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Airborne is an American brand of dietary supplement containing herbal extracts, amino acids, antioxidants, electrolytes, vitamins, and other ingredients originally marketed as preventing the common cold and improving immune function. [1] The benefits of its use are unsupported by robust clinical research. [1]
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; [40] however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only ...
In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. [8] Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition. [8]
In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other ...
Following the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a "special category under the general umbrella of 'foods,'" according to the FDA.
Dexatrim further provides a disclaimer that no claims of efficacy and safety made by Dexatrim have been approved by the FDA. [1] Although available OTC, the active ingredients in Dexatrim products carry risk of side effects, adverse reactions and adverse drug interactions, particularly if used at high-recommended or higher-than-recommended ...
Drospirenone/ethinyl estradiol is the only contraceptive approved by the FDA to treat PMDD. The efficacy can vary from person to person, the experts note. Birth control may improve PMDD symptoms ...
In the United States, glucosamine is not approved by the Food and Drug Administration (FDA) for medical use in humans. [30] Since glucosamine is classified as a dietary supplement in the United States, evidence of safety is required by FDA regulations, but evidence of efficacy is not required so long as it is not advertised as a treatment for a ...
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