Restrictions to dietary supplements for weight loss and muscle building for minors is slated to go into effect on April 22. The Council for Responsible Nutrition (CRN) is challenging the law’s constitutionality by attempting to have preliminary injunctions introduced to stall the law until these challenges can be litigated.
As of Wednesday, April 17, CRN said it is still waiting to hear back from the judge.
"We filed a preliminary motion a couple of weeks ago that would create a temporary injunction and prevent any enforcement of the law while this proceeding is going on," Mister said. "So just sort of freeze the status quo into place. We're waiting to hear back from the judge and hopefully we'll hear something before next Monday when retailers will be under the requirements."
In addition to filing the preliminary motion, CRN has also adopted new voluntary guidelines focused on the formulation, labeling, and packaging of melatonin-containing dietary supplements marketed for sleep support and another dedicated to the labeling of gummy dietary supplements.
Updated guidelines
The updated melatonin guidelines provide recommendations addressing intentional overages during manufacturing, child-deterrent packaging and precautionary label statements for melatonin-containing products. These guidelines are designed to ensure that consumers have access to products that are responsibly formulated, labeled and packaged.
"I think maybe the most important part of this is the recommendation for flavored forms of melatonin products–gummies, chewables, melts, those things that would be attractive to children—the guidelines recommend that companies put those products in a child deterrent package to slow down kids," Mister said.
"We have seen a big increase in ingestions, accidental ingestions of melatonin, both in emergency rooms and poison control centers. And so this is an effort to try to give some consumers some reassurance that we are trying to help parents keep their kids out of melatonin when they're not supposed to be in it."
With the growing popularity of gummy dietary supplements among consumers of all ages, CRN’s other new recommendation is for gummies, and it will focus on labeling clarity, reducing unsupervised access by children, addressing potential choking hazards for small children and ensuring products are used as intended.
'No incentives'
Despite all the progress on NDIs, it all comes down to enforcement. Critics assert FDA should improve enforcement against those who piggyback off other’s NDIs without proving the safety of their own ingredient, thereby diminishing incentives for industry.
"We have seen companies that do a lot of innovation, develop intellectual property, show the safety of their ingredient, go and get that NDI notification and then another ingredient supplier comes along and says, ‘Well, I'm just selling the same ingredient so I don't have to file,'" Mister said.
"FDA needs to enforce this law against those companies. They don't have to do it for everybody. Pick a few high profile cases, send a message to the industry, and the rest of industry will follow. But right now there is no incentive for these companies to file their own NDI and so they just piggy back on the first one and know that FDA won't come after them. That needs to change."
To hear more on CRN’s stance on synthetic botanicals, how the organization plans to navigate the NDI landscape and if it expects NDI guidance this year, watch the full interview.
