Here at Natural Alternative Remedy, we like our dietary supplements. Of course, we are primarily proponents of living a naturally healthy lifestyle through a balanced diet full of whole foods rich in the vitamins and minerals our bodies need to function properly and free of disease. But we also recognize that even with a healthy diet, we might be missing out on the benefits of some of the most effective natural remedies. And perhaps, at times, our bodies could just use a little extra support. That’s where dietary supplements come in. For that extra support, we look to natural dietary supplements in many forms: capsules, tablets, liquids, and even powders.
But not all dietary supplements are created equal. In fact, there is a lot to consider when deciding to introduce a new supplement regimen into your healthy lifestyle – particularly when it comes to the manufacturers who produce them. Here’s what you need to know about the dietary supplements on the market today.
What are Dietary Supplements?
Back in 1994 after intense lobbying on behalf of the supplement industry, Congress defined the term “dietary supplement” by way of the Dietary Supplement Health and Education Act (DSHEA). Using the word defined may be generous, as the definition of dietary supplement still remains rather nebulous. It was also this law that put dietary supplements into their own special category under “foods” rather than “drugs” in terms of their regulatory status. That was an important distinction, but we’ll get back to that later.
DSHEA defined a “dietary supplement” as a product taken orally that contains a “dietary ingredient” meant to supplement the diet. These “dietary ingredients” can include anything from vitamins to minerals to herbs and other botanicals. They can also include other compounds and substances like enzymes and organ tissues or concentrates and extracts. See what we mean? Just about anything you can ingest that isn’t a drug or whole food can seemingly be considered a dietary supplement. So what do these supplements even do?
What Do Dietary Supplements Do?
Supplement manufacturers can legally make three types of claims for their products: health claims, nutrient content claims, and structure/function claims. Each of these types carry its own implications.
1. Health Claims
Health claims depict a relationship between a dietary ingredient and the reduced risk of some health-related condition or disease.
2. Nutrient Content Claims
Nutrient content claims detail the amount of a particular nutrient in the product. Using relative terms like high, low, and free, supplement labels can claim that they have a high level of a desired nutrient or they can compare their nutrient content to another product or food item.
3. Structure or Function Claims
Structure or function claims define the role of a particular dietary ingredient in maintaining some desired structure or function of the body. Everyone has heard the “calcium builds strong bones” claim, which is a perfect example of a structure/function claim. If calcium builds strong bones – a desirable outcome – and this product contains calcium, then the consumer can easily make the connection that the product builds strong bones.
So dietary supplement manufacturers can make these types of claims for their products, but there has to be some sort of claim oversight, right? The answer is not really.
Required Disclaimers
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
You may be familiar with this supplement disclaimer. That’s because while supplement products can legally make any of the three types of claims outlined above, manufacturers are required to include this disclaimer language on any product making a structure/function claim. This disclaimer specifically notes that the product is not intended to “diagnose, treat, cure, or prevent” as only drugs can make such claims, and as we now know, supplements are regulated under the food category,effectively relieving them from the same FDA safety and efficacy testing requirements that drugs must endure. Also, as with all supplement products, the FDA does not evaluate or approve dietary supplements. So who does? More on that next.
The FDA and Dietary Supplements
After the passing of DSHEA, a new regulatory framework for dietary supplements was created to govern their safety and labeling among other aspects of their development, marketing, and sale. Most notably, this new framework placed responsibility for determining safety on the supplement manufacturer. In addition to safety, the manufacturer also became responsible for ensuring that their product’s claims are substantiated by adequate evidence and are otherwise not misleading or false. To put it simply, this means that the entity with a stake in the successful launch and sale of a product is also the one responsible for regulating the product – generally not a recipe for success in terms of public health. And despite the required disclaimer on some products, many consumers do not know that dietary supplements do not require approval from the FDA before they are marketed. There are cases in which the FDA gets involved in pre-market review of a supplement product, but these cases are limited to the introduction of a “new dietary ingredient,” yet another hazy term. So what exactly is the FDA’s role in the supplement industry? It’s limited, to say the least.
FDA’s Role in Regulating Supplements
“Drugs are considered unsafe until proven safe. Dietary supplements are considered safe until proven unsafe.” – Cancer.org
The quote above nearly says it all. With dietary supplements placed in the food category, it is the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) that is responsible for the agency’s involvement in the regulation of supplement products. The FDA’s primary effort in this capacity is to oversee the marketplace for illegal products, or products that contain an illegal ingredient or make illegal claims. While the idea that the FDA is out policing illegal ingredients and claims might be comforting, in truth, the FDA’s reach is generally narrow and most importantly, limited to oversight after a supplement is already on the market. Yes, you read that right. The FDA may monitor the legality and safety of supplement products through consumer complaints, inspection reports, and of course, adverse events reported directly to the agency. But these actions occur after the product has been made readily available to consumers, which means that in many cases, the FDA can only take action after a supplement has already caused harm. To top it off, the FDA has limited resources and must prioritize where those resources will be focused. First priority is always public health emergencies. Lower down the list is enforcement policies and general monitoring.
Common Dietary Supplement Issues
All that said, the self-regulatory structure of the supplement industry is not inherently bad. There are many dietary supplements and dietary supplement manufacturers with a clean history. These reputable companies are conscientious about their manufacturing processes, the claims they make, how they label their products, and the integrity of the ingredients they use. These are the companies with which we like to do business. But as in any competitive market, there are always those that choose to cut corners to gain an edge. And of course, there are also those who, in a global market, simply cannot maintain the standards we would like to see in the products we use. As such,we must navigate the market with these issues in mind.
In studies of the composition of dietary supplements, several issues have come to light. Some supplements have been shown to contain contaminants like bacteria, pesticides, and even toxic heavy metals. Others have been shown to contain more or less than the stated volume of the marketed dietary ingredient. Others still have been exposed to not contain the ingredient that is listed on the label or more troubling, containing ingredients or additives that aren’t listed at all. These issues are not necessarily solely the fault of the manufacturer or distributer. Suppliers may experience accidental contamination or mistaken plant identity. Others may be less honest and instead combine crops with inexpensive alternatives leading to a less potent product or at worst, a contaminated one. But when all is said and done, the manufacturers are ultimately responsible for their product with little to no oversight from regulatory bodies like the FDA until there is a real – and reported – danger.
Report an Adverse Event
Speaking of reported dangers, today the FDA relies on the help of educated consumers to facilitate the monitoring of the safety of dietary supplement products through consumer complaints and reports of any harmful effects. If you think that you have experienced a harmful side effect or illness from a dietary supplement, first consult a medical professional immediately. Then, you or our health care professional can report the event through the FDA’s online Safety Reporting Portal.
Navigating the Supplement Aisle
So how can a holistic, natural alternative remedy-minded consumer navigate the local supplement aisle safely? Knowledge of the environment in which these dietary supplements are manufactured and marketed is the first step. You can check that one off the list after reading this article. But the next steps include more research and some common sense. Check out our 8 Must-Read Tips Before Buying Natural Supplements for more information on finding safe dietary supplements for you and your family.