I’ve been thinking about adding a dietary supplement as part of my daily routine. But I’m not sure how or if dietary supplements are regulated.
Unlike over-the-counter medications, dietary supplements are regulated more like food products than like drugs. Supplements, which are regulated by the Food and Drug Administration, will now be subject to “new enforcement strategies,” including a new rapid-response tool that can alert consumers to unsafe products, the FDA said in a written statement this week.
The move is “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” FDA Commissioner Scott Gottlieb said. “FDA’s priorities for dietary supplements are to ensure that they’re safe, contain the ingredients listed on the label, and are made according to quality standards.”
This is significant, considering that there are now close to 80,000 dietary supplements on the market, with three of every four American consumers now taking a dietary supplement regularly. For older Americans, the rate is four out of every five.
Dietary supplements regulated by the FDA include vitamins, minerals, and herbs. In the 25 years since Congress passed the Dietary Supplement Health and Education Act, which gave the FDA the authority to regulate dietary supplements, the dietary supplement market has grown significantly, the agency said.
“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products, or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb said.
Some of the new FDA oversight steps will include:
- communicating to the public as soon as possible when there is a concern about a dietary supplement on the market.
- ensuring that the FDA’s regulatory framework is flexible enough to evaluate product safety while promoting innovation.
- developing new enforcement strategies.
- continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.
For example, the FDA recently sent 12 warning letters to certain supplement companies whose products the FDA considered as being “illegally marketed as unapproved, new drugs” because they claim to “prevent, treat, or cure Alzheimer’s disease, as well as health conditions like diabetes and cancer.”
Per Commissioner Gottlieb, “Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health. They, however, cannot claim to prevent, treat, or cure diseases like Alzheimer’s.”
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