Modernizing dietary supplement regulations: A comprehensive approach

As we advance further into the 21st century, personal health care is evolving at an unprecedented pace. No longer limited to over-the-counter (OTC) medicines and medical devices, self-care now encompasses a wide array of consumer products, including dietary supplements, which play an increasingly critical role in promoting and maintaining personal health. OTC medicines and medical devices have been long-trusted allies in managing personal health, and now dietary supplements are used more than ever as part of consumers’ health strategies.

This welcome evolution is driven by a growing awareness of the benefits that vitamins, minerals and other supplements can offer, from filling nutritional gaps to supporting physical performance and immunity or providing targeted support that can enhance individual health outcomes, particularly when dietary intake alone may not suffice.

It’s not just a matter of personal health — it also has significant implications for public health. Supplements can play a crucial role in reducing the risk of chronic diseases and improving population health outcomes. For instance, folic acid supplementation is known to prevent neural tube defects in newborns, and adequate intake of antioxidants like vitamins C and E can help reduce the incidence of certain chronic eye diseases that contribute to vision loss. By supporting preventive health measures, dietary supplements can help to alleviate the burden on health care systems and contribute to a healthier society.

But not all supplements are created equal, and the quality and efficacy of products can vary widely. This is especially true when considering the bad actors whose poor manufacturing and marketing practices affect the entire industry’s reputation.

The need for comprehensive improvements

The dietary supplement industry has undergone a dramatic transformation since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. Back then, the industry was valued at $4 billion; today it surpasses $61 billion, with approximately 75% of Americans using dietary supplements. This remarkable growth has outpaced our regulatory framework, allowing bad actors to infiltrate the market with poor quality and potentially dangerous products. The Consumer Healthcare Products Association (CHPA) strongly believes that America’s consumers deserve an updated and modernized DSHEA that will equip the U.S. Food and Drug Administration (FDA) with the tools necessary to efficiently and effectively oversee this vast and rapidly evolving industry.

Why do we believe reform is necessary? While DSHEA was groundbreaking legislation at the time it became law, granting FDA the authority to regulate dietary supplements, the regulatory environment has not kept pace with the industry’s explosive growth to fully ensure consumers have access to safe, beneficial products and accurate information. The law’s boundaries are stretched today under the pressure of modern global problems and sophisticated global problem-makers. Today’s regulations fall short in preventing opportunists from intentionally introducing substandard and adulterated products into the market. For example, the illicit sale of tianeptine — a substance banned by FDA for any use — is a stark reminder of the dangers posed by current regulatory gaps. Increasing reports of severe side effects and fatalities linked to tianeptine provide just one highlight of the need for comprehensive reform.

Over the years, several attempts have been made to bring DSHEA into the modern era through single-solution fixes that may each have merit, but which alone are simply not enough to do the job. For example, recent legislative proposals for mandatory product listing (MPL) represent a good first step, but as a stand-alone measure is simply not enough. That’s because even with MPL, FDA would still lack the resources and authority needed to quickly and efficiently remove illegal products like tianeptine from the market. Without a more comprehensive framework of stronger regulations in addition to MPL, these dangerous products could remain in the market undetected through loopholes such as removing the term “dietary supplement” from their labels to avoid any MPL requirement at all.

As we approach the 30-year anniversary of DSHEA this fall, the time is right for a more comprehensive approach to regulatory modernization, and CHPA is committed to working with Congress, health care professionals, consumers and other industry leaders and stakeholders on effective proposals that will promote consumer safety, foster transparency and trust, and enhance public health.

Below are the five key priorities CHPA is advocating for:

1. Improve transparency with mandatory product listing – Requiring every manufacturer to publicly list their currently marketed dietary supplements in an FDA-maintained database is one of the regulatory improvements needed to improve industry transparency and public trust. At the same time, providing FDA with a fit-for-purpose list of products provides FDA a line of sight into the industry that currently does not exist. This transparency is crucial for consumers, health care providers and regulators to differentiate between legitimate dietary supplements and dangerous or illegal products. MPL would serve as a critical first step in increasing marketplace visibility, enabling the FDA to monitor the industry more effectively.

However, MPL alone is not enough. While it would alert FDA to the presence of potentially misbranded and illegal products, it would not grant FDA the authority or resources to remove such products swiftly and efficiently. Therefore, MPL must be part of a broader strategy that includes additional regulatory measures.

2. Increase manufacturing oversight by allowing third-party audits – Developing an FDA accredited third-party audit program could significantly increase FDA’s ability to monitor compliance with good manufacturing practices. This approach would enhance industry-wide accountability, making it more difficult for bad actors to evade scrutiny. By leveraging third-party audits, we can ensure that manufacturing practices across the industry meet current standards, thereby protecting consumers from substandard products.

3. Stop illegal activity with a new prohibited act – To streamline FDA’s processes used to combat illegal activity by bad actors who don’t care about consumer safety or our industry, we propose creating a new “prohibited act” that empowers FDA to take immediate and decisive action against manufacturers and sellers of illegal, harmful or banned ingredients. This would give FDA the authority to more efficiently address threats posed by products containing dangerous substances like tianeptine, thus enhancing consumer safety and trust in the marketplace.

4. Strengthen innovation by revising the preclusion provision – Current interpretations of DSHEA’s preclusion provision prevent dietary supplement manufacturers from using certain safe and beneficial ingredients if they have ever been researched for use as a prescription drug first, even if those drug products never reach the market. Ingredients like N-acetyl-L-cysteine (NAC) and nicotinamide mononucleotide (NMN) fall into this category. This restriction stifles innovation and limits consumer access to valuable supplements. Revising this provision would allow responsible manufacturers to use these ingredients, promoting innovation and bringing beneficial products to market more quickly.

5. Update information sharing for the digital age by modernizing regulations for online marketing – The regulations established 30 years ago at the dawn of the internet do not reflect the ways consumers access information today. Modernizing these regulations to allow manufacturers to share published scientific studies and relevant product information online would provide consumers, health care providers and others with quick access to beneficial evidence-based information. This update would align regulatory practices with current digital marketing trends, enhancing informed decision-making for consumers and health professionals.

We believe these priorities for comprehensive DSHEA modernization are essential steps not only to better protect consumers now and in the future, but also to ensure the integrity of the dietary supplement industry. By addressing these areas, we can create a regulatory framework that enhances consumer trust and safety, empowers the FDA to act against criminal behavior, and fosters a marketplace that supports innovation and access to more high-quality supplements.

We will be working with our champions in Congress and stakeholders across the consumer, health care and retail sectors to advance a bill that will bring dietary supplement regulations in line with the ambitions of the dietary supplement industry.