FDA Enforcing Strict Actions On Illegal Dietary Supplements

With increased life expectancy and the desire to be fit at an advanced age, the use of supplements has skyrocketed. As of now, three out of four Americans take supplements as part of their daily regimen. This rate is even higher in older Americans. This has promoted opportunists to produce illegal supplements with false marketing. All that will be coming to a stop now.

FDA Supplements

FDA Supplements

FDA Enforces New Actions On Illegal Supplements

The U.S. Food and Drug Administration has recently announced its plans to make the supply and use of supplements more restricted. They plan to restrict the use of supplements by strengthening their regulation on dietary supplements such as vitamins, minerals, and herbs.

Growing demand for supplements has massively surged the supplements supply industry from a $4 Billion industry to more than $40 Billion dollars now.

FDA Commissioner said in an agency news release “the changes would be one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. What was once a $4 billion industry, comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 — and possibly as many as 80,000 or even more — different products available to consumers.”

“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,” he stated.

The Council for Responsible Nutrition, a trade association, which represents the industry of nutritional supplements, presented no objection to the FDA’s action.

The council put out a statement supporting the FDA’s action “Dr. Gottlieb’s enthusiasm for rooting out bad actors who put consumers at risk by spiking products with unapproved ingredients or drugs,” said Steve Mister, president, and CEO of the Council for Responsible Nutrition. “We welcome additional enforcement actions to bring to justice those who would cynically trade on the halo effect of the responsible industry to make a quick buck while ignoring the safety and health of consumers.”

Additionally, Gottlieb expressed concerns that “changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks.”

“The new measures include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders,” Gottlieb added.

On February 12, the FDA sent out 12 warning letters and five online advisory letters to manufacturers and companies that have been illegally selling or marketing FDA unapproved products which have made claims to prevent, treat or cure Alzheimer’s disease, and any other serious conditions.

“Dietary supplements can when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s,” Gottlieb said.

Apart from enforcing actions, the FDA also plans to update the policies regarding supplements.
“I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency,” Gottlieb said.

The FDA’s major priorities regarding dietary supplements are the issues of safety, containing accurate ingredients as listed on the label, and meet the standards of quality set by the FDA.
Gottlieb also stated that the FDA is “developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with [dangerous ingredients], and to notify responsible industry participants to avoid making or selling them.”

Related Article

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

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