What are the Regulations and Guidelines for Dietary Supplements?

Dietary supplements are products intended to supplement the diet and are different from conventional foods. They come in many forms, including tablets, capsules, soft gels, gel capsules, powders, sticks, gummies and liquids. Popular supplements include vitamins D and B12; minerals such as calcium and iron; herbs such as echinacea and garlic; and products such as glucosamine, probiotics and fish oils. Products sold as dietary supplements come with a supplement information label that lists the active ingredients, the amount per serving (dose), and other ingredients, such as fillers, binders and flavors.

Some dietary supplements can help you get adequate amounts of essential nutrients if you don't eat a variety of nutritious foods. However, supplements cannot replace the variety of foods that are important to a healthy diet. The Food and Drug Administration (FDA) does not determine if dietary supplements are effective before they are marketed. Many supplements contain active ingredients that can have strong effects on the body.

Always be on the lookout for the possibility of a bad reaction, especially when taking a new product. Manufacturers can add vitamins, minerals and other supplement ingredients to the foods you eat, especially cereals and breakfast drinks. As a result, you may get more out of these ingredients than you think, and more may not be better. Taking more than you need costs more and may also increase the risk of side effects. For example, too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects.

Excessive iron causes nausea and vomiting and can damage the liver and other organs. Be careful when taking dietary supplements if you are pregnant or breastfeeding. Also, be careful when giving supplements to a child, unless recommended by your healthcare provider. The safety of many supplements has not been well-proven in pregnant women, nursing mothers, or children. If you think you've had an adverse reaction to a dietary supplement, tell your healthcare provider.

He or she can report their experience to the FDA. You can also send a report directly to the FDA by calling 800-FDA-1088 or completing an online form. You should also report your reaction to the manufacturer using the contact information on the product label. The FDA has established good manufacturing practices (GMP) that companies must follow to help ensure the identity, purity, concentration and composition of their dietary supplements. These genetically modified products can avoid adding the wrong ingredient (or too much or too little of the right ingredient) and reduce the chance of contamination or mispackaging and labeling the product. The FDA regularly inspects facilities that manufacture supplements.

Tell your healthcare providers (including doctors, dentists, pharmacists and dieticians) about any dietary supplements you are taking. They can help you determine what supplements, if any, might be of value to you. Keep a complete record of all dietary supplements and medications you take. For each product, write down the name, the dose you take, 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. The FDA is the federal agency that oversees both supplements and drugs but has different rules for each one.

Drugs must be approved by the FDA before they can be sold or marketed while supplements do not require this approval. Supplement companies are responsible for having proof that their products are safe and that their label's claims are true and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15th 1999), the company does not have to provide this safety evidence to the FDA before marketing it. Dietary supplement labels may include certain types of health-related claims but must be followed by “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 (GMP) to ensure the identity, purity, strength and composition of their products.

If the FDA considers a dietary supplement to be unsafe it can withdraw it from the market or ask its manufacturer to voluntarily recall it. The Federal Trade Commission also requires that information about a supplement be truthful and not misleading. The federal government can take legal action against companies that sell dietary supplements when they make false or misleading statements about their products. For more information on what makes for a healthy diet consult The Dietary Guidelines for Americans or MyPlate websites.

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