Experts Urge U.S. to Reclassify 10-mg Melatonin as Drug Over Labeling, Child-Safety Risks
Updated
Updated · Livescience.com · May 28
Experts Urge U.S. to Reclassify 10-mg Melatonin as Drug Over Labeling, Child-Safety Risks
2 articles · Updated · Livescience.com · May 28
U.S. sleep and supplement researchers want melatonin moved from the dietary-supplement category to an over-the-counter drug, arguing current rules leave consumers with weak labeling, uneven dosing and little guidance on safe use.
1994 supplement law means the FDA does not pre-approve melatonin for safety, efficacy or manufacturing quality; one cited study found actual melatonin content ranged from 74% to 347% of label claims.
Nearly 1 in 5 school-aged children use melatonin regularly, while poison-control calls involving young children have surged with its popularity; experts say long-term pediatric safety data remain thin.
1- to 10-mg products can far exceed the body's roughly 0.3-mg nightly output, and mistimed or repeated doses may disrupt circadian rhythms, causing next-day grogginess, irritability, brain fog and insomnia.
Industry groups warn drug reclassification would raise costs and limit access, but some researchers say stronger oversight is needed because melatonin's popularity and benign image have outpaced public understanding of its risks.
With child overdoses soaring, could the 'natural' sleep aid in your cabinet contain 347% of its dose or unlisted chemicals?
Why is melatonin sold like a vitamin in the U.S. when other nations regulate it as a powerful, prescription-only hormone?