The biggest issue with sleep gummies is that, like all dietary supplements, they’re not regulated in the United States.
“Since the passage of the federal Dietary Supplement Health and Education Act (DSHEA) of 1994, any product labeled as a dietary supplement escapes U.S. Food and Drug Administration (FDA) regulation,” says Carl Baum, MD, a professor of pediatrics and emergency medicine at the Yale School of Medicine in New Haven, Connecticut. “Other pharmaceuticals, including over-the-counter products, require evidence of safety and efficacy before they are approved by the FDA.” This means that once a product enters the market, the FDA bears the burden of proving whether it’s mislabeled or dangerous before it can be withdrawn from the market.
“The bottom line is that if you take a dietary supplement, you have absolutely no idea what’s in the product,” he says. “The active ingredient may not be present in the labeled dose — if it’s there at all — and disclosure of contaminants and adulterants isn’t required.”
Breus also notes that, as a general rule, “you can put more stuff in a gummy than a pill,” including sugar, flavoring, and other unnecessary ingredients. “This can easily lead to overdosages,” he says. “Very few, if any, supplements actually have the correct dose of any herb or supplement.”
Additionally, any product in gummy form may lead to what Breus calls candy confusion. “We’re seeing lots of accidental overdoses and kids taking things thinking they’re candy,” he says.
Drug interactions are also a potential risk, notably with sleep gummies containing melatonin, magnesium, CBD, or a combination thereof. “If you’re on any prescribed medications or have any medical conditions, you should always check with your physician first before starting on any supplements,” says Gans.
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