The biggest issue with sleep gummies is that, like all dietary supplements, they are unregulated 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 FDA regulation,” explains Dr. Baum. “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product enters the market, the FDA bears the burden of proving whether it is mislabeled or dangerous before they can be withdrawn from the market. “The bottom line is that if you take a dietary supplement, you have absolutely no idea what is in the product: The active ingredient may not be present in the labeled dose — if it is there at all — and disclosure of contaminants and adulterants is not required.”
Gans adds that melatonin can negatively interact with some medications, “and therefore should be reviewed prior to use with one’s physician,” she says. “If you are on any prescribed medications or have any medical conditions you should always check with your physician first before starting on any supplements.”
Breus notes that, as a general rule, “you can put more stuff in a gummy than a pill,” including sugar and flavoring and unnecessary ingredients. “This can easily lead to over dosages,” he says, adding that “very few, if any, supplement makers actually have the correct dose of any herb or supplement.” Additionally, any product in gummy form may lead to candy confusion. “We are seeing lots of accidental overdoses and kids taking things thinking they are candy,” he says.
