Navigating the Unregulated World of Dietary Supplements  

Supplement bottle with supplements. Photo credit to Anna Clancy.

By: Anna Clancy

Disclaimer: The nutrition and health discussion found in this article is not intended to be a replacement for health or medical advice. Always consult with a licensed healthcare provider before starting a supplement. The views expressed in this news story are those of the contributing author, a Point Loma Nazarene University dietetics student.

Adverse effects from dietary supplements are the reason why 23,000 Americans find themselves in the emergency room each year, according to the New England Journal of Medicine. Many assume supplements undergo robust regulation and testing for safety and efficacy before reaching consumers. But that’s not happening.

The Council for Responsible Nutrition reports that every day, over half of American adults take supplements as part of their routine. Dietary supplements are taken by mouth and include vitamins, minerals, herbs, amino acids, enzymes and certain probiotics. The Food and Drug Administration (FDA) estimates that the supplement industry, once valued at $4 billion, is now a $40 billion industry. Regulations to protect consumers have not kept up with this exponential growth, making poor supplement oversight a relevant U.S. public health problem.

Registered dietitian and professor of kinesiology Heidi Lynch said she believes it’s important for consumers to recognize that dietary supplements are not regulated like pharmaceuticals.

“With prescription and over-the-counter medications, a lengthy process involving clinical trials and close oversight is needed before FDA approval,” Lynch said. “It’s pretty much the opposite with supplements, they can go to market without being tested and the burden is on the consumer to report adverse effects.”

The Dietary Supplement Health and Education Act of 1994 (DSHEA) established that supplements containing ingredients sold in the U.S. before 1994 could be marketed without notification of safety or efficacy. For supplements containing new ingredients, companies are supposed to provide the FDA with a rationale for the new ingredient’s safety, but this has not been enforced.

According to the National Institutes of Health (NIH), “Despite the thousands of supplements introduced to U.S. markets between 1994 and 2012, the FDA received sufficient notification of new ingredients in only 170 supplements.”

Of the companies that didn’t provide notification, the FDA discovered that many products contained compounds found in prescription drugs, analogs of drug compounds not tested for safety and drugs redacted from U.S. markets because of safety concerns. Even if violators are identified, companies can continue to sell the supplement until the court rules in favor of the FDA, which is a slow process.

This opens the door to many problems, such as supplements containing active ingredients in lower quantities than listed on the label, failing to contain active ingredients altogether and supplements being contaminated or adulterated with substances such as heavy metals, drug compounds, microbes and hormones.

Lynch said one population she believes is most vulnerable to supplement adulteration is athletes.

“Some athletes may think they are just taking a creatine supplement, but in reality, there might also be prohormones, testosterone or other illegal substances involved,” Lynch said.

While DSHEA prohibits companies from claiming their product will prevent or treat a disease, they are allowed to communicate a similar message by using a slight rephrase.

Registered dietitian and professor of nutrition Crystal Karges said she believes this is where the wellness jargon can make it challenging for consumers to discern what they are buying.

“While companies can’t say a supplement treats diabetes, they can claim it can support healthy blood sugar levels, which sounds really enticing, but can be misleading and may not be backed by scientific evidence,” Karges said.

Karges said she fears these claims are giving consumers a false sense of hope.

“Insinuating that a supplement can reverse a disease state is selling the false promise that all someone needs to do is to just take this one pill, but human health is so multifactorial,” Karges said. 

In her private practice, Karges said she has witnessed the effects these claims have had on clients.

“I have seen individuals in pregnancy or postpartum stop their medications for depression and anxiety and instead start taking a supplement that is likely not regulated and can include far more risk factors for adverse consequences,” Karges said.

Another cause of confusion for consumers is the word “natural.” While the FDA defines natural to mean “nothing artificial or synthetic included or added to a food that would not normally be expected in the food,” this statement does not address product safety. 

“There are plenty of things in nature that aren’t safe, and this word cannot be regarded as a measure for safety,” Lynch said. “That’s why it’s so important to utilize third-party testing. As consumers, we deserve to know what we’re purchasing, and there truly are good companies out there who want accountability from third parties so they can provide high-quality products.”

When evaluating supplements, third parties look for factors such as active ingredients present in the quantities listed on the label, supplements without contaminants or adulterations and good manufacturing practices. If a supplement has been third-party tested, a logo or seal from the testing organization can be found on the label. 

When shopping for supplements, keep these four principles in mind:

  1. Utilize third-party testing. Reputable organizations include the National Sanitation Foundation (NSF), Informed Choice and US Pharmacopeia (USP). For athletes, Lynch recommends using Informed Sport.
  2. If it sounds too good to be true, it probably is. While a supplement may seem like a convenient quick fix for a health concern, many other factors play a role in human health.
  3. Don’t mistake “natural” for “safe.” When marketing a supplement, many companies try to equate the word “natural” with “safe” because it exists in nature — so do scorpions, great whites and tsunamis, so it’s best to exercise caution. 
  4. Ask your doctor. Always consult with a licensed healthcare provider before beginning any dietary supplement and notify your provider of any supplements you are already taking.