FDA approves drugs and vaccines, but supplements are not advertised as “approved.” Why do supplement labels say they “might help” instead of something more convincing? What evidence must they provide to justify their use and who is responsible for policing the market? Are there any products that cause adverse events?
The FDA doesn't regulate dietary supplements before they are marketed.
Companies do not even need to notify the FDA that a product is being launched.
The supplement manufacturer is responsible for ensuring that claims on the label are accurate.
The FDA’s oversight includes inspecting manufacturing facilities and monitoring adverse events.
Consumers should notify the FDA of adverse events – even a single report can be helpful.
Consumers are increasingly interested in preventive health, including aging well, weight management, improving sleep, and sports nutrition. Dietary supplements are one way to improve health, or at least feel better simply through the act of taking a step toward better health—called the “placebo effect.” Supplements are defined as vitamins, herbs or botanicals, minerals, amino acids, or other concentrates or metabolites that you take by mouth. Probiotics, for instance, are considered dietary supplements when taken as a tablet or a powder.
The supplement industry is currently estimated to be $151.9 billion in value, with an annual growth of nearly 9%. Vitamins comprise the largest category of supplements, but botanicals, omega fatty acids, fibers, and specialty carbohydrates, as well as proteins and amino acids, are contributing to the growth. It is important to understand that the Food and Drug Administration (FDA) plays a different role with drugs and vaccines than it does with dietary supplements, which are regulated like a food product, and what we can do to help keep our families informed as the industry grows.
What is the FDA’s role in regulating drugs?
The FDA is actively involved in drug development, from concept to packaging, testing, manufacturing, and distribution. The drug developer must submit a plan which describes what the drug or vaccine is intended to do, what populations are thought to benefit from the new drug or vaccine, and the plan for testing dosing, safety, and efficacy. Once the drug is available to be prescribed or administered (as with vaccines), the final phase of testing is called “post-marketing surveillance.” During this time, adverse events are reported and analyzed to see if they are happening more often than expected. If a warning is required, the packaging and product information sheets are updated and clinicians are sent an advisory letter.
How does the FDA regulate supplements?
The FDA allows manufacturers to ensure they are meeting safety and labeling requirements. It is not until after the product is marketed that the FDA gets involved through consumer complaints or adverse event reports. This process may take years, though, before a harmful product is pulled off the market.
Are any other agencies involved in regulating supplements?
The Federal Trade Commission (FTC) has the authority to enforce rules against deceptive advertising. The FDA and FTC share responsibility for oversight of products sold on the Internet. In a recent review, the Government Accounting Office (GAO) found 28 examples of memory aid products improperly linking usage to the treatment or prevention of memory-related diseases.
What health claims can supplement manufacturers make?
Unlike drugs, dietary supplements cannot make any claims that they can diagnose, treat, cure, or prevent any disease. Certain claims, based on scientific evidence, are permitted if the FDA is notified within 30 days, such as:
Health claims – how a supplement can reduce the risk of a disease or condition (for example, calcium can reduce your risk of osteoporosis). The FDA has authorized 12 health claims since 1990.
Structure/function claims – describe how a substance can produce an effect on the body (for example, “calcium builds strong bones”).
What should consumers know about claims on the label?
The dietary supplement industry has some unsavory actors who falsely label products or include drugs (sometimes unapproved drugs or novel stimulants) in dietary supplements. These hidden drugs may not be included on the label. The Consumer Healthcare Products Association (CHPA) called on the legislature for more reforms to the Dietary Supplement Health and Education Act (DSHEA) in July 2022 to “…balance consumer access to safe and beneficial dietary supplements with FDA’s ability to swiftly remove dangerous and illegal products from the marketplace...” Much of the burden for the safe use of supplements rests with consumers, therefore it is important to research the FDA website and talk to your doctor before starting a new supplement, and bring all your supplements to doctor visits so potentially dangerous interactions can be spotted.
What are some common adverse events related to supplements?
Adverse event symptoms can include stomach complaints, rash, hives, heart palpitations, low blood pressure, fainting, chest pain, abnormal bleeding from the nose or gums, fatigue, or appetite loss.
Where can I find the latest alerts and warnings before I purchase a supplement?
The FDA publishes an alert for consumers listing companies that illegally market products advertising that they treat or prevent serious diseases. The agency also publishes a health fraud scam list, warning letters, and public notices. Given the proliferation of cannabidiol (CBD) containing products, the FDA is monitoring how companies market their products, issuing warning letters for violations, while also trying to expedite approvals for lawful marketing of cannabis-containing products.
The FDA is conducting detailed reviews of CBD-containing product labeling and marketing — including company websites and social media accounts — claiming that the products reduce chronic pain, arthritis, anxiety, depression, bipolar disorder, PTSD, panic, and more. The agency is also creating consumer education materials to describe potential harmful side effects related to CBD-containing products.
Dietary supplements are generally safe, may not offer any real health enhancement, and are unlikely to be harmful if used carefully after doing sufficient research. Does this sound vague and unhelpful? Remember, the FDA has only authorized 12 health claims in the last 30 years. As with most things moderation is key.
Some obvious dangers include taking a wide variety of supplements and medications at once and purchasing supplements on the internet from unfamiliar suppliers. This does not mean that all manufacturers are untrustworthy, but the market is regulated by consumers in concert with the FDA, so use the resources provided carefully before purchasing and monitor how you feel. Also, consider introducing only one supplement at a time instead of starting a new regimen all at once. Finally, take the opportunity to talk about dietary supplements you might be considering with your teens. Partnering with them may help you all make sound decisions. (Hint: They may also be able to serve as in-house social media experts to identify adverse events not yet reported to the FDA.)
- NIH. Using Dietary Supplements Wisely.
- FDA. The Drug Development Process.
- NIH. Dietary and Herbal Supplements.
- FDA. Supplement Your Knowledge.
- Emerging Drugs in Sport. Contamination of Sports Supplements with Novel Psychoactive Substances: An Old History with New Players.
- FDA. Dietary Supplements: Report Adverse Events to FDA.
- FDA. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
- FDA. What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.