A new proposal to toughen the Food and Drug Administration’s power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts in an uproar. They are mad and upset at the new guidelines and believe that they are too strong. But other’s simply don’t agree. One editorial found in the New England Journal of Medicine says the drug-safety agency’s proposed new powers are not nearly strong enough.
Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements. By law, dietary supplements with established ingredients — ingredients that were sold in the United States before 1994 — may be marketed without any evidence of efficacy or safety.
But to expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use “novel” products — minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in “mega-doses” much higher than have been customarily used in supplements.
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