The Lawless Land of Dietary Supplements: An Under-Regulated Industry
Jordan York, Natalia Rosario Meléndez, Emma Eisenbraun
Key points:
- The use of dietary supplements is ubiquitous in the United States.
- Dietary supplements reach the market with minimal oversight by the Food and Drug Administration (FDA).
- Law governing oversight has not kept up with the rapid growth of the industry.
Millions of individuals use dietary supplements in the US. Supplements have proven benefits for people with specific illnesses or nutritional deficiencies. However, the oversight that goes into bringing supplements to market is minimal.
Dietary Supplements Background
The FDA defines dietary supplements as a product, taken orally, containing one or more ingredients intended to supplement the diet. Dietary ingredients include:
- Vitamins
- Probiotics (i.e. live microbials)
- Minerals
- Botanicals
- Amino acids
Supplement Use in the U.S.
In the U.S., approximately 150 million people of all ages use one or more dietary supplements (Fig. 1). There are many reasons why people take supplements, including perceived benefits for overall health and wellness or to fill nutritional gaps.
Data supports the use of dietary supplements for specific deficiencies or medical conditions. For example, calcium and vitamin D help preserve bone health, folic acid decreases the risk of certain birth defects, and omega-3 fatty acids can help those with heart disease.
However, there is minimal evidence towards either the benefits or risks of healthy individuals taking dietary supplements, including daily multivitamins. In fact, dietary supplements are implicated in approximately 23,000 emergency department visits annually. Some supplements can interfere with other prescribed medications or medical treatments. Additionally, a recent report suggested taking probiotics following antibiotic treatment could result in bacteria in the gut becoming less responsive to future antibiotic treatments.
Over the past three decades, the dietary supplement industry has been rapidly growing.
- Over 80,000 supplements are commercially available.
- The economic value of the supplement industry is projected to reach $60 billion in the U.S. by 2025.
Regulation
Food and Drug Administration
The FDA regulates the processing, manufacturing, labeling, and packaging of supplements.
Dietary supplements are regulated as food by the FDA. This means that, unlike drugs, dietary supplements are not vetted by the FDA for safety and/or effectiveness before they are introduced to market.
Due to financial and legal restrictions, the FDA will only take action against a product if violations are found after it reaches the market. Such violations include:
- Safety issues
- Manufacturing violations
- Improper marketing (i.e. including the use of prohibited disease claims)
Current Regulatory Landscape
Given these constraints and the rapid growth of the supplement industry, policies regulating supplement manufacturers and distributors are minimal. This has led to:
- Adverse side effects of supplements are often underreported.
- Nearly 30% of supplement manufacturers fail to register with the FDA.
- Supply chain complexity can obscure tracking and sourcing of supplement ingredients.
- Lack of quality control can result in inaccuracies in the identity and quantity of ingredients present in a supplement.
This lack of oversight contributed to 73% of inspected supplement manufacturers failing to adhere to regulations in 2011. A recent study found that 22 of 25 commercially available melatonin products were inaccurately labeled. Inaccuracies included products containing CBD instead of melatonin, and melatonin products containing between 74 and 347% of the labeled quantity of melatonin.
Another study found that probiotic supplements contained microbes with antibiotic resistance and indicators of virulence. Additionally, the labels of these supplements inaccurately described the composition of microorganisms present.
Bipartisan Support for Changes in Regulation
Law governing FDA oversight on supplements was established in 1994 with the Dietary Supplement Health and Education Act. This act set the initial regulation standards and labeling requirements for dietary supplements.
Since that time, the industry has grown exponentially and other then several amendments to the 1994 act, the law has not been significantly updated. Current efforts at the federal level include:
- The Dietary Supplement Listing Act (2022): Aimed to establish a mandatory product listing for supplements. Manufacturers would need to provide the FDA the name and amount of each ingredient, warnings and precautions for use, and allergen statements.
- The Food and Drug Administration Safety and Landmark Advancements Act (2022): Amongst other provisions, this act includes the requirement that dietary supplement manufacturers disclose products and ingredients to the FDA.
There have also been regulation attempts at the state level, though these efforts have recently focused on restricting dietary supplements for weight loss and muscle building, and have often failed due to pushback from lobbying groups such as the Natural Products Association. For example, 2022 New York legislation establishing restrictions on the sale of over-the-counter diet pills and dietary supplements for weight loss or muscle building was recently vetoed by the governor.
