Dietary and herbal supplement companies are themselves responsible for evaluating the safety and labeling of their products prior to marketing, in order to make sure that they are compliant with all requirements of the Dietary Supplement Health and Education Act. According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are generally defined as products that contain one or more food ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, enzymes, tissue from organs or glands, or extracts of those one or more food ingredients, which are supplemented with food, and are taken orally (such as a pill, capsule, powder, or liquid). Dietary supplements and their sometimes questionable claims about their health effects are regulated by the FDA in a different way from regular foods or medicines.
At the heart of the Food and Drug Administrations enforcement efforts is our commitment to strengthening the lawful production, sale, and use of dietary supplements, while protecting consumers from unsafe products, fraudulent labeling claims, and other unlawful practices. For example, FDAs Statement on Identity, Nutrition, and Ingredient Labeling for Small Entities Compliance Guide discusses complying with Agency regulations that implement the labeling provisions of the act; and resource utilization through continued coordination with other Federal and State entities engaged in health fraud prevention. Through the Food and Drug Administrations web site, RDRs and DTRs can access product alerts and recalls, regulations governing labeling and claims, and other helpful information for consumers and health professionals.
The FDA has received thousands of reports of adverse health events from consumers using food additives that contained Ephedra, including 117 deaths and 2,000 significant incidents of cardiac, neurologic, and mental health problems. Nearly all patients referred by their healthcare providers are referred by their physicians.9 The use of dietary supplements for diabetes requires cautious consideration, as nutritional deficiencies may cause disruptions of carbohydrate metabolism, and supplementation can increase risk for hypoglycemia.9 Patients should carefully consider the potential risks and benefits of the dietary supplements that they are interested in using to manage their diabetes, including determining whether there is evidence supporting a products benefits in diabetes, as well as whether there is an ADA statement or similar guidelines regarding usage. Dietary supplements should only be used as an adjunctive therapy with FDA-approved prescription medications. Patients should be instructed to report any serious reactions or medical conditions that might arise from use of dietary supplements to FDA.
People taking medications should be particularly cautious because some supplements can interfere with their treatments. Vitamins and mineral supplements may also interfere with prescribed medications and health care treatments.
While taking an overall, wide-spectrum vitamin and mineral supplement in an emergency poses few health risks, and can be beneficial for someone whose diet is restricted and lacking in variety, taking vitamins and mineral supplements in lieu of eating a nutritious diet is discouraged. If you are advised to take vitamin supplements, seeing a nutritionist, who can work with your doctor or another healthcare provider to give you diet recommendations related to your circumstances, is a good idea. Health experts say that your doctor is the best person to consult about whether vitamins or supplements are right for you, but pharmacists or registered dietitians can have valuable input as well.
While there is no guarantee, there are steps consumers can take to increase the odds that their supplements do contain what they say, at the amount they claim, and may actually have a health benefit. As an organizing body for standards aimed at public health, the U.S. Pharmacopeia supports manufacturers of food additives in continuing their efforts to produce high-quality products to meet consumers needs. USPs DSC also includes General Chapters related to Good Manufacturing Practices that manufacturers can use to help ensure their supplements are made using safe, sanitary, and well-controlled production practices. Those who are approved are allowed to put an organizations yellow-and-blackUSP Verified label on their products less than 1% of supplements on the market carry that label.
You will also find what brand and name those supplements are sold under. These fact sheets can be used to educate a reader about a particular food additive, vitamin, mineral, herb, or botanical in a quick manner. The database includes the scientific literature of vitamins, minerals, phytochemicals, ergogenics, botanicals, Traditional Chinese Medicine, and botanical supplements in human and animal models. The US National Library of Medicines MedlinePlus has similar information about other drugs, herbs, and supplements.
Compared with most drugs sold in pharmacies, dietary supplements are lightly regulated by governmental agencies. Without being evaluated as a traditional medicine by the FDA, manufacturers of herbal supplements are prohibited from making health claims regarding the ability of their products to diagnose, alleviate, treat, cure, or prevent any particular illness or category of illness. In fact, some evidence suggests that taking supplements at higher dosages for the prevention or treatment of serious chronic diseases, such as heart disease and cancer, can actually harm health. Large-scale studies consistently find that taking megadoses of supplements has few benefits.
In extreme cases, for instance, when people are taking 100 times their recommended dietary intake (RDI), it may interfere with the effects of anticonvulsant drugs, like the ones used in epilepsy. Now, it is complicated further by the fact that the Food and Drug Administration has many sitting bureaucrats that detest dietary supplements, and they would like to have a premarket approval, thereby driving down the costs of vitamins, minerals, even herbal products. Belief in the effectiveness of herbal products, based on advertisements, recommendations by friends, personal experiences, frustration with the traditional medical care system, and the desire to take control of ones life and health are some of the most common reasons patients mention when using herbal supplements. Encouraging patients to discuss their herbal supplement use, address any negative effects, including HDI, in medication history-taking, and providing credible information on the veracity, safety, and effectiveness of the disclosed herbal products is most useful at every encounter with physicians.
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