USP’s new supplements policy advocates for mandatory product listing

U.S. Pharmacopoeia (USP) has come down strongly on the side of mandatory product listing as part of a DSHEA overhaul in a new policy document released by the organization recently. 

USP’s new policy document, titled “Regulatory reform is necessary to help ensure the quality of dietary supplements,” makes the case that the Dietary Supplement Health and Education Act (DSHEA), the overarching law that governs the supplement industry, is in need of updating. The 1994 law has not been substantially altered since the addition of cGMP (current good manufacturing practices) requirements, the implementation of which was completed in 2010. 

The supplement industry’s trade groups are split over the idea of mandatory product listing. The FDA in its fiscal year 2025 budget request is asking Congress to authorize a mandatory product listing requirement. Sen. Dick Durbin (D-IL) introduced the Dietary Supplement Listing Act in the last Congress, in 2022, and has said as recently as March 2024 that he intends to introduce it again. 

The Council for Responsible Nutrition, which represents over half the industry (the largest companies), has long advocated such a listing protocol. CRN President and CEO Steve Mister told Natural Products Insider that it would help both brick and mortar retailers as well as Amazon by providing them with a listing of supplements manufacturers and marketers that are adhering to the plan. If a company is not listed, it would be easy to not take up that product.  

“This is not a panacea for all that ails the industry but it is a good first step,” said Mister. “Amazon is begging for things they can put in place to differentiate good from bad actors. Mandatory listing is an easy thing to implement.”  

USP: Current regs are behind the times 

The USP policy document, which runs to 18 pages, covers the many ways which in USP’s view the current regulatory regime fails to meet muster. The document cites the often-mentioned data point that DSHEA was conceived to cover a market that at that time had about $4 billion in sales distributed over about 4,000 products. 

Today, the U.S. supplement market is estimated to exceed $60 billion and, according to FDA, contains over 100,000 products. The haziness of the number of supplements on the market is one of the things that a mandatory product listing requirement could be expected to fix, the document asserts. 

Given that as many as 80% of Americans now use dietary supplements at least occasionally, the organization asserts FDA needs new authorities, new tools and more resources to ensure more uniform quality of the products in the marketplace. 

“[A]dditional policy reform should consider enhancing dietary supplement post-market surveillance, increasing visibility into the dietary supplement market with mandatory product listing, additional labeling requirements for dietary supplement products, and the utilization of a risk-based approach for adherence to public quality standards to advance dietary supplement quality,” the document states. 

New regulations priorities 

The new policy lays out seven priorities for how the current regulatory regime could be improved. They are: 

The document notes USP already has more than 800 documentary standards and approximately 200 physical reference standards pertaining to dietary supplement ingredients. Adherence to these standards for many substances like most vitamin and mineral ingredients is relatively straightforward. The monographs detail specifications, testing procedures and more. 

USP has many monographs for botanical ingredients, too, and the situation there is more nuanced. Herbal ingredients can have natural variability and can be produced via different methods to achieve slightly different specifications for different applications. 

Where new spec requirements make sense 

In light of this, the USP policy document advocates adhering to USP standards, which have been officially recognized by FDA, in the following instances: 

The USP document also includes proposals such as doing away with the practice of hiding ingredient amounts and specifications with proprietary blends. It also advocates for stricter standards when it comes to the use of expiration dates on labels.  

FDA capabilities need updating, too 

The policy document also lays out suggestions for ways in which facility inspections can be streamlined and third-party resources can be leveraged. As matters stand now, no more than 5% of dietary supplement manufacturing facilities are inspected in any one year.  

In FY23, for the second year in a row, the Food and Drug Administration performed about 500 inspections of dietary supplement facilities that are subject to manufacturing rules, reflecting a return to normalcy following a substantial decrease in audits at the height of the global pandemic.

To sum up, the USP document echoes a call heard around the industry for more resources for FDA. The industry’s revenues have exploded; the resources FDA can devote to the regulation of dietary supplements haven’t come close to keeping pace. 

“In the interests of public health and patient safety, increasing FDA resources for the oversight of dietary supplements is necessary to appropriately oversee the growing dietary supplement sector,” the document concludes.