Science Policy News

The 2023 ASPET Washington Fellows have authored policy briefs as part of their experience in the Washington Fellows Program. A policy brief is a summary of information with recommendations that highlights a policy problem and helps readers understand, and likely make decisions about, government policies. The fellows were asked to write a brief on any policy area that interests them. This final activity for the 2023 Fellows Program provided an opportunity for participants to implement what they learned from the program that included advocacy and policy writing. Their briefs also provide writing samples they can use in the future. This section includes policy briefs from eight of the fellows.

The Rapid Rise of Dietary Supplement Consumption: A Case for Increased Efforts Towards Regulation and Safety Research

Caitlin J. Risener, M.S., PhD Candidate

Emory University, Molecular and Systems Pharmacology

What are Dietary and Herbal Supplements?

Dietary supplements are defined by congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994 as products that are taken orally (as a capsule, tablet, powder, or liquid), intend to supplement the diet, include one or more dietary ingredient (i.e., vitamins, minerals, herbs or other botanicals, amino acids, enzymes, tissues from organs or glands, or extracts of these). Herbal supplements (also referred to as “botanicals”) are a subset of dietary supplements that contain one or more herbs.

Rapid Market Growth of Dietary and Herbal Supplements

Dietary and herbal supplement sales are multi-billiondollar industries steadily increasing over the last decade in the United States. Experts estimate that the overall sales of dietary supplement market ($33.7 billion as of 2020) will increase by 4% by 2025. Herbal supplement sales in 2011 totaled $5.302 billion, then increased nearly 140% to $12.350 billion by 2021. The COVID-19 pandemic contributed to a notable spike in sales for all dietary supplements

(7.5%), with a 17.3% increase in herbal supplement use from 2019 to 20206-8. These trends suggest that many U.S. residents placed trust in what they believed to be “natural” remedies during difficult times in public health.

“Natural” Does Not Necessarily Mean “Safer”

Many dietary supplements are marketed based on potentially harmful understudied ingredients using overzealous claims not backed by scientific research. The lack of appropriate research funding towards safety and pre-market regulation for dietary supplements poses a risk to public health.

Though sales of herbal supplements increased tremendously, the funding towards researching safety and efficacy of all dietary supplements remains inadequate with a steady average of $262.7 million from 2012-2022. In 2020, $318 million of government funds were devoted to dietary supplement research, which was only 0.94% of the revenue brought into the U.S. market from dietary supplement sales.

While the United States Food and Drug Administration (FDA) regulates medical products under the U.S. Department of Human and Health Service, many consumers are unaware that the FDA does not approve dietary supplements for safety and efficacy before they are sold to consumers. However, the FDA does investigate concerns regarding a product’s compliance with laws and regulations after entering the marketplace as described under the DSHEA.

Dietary Supplement Misinformation on Social Media

Social media provides fast and easy to digest information to consumers, but the rise of health-related misinformation on various platforms (such as TikTok) is concerning. While many posts are well meaning, there are also financial incentives for some content creators promoting their own storefront or programs to sell potentially harmful “natural” alternatives for weight loss supplements, sexual stimulants, and products to reverse or prevent liver disease.

Examples include:

Berberine falsely promoted as a “natural” alternative to Ozempic for weight loss

“100% Herbal Viagra” found to be adulterated with the FDA-approved active synthetic molecule in Viagra

Avenir Nutrition “Liver Shield” – a dietary supplement that claims to cleanse and support the liver

The Future of Dietary Supplement Research and Regulation:

In March 2023, the FDA announced in its budget request of $7.2 Billion for the 2024 Fiscal Year, highlighting numerous ways funds will be invested into dietary supplement safety and efficacy efforts, as well as modernizing the DSHEA. These changes would expand the transparency of dietary supplements in the marketplace, while also clarifying the FDA’s authority. In addition to the FDA, many dietary supplements are funded by The Office of Dietary Supplements (ODS) and the National Center for Complementary and Integrative Health (NCCIH).

The ODS is the branch of the National Institute of Health (NIH) responsible for strengthening the research and public education efforts regarding dietary supplements as a result of the DSHEA. The ODS budget for FY2022 was $27.9 million to largely support research. Many of its projects were co-funded with various agencies to promote further research on safety for dietary supplements, with the area of botanicals as the largest co-funded area (50%) in FY2022.

The NCCIH is a branch of the NIH focused on strengthening the scientific information available regarding the usefulness and safety of complementary and integrative approaches. The FY2023 budget was $170.3 million, with a large focus on dietary supplement research. The NCCIH issued multiple notices from 2020-2023 highlighting funding opportunities for programs such as Centers for Advancing Research on Botanicals and Other Natural Products (CARBON) Program, Botanical Dietary Supplement Research Centers (BDSRC), and Center of Excellence for Natural Product Drug Interaction Research.

Consumer Resources:

■ To better inform consumers, the FDA released the Dietary Supplement Ingredient Directory in March 2023. This resource allows the public to access all current information for ingredients listed in dietary supplements and will eventually serve as a tool to alert consumers of unlawfully marketed ingredients and other advisories.

■ The FDA publishes Warning Letters – Health Fraud for consumers to cross-check their dietary supplements for all fraud including adulterated products and any unapproved or unsubstantiated claims.

■ Independent of government regulation, there are two not-for-profit groups, U.S. Pharmacopeial Convention (USP) and NSF International (NSF) that analyze dietary supplements to verify the product is unadulterated, uncontaminated, and potent. Additionally, these groups will audit the manufacturing facilities. Labdoor is a for-profit option that teams up with FDA-certified laboratories for chemical analysis of dietary supplements.