'Gray marketing' supplements
Navigating the benefits and blind spots of U.S. supplementation regulation
In theory, dietary supplements in the U.S. are regulated – but not with the same scrutiny we expect for drugs or food additives. The regulatory system, shaped by the 1994 Dietary Supplement Health Education Act (DSHEA), permits supplements to be sold without FDA approval so long as they avoid claims to treat or cure disease. Because products can be sold without pre-approval or rigorous testing, supplementation is widely accessible but may come with little to no proof of safety or efficacy (Wallace & Koturbach, 2024).
The FDA’s role in supplement regulation is mainly reactive, intervening when adverse events occur or labeling and claims laws are violated. In contrast, research institutions such as the Office of Dietary Supplements (ODS) and the National Center for Complementary and Integrative Health (NCCIH) take a more proactive, research-oriented approach to strengthen the scientific foundation for supplement use. ODS has invested in public supplement ingredient and labeling databases, validated reference materials, systematic reviews, and supplement evaluations (Dwyer et al., 2018; Coates et al., 2024). Meanwhile, NCCIH has funded large-scale clinical trials and, more recently, shifted toward funding more mechanistic and translational work on botanicals and bioactive compounds (Coates et al., 2024; NCCIH, 2024).
Unfortunately, science has not been effectively translated into public policy or rigorous regulation. Despite the efforts of these institutions, many products still enter the market without testing. As of 2018, Dwyer et al. reported that over 85,000 supplements are sold in the United States, and the quality of ingredients varies widely. Furthermore, Coates et al. (2024) note that complex botanical formulations can be challenging to standardize, even with good manufacturing practices. Dwyer et al. (2018) emphasize that many supplements, especially those with botanical ingredients, are frequently adulterated or misidentified. Furthermore, the authors note that botanicals and blends, where active compounds may not be identified, can vary significantly from brand to brand. Even within marketing, there is a gray area, and consumers are left navigating products based on gray marketing rather than substantiated science. This also introduces a risk of medication interactions, especially for people managing chronic conditions.
The supplement industry is not going anywhere; it is growing fast. Emerging trends, such as precision nutrition, microbiome mapping, and wearable technology, are only widening this gap. As consumers increasingly rely on self-diagnosis, the science is advancing rapidly, but regulations have not yet kept pace (Coates et al., 2024). This creates both an opportunity and a responsibility for the supplement regulatory system to evolve. More consistent quality testing, improved enforcement of ingredient standards, more transparent labeling, and investment in research so that supplements deliver on what they claim could make a real difference.
References
Coates, P. M., Bailey, R. L., Blumberg, J. B., El-Sohemy, A., Floyd, E., Goldenberg, J. Z., Gould Shunney, A., Holscher, H. D., Nkrumah-Elie, Y., Rai, D., Ritz, B. W., & Weber, W. J. (2024). The Evolution of Science and Regulation of Dietary Supplements: Past, Present, and Future. The Journal of nutrition, 154(8), 2335–2345. https://doi.org/10.1016/j.tjnut.2024.06.017
Dwyer, J. T., Coates, P. M., & Smith, M. J. (2018). Dietary Supplements: Regulatory Challenges and Research Resources. Nutrients, 10(1), 41. https://doi.org/10.3390/nu10010041
National Center for Complementary and Integrative Health. (2024, January). Dietary and herbal supplements. U.S. Department of Health and Human Services, National Institutes of Health. https://www.nccih.nih.gov/health/dietary-and-herbal-supplements
Wallace, T. C., & Koturbash, I. (2025). DSHEA 1994 - Celebrating 30 Years of Dietary Supplement Regulation in the United States. Journal of dietary supplements, 22(1), 1–8. https://doi.org/10.1080/19390211.2024.2419434