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Dietary Supplements Fact Sheet

It’s not uncommon for both children and adults in the United States to turn to vitamins or other dietary supplements to support their well-being. These supplements can include an array of ingredients, spanning from vitamins and minerals to herbs and amino acids. Their various forms are another aspect that makes them appealing, as they come in a range of choices, such as tablets, capsules, gummies, powders, drinks, and energy bars. Popular supplements among these diverse options include vitamin D and B12, calcium and iron minerals, echinacea and garlic herbs, and supplements like glucosamine, probiotics, and fish oils.

Table of Contents

Supplement Labels

When purchasing dietary supplements, you can expect to find a Supplement Facts label that details the active ingredients, the amount per serving, and any other added ingredients such as binders, fillers, or flavorings. The label will typically provide a suggested serving size, but it’s worth noting that your healthcare provider may recommend a different amount that better suits your individual needs.

The FDA requires that all dietary supplement manufacturers include certain information on their product labels, such as the name of the supplement, the serving size, and a Supplement Facts panel that outlines the active and inactive ingredients, among other requirements. Additionally, supplement manufacturers are responsible for ensuring that their products are safe, properly labeled, and in compliance with all FDA regulations.

Buyer Beware

It is important to note that many health claims for supplements have not been evaluated by the FDA. While supplement manufacturers are required to follow FDA regulations when it comes to labeling and safety, they are not required to provide evidence that their products are effective for treating or preventing specific health conditions. As a result, it is possible for supplement manufacturers to make health claims that have not been evaluated or approved by the FDA. Consumers should be cautious and do their research before purchasing and using any dietary supplement.

How Effective are Supplements?

While some dietary supplements can assist in providing adequate amounts of essential nutrients if your diet is lacking, it’s important to note that they can’t replace the nutritional benefits of a varied and healthy diet. For guidance on building a healthy eating routine, the Dietary Guidelines for Americans and MyPlate are excellent resources to turn to.

Nutritional supplements should be not be considered to be substitutes for a good diet, because no supplements contain all the benefits provided by healthy foods.

Here is a list of some dietary supplements that have been shown to be effective in managing certain health conditions:

  • Calcium and vitamin D for maintaining strong bones and reducing bone loss
  • Folic acid for reducing the risk of certain birth defects
  • Omega-3 fatty acids from fish oils for benefiting some individuals with heart disease
  • AREDS formula (vitamins C and E, zinc, copper, lutein, and zeaxanthin) for slowing down vision loss in individuals with age-related macular degeneration (AMD)

However, it’s worth noting that many other dietary supplements require further study to determine their effectiveness, and the FDA does not evaluate the efficacy of dietary supplements before they are sold on the market. As a result, consumers should be cautious and do their research before using any dietary supplement.

Supplement, Not Substitute

While supplements can be helpful in certain situations, such as when someone has a nutrient deficiency, they cannot replace the nutritional benefits of whole foods. A healthy diet should consist of a variety of nutrient-dense foods, such as fruits, vegetables, whole grains, lean proteins, and healthy fats. We recommend following the Harvard TH Chan Healthy Eating Plate.

Additionally, lifestyle factors such as regular exercise, stress management, and getting enough sleep are also important for overall health and well-being. Supplements cannot compensate for a sedentary lifestyle, chronic stress, or lack of sleep.

Supplement Safety and Risks

It’s important to understand that some supplement products contain active ingredients that can have potent effects on the body. While supplements can be helpful in promoting health and wellness, it’s crucial to be aware of the possibility of negative reactions, especially when trying a new product.

If you’re taking supplements at high doses or in place of prescribed medications, or if you’re combining multiple supplements, you may be at a higher risk of experiencing side effects. Some supplements can even increase your risk of bleeding or alter your body’s response to anesthesia during surgery. Additionally, certain supplements may interact with medications you’re already taking in ways that could cause harm.

For instance, vitamin K can reduce the effectiveness of the blood thinner warfarin, while St. John’s wort can interfere with the effectiveness of antidepressants, birth control pills, and other medications. Antioxidant supplements like vitamins C and E may also interfere with certain types of chemotherapy used to treat cancer.

Keep in mind that many food manufacturers add supplements like vitamins and minerals to their products, including breakfast cereals and beverages. While this can be beneficial in moderation, taking in too much of these ingredients can be harmful and even lead to side effects. For example, too much vitamin A can cause headaches, liver damage, and other problems, while excess iron can cause nausea and vomiting and damage to various organs.

If you’re pregnant or nursing, it’s important to be cautious about taking supplements beyond a standard prenatal vitamin. Additionally, it’s generally not recommended to give supplements to children without guidance from a healthcare professional, as many supplements have not been well-tested for safety in children and pregnant or nursing individuals.

If you experience any negative reactions to a dietary supplement, it’s crucial to inform your healthcare provider. Your provider can help you report the reaction to the FDA or the supplement manufacturer and provide guidance on how to proceed. Remember, staying informed and cautious is key when it comes to using dietary supplements safely.

Talk to Your Health Care Provider

It’s essential to keep your healthcare providers informed about any dietary supplements you’re taking, including doctors, dentists, pharmacists, and dietitians. They can provide valuable guidance on which supplements, if any, may be beneficial for you.

To ensure you don’t forget any details, it’s best to maintain a complete record of any dietary supplements and medications you take. The Office of Dietary Supplements website offers a helpful “My Dietary Supplement and Medicine Record” form that you can fill out at home. For each product, note the name, the dosage, how often you take it, and the reason for use. You can share this record with your healthcare providers to discuss what’s best for your overall health.

Quick Tips

  • At this time, megadose supplements (many times the recommended dietary allowance, or RDA) do not appear justified, and these can sometimes be harmful.
  • Avoid any supplements promoting wild health claims. At this time, the US Food and Drug Administration has been monitoring and warning companies offering fraudulent products claiming to prevent, diagnose, treat, or cure COVID-19 and other diseases.
  • Nutritional supplements should be not be considered to be substitutes for a good diet, because no supplements contain all the benefits provided by healthy foods.

Quality Standards

Maintaining the quality of dietary supplements is a top priority for both the Food and Drug Administration (FDA) and independent organizations. Dietary supplements are a significant part of the healthcare industry, and the FDA has established good manufacturing practices (GMPs) that supplement companies must follow to ensure the identity, purity, strength, and composition of their products.

The GMPs help to prevent the inclusion of incorrect ingredients, incorrect amounts of ingredients, contamination, and improper packaging and labeling of supplement products. The FDA also conducts periodic inspections of supplement manufacturing facilities to ensure compliance with the GMPs.

In addition to the FDA’s regulations, several independent organizations offer quality testing to assess supplement products’ quality. The products that pass these tests receive a seal of quality assurance that indicates the product was properly manufactured, contains the ingredients listed on the label, and is free of harmful levels of contaminants.

It’s important to note that these seals don’t necessarily indicate the product’s safety or effectiveness. However, the seals do provide consumers with an extra level of confidence in the product they are purchasing. Notable organizations that conduct quality testing and offer quality assurance seals include ConsumerLab.com, NSF International, and U.S. Pharmacopeia.

Consumers should also be aware that the FDA does not have the authority to approve dietary supplements before they are sold, as they do with prescription drugs. The responsibility for ensuring the safety and effectiveness of supplements lies with the manufacturers. As such, consumers should do their research and consult with a healthcare professional before starting any new supplement regimen.

Organizations that offer quality testing include:

  • ConsumerLab.com
  • NSF International
  • U.S. Pharmacopeia

Federal Regulation of Dietary Supplements

Dietary supplements are products intended to supplement the diet. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both supplements and medicines, but the FDA regulations for dietary supplements are different from those for prescription or over-the-counter medicines.

Medicines must be approved by the FDA before they can be sold or marketed. Supplements do not require this approval. Supplement companies are responsible for having evidence that their products are safe, and the label claims are truthful and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1994), the company does not have to provide this safety evidence to the FDA before the product is marketed.

Dietary supplement labels may include certain types of health-related claims. Manufacturers are permitted to say, for example, that a supplement promotes health or supports a body part or function (like heart health or the immune system). These claims must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Manufacturers must follow good manufacturing practices (GMPs) to ensure the identity, purity, strength, and composition of their products. If the FDA finds a dietary supplement to be unsafe, it may remove the product from the marketplace or ask the manufacturer to voluntarily recall the product.

The FDA monitors the marketplace for potential illegal products that may be unsafe or make false or misleading claims. The Federal Trade Commission, which monitors product advertising, also requires information about a supplement product to be truthful and not misleading.

The federal government can take legal action against companies and websites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

Resources

  1. NATIONAL INSTITUTES OF HEALTH (NIH) – NIH supports research and provides educational materials on dietary supplements.
    https://www.nih.gov/health-information/dietary-supplements
  2. Office of Dietary Supplements (ODS) – ODS provides accurate and up-to-date scientific information about dietary supplements.
    https://ods.od.nih.gov/
  3. National Center for Complementary and Integrative Health (NCCIH) – NCCIH also has scientific information about dietary supplement ingredients.
    https://www.nccih.nih.gov/health/dietary-and-herbal-supplements
  4. National Library of Medicine – Medline Plus provides trusted health information.
    https://medlineplus.gov/druginfo/herb_All.html
  5. PubMed – PubMed contains more than 35 million citations from the scientific literature.
    https://pubmed.ncbi.nlm.nih.gov/
  6. NIH Health Information – Information about healthy living and wellness from across NIH.
    https://www.nih.gov/health-information
  7. U.S. FOOD AND DRUG ADMINISTRATION (FDA) – FDA issues rules and regulations and oversees dietary supplement labeling, marketing, and safety. Recall notices are also posted on the FDA webpage or you can subscribe to receive FDA notices of recalls, market withdrawals, and safety alerts.
    https://www.fda.gov/food/dietary-supplements
  8. FEDERAL TRADE COMMISSION (FTC) – FTC regulates health and safety claims made in advertising for dietary supplements.
    https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing/health-claims
  9. U.S. DEPARTMENT OF AGRICULTURE (USDA) – USDA provides information on a variety of food and nutrition topics.
    https://www.usda.gov/topics/food-and-nutrition
  10. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) – HHS provides wellness information, personal health tools, and health news.
    https://www.hhs.gov/programs/index.html

Frequently Asked Questions

Supplements are products that contain one or more dietary ingredients such as vitamins, minerals, herbs, amino acids, or other substances. People take supplements to supplement their diet, fill nutrient gaps, improve their health, or enhance performance.

Not all supplements are safe, and some may interact with medications or have adverse effects. It’s important to consult with a healthcare provider before taking any supplements, especially if you have underlying medical conditions or are taking medications.

No, supplements cannot replace a healthy diet. While supplements can help fill nutrient gaps, they cannot provide all the nutrients and other beneficial substances that a balanced diet can offer. A healthy diet should be the primary source of nutrients, and supplements should be used as a complement.

When choosing a supplement, it’s important to look for reputable brands that use high-quality ingredients and follow good manufacturing practices. You should also check the label for the amount of active ingredients, potential allergens, and any other warnings or instructions. Lastly, it’s important to consult with a healthcare provider to ensure the supplement is safe and appropriate for your needs.

 

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