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Does the FDA regulate vitamins?

Does the FDA regulate vitamins?

We know that the FDA regulates our medical products and drugs. So, it stands to reason that the FDA must also regulates vitamins, right? The answer is…nope. The United States Food and Drug administration or FDA for short, regulates almost everything Americans consume. So, many of us assume the FDA also regulates vitamins. Even though we see that “not evaluated by the FDA” disclaimer, we think there has got be some level of safety regulation. 

I didn’t spend a lot of time thinking about how safe my vitamins are. I also assumed that the FDA regulated vitamins. I mean, my go-to is Target’s Up & Up brand. Target and their beloved generic brand would never sell me anything harmful. Right?

Well, last weekend my boyfriend and I took the 75 mile drive into the suburbs where our families live. Often, when we dive over to their homes, we listen to podcasts to make the commute more enjoyable. This is how I discovered a podcast called The Dream

The first season of The Dream centered around MLM or multi-level marketing companies. The second season was about wellness MLMs. I knew my boyfriend wouldn’t be too interested in this topic, so I emailed myself a link to listen later. I ended up listening to the entire second season in a day and a half. I was shook! 

Honestly, I hated The Dream podcast at first. It made me extremely defensive right from the start. Sure, MLMs are shady. And just because an MLM sells a wellness product the MLM shouldn’t be any less scrutinized. But, I wasn’t quite prepared to confront the notion that wellness can be harmful to my health.

I preached the benefits of vitamins to anyone who would listen. Every morning, I take both, B and D vitamins. Then at night, depending upon my mood, I may take melatonin. As a woman approaching 35 who is interested in having a child sometime soon, I also take prenatal gummy vitamins with some regularity. 

As defensive as I was when I began listening to that podcast, I also couldn’t believe that:

  1. Vitamins are not regulated by the FDA 
  2. The wellness industry was successful in blocking attempts to regulate their products! 

We are talking about an industry that I personally relied on and trusted; then I find out they spent millions of dollars blocking regulations meant to protect consumers.  What the heck is going on here!? 

What is the difference between vitamins and supplements?

Before I dive into the reasons that vitamins aren’t regulated by the FDA it would be helpful to explain the difference between vitamins and supplements. The term vitamin and supplement are often used interchangeably. Perhaps because supplements often contain vitamins. 

Technically, vitamins are the naturally occurring nutrients that our bodies need. Often, we receive vitamins from the foods we eat. But due to industrialization and the way our modern foods are produced; we increasingly receive vitamins in pill form or because they are added back into our foods. Examples of vitamins are Vitamin A, B, C, D, E and K.

Supplements on the other hand technically refers to something we take to supplement our diets. That could be in the form of a pill, powder, drink or bar. Examples of supplements are: fish oil, echinacea, chromium, magnesium, ginkgo, zinc, cayenne, milk thistle, and valerian.   

Does the FDA regulate supplements?

So, does the FDA regulate supplements? Again, the answer is, nope. To understand why vitamins and supplements are not regulated by the FDA in the same way that food and drugs are, we have to go back to the 1970s. Back then, the Food and Drug Administration wanted to crack down on some of the beneficial claims made about vitamins and supplements. 

In the 1970s vitamins and supplements were experiencing a surge in popularity. There was increasing concern that vitamins and supplements may contain ingredients that are unsafe. Because there was no regulatory oversight no one was certain of the truth.

So there was a push to classify vitamins and supplements as drugs. The ramifications of this classification would potentially make it necessary to get a prescription from a doctor in order to buy them. This kind of regulation was troublesome to the industries that produced and sold this kind of product. 

Why the FDA should not regulate supplements 

So the Proxmire Amendment was created. A senator for Wisconsin, William Proxmire, who was instrumental in passing the Proxmire Amendment, did so because he believed that the FDA was a prime example of wasteful government spending. The theory being that consumers should have the ability to do their own research and purchase as many or as little supplements as they desire.

Back in the 1970s, the supplement industry claimed their resistance to regulation had everything to do with consumer freedom. It was agreed that vitamin and supplement manufacturers are capable of producing safe and effective products and oversight wasn’t necessary.   

Consumer perspectives on regulations 

Ok, so while this is way before my time (I was born in the 80s), I can sympathize with how supplement users must have felt during the Proxmire debates. Like I said, I am a vitamin advocate. I would be enraged if someone told me, for example, the vitamin D pills I take because I rarely see natural sunlight were somehow dangerous. I would be upset because I have years of anecdotal evidence that vitamin D is both safe and effective. Personally, I trust the brands I buy from and would have a hard time accepting there is anything wrong with their products. 

On the other hand, it is crazy to think that there would be any pushback from the seemingly obvious safety regulations that were being proposed. For instance, it was proposed that if a supplement claims to do something, there must be scientifically verifiable proof that it actually does that thing. You know, if something claims to be for weight loss you should be able to prove it actually contributes to the individual losing weight.

Another safety regulation that was rebuffed was the labelling of all ingredients on product packages. The pushback to those common sense safety regulations makes me feel as if the industry had something to hide. 

Are vitamins and supplements safe?   

More recently, the Dietary Supplement Health and Education Act of 1994 was passed. The goal of the DSHEA was to make vitamins and supplements safer by regulating products that are mislabeled or adulterated

Still, the FDA does not evaluate vitamins or supplements for safety and effectiveness prior to going to market. But, the FDA can now take action after the product becomes available and sickens people. The DSHEA also sets a label standard for vitamins and supplements that came to market after 1994.

We also have the United States Pharmacopeia (USP) which is an independent, not for profit organization that evaluates products such as vitamins and supplements. Companies can voluntarily submit their products for evaluation. You can check their formulary to see if your favorite vitamin or supplement has been evaluated. If a product has met USP standards it will also receive a certificate that can be used on the products label. 

 DSHESA regulations and the USP are helpful in establishing vitamin and supplement safety. However, it is difficult to say that vitamins and supplements that are sold in the United States are safe. It is even more difficult to say that vitamins and supplements in the United States are even effective.

The truth is, we do not know until a significant number of people are sickened or killed by a supplement that is unsafe. Because there is no safety oversight, when a new product comes to market in the US, we are unaware of any potential negative effects.  Moveover, a product may be sold for years which is ineffective because of a lack of regulation. Remember, there is no regulation that requires that a manufacturer prove its products’ health claims. 

Personal freedom over safety 

The FDA’s power to regulate vitamins and supplements was successfully blocked with two powerful acts. Both acts were passed because they framed their argument on the claim that our personal freedoms will be taken away if the FDA has the ability to ban dietary supplements and/or vitamins. That begs the question, do we really need a competition between our personal freedom and safety? 

Perhaps you’ve read my previous blog about how I am not a person who is drawn to conspiracy theories and extreme beliefs. Still, I am going to go out on a limb and tell you that I am inclined to believe there is some truth to the theory that pharmaceutical companies have a vested interest in convincing you to choose their product over a vitamin or supplement. However, the choice to take a vitamin and/or supplement over a drug should be based upon all products passing a basic safety and effectiveness review.

It feels like the freedom that is actually being valued is the freedom given to vitamin/supplement producers in order to deceive consumers. The burden of research is extremely high when you are looking for a useful nutritional supplement or safe vitamin source. Deceptive marking is a huge problem as far as healthy choices are concerned. No one wants to waste money on something that is ineffective or dangerous.

Additionally, the tension between personal freedom and safety permeates every aspect of our lives in the United States; and it is a political tension. For instance, mask regulations to curb the spread of Covid19 has become a politicalized issue of possible personal freedom infringement. There are countless other examples of how the concept of freedom has convoluted our actual safety. 

Science is not nature’s enemy 

No one has ever explicitly stated to me that science and nature are a dichotomy. But you get that sense, the more you learn more about wellness products and services. This is because many wellness products and treatments fall under the pseudoscience category.

Traditionally, little academic research has been done on items or activities that are deemed pseudoscience. As a result there is a stigma that wellness is ineffective. On one hand you have a group who has experienced the benefits of wellness and are undeterred by the lack of research. And on the other hand you have a group of people who refuse to consider something that is not scientifically proven.

Increasingly, academia has renewed interest in studying approaches to holistic health and evaluating those modalities using the scientific method. Personally, I believe this is great! But I am also aware of the ways in which this can be problematic. 

The 800 pound gorilla in the room is the placebo effect. For a variety of reasons that I will explore in another blog, the placebo effect faces major stigmas. However, like it or not, the placebo effect is – well, effective. 

Who can you trust?

When I became a massage therapist, one of my first mentors told me about the fascinating process he used to select vitamins and supplements. He goes to Whole Foods and walks down the wellness aisle then uses Reiki to discover the products he is meant to be using. You are not alone if this sounds a bit- crazy. When he told me this, I was polite but highly skeptical. 

Years later, I became a Reiki practitioner and thought back to my former mentor’s shopping technique. I decided to give it a try for myself. Unfortunately, I didn’t connect with his process. I did not feel a spiritual or vibrational connection to anything. So I left the wellness department and headed home. But, on my way to the door I passed one of those displays with the rotisserie chickens for sale. Now, I (like most who eat meat) enjoy those whole roasted chickens quite a bit! However, I had no reason to buy one at this time as I had recently had lunch. Still, something called out to me to turn around and buy myself a delicious roasted chicken treat. So I did.

Later that week, I had a routine check-up and found I had a slight iron deficiency. Nothing serious but my doctor recommended I take an iron supplement and change my diet moving forward. Because I am an over-sharer, I told my doctor about my Reiki experiment at Whole Foods and how I ended up buying a rotisserie chicken. She laughed and lamented that I wasn’t totally off base because obviously chicken contains the iron my body was lacking. 

If I haven’t lost you yet, here is my main takeaway from the chicken-reiki saga: Reiki worked! Of course this is an anecdotal claim. But one I firmly stand behind! There is a great deal of research that shows most dietary supplements are ineffective. Because I was in tune with my body through my Reiki practice, I felt the need to consume iron by purchasing chicken rather than an ineffective supplement. So, corny as it might sound, you should always trust yourself. I mean, verify with your healthcare team. But ultimately trust yourself.

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