A dietary supplement is defined as a manufactured product intended to supplement one’s diet. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. Dietary supplements come in a variety of forms, including tablets, capsules, gummies, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and B12; minerals like calcium and iron; herbs such as echinacea and garlic; and products like glucosamine, probiotics, and fish oils.
Approximately 77% of the US adult population use supplements and the global supplement market is predicted to reach a value of $216.3 billion by 2026. FDA regulates both finished dietary supplement products and dietary ingredients. By law, it is illegal to manufacture or market dietary supplement products that are adulterated or misbranded and FDA has regulatory authority to remove such products from the marketplace. Manufacturers and distributors of dietary supplements and dietary ingredients are also prohibited from marketing products that are adulterated or misbranded.
Why are supplements not FULLY regulated?
Because supplements aren’t considered drugs, they aren’t put through the same strict safety and effectiveness requirements that drugs are. So all the drugs you can buy, even without a prescription, must be proven safe and effective – but dietary supplements do not.
Who needs food supplements?
Supplements are not a substitute for a balanced healthy diet. A diet that includes plenty of fruits, vegetables, whole grains, adequate protein, and healthy fats should normally provide all the nutrients needed for good health. Most countries agree that messages aimed at the general public should focus on food-based dietary guidelines. There are certain population groups or individuals who may need advice about supplements, even when they eat a healthy balanced diet, i.e. women of childbearing age, individuals on specific medications.
Supplements can be beneficial, but the key to vitamin and mineral success is eating a balanced diet. Before taking vitamin and mineral supplements, talk to your physician about your personal dietary plan.
Do all supplements need to be FDA approved?
Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.
Dietary Supplement Safety
Some vitamins could be harmful if taken in excessive amounts, meaning above the small Recommended Dietary Allowances (RDAs) required for good health. Here are two to avoid:
Vitamin E: In research, vitamin E has largely failed the test as a heart-health booster. In fact, in one large clinical trial, people who took 400 international units (IU) were more likely to have heart problems compared with those who didn’t take vitamin E. The Selenium and Vitamin E Cancer Prevention Trial (SELECT) found that men who took daily supplemental vitamin E were at greater risk of prostate cancer.
Vitamin A: Taking vitamin A supplements can raise blood levels of retinol, which in some research is associated with a greater chance of hip fractures. The link isn’t proven to be cause-and-effect, but there is not any strong evidence that vitamin A supplements help you, either. Why take the risk?
Unless your doctor says you should be taking a vitamin or mineral supplement—be it calcium, iron, or others—don’t worry about it. Just eat a well-balanced healthy diet and stay away from supplements.”
In a study of 3,000 adults middle-aged and older, one in 25 (4%) was found to be taking prescription drugs and dietary supplements that could interact harmfully. The supplements can also cause side effects on their own. You really never know what’s in a supplement or if it will interact with the other medications you are already taking. Here are some you should watch out for:
St. John’s wort: St. John’s wort is often pitched as an herbal remedy for depression, anxiety, fatigue, and sleeplessness. However, it can have a range of bad side effects. These include dry mouth, dizziness, stomach or intestinal discomfort, fatigue, and headache. St. John’s wort can alter blood levels of prescription drugs by speeding up or slowing down their metabolism. In several documented cases, the herb interfered with immune-suppressing drugs people were taking to prevent organ transplant rejection.
Blood-thinning herbs: Ginkgo biloba and vitamin E can thin the blood. This could be risky if you are already taking a blood thinner, like warfarin (Coumadin), to prevent clots. “The number of herbal ingredients that interact with warfarin are endless.
The FDA does not require dietary supplements to be tested before marketing to prove they are safe and they work, as is the case with prescription drugs. As a result, products may contain unlisted ingredients and contaminants; some products have tested positive for prescription drugs not listed on the label. One thing you can do is make sure the product is certified by the United States Pharmacopeia or NSF International, which independently assess supplement ingredients.
What supplements can you trust?
If you want to know what’s really in your supplements, look for those that have been tested by the following independent nongovernmental organizations:
States Pharmacopeia. A supplement manufacturer can submit its products for analysis by USP to verify its ingredients’ identity, strength, quality, and purity. Look for the “USP verified mark” on the product.
NSF International. This organization also tests dietary supplements. The NSF stamp on a dietary supplement product means it was tested for quality and safety.