Elephant in the room: A tribute to the U.S. Pharmacopeia Verified Mark for supplements

Created over two centuries ago, the U.S. Pharmacopeia (USP) is a world-renowned, impartial scientific organization that sets standards for medicines and other products, including dietary supplements. Through the USP Verified Mark, dietary supplement brands can demonstrate to consumers that their products are made to quality standards.

I gathered information on the USP Verified Mark as part of an Elephant in the Room series of articles about quality issues in the dietary supplement industry — the good, the bad and the ugly.

According to USP, the mark indicates that a product:

- Contains the ingredients listed on the label, in the declared potency and amount.

- Does not have harmful levels of specified contaminants.

- Will break down and release into the body within a specified period of time.

- Has been made according to FDA current good manufacturing practices (cGMPs) using sanitary and well-controlled procedures.

United Natural Products Alliance (UNPA) President Loren Israelsen said he has worked with USP for decades. He described USP’s verification program as “the Marines of the dietary supplement certification military,” or “a gold nugget in a gold mine, and it’s going to take you more time, work and expense to get to it. And for some, it’s really worth it.”

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“Some” is the operative word. As many as 100,000 different dietary supplement products are sold in the U.S., according to FDA estimates. Yet only a little over 150 products carry the USP Verified Mark.

That’s according to Michael Rashed, USP’s former director of non-pharma programs. Rashed is no longer with USP, but he had been working with the nonprofit group for seven and a half years when I interviewed him in June.

The vast majority of products with the USP Verified Mark — over a whopping 90 — are held by Nature Made, the brand owned by Pharmavite. Nature Made became the first USP-verified brand in 2002, according to Martin Dennison, Pharmavite’s DVP (divisional vice president) of quality.

“The USP Verified Mark on Nature Made products tells you that the offering has been independently verified for quality and contains the ingredients listed on the label in the declared potency and amounts, will break down and release into the body within a specified amount of time, has been made according to FDA current good manufacturing practices [cGMPs] using sanitary and well-controlled procedures, and doesn’t contain harmful levels of specified contaminants,” Dennison said.

That all sounds great to me, but I asked Rashed why relatively so few products — and brands in the industry — carry the USP Verified Mark. He admitted the cost of the verification program is “a potential factor,” though added USP has “high standards.”

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Few certification bodies “do anything close to what we do in terms of the quality control and manufacturing document review,” said Rashed, who described the verification program as “fairly intensive.”

Trident Seafoods is among the roughly 20 brands that have participated in the USP verification program. Senya Joerss, technical manager of supplements with Trident Seafoods, described USP’s program as a “three-tier program that includes extensive maintenance and continual compliance activities.” The company has two products that are USP-verified: Pure Alaska Omega Wild Alaskan Salmon Oil 1000mg Softgel and Kirkland Signature Wild Alaskan Fish Oil 1400mg Softgel.

USP audits all bottling and manufacturing facilities and performs a documentation review during the physical audit along with a review of testing methods, Joerss explained.

“All USP-verified items are submitted annually for testing to confirm that what’s on the label is what’s in the bottle,” she added. “Testing criteria cover the four ‘Ps’: positive identity, purity, potency and performance.”

Joerss contrasted USP’s verification program with other third-party programs, noting others may only test products once to demonstrate compliance.

“Or, programs might have no facility audit component, raw material testing review, final product release activities, or review of product stability,” she said. “Single-timepoint product testing is only as good as the time the product was tested and fails to ensure overall product safety compliance with global standards or demonstrate compliance throughout the product’s declared shelf life.”

A spokesperson for USP confirmed that its review of document manufacturing records is a separate step and is done in addition to the cGMP audit requirements.

UNPA’s Israelsen wagered that the chances of a dietary supplement brand carrying the USP Verified Mark are slim to none if it’s only sold on Amazon, for example, and relies on a contract manufacturer to make its products.

“People will generally say, ‘Yes, [the USP Verified Mark is] probably the most difficult one to achieve,” Israelsen commented.

Most of the dietary supplement products in the market, Rashed shared, will not be USP-verified because they “would not make it through the program.” He nonetheless suggested USP is happy to engage with additional brands interested in obtaining the prestigious mark, especially those “serious about quality.”

Duffy MacKay, senior vice president of dietary supplements with the Consumer Healthcare Products Association (CHPA), cautioned that the USP Verified Mark — and other certification programs — are not the only way to demonstrate quality. For example, he mentioned CHPA members who tout the legacy of parent brands that have been in business for decades and built trust with consumers.

“Others use product transparency,” MacKay noted, such as disclosing certificates of analysis, sharing videos of their production facilities and encouraging people to visit their manufacturing plants.

MacKay said he’s noticed over the last decade that mainstream media articles often recommend that consumers should avoid dietary supplements unless they carry some type of third-party certification. MacKay described the trend as “unfortunate” and among the reasons his trade organization endorses regulatory modernization “so that generally people can have more confidence in all supplements in the areas of transparency, product quality [and] accurate information.”

While he acknowledged a third-party certification like the USP Verified Mark contributes to building consumer confidence, MacKay noted these programs are voluntary, and federal regulations already require that products list ingredients on the label, meet the declared potency and don’t contain harmful levels of environmental contaminants like heavy metals or pesticides.

Rashed also acknowledged the federal cGMPs applicable to dietary supplement products that govern such areas as testing methods, establishing specifications and setting limits on contaminants. But he noted the U.S. Food and Drug Administration often finds that firms don’t have proper testing methods and specifications.

This is a topic I have written about ad nauseam, or for over a decade. The top five dietary supplement manufacturing violations cited in FY23 by FDA related to quality control (QC), written procedures and establishing specifications, I previously reported. Based on FDA inspections of facilities in FY23, the most common “observation” or violation of the current good manufacturing practices was tied to a requirement in 21 CFR 111.70(e) that manufacturers establish product specifications for identity, purity, strength and composition, and limits on contaminants.

USP’s “standards and what we ask of our participants to get through the program is not miles above what the actual law and the GMPs say they need to do,” Rashed said.

Asked for comment on USP’s program, an FDA spokesperson said, “The FDA is committed to working collaboratively with all of our stakeholders to help ensure that dietary supplements are safe, well-manufactured and accurately labeled. In general, we appreciate efforts by industry stakeholders, such as the USP Dietary Supplement Verification Program, to enhance the level of overall compliance and ensure that dietary supplements meet the applicable requirements.”

During my reporting for this story, I inquired whether consumers appreciate — and truly understand — the significance of the USP Verified Mark or any other third-party certification program. According to Pharmavite’s Dennison, the mark does make a difference in purchasing decisions.

“Consumers are more focused on health and wellness than ever before and, as the continued growth within the vitamin and supplement industry has led to an influx of new brands and products in the space, the USP Verified Mark helps identify the brands prioritizing quality and transparency,” he said.

Consumers value a commitment to the above attributes, according to Dennison. He cited as examples consumer reviews that show Nature Made’s credentials, such as the USP Verified Mark and the #1 Pharmacist Recommended vitamin and supplement brand based on a survey of pharmacists.

Israelsen noted consumers are prone to recognize a mark, like the blue dot associated with NSF certification, though he suggested that relatively few consumers of dietary supplement products discern differences between third-party certification programs.

Consumers “become very visual in terms of recognizing something they know represents something good, but beyond that, you ask for a few details, and they say, ‘I really don’t know,’” Israelsen said.

Some explanations for this lack of nuanced understanding or knowledge may be that American consumers are inundated with too much information — and disinformation.

“In the age of social media influencers and online purchasing power, it’s difficult to know if consumers really understand the value of the USP verification mark,” Joerss of Trident Seafoods said. “The U.S. dietary supplement industry is very competitive and creative marketing tactics and misinformation are common. Because consumers get information from so many different sources, it is difficult to determine which messages are being well received to ultimately lead to a purchasing decision. That said, educated consumers seem to understand the value of a USP Verified Mark or NSF Sport quality seal as an independently verified product.”

She added, “The USP standard for approving drugs and pharmaceuticals is better understood by physicians and doctors and thus recommendations for taking dietary supplements holding a USP Verified Mark are favored over supplements without.”

As of press time, neither the American Medical Association (AMA) nor the American Pharmacists Association responded to a request for comment on the USP Verified Mark.

Editorial analysis

Perhaps whether consumers fully appreciate the USP Verified Mark is a sidebar, or distraction from the more important point. In my view, rigorous certification programs like the one offered by USP give brands like Nature Made and Trident Seafoods a chance to showcase the quality of their products and combat the notion that consumers can’t trust that what’s declared on the label in dietary supplements is in the bottle.

Responsible industry should have no problem with that.