It seems there’s a dietary supplement for everything today. On store shelves and online, we see supplements to lose weight, gain muscle mass, have softer skin, stabilize our moods, improve our sleep, increase our sexual stamina, and reduce our breakouts. Whether you’re young or old, male or female, overweight or underweight, muscular or lean, there’s a supplement for you to “fix” whatever ails you. The Food and Drug Administration (FDA), however, is not so happy about all the supplements available today and is planning to implement tougher oversight on the $50 billion a year industry known collectively as “dietary supplements.”
Message From the FDA
The FDA said recently that the “explosive growth” of the dietary supplements industry is putting consumers in danger because many of these products are sold with unlisted drug ingredients and false or misleading labeling regarding the health benefits of the product. In early February, the FDA sent 12 warning letters and five advisory letters to companies selling products that contain drugs that have not been FDA approved or for making illegal claims that the products treats or even cures certain conditions and disease. One disease that products often claim to treat or cure is Alzheimer’s, a brain disease that causes a slow decline in memory, thinking, and reasoning skills.
FDA Commissioner, Scott Gottlieb, announced recently that the agency is working on policy changes that “could lead to the most important regulatory modernization since enactment of the 1994 Dietary Supplement Health and Education Act.”
As the law stands now, dietary supplements are regulated as food, which means they are not subject to premarket approval or the kind of safety and effectiveness testing required for new drugs that want to come available on the market. Since the enactment of the Dietary Supplement Health and Education Act of 1994, the supplement industry has grown from 4,000 products and $4 billion a year in sales to as many as 80,000 products and $50 billion in sales, the FDA reports. Even though the FDA is not required to approve supplements ahead of time, it is required to remove unsafe products from the market.
Dangers of Supplements Seen in ERs
The burgeoning growth of the dietary supplements industry has allowed many less-than-reputable companies tout products that are unsafe and many that are downright dangerous. Ingredients are purposefully left off labels, and health benefit claims are made that simply are not true. Over 23,000 Americans visited emergency departments in the United States last year due to adverse effects of dietary supplements, according to an article in the New England Journal of Medicine. Many of those ER visits were for heart problems from weight-loss and energy supplements that contain dangerous substances.
With three out of four Americans taking some kind of dietary supplement on a daily basis, the FDA feels it’s imperative to act now to “improve safety, reduce inaccurate claims, and encourage industry innovation.” One step the FDA will take to achieve these goals is to create a rapid-response tool to quickly alert the public if a supplement contains an illegal and dangerous ingredient.