The Dietary Supplement Health & Education Act (DSHEA) and the Food & Drug Administration (FDA)
Have you ever taken a fish oil capsule or a multi-vitamin? Chances are that you have. You may have never considered why a typical consumer is allowed to purchase these items from a store shelf and ingest them with no medical prescription. After all, they are health supplements that we choose to put into our bodies almost every day. Shouldn’t that mean that they are all approved by the US Food and Drug Administration (FDA)? The answer is “no.”
Many US consumers today believe that if a product is being manufactured and sold on store shelves, it must be FDA approved. To understand “FDA Approval” it is helpful to understand the true role FDA plays in the supplement industry and why implementing the phrase “I only want to consume substances that are FDA approved” is practically impossible in a world where approximately 74% of US adults take dietary supplements. A 2023 survey by the Council for Responsible Nutrition found that 55% of those adults consume dietary supplements on a regular basis. Ninety-two percent of consumers believe dietary supplements are essential for maintaining health.
Supplements, vitamins, minerals, plant medicine, botanicals and herbs are all terms that the American public are accustomed to hearing. Ads for such products are common on social media sites and popular search engines. There are a plethora of articles and studies shared by the scientific community as well as publications by news media, magazines and bloggers. Never in history have people had more access to information regarding their health, wellbeing and diet.
Consumers are familiar with common dietary supplements such as multivitamins, fish oil, melatonin, magnesium and even caffeine. Dietary supplements also include a variety of herbals such as kratom, valerian root, ashwagandha, akuamma seed, ginseng, turmeric, kava and many more.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Bill Clinton. This act was introduced by Senator Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) in 1993. The act’s main goals were to ensure consumers had access to a variety of dietary supplements and to provide more information about their intended uses. The act also established a regulatory framework for dietary supplements, which were previously considered “foods for special dietary uses”.
DSHEA gave the FDA more authority to regulate the dietary status of dietary supplements as a category of foods. For example, dietary supplements are still not subject to the same strict regulations as food and drugs, and they do not require pre-approval before being released into the market. However, any supplements sold must adhere to labeling restrictions.
The passage of the DSHEA opened the door to the present-day American supplement industry. In 1994, FDA acknowledged approximately 4,000 supplements available in the marketplace. By March of 2024, that number grew to 100,000 making the dietary supplement industry worth over an estimated $60 billion. It is no wonder why the FDA sees this industry as a runaway train. To oversee such a large number of supplements is challenging in such a rapidly changing and diversifying industry. Since Congress is the only government body to have the power to regulate the behemoth which is FDA, often the duties, priorities, decision-making and obligations of the FDA to fulfill (or fail to fulfill) their mandates go mostly unchecked. Due to current laws, FDA has more autonomy and power than many people realize.
With respect to dietary supplements, FDA has four main roles to play:
1) Regulation – The FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. The FDA's regulatory authority is also “reactive” rather than preventive. If the FDA decides a claim to be misleading, it must issue a regulation or go to court to stop its use, which some say can be cumbersome and weaken the FDA's ability to protect consumers.
2) Enforcement - Products cannot be adulterated or misbranded. If these events occur, the FDA has the authority to take action against the company producing the product. For the vast majority of supplements, no health claims can be listed on product labeling. The disclaimer will read something similar to, “The FDA has not evaluated this health claim, and this product is not intended to diagnose, treat, cure or prevent disease.” Since 1990, there have only been 12 authorized supplement health claims. These are the only supplements not required to list the disclaimer on their labels.
3) Guidance - Under the DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. The FDA is obligated to update consumers regarding product approvals, safety issues and other health information. They are also charged with alerting the public to serious health risks associated tied to specific ingredients or products along with notifications regarding recalls, warnings and health fraud.
4) Monitoring – The FDA monitors the marketplace, inspects manufacturing establishments, reviews new dietary ingredients (NDI) notifications and reviews adverse event reports to identify if products could be unsafe.
In today’s culture, it is becoming more common for consumers to insist on making their own choices regarding their quality-of-life, diet, well-being, and health management. This is especially true when it relates to the array of dietary supplements now on the market. DSHEA provides FDA with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them to access a wide variety of affordable, high quality, safe and beneficial dietary supplement products.
It is important for consumers to understand that even if a dietary supplement is not “FDA approved” and it lists a health disclaimer, it does not mean that the product is not safe for consumption. This is especially true if the supplement contains laboratory tested ingredients, properly labeling and is manufactured with Good Manufacturing Practices (GMP) standards.
Consumers must be diligent and cautious as they purchase dietary supplements for consumption.
1) Always purchase from a reputable company who complies with FDA dietary supplement standards.
2) If purchasing from an online vendor, do not hesitate to reach out to the manufacturer to request information regarding laboratory testing. Choose supplements that have easy to read labels that include serving sizes, directions for use, and a full list of ingredients.
3) Research, research, research. Do not consume a dietary supplement (herbal or vitamin) if you are unsure about interactions with prescription medications or other dietary supplements. Interactions can even occur if certain supplements are taken with common items such as grapefruit juice.
4) Do not exceed the recommended serving sizes without consulting your doctor.
Dietary supplements are used by over three-quarters of Americans. They are used to help control pain (kratom, turmeric), sleep (melatonin), promote energy (caffeine), aid in constipation (magnesium), and even to protect your heart (fish oil). The DSHEA act allows Americans to purchase and consume these products at will. The International Plant and Herbal Alliance encourages the production and sale of safe, tested and properly labeled dietary supplements (both vitamins and herbals) to aid in the overall health and well-being of consumers.
References:
https://www.fda.gov/food/dietary-supplements
https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements
https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling