Between the year 2000 to 2017, retail sales of nutritional supplements have more than doubled, skyrocketing from $17.2 billion to $36.1 billion. Which might make sense, considering the fact that 52 percent of Americans have taken a dietary supplement within the past 30 days.
But just what are these products? Do they work? Are there any potential downsides? How can you tell the difference between a quality supplement and a scammy one?
While these questions might seem straightforward, the supplements industry is wrought with nuance. So, to help you make a more empowered decision about what you put in your body, we’ll start our five-part series by looking at the history of dietary supplements regulation – and why it makes all the difference to you as a consumer.
Just What Is a Dietary Supplement, Anyway?
Whether called a dietary ingredient, nutritional supplement, or health or food supplement, the FDA—the regulatory agency that provides oversight for the supplements industry—defines it as “a product intended for ingestion that contains a ‘dietary ingredient’ intended to add further nutritional value to (supplement) the diet.”
This can include a vitamin, mineral, herb, botanical, amino acid, concentrate, metabolite, constituent, extract, or “a dietary substance for use by people to supplement the diet by increasing the total dietary intake.”
Some of these products are intended to help ensure you’re getting enough nutrients, while others are promoted as helping to reduce disease.
How can you ingest a dietary supplement? These ingredients are available in many different forms, including “tablets, capsules, softgels, gelcaps, liquids, or powders.”
Armed with this information alone, it’s easy to recognize why there are so many different kinds of dietary supplements available in the marketplace.
But how did we arrive at such an expansive definition in the first place? Let’s start by hopping in our time machine and traveling back a little more than a century.
When Did Vitamins & Dietary Supplements Start
Do you lie awake at night worrying about scurvy, a vitamin C deficiency that can lead to anemia, extreme exhaustion, swelling in some areas of the body, and tooth loss?
Very likely not, since it’s largely been eradicated in modern times. But even before vitamin C (ascorbic acid) was discovered by Albert Szent-Györgyi, it was widely understood that certain foods—especially citrus—could help address scurvy symptoms quickly and effectively.
But why is vitamin C—and all other vitamins, for that matter—so important for our health?
How Many Vitamins Are There & Why Are They Important?
In Vitamania: How Vitamins Revolutionized the Way We Think About Food, Catherine Price reports that the word ‘vitamine’ first appeared in print in June 1912. Since that time, the medical community has identified a total of 13 different vitamins that are essential to our health:
- Vitamin A
- Vitamin B1 (Thiamine)
- Vitamin B2 (Riboflavin)
- Vitamin B3 (Niacin)
- Pantothenic Acid
- Vitamin B6 (Pyridoxine)
- Folic Acid
- Vitamin B12 (Cobalamin)
- Vitamin C (Ascorbic Acid)
- Vitamin D
- Vitamin E
- Vitamin K
Without them, our body cannot function properly. For example, healthy teeth and bones require vitamin A. Vitamin B6 is essential for helping various proteins in the body job their jobs. Vitamin D helps the body absorb calcium, vitamin K helps blood coagulate, and vitamin B1 is essential for turning carbohydrates into energy.
As a result, ingesting proper amounts of these 13 vitamins is scientifically proven to prevent many devastating nutritional diseases.
Despite their immense importance, though, Catherine Price explains that there’s no definition of precisely what a vitamin is. Consequently, the word “has taken on a life of its own, used and abused by advertisers to such an extent that it can be seen as one of the most brilliant marketing terms of all time.”
What she’s talking about? Let’s jump forward a few years.
What’s the Difference Between a Vitamin, a Dietary Supplement, and Food?
Because the general population tends to have a basic understanding of the importance of vitamins, the thought process is that “more = better.” Or, in some instances, we believe these chemicals have other, undiscovered benefits—something which marketers are eager to capitalize on.
Here’s how Catherine explains it: “Vitamins’ amazing ability to prevent devastating deficiencies has also helped to create our modern obsession with isolated dietary chemicals—the assumption being that if food contains vitamins, then it must contain other miraculous chemical compounds as well.”
In the past, this line of reasoning led to surges in the popularity of vitamins A and C during the 1920s, while vitamin B2 was a hot commodity during the 1930s. More recently, vitamin C has made a comeback, along with vitamins E and D.
Even in this 1946 Vita-Sert advertisement, we can see for ourselves the blurry line between food, the vitamins they contain, and a dietary supplement. Image credit: Classic Film via Flickr
Bringing everything full circle, we can see the close interplay between:
- A food (something we must regularly consume to support our body's energy needs),
- A vitamin (essential compounds contained in the foods we eat), and
- A supplement (purposely ingesting additional vitamins, above and beyond what’s in food).
So, how did we go from identifying the importance of these 13 compounds and making sure we collectively ingested enough, to the current marketplace that encompasses hundreds of ingredients and spans tens of thousands of different supplement formulations?
How Are Dietary Supplements Regulated in Modern Times?
Although there have been many significant dates in the history of U.S. food and drug law, there were five watershed moments responsible for our modern supplements industry.
The 1938 Food, Drug, and Cosmetic Act
Intended to update the original 1906 Pure Food and Drugs Act, the 1938 Food, Drug, and Cosmetic Act (FDCA) officially gave the Food and Drug Administration (FDA)—which was only eight years old at the time—responsibility for overseeing the safety of food, drugs, and cosmetics.
Most understood that the original 1906 Pure Food and Drugs Act wasn’t sufficient to address the rapid increase in dietary-related products, but the tipping point for the Act’s implementation occurred when more than 100 people across 15 states died from Elixir Sulfanilamide poisoning.
In addition to their increased drug regulation capacity, the FDCA also granted the FDA oversight for cosmetics and medical devices, as well as boosted the agency’s ability to enforce these laws.
The Proxmire Amendments
Until 1976, the FDA had the ability to limit the vitamin and mineral potency found in food supplements, or even regulate them as drugs based on this criteria.
However, on April 22 of that year, the supplements industry struck gold with the passage of the Vitamins and Minerals Amendment, also known and the Proxmire amendments (they were principally sponsored by Wisconsin Democrat Senator William Proxmire).
Why? This effectively ended the FDA’s ability to regulate food supplements based on potency.
In Vitamania, Catherine Price further explains that the VMA also “made it illegal for the FDA to ever establish standards for supplements, classify them as drugs, or require that they only contain useful ingredients. It forbade the FDA from ever setting limits on the quantity or combination of vitamins, minerals, or other ingredients that a supplement could contain unless the FDA could prove (usually after the product was on the market) that the formulation was unsafe—an extremely important shift of responsibility.”
Nutrition Labeling and Education Act of 1990 & Dietary Supplement Act of 1992
In 1990, the Nutritional Labeling and Education Act (NLEA) went into effect, granting food labeling oversight to the FDA and allowing them to regulate nutrient content claims.
While the FDA was working to comply with the Act’s 1993 deadline, Senator Orrin Hatch of Utah introduced the Health Freedom Act of 1992, citing that these new labeling guidelines could put “anybody out of business.”
While Hatch’s Act didn’t pass, it did provide a great deal of momentum for Congress to enact the heavily-lobbied Dietary Supplement Act of 1992, which stipulated that the FDA’s forthcoming labeling guidelines would not apply to dietary supplements until the end of 1993.
The Dietary Supplement Health and Education Act of 1994
During this year-long moratorium, The Dietary Supplement Health and Education Act of 1994 was introduced, claiming to grant consumers “access to current and accurate information about supplements, and [address the] controversy over the Food and Drug Administration's (FDA) regulatory approach to this product category.”
Marketing-speak aside, the DSHEA outlined three main components:
- The definition of a supplement (it also excluded supplements from being classified as food additives, or as adulterated food)
- Required information on labels (net quantity, nutrition information, name of business or manufacturer, the "This statement has not been evaluated by the Food and Drug Administration” disclaimer,” etc.)
- Supplement manufacturers did not have to obtain FDA approval prior to marketing their products
In other words, the DSHEA allowed companies to create their formulations using Generally Recognized As Safe (GRAS) ingredients, the same classification under which food is found (remember the “food à vitamin à supplement” blurriness from earlier?).
In fact, after its passage, dietary supplements faced less regulatory oversight than conventional food. According to Ruth Kava, Senior Nutrition Fellow at the American Council on Science and Health:
“[The passage of the DSHEA] took supplements into the realm of food rather than drugs, which is really what they are. While new foods have to be shown to be safe before offering them in the marketplace, drugs must also be shown to be effective. Eliminating that latter requirement means that supplement manufacturers can imply all sorts of health effects. And although the manufacturers are supposed to have data showing their products are safe, they don’t have to give that data to the FDA prior to marketing. So the consumer is truly a guinea pig — there’s no real quality control.”
The DSHEA furthered clarified that it would be the FDA’s responsibility to prove that a supplement was unsafe, instead of the manufacturer being required to prove it was safe in the first place. All these companies had to do was avoid claiming that their supplement could “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.”
Pro tip: This is why you always find the following wording on supplements labels, websites, and advertisements: ''This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
What Do Dietary Supplements Regulations Mean for Consumers?
In short, the DSHEA stipulates that the supplements industry is almost wholly responsible for self-regulation, which some could argue—despite the name of the Act—ended up providing consumers with less education about the supplements they’re putting in their bodies, to say nothing of the potential health consequences.
This has also led to multiple instances where the industry has found itself in hot water, including a 2015 NY State Attorney General investigation that found four out of five supplements available at national retailers didn’t contain any of the herbs on their labels.
Furthermore, “The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.”
Speaking of which, Morton Tavel, MD, and Clinical Professor Emeritus of Medicine at the Indiana University School of Medicine, told us that:
“Between 2007 and mid-April of 2012, more than 6,300 adverse events associated with dietary supplements were reported to the FDA from supplement companies, consumers, health-care providers, and others. Included were 115 deaths, more than 2,100 hospitalizations, and 1,000 serious illnesses.”
“One objective study (Geller et al, 2015) estimated that more than 23,000 annual emergency department visits for adverse reactions attributed to dietary supplements occurred nationwide from 2004 through 2013. These reports by themselves don’t prove the supplements caused the problems, but these sheer numbers are cause for major concern. The haphazard way of data collection suggests that these numbers underestimate the true incidence of adverse events,” Morton said.
The fact of the matter is that drug development, testing, and approval is a lengthy—and very expensive—process. Returning again to Vitamania, Catherine Price adds some insightful perspective into the overall situation by noting:
“According to a 2013 analysis by Forbes magazine, some 95 percent of experimental medicines—that’s nineteen out of twenty!—fail to meet the FDA’s standards for safety and effectiveness for humans.”
Further, of those that do receive approval, combined with development, Catherine tells us the process generally takes 12-13 years and costs about $5.2 billion (since the successes must account for all the failures).
But, “thanks to DSHEA, none of these requirements applies to supplements—not the research, not the testing, and certainly not the cost,” Catherine writes.
Given all of this, if you’re set on purchasing a supplement, what can you do to help ensure your safety, as well as maximize the value received for your hard-earned money?
5 Steps for Choosing a Nutritional Supplement
As you can see, the history of supplements regulation blurs the line between food and drugs, and also draws a fuzzy distinction between consumer-oriented laws and pro-business carte blanche.
But if you’re on the hunt for a new vitamin, mineral, or supplement, here are five clear-as-day recommendations to help put you on the right path:
1. Talk With Your Doctor
Always be sure to discuss any new supplement with your physician, including why you’re interested, who can then make recommendations based on your specific diagnosis.
While it’s certainly not a requirement that you discuss any supplements you’re taking (or thinking about taking) with your physician, Nutrition.gov strongly recommends doing so, as:
“You may think side effects happen only with prescription medicines, but some dietary supplements can cause side effects if taken with other medications or if certain health conditions exist. Even if you don't take medication or have a chronic health problem, the wrong dietary supplement or the wrong amount can cause problems. So check with your doctor before taking a dietary supplement.”
2. Take a Close Look at the Company
Does the company have a website? As difficult as it might be to believe in this day and age, a meaningful number of supplements companies don’t have main/corporate websites, which can be a big red flag.
What about a Better Business Bureau listing? What are customers saying on consumer-focused sites like HighYa? Ruth Kava, Senior Fellow of Nutrition at ACSH, told us in our interview: “I might also try to eliminate supplements made in countries (if that is available) that have been shown to produce supplements that are contaminated with drugs (such as some for ED) or with dangerous drugs.”
Recent examples include tadalafil and sildenafil (both erectile dysfunction prescription medications), sibutramine (a prescription anorexiant), and ephedra (a banned substance in the US).
3. Take a Close Look at Their Claims
Things to ask: Do their claims seem over-to-top or too good to be true? Do they provide clinical evidence to support their claims? Has it been published in a peer-reviewed journal?
If a company makes bold claims but doesn’t provide robust clinical evidence for support, this could be a red flag.
4. Take a Close Look at the Label
Ruth Kava also recommended looking for labels that meet USP standards, although “you won’t find many,” she emphasized.
Why are these standards important? According to the USP website, they “help ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients.”
While certainly not required, this can go a long way toward indicating that the manufacturer is focused on bringing the highest-quality product to the marketplace.
5. Mind These Billing Concerns
If you’re planning to order online (versus purchasing at a retail location), consumers often report negative experiences with free trials and autoship programs.
As a result, if you encounter a product sold only through these methods, pick up the phone (or send an email) and try contacting support. Are they easy to reach? Do they respond quickly? Are they pleasant and eager to answer your questions?
Also, the Terms and Conditions can be an invaluable source of information about the company’s trial details (e.g. how long it lasts, how much you’ll be charged once it ends, how often you’ll receive automatic shipments, and so forth), which might not always be spelled out directly on their website.
Can’t find their Terms? This could be another red flag that you might want to avoid.
The bottom line is that, when it comes to dietary supplements, the onus is on you as a consumer to arm yourself with information that can keep you safe.