FDA is considering controversial rule change around supplements
Ella Scott
Featured Image Credit: Malorny/Getty Images
The way dietary supplements are regulated in the United States is on the brink of change, with experts concerned of possible health implications.
The Council for Responsible Nutrition (CRN) reported that three quarters of Americans take dietary supplements, with some of the most popular being Vitamin D, biotin, magnesium, calcium, and iron, as per BBC Good Food.
Unlike medications, the Food and Drug Administration (FDA) doesn’t usually approve these tablets for safety and effectiveness.
Instead, the agency requires manufacturers to list active and inactive ingredients, the serving size, and amount per serving.
Advert
A disclaimer that reads 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease' must also be present on the packaging.
This notice should be present after every bold health claim, including ‘promoting heart health’ and ‘improving immune health’.
According to a new report, the FDA is considering scrapping the need for this dispensation to be stated every time a health claim appears.
Instead, the agency is suggesting it be written just once on the tablet bottle, as per NBC News.
Kyle Diamantas, the head of the FDA’s food division, reasoned that in the past, the agency has seldom enforced this rule.
He claimed that the new strategy would also help cut down on label costs.
The outlet reported that the agency representative failed to state when this rule change would come into effect.
Diamantas said in a letter that the agency will not enforce the existing requirement while the policy is under review.
“If FDA does not identify significant concerns as we continue our review of the available data and information regarding this request, we are likely to propose a rule to amend this requirement,” Diamantas stated.
Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, has raised concerns about the FDA relaxing regulations, claiming it could be the catalyst for further changes.
“Then you start saying things like, ‘We only need it on the actual bottle,’” he told the publication. “Then you say, ‘It only needs to be on the back.’ Then you let the print get smaller.”
In a statement, Andrew Nixon, a spokesperson for the Department of Health and Human Services, which oversees the FDA, insisted the change would not make it more difficult for consumers to heed the warning.
He added that a ‘growing number of Americans are paying closer attention to product labels’.
Earlier this month, Republicans urged US President Donald Trump to help ‘protect’ the nation’s vitamin supply.
In a letter, highlighting concerns about the US’s ‘overreliance on China for the supply of its vitamins and amino acids used in both human and animal food’, the American Feed Industry Association president and chief executive officer Constance Cullman claimed he was America could face a ‘national security risk’.
“Working with several champions in Congress – Republican Representatives Ashley Hinson and Brad Finstad – and now their Republican colleagues, we believe we have the momentum needed to proactively address this issue,” he continued, as per Feedstuffs.
“We know the Trump Administration is committed to investigating the situation further and look forward to working with the president on next steps.”