The FDA regulates nutritional supplements
FDA wants to turn the dietary supplement market upside down
A quarter of a century ago, the US passed the Dietary Supplement Health and Education Act (DSHEA). According to this, dietary supplements, before they can be marketed, must be reported to the FDA as "New dietary ingredients (NDI)", along with documentation on their safety. Approval, as is the case with pharmaceuticals, is not associated with this. Food supplements that were already on the market before enjoy grandfathering.
One in four Americans takes dietary supplements
Now FDA Commissioner Scott Gottlieb is concerned that his agency will no longer be able to keep up with the rapid developments in the market. What was once a 4 billion dollar industry with around 4,000 products is now an industry worth more than 40 billion dollars with more than 50,000, possibly up to 80,000 or even more different products, Gottlieb explains in a statement.
The use of dietary supplements with vitamins, minerals or herbal ingredients has become an integral part of the American lifestyle. Three out of four consumers regularly take such products, four out of five for older consumers and one in three for children.
More and more black sheep
"We know that most of the players in this industry act responsibly," writes Gottlieb. "As dietary supplements have become more popular, so has the number of companies marketing potentially dangerous products or making unproven or misleading claims about their health benefits."
The FDA does not stand idly by this goings-on. For example, last April the agency took measures to protect consumers from the dangers of dietary supplements containing pure and highly concentrated caffeine. In November, a warning was issued not to purchase tonics for men from a product line called “Rhino”, as these contained undeclared active ingredients of the sildenafil / tadalafil type that require approval.
Twelve warning letters and five notifications were also recently sent out to companies selling more than 58 illegal nutritional supplements through websites or social media platforms, with unsubstantiated claims to prevent or treat Alzheimer's disease and a number of other serious diseases including diabetes and cancer.
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