The Food and Drug Administration (FDA) is limited to post-marketing application when it comes to dietary supplements. This means that unlike drugs, which must be proven to be safe and effective before they can be marketed, the law does not provide provisions that allow the FDA to approve the safety of dietary supplements before they reach consumers. Despite this, it is still important to take precautions when selecting the right supplement for you. The FDA is a federal agency responsible for regulating products that affect public health, such as food products, drugs, medical devices, cosmetics, and even tobacco products.
The FDA plays an important role in ensuring the safety of the products we use every day, but it does not grant prior approval to every industry it oversees. Drugs are used to treat, prevent, mitigate, diagnose or cure diseases. Clinical trials in humans must demonstrate that a drug is safe and effective for its intended use before it is pre-approved by the FDA for consumer use. On the other hand, supplements are only for nutritional purposes and do not require prior FDA approval before they are released for sale.
The Dietary Supplements Health and Education Act of 1994 (DSHEA) defined the role of supplements and described what dietary supplement companies can legally say about their products. The law dictates that supplement companies cannot insinuate or claim that their product diagnoses, treats, cures, or prevents diseases of any kind. In addition, the FDA has interpreted some normal conditions as precursors or markers of diseases. That's why you might see vague wording about what a supplement does to comply with FDA guidelines on claims of approved dietary supplements.
The FDA oversees the manufacture and labeling of supplements and regularly inspects companies to ensure that they comply with all regulations. If a supplement company does not comply with FDA regulations, the FDA may prohibit it from selling its product. For a list of possible serious reactions to watch out for and to know how to report an adverse event, see the FDA website, How to Report a Problem with Dietary Supplements. The FDA does not determine if vitamins and other supplements are actually effective; as the FDA itself points out, it is the responsibility of manufacturers to ensure that their products are safe and that the claims they print on their labels are accurate.
The FDA recommends that people talk to their doctor, pharmacist, or other health professional before starting to use a dietary supplement. There are other independent organizations besides the FDA that will approve supplements even though there are no supplements officially approved by the FDA. If a supplement is harmful, such as when a product contains harmful components, the FDA can take steps to protect the public. Because FDA-approved supplements don't exist, but are more beneficial for people with specific dietary needs or people who have certain medical conditions, your doctor can help you determine which supplements are best for you, how much you should take (it may be different from what's in the package), It will either interfere with any medical treatment you are already receiving or with anything else that is specific to your situation. It should be noted that the Food and Drug Administration (FDA) does not have the authority to review the safety and efficacy of dietary supplements before they are marketed. However, there are organizations such as USP (United States Pharmacopeia), NSF International (National Sanitation Foundation), and ConsumerLab which certify dietary supplements. Harvard Health emphasizes the importance of selecting a dietary supplement that has been approved by one of these three organizations.
These types of statements are only allowed for drugs that have undergone extensive clinical testing and review by the FDA. The FDA hopes to close this gap by providing new online resources for consumers, health professionals and educators so they can make informed decisions about their health.
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