Dietary supplement LINK集
The dietary supplements industry in the UK, one of the 27 countries in the European Union, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, have signed petitions against what are viewed by the petitioners as unjustified restrictions of consumer choice.[5] In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the European Union's Food Supplements Directive[6] referred to the European Court of Justice by the High Court in London.[7] Although the European Court of Justice's Advocate General subsequently said that the EU's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[8] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements?and not to vitamins and minerals normally found in or consumed as part of the diet.[9] Nevertheless, the European judges did acknowledge the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.
Pursuant to the DSHEA, the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to obtain FDA approval proving the safety or effectiveness of their products prior to their entry into the market, dietary supplements, like food, do not need to be pre-approved by FDA before they can enter the market.The DSHEA gave the FDA the express responsibility to regulate the manufacturing processes of dietary supplements, and the FDA issued its first proposed rule in 2003.[15] In June 2007 it issued its final rule,[16] which requires all dietary supplement manufacturers to ensure by June 2010 that production of dietary supplements complies with current good manufacturing practices, and be manufactured with "controls that result in a consistent product free of contamination, with accurate labeling."[17] In addition, the industry is now required to report to the FDA "all serious dietary supplement related adverse events." The new rules have been criticized, however, with skeptics arguing lack of FDA resources, loopholes, and an exception on quality assurance for raw material suppliers (with the burden placed on manufacturers) will lead to continued quality problems.[18] There's also concern that supplement manufacturers and retailers will hide behind the new regulations.[18] Prior to the rule supplements have had major quality problems, and the number of FDA investigators has declined.
出典:フリー百科事典『ウィキペディア(Wikipedia)』