Drugs health claim

Since 1999, when the Food and Drug Administration allowed the first health claim for soy-fortified foods in the USA, there has been a large increase in the sales of food products claiming to contain soy isoflavones. At the same time, over-the-counter supplements have become widely available. However, concerns have been raised about the real health benefits of such supplements in the absence of adequate information about bioavailability, pharmacokinetics and safety. To fill this gap, an extensive study on pure isoflavones and commercial soy isoflavone supplements has recently been carried out (Setchell et al, 2001). A selection of 31 commercially available supplements showed a wide variation in isoflavone composition and in the amount provided by one tablet. Furthermore, a lower isoflavone content, with respect to the claimed levels, has been observed in almost 50% of the analysed products. In one case, no isoflavones at all could be detected (Setchell et al, 2001). 

Trumbo, R R. and K. C. Ellwood (2006). Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts An evaluation using the Food and Drug Administration s evidence-based review system for health claims. Am. J. Clin. Nutr. 84(5) 971-974. 

Food and Drug Administration (1999). Food labeling health claims soy protein and coronary heart disease. Fed. Regist., 64, 57700-57733. 

Food And Drug Administration (2008). USA. Food Labelling Health Claims Soluble Fiber from Certain Foods and Risk of Coronary Disease. Federal Register 73, No. 85. 

All of the vitamins are used as specific treatments for their respective deficiency diseases. The dosages required will vary depending on the severity of the disease and the vitamin. Vitamins have also been used like drugs to treat diseases. However, unlike drug products, vitamins are not reviewed by the U. S. Food and Drug Administration before formulations appear on the market. Vitamins are considered to be dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Vitamins and other dietary supplements are not permitted to be marketed as a treatment or cure for a specific disease or condition unless the vitamin is approved as a drug for that purpose. However, under DSHEA, supplement manufacturers may make health claims, such as the link between a food substance and a disease or health-related condition. This may make it difficult for patients to assess the need for vitamin supplementation. 

FDA (13,S. Food and Drug Administration). 1997. Food Labeling Health Claims Oats and Coro-... 

Before the Food and Drug Administration Modernization Act of 1997, companies could not use a health claim or nutrient-content claim in food labeling unless the FDA published a regulation authorizing such a claim. Two new provisions of FDAMA now permit distributors and manufacturers to use such claims if they are based on current published authoritative statements from certain federal scientific bodies, or from the National Academy of Sciences. These provisions are intended to expedite the process by which the scientific basis for such claims is established, and they place dietary supplements on an equal footing with conventional foods. 

Because herbal medicines are not classified as drugs by the FDA, the manufacturers of herbals cannot make claims that their product is effective at treating any disease or disorder. They can, however, make more general health claims. For example, companies that sell St. John s wort cannot say their product is useful for treating depression or anxiety, but they can say St. John s wort... 

Dietary supplement health claims guidance http //www.cfsan.fda.gov/ dms/opa-noti.html Botanical drug product guidance www.fda.gov/cder/guidance CDER http //www.fda.gov/Cder/... 

Food and drugs have traditionally been considered separate categories in the legislative process. Until relatively recently, health claims on foods were prohibited in many countries. However, in recent years consumers have been deluged with health information relating to their foods. Some of this information has been negative, such as information about the effect of fat on the incidence of heart disease other information has been positive as for instance the beneficial effect of dietary fiber. 

Food and Drug Administration (FDA) health claims" show that a relationship between a nutrient(s) or other substances and a disease or health-related condition, i.e., foods with soy protein, soluble fiber, and plant sterols, helps lower the risk of coronary heart disease (Table 8.5). These claims help individuals to select foods as either part of following recommended dietary guidelines, such as the TLC and Heart Healthy diets, or part of a self-treatment in response to You need to eat less fat and cholesterol and more fiber. ... 

Food and Drug Administration, Talk Paper, FDA authorizes new coronary heart disease health claim for plant sterol and plant stanol esters, http // www.fdagov/bbs/topics/ANSWERS/ANS01033.html. Accessed June 7, 2002. 

Like Indiana Jones, virtually every manufacturer of a superfruit product is hot on the trail of the Holy Grail—a health claim approved by a national regulatory agency such as the U.S. Food and Drug Administration (FDA) or European Food Safety Authority (EFSA). In simple terms, a health claim would verify that the product or compound has been scientifically proved to have a direct effect on health or the specific ability to alter the course of a disease. 

U.S. Food and Drug Administration. A Food Labeling Guide, FDA-qualified health claims about foods, appendix C. cfsan.fda. gov/ dms/2lg-xc.html. 

There is worldwide confusion about the regulations on natural products and dialogue between countries for harmonization is needed. This is important for both the consumers and the developers and producers of new products. Some general regulations exist in the United States, Canada and Europe, where health claims permitted are generic and not product-specific. Products that claim benefits in the prevention or treatment of disease or illness are considered drugs or medicinal products and not foods (Stephen, 1998). This trend may, however, change with the renewed interest in functional foods and alternative medicine. 

Although isoflavones are present in several species of legumes, most of the research has been on soybean and soybean foods, due to the widespread use of soybean in traditional and modem foods (Liu, 1997 Messina, 1997). Recently, the Food and Drug Administration (FDA) approved a health claim for the relationship between the consumption of soy protein and heart disease (Federal Register, 1999). This approval further encourages soy isoflavone research. There may be health claims that could be made in the future to associate the intake of the isoflavonoids and the lowering of the risk of certain chronic diseases. 

The US Food and Drug Administration (FDA) permits certain health claims on food labels. The FDA determines the wording to be used in the claims and also specifies the composition of the food. Approval is general. As soon as a food meets the defined specifications, the manufacturer can use the health claim. 

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