Popularity of Dietary Supplements
Dietary supplements are classified under the food umbrella according to the 1994 Dietary Supplement Health and Education Act (DSHEA). The DSHEA states that ingredients sold in the U.S. before 1994 can be sold with no evidence of effectiveness or safety. Because food products are not subjected to the same large-scale clinical trials that are typically conducted for prescription drugs, they are generally untested for their general safety or efficacy profiles. The (DSHEA) Dietary Supplement Health and Education Act of 1994 seeks to prevent manufacturers from making unsubstantiated claims, disseminating unsafe or forged molecular entities, to the general public. While the DSHEA does require manufacturers to label their products as supplements and provide an exhaustive list of ingredients, manufacturers are not required to notify FDA of adverse event reports that they might obtain from consumers. If the product contains a new food additive, which is one that was not sold in the U.S. before Oct. 15, 1994, The Food requires the manufacturer or distributor to inform FDA 75 days prior to marketing of the product, unless the new food additive has been introduced into the food supply as a chemically modified food.
Under DSHEA, it is the U.S. Food and Drug Administrations burden to demonstrate that a specific dietary supplement is unsafe for use by consumers before it may be taken off the market. The DSHEA is intended to achieve a proper balance between providing consumers with access to safe dietary supplements they may choose to support and enhance their health, and giving FDA regulatory power to act against supplements and ingredients in supplements if they are unsafe, impede a safety issue, or are otherwise false or misleading claims, or are otherwise promoted or misbranded. Under DSHEA, supplement manufacturers are not required to prove safety or effectiveness; Rather, DSHEA deliberately minimizes the U.S. Food and Drug Administrations oversight, focusing on the industrys value to the U.S. economy. Importantly, DSHEA established a new regulatory structure for food supplements, which limits FDAs authority over these products to that of traditional foods, compared to FDAs authority over additives to foods or novel drugs.
DSHEA established the first comprehensive definition of dietary supplements, which led to botanicals and amino acids being considered foods by intended use, just like vitamins and minerals, which were already classified as foods by intended use. Nutrition Labeling and Education Act of 1990 and Health Claims With FDAs reversal of attempts to develop a narrower regulation, the scope of products sold as dietary supplements continued to expand, including botanicals and amino acids, and vitamins and mineral products. Multivitamin-mineral products remained the most frequently reported type of supplements, and were used mainly for the purpose of improving or maintaining health. Multivitamin-mineral supplements were the most commonly used food additives among adults in all age groups, followed by vitamin D and omega-3 fatty acid products.
Results The most frequently reported reason was to enhance (45%) or to maintain (33%) general health. Adults also reported using supplements for energy (11%), for mental health (4%) and prostate health (4%) in males, and for weight loss (3%) or for menopause or hot flashes (2%) in females. Factors found significantly associated with use of supplements included age (higher levels used in younger years), education (higher levels used in higher educational levels), gender (women were higher users), and a belief that food nutritional quality has decreased in the last decade. Compared to light and moderate users of food supplements, heavy and very heavy users were more likely to shop in health food stores, purchase supplements by mail, read health-related specialty literature, believe that they personally control their health, exercise daily, avoid having a doctor involved in supplement decisions, and perceive specific health benefits from their supplements, as opposed to overall health benefits.
The most comprehensive U.S. survey on the use of dietary supplements was conducted in 1980 by the Food and Drug Administration (FDA) via telephone interviews with 2,991 U.S. representatives aged over 15 years (Stewart et al., 1985).
Dietary supplements were used by approximately half of adults (49%), in 2007-2010, though that was somewhat lower than 2003-2006 (53%). Dietary supplements are defined under the Act as products intended to complement the diet; they are not medications, and thus are not intended to prevent, diagnose, treat, alleviate, mitigate, or treat diseases. Because the U.S. Food and Drug Administration (FDA) does not regulate vitamins and dietary supplements rigorously, there is no standard or regulatory definition that distinguishes vitamins, multivitamins, mineral supplements, and dietary supplements (i.e., which nutrients vitamins are contained or in what quantity). In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods with specific uses and are regulated by food authorities. In Australia, most dietary supplements are regulated under a category of complementary medicines, which includes vitamin, mineral, herbal, aromatherapy, and homeopathic products, although some products may be regarded as foods for special purposes and regulated under the food authority. Federal guidelines, such as the Dietary Guideline for Americans 2010, issued by USDA and US Department of Health and Human Services, recommend meeting nutritional requirements mostly by eating foods, and using vitamins and supplements only sparingly. The guidelines advocate using supplements for pregnant and nursing women (e.g., iron), women who are pregnant or breastfeeding (e.g., folate), women who are childbearing, and those aged 50 years or older (e.g., vitamin B 12). The NLEA provides that health claims that describe the linkage of a nutrient with disease or a health-related condition are allowed for traditional foods as well as dietary supplements, if the claims are consistent with FDA regulations.