FDA Drafts New Guidelines for Dietary Supplements
Jupiterimages/Thinkstock(WASHINGTON) -- Millions of Americans take dietary supplements in the form of vitamins and minerals. There has long been debate over regulating their claims and their contents. Now the federal government is proposing stricter guidelines for makers of dietary supplements.
The FDA has drafted revised guidelines for when the manufacturers need to notify regulators about new ingredients.
A 1994 law already regulates new ingredients in pills, liquids and other supplements. Companies are required to file a safety notification with the FDA before adding ingredients that were not in their products when the law passed.
But the FDA has received only about 700 such notifications covering an estimated 55,000 supplement products. The new rules are supposed to increase compliance by clearing some of the confusion over just when notification is required. The guidelines also provide a template for filing notices. But one trade group is already asking the government to relax some of the rules. The FDA is inviting public comment on the proposed changes.
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