A report recently released by Consumer Reports has brought a large amount of attention to the FDA’s regulatory standards of dietary supplements. They discovered that every year, over 23,000 consumers end up in the Emergency Room due to unsafe consumption of supplements. This staggering number prompted our team to look into this issue a bit further and figure out why this number was so high for a product that appears to have a “healthy” reputation.
Our first reason for concern occurred when we realized, the U.S. Food and Drug Administration (FDA) does not have the authority to review any dietary supplement products for safety and effectiveness before they are released to market. These items fall under a separate umbrella than “conventional drugs” and instead are mandated by the FDA’s Center for Food Safety and Applied Nutrition. Meaning, the responsibility is placed solely on the manufacturer to ensure their products meet the regulations created by the FDA. The very same manufacturer that spends millions of dollars in marketing to advertise their products to the masses.
The Effect of No Regulation
Of course, we wanted to know more about why this seemingly lax policy was in place. How can the FDA trust the manufacturer to abide by their rules and allow items to be sold and considered safe until proven unsafe in an open market?
Well, dietary supplements are about a $30 billion industry, and the FDA is only able to inspect a fraction of manufacturers to determine if a product really has the effect or contains what it claims. With a margin so big, it’s difficult to fully monitor the market and insure all items are preserved for consumption. This beast of a workload can be tasking to the FDA as it’s time is mainly consumed with putting prescription drugs through numerous rounds of testing and clinical trials. In comparison to supplements that are produced to go to the masses fast, prescription medication can take anywhere from 8-10 years per drug for approval prior to hitting the shelves.
This rapid turnaround is a little too unsettling as news broke about one of the more recent herbal supplement recalls containing dangerously elevated lead levels. The Ton Shen Health/Life Rising tablets tested 56 times the accepted level, making it an alarming risk for children if consumed. When the manufacturer was questioned over the purpose for taking the drug, they were unable to provide real clarification, and stated, “it can help regulate blood circulation.” Not quite the specifics one would like to hear if having been previously encouraged to use this supplement.
The Potential for Regulation
Great minds think alike. Regulators are extremely concerned for the common consumer with this exposure gap for recalls and safety alerts. Everything from weight loss pills, vitamins, to herbal supplements fall under the supplement category and recent exposure to the industry standards has raised numerous eyebrows.
The concerns have and will continue to grow with the market as it expands. The risk of mislabeled products, potentially harmful unlisted ingredients, false testing, and many times unproven health claims have linked to serious health problems and in some cases, deaths.
According to the Nutrition Business Journal, in the last decade supplement sales have increased by 81%. The number one reason being, the ease of availability to obtain these “natural and safe” supplements. It’s become much easier for consumers to get their hands on the quick fix items, like those claiming to melt all body fat in just 5 days. We need to create awareness around these marketing “ploys” and encourage people to become knowledgeable about their health. If a supplement’s claims are too good to be true, it 100% is.
There is much more to lose than gain when taking a risky supplement. Stick to the safe items, and make sure to do your research prior to buying anything online or overseas and routinely check the FDA’s list of alerted ingredients.
What can you do?
- Consumers should talk to their doctors before consuming any health supplements.
- Always read package inserts and labels, but be conscious these too are not evaluated by FDA prior to hitting the market.
- Be cautious about taking dietary supplements if you are pregnant or nursing
- Beware of supplements promising a “quick cure” – especially the weight loss products promising you can eat all you want and still lose weight.
- Report any health product you believe to be fraudulent to the FTC.