Updated on 13 May-2013.
What is a dietary supplement?
Is defined as the Congress in the Act on the health and education of dietary supplements, which came into force in 1994, a dietary supplement is a product (other than snuff)
- to the diet supplement
- contains one or more food ingredients (including vitamins, minerals, herbs, or other plants, and other amino acids) or their components,
- It should be taken orally in pill, capsule, tablet or liquid
- featured on the front as nutritional supplements
What's a new food ingredient?
A new food ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.
Dietary supplements are different from foods and drugs?
Although dietary supplements are regulated are from the Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and drugs. When a product classified as a dietary supplement, a food or medicinal product is conventionally based on the intended use. Very often classified as a dietary supplement is determined by the information provided by the manufacturer or in the literature accompanying label, although many food labels and dietary supplements do not contain this information.
Manufacturers can make claims for dietary supplements and drugs?
The types of applications that can be prepared in the labels of the food supplements and pharmaceuticals are different. Drug manufacturers say their product diagnosis, cure, mitigation, treatment or prevention of disease. These statements can not be made legal for dietary supplements.
The label of a dietary supplement or food may contain one of three types of claims:
- a health-promoting properties
- Nutrition
- a function / application structure
Health claims describe a relationship between a food ingredient or dietary supplement ingredient, and reducing risk of a disease or health condition.
Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product.
A claim for structure / function is a statement describing how a product, the organs or systems of the body can relate to and can not speak of a specific disease. Claims Structure / function does not require FDA approval, but the manufacturer has the FDA with the text of the application within 30 days, to provide the product on the market.
Product labels that such claims must include a warning that states include, :. "This statement has not been approved by the FDA This product is not intended to diagnose, treat, cure or prevent any disease have been studied."
How the FDA regulates dietary supplements?
In addition to the regulation of the label, the FDA regulated food supplement in other ways. Supplement ingredients sold in the United States are not obliged to be considered by the FDA for their safety before being marketed before October 15, 1994 in consideration, because it sure as to their history of use on the basis of people.
For a food new ingredient before 1994 not sold as a dietary supplement, the manufacturer must notify the FDA of their intent to market a dietary supplement containing the new dietary ingredient and provide information on how they determined that there was sufficient evidence to safe product for human use . FDA may refuse to allow new ingredients or known ingredients on the market for safety reasons.
Manufacturers are not required to provide the FDA with evidence that dietary supplements are effective or safe; However, you are not allowed unsafe or ineffective products to market.
Once a dietary supplement is marketed, the FDA must demonstrate that the product is not safe to restrict its use or withdraw from the market. However, before a drug on the market, manufacturers have FDA approval by convincing evidence that they achieve safe and effective.
The label of a dietary supplement product is required truthful and not misleading. If the label does not not meet this requirement, the FDA can withdraw the product from the market or take any other appropriate measures.
What methods are used to evaluate the health benefits and safety of dietary supplements?
Scientists use several approaches to evaluate dietary supplements for their health benefits and potential security risks, including the history of use and laboratory studies using cellular and animal models.
Studies on humans (case reports, observational and clinical studies), information which is relevant to dietary supplements, such as used. Researchers can summarize a systematic review and interview a group of clinical trials that meet certain criteria to evaluate. A meta-analysis is an analysis that includes statistical analysis of the data by many studies.
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