The U.S. Food & Drug Administration regulates but does not approve dietary supplements, which includes herbs, minerals, vitamins and other ingredients, under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law requires manufacturers and distributors to ensure their dietary supplements are safe before they are marketed. Consumers, in turn, are advised to first research the supplements they are interested in taking.
What are Dietary Supplements?
Dietary supplements are products taken by mouth that contain a dietary ingredient that augments a person’s diet. This dietary ingredient may be herbs or other botanical product, minerals, vitamins, amino acids, extracts or concentrates. Supplements come in the form of a pill, soft gel, liquid, capsule, powder or even a bar. Some examples of dietary supplements include Vitamin D, St. John’s Wort, Ginkgo, Ginseng, Glucosamine and Green Tea.
Dietary supplements are a different classification of drug. They are not intended to diagnose, treat, cure or prevent diseases.
Supplements work in various ways. Some reduce the risk of disease while others give you substances that help your body function well. Supplements should never be taken in place of a healthy diet. You should also be careful if the marketing or labeling of a dietary supplement sounds too good to be true. The FDA does not approve dietary supplements before they go on the market.
Regulation and Risks
According to the FDA, it is the responsibility of manufacturers and distributors to ensure their product is safe, correctly labeled and meets all DSHEA and FDA regulations. The FDA will review a supplement for safety before it goes to market only if it contains a new ingredient. The agency, however, does not approve the product or research the effectiveness of it as claimed by the manufacturers.
The FDA has limited resources to review the composition of dietary supplements. But it has the power to remove products from the market after it has shown that the supplement is unsafe or mislabeled. Because the FDA doesn’t approve supplements before they go on sale, consumers, health care professionals, industry officials and others need to report any serious reactions or illnesses to the FDA so it can act. These symptoms include:
- Rash, hives, itching, swelling in the throat, wheezing
- Low blood pressure, chest pain, fainting, irregular heart beat
- Severe or persistent nausea
- Fatigue, loss of appetite
- Slugged speech
- Severe joint or muscle pain
- Marked changes in mood, behavior; thoughts of suicide
Medical calls about dietary supplements are on the rise in recent years. A 2017 study from the Center for Injury Research and Policy and the Central Ohio Poison Center found that the rate of calls regarding dietary supplement exposure increased 49.3 percent from 2005 to 2012. Study authors say that many consumers believe that dietary supplements are held to the same safety standards as over-the-counter medications but they are not.
Who Verifies the Claims on Products?
The FDA does not require dietary supplement manufacturers and distributors to disclosure to the agency or consumers the evidence, data or other information they have about the safety or purported benefits of their product. It’s up to each firm to create policies on how to disclose that information.
Basically, manufacturers may make three types of claims about their product: health claims, structure/function claims, and nutrient content claims. Each type of claim has specific requirements, and you can learn more on this page. The DSHEA requires a disclaimer on dietary supplements when a manufacturer makes a structure/function claim on the product label. The disclaimer usually says: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”
Another agency, the Federal Trade Commission, regulates the advertising for dietary supplements. Both agencies work together in this area. You can learn more about the FTC on its website.
Tips Before You Use a Dietary Supplement
The FDA recommends consumers review their diet and consider whether supplements are needed. You should also check with your healthcare provider on whether using a particular supplement is a good idea. People with certain conditions such as those who are pregnant or are nursing a baby, or who have a chronic medical condition such as diabetes, heart disease or hypertension should consult their doctor.
Also, be sure you notify your physician if you’re taking any supplements in place of or in combination with drugs. Some supplements may interact with over-the-counter medicines or your prescriptions.
Before taking a supplement, be sure the product’s labels contain certain information. FDA regulations require the label include a complete list of ingredients, the net contents of the product, the name and location of the manufacturer or distributor. Nutrition labeling is also required for each dietary supplement, except in a few cases.
The FDA recommends researching supplements online using non-commercial sites rather than the information provided by sellers on their product websites. You can learn more about dietary supplements on this tips page by the FDA.
Report a Problem With a Supplement
You or your healthcare provider may report problems caused by dietary supplements to the FDA through the Safety Reporting Portal. You may also download a postage-paid MedWatch form from the FDA website. If you don’t have access to the Internet, you may call the FDA’s MedWatch hotline at 1-800-332-1088.
The agency wants to know about any serious adverse effect or illness related to a supplement, as well as problems with the product itself, such as a foreign object in the packaging or any other quality control issue. All submissions will be kept confidential.
Dietary supplements can be beneficial to your health. But you’ll need to be vigilant about assessing their claims and effectiveness, and distinguishing the hype from the science-based data. The FDA doesn’t approve dietary supplements before they enter the market. Consumers need to be skeptical about anecdotal information from individuals who have no formal training in nutrition or from personal testimonials. Remember, it a supplement sounds too good to be true, it just might be.