplements). The USP Dietary Supplement Verification Program (DSVP) checks all these boxes set forth by Amazon, as well as other retailers.

To earn the USP Verified Mark, USP DSVP participants undergo extensive current good manufacturing practice (cGMP) facility audits, quality control and manufacturing evaluation, and laboratory testing of their product for full compliance to specifications. This is a benefit to brands because DSVP is an independent verification of quality, which brings third-party scientific verification that is comprehensive and unbiased. Additionally, participants in the program will not have to do duplicative work with auditing and testing because it meets the rigor required by retailers.

Question: Manufacturers often have the USP Verified Mark on some products and not others. How do manufacturers decide which supplements to verify?

Answer: Some brands may only have the USP Verified Mark on their products at certain retailers, or only on some of their products. For example, for a brand that is sold at Costco, it may be USP Verified, so manufacturers seeking to sell in those stores will often seek out the USP Dietary Supplement Verification Program. With new products, brands will sometimes wait to see if a product takes a hold in the marketplace before moving forward with verification as the process takes time. Manufacturers often decide to become USP Verified to help differentiate their products with consumers and communicate their commitment to quality, given becoming USP Verified is voluntary.

Question: How have the latest disruptions due to the COVID-19 pandemic impacted the global supply chain? How has that affected the importance of third-party verification for dietary ingredients and supplements?

Answer: The global drug supply chain is complex and has always been vulnerable to disruptions. The COVID-19 pandemic is a disrupter unlike any the global supply chain has seen, and with increased disruption comes increased risk. Manufacturers must streamline and simplify operations more than ever before, which could come at a cost to quality assurance. Additionally, high demand for certain dietary ingredients and supplements are causing shortages, which, in turn, are leading to surges in production of those dietary ingredients or supplements. While shortages are worrisome, so are surges—materials coming from new suppliers to combat shortages may lack quality. For the same reason, there is increased risk of adulteration motivated by economic gain and not dedicated to quality.

For example, during COVID-19, there was an increase in demand for elderberry extracts, leading to shipment delays of elderberry bulk ingredients and as well as falsified materials, which led to an increase in adulteration. A recent investigation discovered that 76 percent of elderberry bulk extracts failed the identity test. Among the 25 bulk extracts that were analyzed, 14 failed the identity test, five contained no elderberry extract at all, and an adulterant of black rice extract was found in two.

There has always been a need for ensuring quality dietary supplements; however, the COVID-19 pandemic has brought this issue into the forefront. Dietary supplement sales were already on the rise, and the pandemic contributed to an even greater spike, causing dramatic growth in the market, while regulatory frameworks have continued to remain the same. To help ensure quality ingredients and products, the USP Dietary Supplement Verification Program continues to provide a safety net for consumers by ensuring that what is on the label is what is in the bottle.