Longevity Supplements Part 1: Regulatory Landscape

Written By Adama Diarra, DO, FACP

By Adama Diarra, DO, FACP

I want to start by admitting that writing about supplements has been one of the most challenging newsletters I’ve written to date. With so many supplements on the market, I assumed there would be ample high-quality data supporting their safety and efficacy in human patients. Naturally, I began my research as I would for any clinical or scientific topic—by looking for data-driven, objective studies conducted in humans. But to my surprise, those studies were either scarce or lacking in clarity.

This prompted me to dig deeper into why such convincing, objective research was so hard to find. While I had a few initial hypotheses, I approached the topic with an open mind and a critical eye, determined to guide my readers through the noise. It soon became clear that in order for readers to truly understand how to differentiate scientifically validated supplements from snake oil, they would first need to grasp the underlying regulatory landscape.

Supplements, Vitamins, and Longevity: Understanding the Regulatory Landscape

The role of supplements and vitamins in promoting longevity has garnered significant attention in recent years. However, distinguishing between effective compounds and those with unsubstantiated claims can be challenging. A primary reason for this difficulty lies in the differing regulatory standards: dietary supplements are not subjected to the same rigorous premarket scientific and clinical evaluations by the U.S. Food and Drug Administration (FDA) as prescription medications are.

While the prescription drug approval process is not without its flaws, it does enforce more stringent and transparent standards before granting FDA approval. To better understand the implications of these differences, let's first examine the approval processes for both prescription drugs and dietary supplements.

Prescription Drug Approval Process

The FDA oversees a comprehensive drug approval process designed to ensure that new pharmaceuticals are both safe and effective for public use. This process encompasses several critical phases, each with specific objectives and methodologies.

Duration and Cost: The entire drug development process, from initial discovery through FDA approval, is both time-consuming and costly. On average, it takes over a decade to bring a new drug to market. Financially, the investment is substantial. A study by Wouters et al. (2020) estimated that the median cost of developing a new drug is approximately $985 million, with the mean cost around $1.3 billion. These figures account for the expenses of clinical trials and the costs associated with failed drug candidates.

Case Study – Sildenafil (Viagra): Sildenafil, commonly known by its brand name Viagra, serves as a notable example of the FDA's drug approval process. Originally developed by Pfizer to treat angina, a type of chest pain associated with heart disease, the drug did not demonstrate significant efficacy for this purpose during clinical trials. However, researchers observed that it had a notable effect on erectile dysfunction. Recognizing this potential, Pfizer redirected its focus, and after rigorous clinical testing to assess safety and efficacy for this new indication, the FDA approved Viagra in 1998. This case underscores the importance of thorough clinical trials and the potential for drug repurposing based on observed effects during the research process (U.S. Food and Drug Administration, 2018). Table 1 summarizes the key phases in a drug approval process. 

Table 1: Pharmaceutical Approval Process. Sources: U.S. Food and Drug Administration, 2018; Wouters et al, 2020.

Supplement Approval Process

In contrast, the FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, supplements are categorized as a subset of food, not drugs. This classification means they are not subject to the same premarket approval processes as pharmaceuticals. Instead, manufacturers are responsible for ensuring the safety and labeling accuracy of their products before they reach consumers.

Premarket Requirements: If a dietary supplement contains a "new dietary ingredient" not marketed in the U.S. before October 15, 1994, the manufacturer must notify the FDA at least 75 days before marketing. This notification must include information demonstrating that the ingredient is reasonably expected to be safe under the recommended conditions of use (U.S. Food and Drug Administration, 2022).

Labeling and Claims: Dietary supplement labels must include the product name, the term "dietary supplement," a complete list of ingredients, the net quantity of contents, the name and place of business of the manufacturer or distributor, and a Supplement Facts panel. Any claims made must be truthful and not misleading. Supplements can make structure/function claims (e.g., "supports immune health") but must include a disclaimer stating that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease (U.S. Food and Drug Administration, 2022).

Post-Market Surveillance: The FDA monitors adverse event reports and can take action against products found to be unsafe or misbranded. Manufacturers are required to report serious adverse events to the FDA. However, the FDA's ability to act is often reactive, relying on post-market surveillance rather than premarket approval (U.S. Food and Drug Administration, 2022). Table 2 provides a brief overview of the supplement approval process. 

Table 2: Supplement Approval Process. Sources: Food and Drug Administration, 2022; NutraSeller, 2024

Table 3: Pharmaceutical and Supplement approval processes compared and contrasted. Sources: NutraSeller, 2024; US Food and Drug Administration, 2018; US Food and Drug Administration; 2022; Wouters et al, 2020. 

Conclusion

Understanding the distinctions between the regulatory processes for prescription drugs and dietary supplements is essential for consumers who want to make informed decisions about their health. For every dollar spent developing a dietary supplement, an estimated $20,000 to $200,000 is spent developing a pharmaceutical drug. This is due to the far more rigorous regulatory requirements to prove safety and efficacy before a medication can be approved for widespread use. Table 3 above compares and contrast the pathways. 

Because bringing a supplement to market is significantly less expensive and less demanding, many companies opt for the easier, more cost-effective route. As a result, the safety and effectiveness of supplements are not demonstrated at the same standard as pharmaceutical drugs.

It’s a bit like comparing my recreational soccer league team to a Premier League professional team. While I believe in my teammates and love a good underdog story, my rational brain knows we’d be in over our heads on that field. In our own league, though, we do really well—we’ve even won the championship multiple times.

All this to say: while supplements can play a meaningful role in supporting wellness, it's important to approach them with a critical eye—just as you would with any other health intervention—recognizing the vast differences in regulatory oversight and the implications that has for their safety and efficacy.

References:

  • DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33. https://doi.org/10.1016/j.jhealeco.2016.01.012​:contentReference[oaicite:3]{index=3}

  • Investopedia. (2014). Clinical Trials: What It Means, How It Works. Retrieved from https://www.investopedia.com/terms/c/clinical-trials.asp​:contentReference[oaicite:4]{index=4}

  • NutraSeller. (2024). Cost of Starting a Supplement Company: Realistic Breakdown. Retrieved from https://nutraseller.com/how-much-does-it-cost-to-start-a-supplement-company/

  • U.S. Food and Drug Administration. (2018). The Drug Development Process. Retrieved from https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process​:contentReference[oaicite:17]{index=17}

  • U.S. Food and Drug Administration. (2022). Dietary Supplements. Retrieved from https://www.fda.gov/food/dietary-supplements

  • U.S. Food and Drug Administration. (2022). Questions and Answers on Dietary Supplements. Retrieved from https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements

  • Wouters, O. J., McKee, M., & Luyten, J. (2020). Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA, 323(9), 844–853. https://doi.org/10.1001/jama.2020.1166​:contentReference[oaicite:18]{index=18}