Fact Or Fiction? The Truth About the Nutritional Supplement Industry, Part One: The FDA

The nutritional supplement industry is a billion-dollar business in the United States and across the globe. Finding a medicine cabinet in any given household in the states that doesn’t contain at least one nutritional supplement would be quite a challenge. In fact, more Americans than ever before are venturing into the world of supplementing nutrition for an array of reasons. In 2017, The Council for Responsible Nutrition estimated that over 75% of American adults took at least one dietary supplement. This is a new record in the supplement industry. Yes, this is a step in the right direction. Sadly, there are always two sides to every story. As people spend more money on nutritional supplements with each passing year, as with any industry, there will still be a percentage of people attracted for the wrong reasons. Where there is money to be made, you will find greed and deception. No doubt, most of us are here for the right reasons, ultimately improving overall health and wellness. With that being said, we must be equally cautious of the wolves hiding in the shadows. They’re ready to bleed money from those of us desperately searching for solutions to improve our lives. As always, we encourage you, the individual to do your due diligence.  Educate yourself about what is fact versus fiction when it comes to improving your health. Unfortunately, the lines aren’t nearly as defined as they should be. In general, there are several major misconceptions that float around this booming industry. The biggest grey area for most is how supplements are regulated, tested and what role the Food and Drug Administration (FDA) plays in monitoring products and protecting us from dangerous supplements and untested ingredients. We will spend part one of this blog looking at how exactly products make it to the market. When does the FDA intervene for our safety?

In an industry that is growing faster than ever, it’s essential to make sure you know exactly what you are consuming. Most of us would assume that supplements in mass distribution, the products that can be purchased nationwide, would have had to go through some type of testing, either for quality or safety, right? Wrong. Just because a supplement is available for purchase, confirms nothing. Not all supplements are regulated by the FDA, nor do they need to be tested before sale or consumption. There are no baseline tests in place ensuring product safety or quality for the unregulated supplement market. Most would assume that the FDA, at a minimum, keeps a close watch on new supplements and the overall industry for potential dangers, quality control, etc. Regrettably, this just isn’t the case. It could be argued as one of the biggest myths or misconceptions regarding the FDA and its role in this market.

A self-regulated industry is run as it sounds, through internal checks and balances. The FDA allows supplement manufacturers to regulate their own product testing and trusts that any questionable or potentially dangerous side effects or ingredients will be reported by the manufacturer. The bottom line is supplements need no type of testing for safety by the FDA before entering the open market. The FDA comes into play only after a supplement has been on the market and has caused some type of adverse or dangerous effects on its users. At this point, the FDA trusts and assumes the supplement manufacturer in question will report these issues.

In most cases, FDA intervention occurs at the expense of any number of people who ended up as involuntary guinea pigs. By consuming a specific supplement, they could have experienced one or more adverse side effects that directly impacted their health. When people are affected by adverse health effects from supplements designed to improve our health, it seems about as backward a result possible in this industry. One of the most prominent examples of this came from the introduction of ephedra as a favorite ingredient in weight-loss supplements. Ephedra was ultimately banned from use in supplements by the FDA in 2004. However, the damage had already been done; there were more than 16,000 cases reported by consumers who experienced some type of adverse effects from ephedra as well as killing around 150 people.

Ephedra was an example of this on a massive scale and has provided us with a prime example to ask what the FDA should be responsible for? Although there was a tragic end to the story of ephedra, there are still two sides to every tale. The question at hand is still: What role should the FDA play in the supplement industry? It’s not as clear-cut as some may think. Yes, the FDA should be on the front lines when it comes to protecting the general public from ingredients like ephedra and other harmful ingredients and products. On the other hand, The FDA already has its hands full. Should The FDA step in and develop and integrate a system for testing all products for safety and quality? This would mean every single supplement would have to adhere to the same laws. From supplements being manufactured in industrial sized labs and sold globally to local nutritionists selling herbal blends made at home and sold at their local farmers market. They would all have to adhere to the same rules. If your answer is yes, the FDA should take control, on the surface, that does not seem too illogical an answer. An FDA takeover may prevent products like those filled with ephedra from hitting the market but it is never that simple.

The first thing to happen, if the FDA imposed regulations, would be to eliminate most, if not all boutique supplements and starter companies from ever reaching the market. Government regulations would naturally cater to the manufacturers and companies with the deepest pockets. There are two main problems with this. First, by squashing competition, a large percentage of effective solutions would be eliminated. Second, as we have seen with big pharma in some instances, some of the bigger fish in the supplement industry could become powerful enough to leverage regulations in their favor. They could become immune to the laws initially set in place. FDA intervention also has the potential to destroy the entire industry with ease. As it stands now, the industry is so large that testing every single ingredient or product would be virtually impossible. Rather than establishing regulations, the FDA may decide the easiest thing to do would be to shut the whole thing down. This would be a death blow to the industry and the millions of people looking for health solutions.

There is a fine line here. There is no doubt that all supplement manufacturers, big and small, need to hold up their end of the bargain.They need to follow through by responsibly self-regulating their product testing for safety and quality. Again, this is where you, the individual can play a crucial role. Protect yourself by taking the time to understand what you are choosing to put in your body. Ultimately, we do not want to see the FDA take control of this market for many reasons; the most important being that there are a tremendous amount of products out there that have been rigorously tested and have proven to help people. Don’t throw the baby out with the bathwater. We will finish our look at some of the more prominent misconceptions, myths and lies within this industry in part two.


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