The average American diet leaves a lot of room for nutrients: 32% of our calories comes from animal foods, 57% from processed plant foods, and only 11% from whole grains, beans, fruits, vegetables, and nuts. Research finds our plates lacking in a number of essential nutrients, including calcium, potassium, magnesium, and vitamins A, C, and D. So, it is no wonder that 74% of U.S. adults take dietary supplements in hopes of getting their nutrients. Assuring that dietary supplements are safe is imperative to public health, and as such, NSF/ANSI 173:2024— Dietary Supplements serves as an evaluation tool for analyzing dietary supplements.
What Is a Dietary Supplement?
Supplements are available without a prescription and are often available in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids. The objective of dietary supplements is to add or supplement the diet. So, people take supplements to make sure they get enough essential nutrients and to maintain or improve their health. Common supplements include:
- Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
- Minerals (such as calcium, magnesium, and iron).
- Botanicals or herbs (such as echinacea and ginger).
- Botanical compounds (such as caffeine and curcumin).
- Amino acids (such as tryptophan and glutamine).
- Live microbials (commonly referred to as “probiotics”)
Are Dietary Supplements Regulated by the FDA?
Yes, dietary supplements are regulated by the FDA, but they are not approved by the FDA. In other words, the FDA’s regulatory role largely begins after products enter the marketplace. Companies typically produce and sell dietary supplements without even notifying the FDA.
The FDA’s regulatory role includes enforcing the laws and regulations governing dietary supplements. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements. The FDA also periodically inspects dietary supplement manufacturing facilities as well as reviews product labels and other labeling information (including websites) to verify companies are meeting applicable manufacturing and labeling requirements.
The FDA additionally works to ensure that dietary supplements meet applicable safety standards. NSF/ANSI 173:2024, one such safety standard, notes that manufacturers of dietary supplements should submit an application to FDA for registration to assure their compliance.
What Is NSF/ANSI 173?
NSF/ANSI 173:2024 provides test methods and evaluation criteria to allow for the determination that a dietary supplement contains the ingredients claimed on the label, either qualitatively or quantitatively, and that it does not contain specific undeclared contaminants. This American National Standard establishes criteria for determining that good manufacturing practices (GMP) were followed in the production of dietary supplements. Dietary supplements, in the scope of NSF/ANSI 173:2024, contain one more of the following dietary ingredients:
- A vitamin
- A mineral
- An herb or other botanical
- An amino acid
- A dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
Certification to NSF/ANSI 173:2024 serves as a communication tool between manufacturers of ingredients and finished product, retailers, healthcare practitioners, and consumers.
What Are the Benefits of Dietary Supplements?
Dietary supplements can help people improve or maintain their overall health. They can also help you meet your daily requirements of essential nutrients. For example, calcium and vitamin D can help build strong bones, fiber can help to maintain bowel regularity, folic acid helps produce and maintain new cells, and vitamin A helps preserve a healthy immune system and vision. While the benefits of some supplements are well established, other supplements need more study.
It is also important to highlight that supplements should not take the place of a healthy diet. Some dietary supplements even can be dangerous, especially when taken in larger-than-recommended amounts. Fruits, vegetables, fish, and other healthy foods contain nutrients, which work together to keep us healthy. We cannot get the same synergistic effect from a supplement.
NSF/ANSI 173:2024— Dietary Supplements is available on the ANSI Webstore.