Natural and Dietary Supplements
The FDA regulates dietary supplements safety, production, and labeling, and the FTC has primary responsibility for regulating advertising for such products. 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. Dietary supplements, which include vitamins, minerals, plant and animal extracts, hormones, and amino acids ingested orally, are used widely in the U.S., with four out of five adults reporting having taken one. The dietary supplement market has grown exponentially in the past 25 years from a $4-billion industry with 4,000 products in 1994 to one valued at over $40-billion today, with up to 8,00 products but consumer-protection regulations have failed to keep up. In the U.S., supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations have prevented the FDA from effectively regulating supplements (e.g., increasing risks to public health, and has generated many calls for reform.
In Australia, most 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 the European Union, food supplements are regulated as foods, with the legislation focused on vitamins and minerals used as ingredients of food supplements. These only apply to supplements containing vitamins and/or minerals in which those products are regulated as foods, and address the ingredients of supplements, including their safety, purity, and bioavailability. Many supplements contain at least one food ingredient, such as vitamins, minerals, herbs, botanicals, amino acids, or enzymes.
Some supplements contain base ingredients, such as protein or multivitamins. Some botanicals are considered to be traditional medicinal herbs used in medicine and in dietary supplements. Some supplements may contain ingredients that are not listed on their labels, and those ingredients can be unsafe.
Many supplements are definitely good for you, evidence is varied, and it is important to understand what can be good for you, and what may be bad. Your first step should be discussing your options with your healthcare provider, as the effectiveness and safety of a supplement can depend on your personal situation and health. Amid all of the noise, it is difficult to figure out which supplements if any are best for you.
You might be trying to address a vitamin deficiency or reduce the risk for some diseases or maybe you are simply feeling proactive about your health after popping a supplement promising improved health. Whether it is sloshing from your medicine cabinet or filling up your bathroom counter, you are not alone if you are one of the millions of Americans taking a vitamin or supplement every day. Studies have shown that almost two out of three active duty members takes some type of dietary or herbal supplement on a daily basis.
Texas does not typically impose sales taxes on vitamins and supplements. Texas does not consider vitamins or supplements to be foods, but rather to be medical supplies, which are exempt from sales tax. It should be noted that nutritional supplements were exempt before the 2005 repeal of the South Dakota exemption. The exemption applies to any dietary supplements purchased under a specific women, infants, and childrens Supplemental Nutrition Program established under 42 U.S.C.
Foods, such as products made from acidophilus bacteria, soymilk, yeast from bakers, rosehip powder used to prepare tea, sunflower seeds, and wheat germ, would qualify as foods. Dietary supplements are included under the health functional foods (HFF) category in Korea, regulated by the Ministry of Food and Drug Safety (MFDS) according to the HFF Law for ensuring safety. Dietary supplement companies are themselves responsible to assess the safety and labeling of their products prior to marketing, in order to make sure they comply with all requirements under the Health and Education Dietary Supplement Law.
Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 act that established the current regulatory framework for dietary supplements the FDA does not typically perform a premarket review of dietary supplements, nor are manufacturers required to submit essential information about their products, including names or ingredients, to the agency prior to sale. This leaves the agency without clear visibility into what is available in the marketplace at any given moment. Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 law that established the current regulatory framework for dietary supplements the FDA generally does not conduct premarket review of dietary supplements, and manufacturers are not required to provide the agency with basic information about their products, including names or ingredients, before selling them. This leaves the agency with no clear view of what is on the market at any given time. Manufacturers are required to inform FDA prior to marketing any new ingredients. CFSAN has also issued consumer advisories regarding unsafe products, such as an advisories that the Agency issued regarding dietary supplements that contained Kava, a botanical ingredient; it continues to engage the dietary supplement industry regarding practices allowed by the Act.
For example, FDAs Statement on Identity, Nutrition, and Labeling of Ingredients in Dietary Supplementss small entity compliance guidance discusses adherence to Agency regulations that implement DSHEA labeling provisions; and using resources, continuing to coordinate with other Federal and State entities involved in addressing health fraud. USPs documented standards for dietary supplements are supported by chemical reference standards, which are highly characterized samples of food ingredients, impurities, and degrading products, and by compendium-grade reagents and performance calibrators specified for use in conducting formal tests and analyses. To legally be sold in China, each dietary supplement must receive the CFDAs health food approval certificate, which indicates Chinas increased emphasis on the products safety and scientific evidence of function.