How to Improve Regulatory Measures for Dietary Supplements
Considering that 80% of adults in the United States use or have used dietary supplements, improvements to the current regulatory measures for dietary supplements are vital.
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- Across every pharmacy, grocery store, and convenience store in the United States, dietary supplements — in some shape or form — line the shelves. Many patients have the misconception that because these products are sold and positioned with other approved over-the-counter medications, they undergo the same regulatory processes.
However, the regulatory pathways of dietary supplements and medications are drastically different and significantly less rigorous than those of medical devices and pharmaceutical products. Considering that 80% of adults in the US use or have used a dietary supplement, there is an urgent need for improved regulatory measures.
Dietary Supplements
According to the American Journal of Public Health, dietary supplements are defined by the Dietary Supplement Health and Education Act as “a large heterogeneous group of products, intended to supplement the diet, that are not better described as drugs, foods, or food additives.”
Dietary supplements encompass a broad range of items available over the counter:
- vitamins
- minerals
- plant and animal extracts
- hormones
- amino acid
Dietary supplements come in many forms, including capsules, tablets, gels, powders, and liquids.
The Dietary Supplement Market
In a 2022 article in the AMA Journal of Ethics, Elizabeth Richardson, MSc, and her colleagues note that the market for vitamins and dietary supplements has multiplied over the past few decades.
Data from the journal notes that, in 1994, the dietary supplement industry was valued at $4 billion, with a mere 4,000 products available on the market. Today, the industry has roughly 80,000 products. The value has increased tenfold, reaching $40 billion. Despite this, regulatory laws for dietary supplements have remained unchanged since 1994.
Adverse Effects Associated with Some Supplements
The AMA Journal of Ethics highlights a need for increased regulation. The publication revealed that, between 2004 and 2013, there were 15,000 reported health problems associated with dietary supplements. Of those 15,000 incidents, 339 resulted in death, and 4,000 resulted in hospitalization.
According to Richardson and her peers, these incidents are a conservative estimate of dietary supplements' potential adverse side effects. In the publication, she notes there are underreporting issues and incomplete reporting, especially by voluntary reporters.
In the article, Richardson writes, “hundreds of dietary supplements on the market have contained undeclared or banned pharmaceutical ingredients, including some that were the subject of FDA warnings. Many products marketed for weight loss, muscle building, or sexual function have contained illegal substances that caused severe AEs, especially among young adults using them more frequently.”
Current Regulatory Issues
Despite this growth and the confusion around when to use dietary supplements, there is little regulation to protect consumer safety.
According to the AMA Journal of Ethics, “In the United States, supplements’ safety is regulated by the US Food and Drug Administration (FDA), but statutory limitations prevent the FDA from effectively regulating these products, exacerbate public health risk, and have generated numerous calls for reform.”
The AMA Journal of Ethics notes that there are significant issues in the supply chain of dietary supplements that pose a threat to consumers. The FDA is currently unable to regulate or evaluate dietary supplements on efficacy as it can with medical devices and pharmaceutical products without updated policy regulations.
Historical evidence from FDA inspections has found that manufacturers of these products often do not comply with federal quality and labeling standards.
Alongside other critics, Richardson comments that dietary supplement manufacturers often tiptoe around regulatory lines. Federal law prohibits these products from being marketed as cures or prevention methods for illness; however, manufacturers can use particular language to allude to those outcomes without providing evidence on the efficacy or validity of their claims.
Richardson notes, “the evidence supporting the use of dietary supplements is mixed. While there is relatively robust evidence to support the use of some supplements (e.g., folic acid in early pregnancy to avoid congenital disabilities), the evidence is minimal or even nonexistent for many products.”
The current regulatory framework for dietary supplements is based on the Dietary Supplement Health and Education Act (DSHEA), established in 1994. Under this act, the FDA cannot review dietary supplements before they are marketed. Manufacturers are not required to share information as essential as the name or ingredients in the product before sale.
With those rules in place, the FDA is left to rely on post-market assessments of these products. Even after products are on the market, the FDA carries no authority to regulate these products unless it or one of their ingredients is unsafe.
Even with the bit of regulatory power that the FDA has, bans and recalls require extensive time and resources. In an article published in the AMA Journal of Ethics, Richardson notes that “it took the FDA 7 years of litigation, which went all the way to US Supreme Court, to ban the use of the amphetamine derivative 1,3-dimethylamylamine, and 7 years to ban ephedra, an ingredient associated with increased risk of stroke and death.”
Proposed Regulatory Solutions
In her article for the AMA Journal of Ethics, Richardson puts forth some recommendations for reform, including the following:
- mandatory product listing
- clarified mandatory recall authority
- development of standards
- premarket review of labeling and claims
- new dietary ingredient notification (NIND) pathway reform
- adequate funding for FDA oversight
Mandatory product listing would force manufacturers to share product information with the FDA. This kind of transparency would allow the FDA to conduct a more comprehensive review of products.
Updated or clarified mandatory recall authority would allow the FDA to recall tainted, contaminated, or harmful products.
Many experts have recommended developing a standard for the manufacturing of dietary supplements. According to the AMA Journal of Ethics, criteria should include information on good manufacturing practices, regulation and quality assurance, quality control, purity, composition, and more.
The AMA Journal of Ethics suggests “that supplement labels be subject to a premarket review process, wherein manufacturers would be required to submit all label information to the FDA before marketing products to ensure regulatory compliance.”
Proposed Legislation
In an article published by Pew Trusts in April 2022, the organization mentions that on April 26, 2022, senators Richard Durbin (D-IL) and Mike Braun (R-IN) introduced legislation that would bestow additional authority on the FDA to regulate supplements more closely.
This legislation, called the Dietary Supplement Listing Act of 2022, would require the manufacturers of these products to provide the FDA with mandatory product listing, warnings, precautions, allergen statements, and more. The rule would allow the FDA to share and disclose the information with the general public.
The AMA Journal of Ethics concludes, “Congress is currently considering legislation that would provide the FDA with better and clearer authority to regulate dietary supplement products and protect public health. Outside of these reforms, however, healthcare practitioners should regularly engage their patients in conversations about supplement safety to ensure that they make more informed decisions about their consumption of these products.”
