Nutrition Supplements & Integrative Medicine

Nutritional supplements are regulated by the Food and Drug Administration (FDA). The FDA was granted regulatory authority in the Federal Food, Drug, and Cosmetic Act of 1994 and the Dietary Supplement Health and Education Act of 2006. Additionally, the Federal Trade Commission (FTC) regulates advertisements of nutritional supplements according to its truth-in-advertising laws. Nutritional supplements may include minerals, vitamins, herbs, and other dietary ingredients. However, these supplements are classified as foods rather than drugs, so they are managed with a different set of regulations than medications. 

There is no requirement that the FDA approve nutritional supplements prior to their availability on the market. It is entirely possible for a company to produce nutritional products and sell them without the FDA being aware that the products are available to the public. If a nutritional supplement isn’t safe or has incorrect branding, the FDA is responsible for investigating these issues. In the event that a nutritional supplement is found to be unsafe, the FDA can work with the manufacturer to ensure that it achieves compliance or remove the supplement from the market if it is truly unsafe. 

If the labeling on a nutritional supplement claims that the product can diagnose, treat, prevent or cure a disease, the FDA can treat the product as a drug rather than as food. Drugs are subject to closer scrutiny and are regulated much more strictly, which is why most nutritional supplements include a visible disclaimer stating that the product is not intended to diagnose, treat, prevent or cure any disease.

The FDA also monitors and regulates the production of nutritional supplements. Companies must follow strict guidelines when it comes to manufacturing these products, such as utilizing proper equipment and testing for quality assurance. The FDA inspects facilities and checks for compliance with its regulations in order to protect consumers.

With that being said, many healthcare advocates believe regulation of nutritional supplements in the U.S. is insufficient due to potential gaps, issues with safety, and lack of visibility into quality assurance in supply chains. Most individuals believe that if nutritional supplements are marketed as having natural ingredients, they must be safe. As a result of this misconception, healthcare professionals and other experts frequently issue reminders of the risks associated with taking supplements.  It is crucial for individuals to thoroughly research nutritional supplements and to consult their healthcare provider before integrating any supplements into their diet. By doing so, individuals can ensure they make informed choices that align with their health goals and needs.

Sources

“Dietary Supplements”. U.S. Food and Drug Administration. https://www.fda.gov/food/dietary-supplements 

“FDA 101: Dietary Supplements”. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements 

“What Should Dietary Supplement Oversight Look Like in the US?” AMA Journal of Ethics. https://journalofethics.ama-assn.org/article/what-should-dietary-supplement-oversight-look-us/2022-05 

“Dietary supplements are regulated by FDA and FTC”. Council for Responsible Nutrition. https://www.crnusa.org/regulation-legislation/dietary-supplements-are-regulated-fda-and-ftc 

Nutritional or dietary supplements are categorized as biologically based practices in Integrative and Alternative Medicine (CAM). Integrative medicine encompasses a wide variety of practices, therapies, and products that can be used in conjunction with traditional medical treatments. This includes nutritional supplements, which may contain minerals, vitamins, herbal remedies, botanical extracts and more. People generally take these products orally to provide additional nutrients or support to the body. 

Unlike medications, FDA approval is not required before nutritional supplements are sold to consumers.. Companies that make nutritional supplements are expected to follow Good Manufacturing Practices (GMPs), which means that the supplements must be produced according to specific quality standards. The manufacturer must also list the ingredients on the label, and the product cannot contain impurities or contaminants. The FDA maintains oversight of reports of adverse reactions, injuries, or illnesses associated with supplements. However, since the efficacy and safety of these supplements can vary, they should be used with caution. 

Individuals are encouraged to communicate with their healthcare provider if they intend to start a new supplement regimen or use supplements in combination with medications. It should be noted that combining nutritional supplements with medications may result in unwanted side effects including the increase or decrease of the medication’s effects or adverse reactions. Additionally, it is important to remember that these supplements should not be used as a substitute for receiving traditional medical care and treatment. 

Sources

“Complementary and Alternative Medicine”. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/cam 

“Good Manufacturing Practice (GMP) Resources”. ISPE. https://ispe.org/initiatives/regulatory-resources/gmp 

“What Are Dietary Supplements?” American Cancer Society. https://www.cancer.org/cancer/managing-cancer/treatment-types/complementary-and-integrative-medicine/dietary-supplements/intro.html 

“Know the Science: How Medications and Supplements Can Interact”. National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/health/know-science/how-medications-and-supplements-can-interact/introduction