The implications of FDA actions on dietary supplements

The FDA says it plans to step up its policing of the growing dietary supplements industry.

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The implications of FDA actions on dietary supplements

The FDA says it plans to step up its policing of the growing dietary supplements industry.

The FDA is trying to ban products marketed with false claims

The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle and is a growing trend also in European countries. Three out of every four American consumers take a dietary supplement on a regular basis. When it comes to elderly Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own.

The agency sent 12 warning letters on February 11th to companies selling dietary supplements concerning their “unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions.”

He noted that since passage of a 1994 law regulating the supplements, the industry has grown from a $4 billion industry to one worth more than $40 billion industry, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly.

FDA commissioner Scott Gottlieb thinks that making healthy choices about diets can have a significant and positive impact on Americans’ health. To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products.

DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements. We know that most players in this industry act responsibly. “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 also added. “Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs – good manufacturing practices – that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases. We take seriously our obligation to protect consumers from all of these dangerous products.”

These new FDA efforts come at a time when, on one hand, the advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misleading products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.

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