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U.S. Pharmacopeial Convention (USP): 2016 Science of Ingredients

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USP Verified Mark

Recent reports challenging the quality of dietary supplements have prompted industry leaders and health professionals to find ways to distinguish quality products from subpar products as they strive to protect their brands and consumers. A prominent solution that manufacturers, health professionals and consumers have relied upon is to look for the USP Verified Mark.

Pharmacists Know and Trust USP Verified

Pharmacists are strong proponents of the USP Verified Mark primarily because they are familiar with USP’s role in establishing quality standards for medicines. Since 1906, Congress has required that medicines sold in the U.S. meet public standards, and recognized the US Pharmacopeia and the National Formulary, or USP and NF, as “official compendia” of those standards.

Pharmacists are accustomed to seeing the letters “USP” on the medicines they dispense. So when the quality of dietary supplements are challenged, it is not surprising that they would look to USP for an assurance of quality. “How can we protect patients in this milieu?” asked Cydney McQueen, PharmD in a Guest Editorial published in the March, 2016 issue of the journal Hospital Pharmacy. Her answer: “Provide education on the problem of quality and practical guidance on how to navigate store shelves.” Her top recommendation for both pharmacists and consumers is to look for third-party verification of quality, specifically the USP Verified Mark. Sarah Erush, PharmD, clinical manager of the Pharmacy at the Children’s Hospital of Philadelphia, took this approach one step further and required her hospital pharmacy to try to only stock dietary supplements that have been independently tested for product quality. She also prefers the USP Verified Mark.

Industry Appeals to USP to Help Make Quality Visible When Congress created a separate regulatory category for dietary supplements in 1994, it continued to recognize USP standards as official, but made them voluntary. An unintended consequence of this law, was that it created a disincentive for what had been an accepted practice, adding the letters “USP” after the product or ingredient name to indicate it was made to USP standards. But many manufacturers still wanted a way to indicate their products were made using USP’s rigorous, science-based standards. So, at the request of industry, USP created “USP Verified,” a voluntary independent third-party verification program based on USP standards to help address their concerns. The USP Verification process includes facility audits, full document review of quality control procedures, and testing products against USP’s public standards. Products that meet USP’s rigorous procedures are awarded the USP Verified Mark.

The USP Verified Mark offers assurance that what’s on the label, is in the bottle; in the right amount; it has been tested for harmful levels of contaminants; and will break down so it can be absorbed by the body. Early participants in the program were NatureMade and Costco’s Kirkland Signature brand. The USP Verified Mark makes a participant’s commitment to quality visible and helps differentiate their products in a competitive marketplace.

Retailers Can Look to USP Verified to Manage Risk

In February 2013, the New York attorney general (NYAG) sent cease and desist letters to several major retailers demanding they remove some of their herbal dietary supplement products from store shelves because tests using DNA methodology showed they did not contain the ingredients listed on the label. Although the test methods used by the AG’s office were challenged, the move garnered negative press for those retailers and the industry.

Among the 500-plus quality standards for dietary supplements and dietary ingredients in the USP-NF are standards and test methods for all of the botanical extract products and ingredients targeted by the NYAG. None of these standards currently include DNA test methodology. None of the brands cited in the NYAG’s letters were USP Verified. If they were, USP would have conducted an investigation to ensure they complied with standards found in the USP-NF, and USP would stand by the quality of those products.

Media Reports Advise Readers to Look For the Mark

Increased scrutiny of the dietary supplement industry did not end with the investigation by the NYAG. Federal enforcement actions against a few manufacturers of products primarily in the sports, sexual enhancement and weight loss segments, included product recalls and other events making dietary supplement quality a steady focus of news reports over the past year. Many stories have pointed to USP Verified and other third-party seals as a way to help consumers choose quality products.

Demand for Verification Seals is Growing

The supplement industry is under unprecedented scrutiny. Reports of poor quality among products in a few segments have called into question the quality of almost all products. And independent verification seals are popular and a useful tool to help distinguish quality products. Pharmacists, national brands, major retailers, and the media rely on these seals to help patients, consumers, and readers determine quality products. Consumers are learning to look for the USP Verified Mark to ensure what’s on the label is what’s in the bottle. As a result, interest in the USP Verified program is growing.

More information about the USP Dietary Supplement Verification Program can be found at www.uspverified.org.