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(Source:NIH)

The National Institutes of Health’s Office of Dietary Supplements is doing all it can to help improve the US vitamin, mineral and supplement market, an area where it sees a lot of room for improvement.

Sponsoring research on potential health benefits from vitamins, minerals and other nutrients and compiling databases of labels and of ingredients for VMS products sold in the US are prominent among ODS’s work.

However, while working to improve the quality of VMS products available in the US and to provide information on the products to consumers, the ODS doesn’t have authority to impose change on the industry or in the marketplace.

“We are not a regulatory agency. So, we are not buying products off the shelf and testing them. That's not our job,” said acting director Joe Betz on 26 October during an online conference marking ODS’s 25th anniversary as an NIH office established by the Dietary Supplement Health and Education Act passed by Congress in 1994, Public Law 103-417.

Betz, who’s been acting director since 2018 after joining the office as Analytical Methods & Reference Materials Program director in 2001, and other officials discussed the ODS’s impact on the US supplement market in response to questions during the two-day webinar conducted online. It originally was scheduled as an in-person event in 2020 but due to travel restrictions was delayed until July before ODS opted for an online conference. (Compiling PreDSHEA Ingredient List Relies On Bridging FDAIndustry Gap)

“We work very hard at the [databases] to accurately and neutrally report exactly what is on the label. We don't make any judgments about what is legal or illegal, that's not our job. We just present that information in a searchable format. That's what the database is about,” Betts said

"If people call the same thing apple, orange and cherry, you can't put them into a database. You have to have a standard definition.” — Johanna Dwyer, ODS senior nutrition scientist

ODS’s supplement label and ingredient databases, they said, came about due to concerns about the accuracy of information consumers get about VMS products.

Labeling for supplements, although subject to Food and Drug Administration requirements, was an early area of ODS concern concerning their accuracy.

“We have a heck of a lot more [confidence] in labels than we did before ODS was established,” said Johanna Dwyer, a senior nutrition scientist in ODS’s Interagency Personnel Acquisition Program.

“That was one of the reasons why we started the dietary supplement ingredient database, because that does analytical estimates of the amounts on the label, like really going to the supplement and doing the chemical analysis,” she added.

Still, compiling the label database keeps ODS on top of errors on labeling for supplements sold to US consumers.

“They’re not all labeled very well. There are spelling mistakes, there are a whole bunch of different mistakes,” Dwyer said.

DSHEA Left Room For Misleading, Inconsistent Labeling

Additional problems ODS sees in the labels aren’t errors that make information noncompliant with FDA regulations. Leeway allowed for labeling information leads to inconsistent and misleading references.

DSHEA Opened Market 

Another authority the ODS doesn’t exert over the VMS market is the number and variety of products available in the US.

The large majority of supplement product categories and brands and businesses in the market have emerged since Congress passed DSHEA. In establishing a regulatory framework for marketing VMS products to benefit consumers’ health and wellness, the legislation also opened the door for a still-burgeoning market.

“A useful thing to consider is what kind of market force-effect the law had in changing the definition and the regulation of supplements in a free market, which provided a lot of freedom for the development and sale of supplements. In a way that has nothing to do with health, and everything to do with market,” said Abby Ershow, an ODS senior nutrition scientist focused on iodine nutritional status.

To a question of “why there's so many supplements on the market,” Betz said, “One answer is because there can be.”

When Congress passed DSHEA, around 600 manufacturers were making around 4,000 products in the US; currently, more than 17,000 manufacturers are making closer to 80,000 products.

As well, trade groups estimate the industry has grown from $6bn in annual sales in 1994 to more than $55bn in 2020.

“If people call the same thing apple, orange and cherry, you can't put them into a database. You have to have a standard definition,” Dwyer said.

“This is not something that's required by law, but people who want flavanoid databases or glucosinolate databases or whatever databases of these bioactives need to get together and make a common definition. Because otherwise you can't build a database. It’s putting apples, oranges and everything else into a goulash.”

Another inconsistency in VMS product labeling, Betz noted, is information on botanical ingredients.

“Nutrients and pure-chemical entities, isolates and things like that tend to have much-easier-to-interpret labels than do things like botanicals,” he said.

A single-ingredient botanical supplement or those with multiple, separate botanicals must list the amount of each and its source along with the part of the plant used. But under the “prepared proprietary blends” label policy for foods that extends to supplements, a single ingredient comprising multiple botanicals can be identified without amounts for the separate botanicals, he added.

“One is required to list the amount of the proprietary blend. On another part of the label one is required to list the components of the proprietary blend in order of decreasing presence in the proprietary blend. But there are no quantitative units associated with that. It's simply relative amounts,” Betz said.

Products with limited information on botanical amounts are difficult to assay for the ODS’s dietary ingredient database.

“If you're trying to measure the amount of phytochemicals that are declared on the label, and all that's declared on the label is the amount of the raw botanical, and there's no phytochemical constituents labeled, then it becomes difficult to do that evaluation,” Betz said.

Diseases In Studies, Not In Labeling

Changes in labeling regulations, though, won’t come through ODS.

“In theory, if it's on the market as a dietary supplement, labeling is required to be accurate. Inaccurate labels would render a product misbranded. There are some cases where having less or more of a certain ingredient would render the product adulterated. Again, that's not our call,” Betz said.

“Theoretically, everything that's on the market is accurately labeled. But that's FDA job.”

“Congress decided that there would be a category called dietary supplements, not focused on disease treatment, because there's already a congressionally created category of products for disease treatment, and those are called drugs.” – Joseph Betz, ODS acting director

It’s the FDA’s job under DSHEA, which also imposed rules including prohibiting VMS products using disease or drug claims on labeling and in advertising as well other manufacturing and marketing requirements.

Prohibiting disease and drug claims might seem incongruous when NIH and other public and private organizations as well as drug and VMS firms sponsor studies testing whether dietary ingredients help prevent or treat myriad disease conditions.

“The legislation was written by the Congress, and Congress intended the dietary supplement field to address health and wellness, general health and wellness,” Betz said.

“How the supplement industry could be benefited by disease claims, disease treatments? That is not up to us. That's up to the Congress.”

However, “risk-reduction work, even secondary or tertiary disease prevention” research can reveal reactions or relationships between dietary ingredients and disease conditions, Betz said. “Several steps before when we get to disease treatment.”

“Congress decided that there would be a category called dietary supplements, not focused on disease treatment, because there's already a congressionally created category of products for disease treatment, and those are called drugs.”

LaVerne Brown, director of the ODS Resilience Health Studies Program, also pointed out dietary ingredient research will reveal potential disease-prevention or -treatment links.

“Our focus is quite naturally not on disease at all. Our focus is on resilience, and how dietary supplements might impact resilience, might lead to enhancing pathways or outcomes that effectively are resilient outcomes,” Brown said.

“Quite frankly, you need both. We need to have an understanding of the disease outcomes as well as an understanding of resilience outcomes in order to know how dietary supplements make an impact,” she added. 

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