Are weight loss supplements regulated by the FDA?

The Food and Drug Administration (FDA) regulates dietary supplements, including those promoted for weight loss. Like other dietary supplements, weight-loss supplements differ from over-the-counter or prescription drugs in that the FDA does not classify them as drugs.

Dietary supplements

are regulated by the FDA as foods, not drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a drug you are taking or with a medical condition you may have.

Products containing hidden drugs are also falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it is important to consult with a healthcare professional before using any dietary supplement. Read these consumer updates to learn more. The FDA has developed these questions and answers (Q & A's) to help consumers, health professionals and the general public understand the FDA's actions regarding weight-loss products contaminated with various prescription drugs and chemicals.

Many of these products are marketed as dietary supplements. Unfortunately, the FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants to ensure their safety. Compliance measures and consumer warnings for unapproved products only cover a small fraction of potentially hazardous weight loss products that are marketed to consumers on the Internet and in some retail outlets. The FDA is the federal agency that oversees dietary supplements in the United States.

Unlike over-the-counter and prescription drugs, which must be approved by the FDA before they can be sold, dietary supplements do not require FDA review or approval before they are marketed. In addition, manufacturers do not have to provide evidence to the FDA that their products are safe or effective before selling them. Learn about COVID-19, COVID-19 vaccines, and updates for patients and visitors from Mayo Clinic. Tempting claims, but are the products compliant? The promise of rapid weight loss is hard to resist.

But do weight-loss supplements lighten more than just your wallet? And they're safe? Dietary supplements are sold as health aids. Common ingredients are vitamins, minerals, fiber, caffeine, herbs, and other plants. Some of the most popular supplements claim to improve nutrition, increase energy, build muscle or burn fat. They are not intended to treat or cure diseases.

Companies that manufacture supplements are responsible for the safety of their products. They must ensure that their products are free of contaminants and that they are accurately labeled. Dietary supplements do not require U.S. UU.

But if a supplement is found to be unsafe, the FDA may issue warnings or ask for it to be recalled. The FDA may also take action against companies that make false or unsubstantiated claims to sell their supplements. You may be surprised to learn that manufacturers of dietary supplements rarely conduct clinical trials. That is partly why there is little scientific evidence to show that weight-loss supplements work.

For example, raspberry ketone is marketed as a clinically proven weight loss product. This statement is supported by a clinical trial. The trial included 70 adults with obesity. All of them underwent a restricted diet and exercise program.

They were then randomly assigned to receive a placebo or supplement containing raspberry ketone, caffeine, bitter orange, ginger, and garlic root extract. While these results are intriguing, the fact that the trial was small and lasted only eight weeks means that the results cannot be reliably generalized to real-world situations. More importantly, a short trial like this can overlook side effects that only manifest with prolonged use. In addition, a supplement containing several ingredients was used in the trial.

Therefore, it is impossible to know which ingredient was responsible for weight loss. Ideally, these initial results would be tested in a much longer trial involving hundreds of participants with careful follow-up of side effects. The results of such a test would allow an informed decision on the safety and efficacy of such a product. Until data from such trials are more readily available, claims about dietary supplements and weight loss should be treated with caution.

A product is not necessarily safe simply because it is natural. Although rare, some dietary supplements have been linked to serious problems, such as liver damage. Ephedra (ma-huang) is an herb that was once used for weight loss. It is now banned by the FDA because it was associated with adverse effects, such as mood swings, high blood pressure, irregular heart rate, stroke, seizures, and heart attacks.

Some weight-loss supplements have been found to contain hidden ingredients, such as prescription drugs, that can be harmful. It's important to do your homework if you're thinking about trying a weight-loss supplement. See credible websites, such as those managed by the U.S. Office of Dietary Supplements and the National Center for Complementary and Integrative Health.

Also be sure to talk to your doctor before taking any supplements. This is especially important if you have health problems, take prescription medications, or are pregnant or breastfeeding. ErrorIncluding a valid email address Mayo Clinic does not support companies or products. Advertising revenue supports our nonprofit mission.

As an added bonus, lifestyle changes that help you lose weight may also improve your mood and energy level and reduce your risk of heart disease, diabetes, and some cancers. It is understandable that some doctors are reluctant to prescribe drugs for weight loss because of this sordid past. Many weight-loss supplements have ingredients that have not been tested in combination with each other, and their combined effects are unknown. FDA laboratory tests have revealed the presence of sibutramine, phenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat, and phenolphthalein in over-the-counter weight loss products.

If you haven't lost at least 5% of your body weight after three to six months on a full dose of a medicine, your doctor will probably change your treatment and you can switch to another weight-loss medicine. Now, people trying to lose weight have a new option: a drug called Wegovy (semaglutide) that is injected under the skin once a week. But making these lifestyle changes isn't easy, so you might be wondering if taking a dietary supplement promoted for weight loss might help. Ephedra (also called ma huang) is a plant that contains substances that can stimulate the nervous system, increase the amount of energy it burns, increase weight loss and suppress appetite.

To find out if a weight loss supplement can help people lose weight safely and keep it off, it is necessary to study larger groups of people for a longer time. If you've lost enough weight to improve your health and haven't had serious side effects, your doctor may suggest that you take the medication indefinitely. If you take dietary supplements and medicines on a regular basis, be sure to discuss this with your healthcare provider. .


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