The FDA previously set standards only for foods and medicines, but last June, it added a separate set of regulations for dietary supplements. The new rules concern what the FDA has dubbed Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. After a grace period, supplements made in factories that have not been certified under the new standards will not be permitted into the United States.
Toyo Shinyaku received certification for its Tosu factory in Saga Prefecture, where nearly all of the company's dietary supplements are manufactured. The company has a line of 112 products that have been designated by the Health Ministry as Foods for Specified Health Use -- the most of any company in Japan.