Confidence In Your Supplements

By Dr. Leslie Foster MD, CHN

Discovery and Regulation of your Supplements
The dietary supplement market is a multibillion-dollar industry making $140.3 billion dollars globally in 2020 with growth projection of $298 billion by 2027. The United States leads in sales with ~ 77% of Americans taking a dietary supplement. Although 75% of supplement users say they have confidence in the supplements they take, 44% of users still are concerned with their safety. With the vast number of products available for purchase, each making “needed” claims for optimal health, supplements have become highly debatable. The need to take supplements, regulation, effectiveness, safety and absorption are all in question. So, are supplements the key to great health? Or are we just wasting our money?

Let Food Be Thy Medicine, A History

Dietary supplementation is not a new thing. In the earliest recorded medical documents found, the Ebhers papyrus in Egypt around 1515 BC, showed that onion containing vitamin C was given for Scurvy. Drawings also displayed cow’s liver, high in vitamin A, was given for night blindness. Hippocrates was quoted saying “let food be thy medicine and the medicine be thy food” and had documented the symptoms of a patient with Scurvy. During the 3rd century AD, China used soybeans to treat Beriberi, a vitamin B1 deficiency, also found in Japan in 1880 by the consumption of brown vs white rice. In 19th century London, because of pollution blocking the sun, people were treated with cod liver oil for their brittle bones. All early events were solved by happenstance without the knowledge of the healing compound in the food that cured the patient. The treatment of sailors ailed by Scurvy in 1753 by eating citrus fruit was discovered by the use of limes added to their rum.
Not until 1905 did scientists discover specific factors and accessory factors in foods that were needed for growth and development. In 1912 Cashmir Funk coined the term “vitamine”, vita for life and amine for thiamine which was the first discovered vitamin. By 1916 Mastin’s yeast vitamon tablets were being sold with the claims: “This preparation contains vitamines together with other ingredients which should prove of value in helping to improve appetite, aid digestion, correct constipation, clear the skin, increase energy, and as a tonic, to assist in putting on weight in weakened, run down conditions due to malnutrition.”.

During WW2 President Roosevelt created the National Nutrition Conference of Defense because American soldiers suffered disabilities resulting from poor nutrition. The 1941 Conference set up the 1st set of government sponsored recommended daily allowances, the RDAs for 6 vitamins and 2 minerals. They also began fortifying foods with vitamins such as bread with folate and milk with vitamin D. The 1st multivitamin that we are familiar with today, was sold on the market (and in some countries every breakfast table in the form of Vegemite).

The government tried to place regulations of dietary supplements in the 1970’s when the 2-time Nobel prize winner Linus Pauling published a paper claiming consumption of 3,000mg of Vitamin C daily would eliminate the common cold. He also claimed Vitamin A, E, and beta carotene could cure cancer and AIDS. The following year the Food and Drug Administration (FDA) proposed regulation on supplements. The Vitamin Industry lobbied against the FDA regulations, ultimately winning with a bill being passed in 1976 preventing the FDA regulating supplements.

Supplement Regulations: The Great Debate
Supplement use continued to grow through the 1990’s with >50% of people consuming supplements, most commonly being a multivitamin. Phytonutrients were also added to the growth at this time to the supplement market. With the continued growth of the supplement industry, the FDA began the Dietary Supplement Health and Education Act (DSHEA) to establish regulations on supplement companies. These included: 1. Must include designation “Dietary Supplement” on the label, and 2. Only making claims about structure and function of supplement, but not potential therapeutic or preventative effects. The DSHEA, however, places the burden of proof back on the FDA to analyze the supplements potential health risk. Every supplement developed after 1994 needed to provide “reasonable evidence” they are safe. In 1995, the Office of Dietary supplements was created as part of the DSHEA, the leading federal agency devoted to the scientific exploration of dietary supplements. 4 goals were established:

- To expand the scientific knowledge base on dietary supplements by stimulating and supporting a full range of biomedical research and by developing and contributing to collaborative initiatives, workshops, meetings and conferences
- Enhance the dietary supplement research workforce through raining and career development
  Foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research
- Translate dietary supplement research findings into useful information for consumers, health professionals, researchers, and policymakers.

A Consumer reports survey found that 55% of Americans believe that supplements should have warnings on their labels containing any relevant safety concerns of the product. 47% of people believe that the FDA should review products safety and effectiveness before sale and 45% believe that claims should be backed by scientific evidence. So, are there any specific regulations on supplements, and how are they being implemented or not?

FDA Regulations: It’s All About the Label

92% of people taking dietary supplements DO say they read the labels of products however many say they don’t understand everything that is on it. To understand supplement labels, consumers should know what is on them and also what is NOT on the label. There are no requirements for companies to put any warnings about the products on the label. The FDA only requires iron supplement labels to have a warning that accidental overdosing of iron can be fatal.
The FDA Does require 5 statements written on all Supplement labels:

The name
The amount
Nutrition labeling
Ingredient’s list
Name and place of business

However, small businesses are exempt from the labeling regulations. This is good to know when buying your supplements from small batch companies. Many small batch companies have their buyer’s confidence based on the integrity of the product. Be sure to look into the supplier, ask questions, and learn about the company you are buying from no matter big or small.

Reading the Supplemental Facts

Nutritional labeling in supplements is called the supplemental facts. Supplement facts differ from Nutritional Fact labels on our foods by a few factors that supplement users should know:

Supplement facts must list all ingredients, even if the ingredient does not have an RDI or DRV. The source of the ingredient can be written in the supplement facts or the ingredient list.
Nutrition facts on foods do not need to state the source of the ingredients on the labels.
If plant-based ingredients are being used in the supplement, part of the plant must be included.
Supplement Facts are not allowed to have anything listed in them that have 0%.
The identity with the serving size and the serving size of the container of an ingredient must be in the supplemental facts. The serving size of supplements are the maximum daily taken, so if the directions are to take 1-3 tablets, the serving size on the supplements represents taking 3 tablets.
Any binding agents, flavorings, sweeteners, fillers, and colorants must be included in the ingredient list.
Any chemical preservative must have its reason of use in the product on the ingredient list.
Small businesses that make less than $500,000 yearly sales or sell less than 100,000 products with less than 100 employees do not need to use supplemental facts as long as they don’t make claims on their labels. Expiration dates are not required on the labels for supplements.

In the US, dietary supplements are regulated as foods by the trade commission and evaluated for their advertising claims. The FDA sets guidelines for supplement claims based on whether it is a health claim vs a structure/function claim made by companies. Health claims state the ingredient reduces the risk of a particular disease. These claims have to be backed by undisputed scientific evidence and authorized by the FDA. Claims made on structure or function describes how the supplement is used in the body for general maintenance. Structure/function claims do not have to be authorized by the FDA. There is a subset that makes things even more confusing, called qualified health claims, in which there is some evidence a supplement supports its claims, however when using qualified health claims a company needs to add a disclaimer on the product.
Another thing to look for on the supplement label is the potency. The FDA allows certain words to be used. A company may use a “high” amount claim if the ingredient is over 20% of the daily value versus using the term “good source” if it is 10-19% of the daily value. Potency of a supplement can be a double-edged sword: the higher the potency, the more risk to safety.

Why Do Consumers Lack Confidence in Supplement Regulations?

It’s HOW the regulation process is performed. The FDA uses a post-market process. Supplements ONLY need to be tested on a warranted basis AFTER they are already being sold. Product claims, potency, and contaminants have to be submitted before sale; however, the actual product is not analyzed before sale. The FDA has a database run by the United States Department of Agriculture (USDA) and the National Institute of Health (NIH) to report serious adverse effects or proposed false claims of a product called the Dietary Supplement Label Database. From the information received, the USDA and NIH make decisions on if a supplement requires to be analyzed.
The Journal of Nutrition published testing performed on dietary supplements found on the supplement database. The results of commonly consumed vitamin and mineral supplements showed ~20% higher amounts of the vitamin than was stated on the label. Companies giving you more products? Since vitamins and minerals degrade easily over time, they increase the amount in the product to prolong the shelf-life. As described previously, increased amount of product can lead to increases in the potential of adverse effects and vitamin toxicity. In 2012, 20% of claims made by 127 different supplements for weight loss and immune health were illegal claims. Elevated blood pressure was the most reported adverse effect.

Taking a Different Approach

Different countries have different regulatory practices when dealing with dietary supplements depending on how they categorize them. They are placed under drugs/medications or as foods. Some countries go a step further and assign them their own subcategory with specific regulations, an example is Canada which created the Natural Health products category, a subset in drug regulations. Countries that place supplements under drugs/medications allow for supplement companies to place larger and more specific claims to them. For example, in Australia these are only prescribed by a physician, not allowing consumers to purchase supplements over-the-counter. Countries with supplements under drugs/medications perform pre-market testing on new products. Remedies used in Ayurvedic and Chinese medicine are mostly exempt from the drug/medication regulations unless new claims are being made for an old supplement.
Physicians only receive on average 19.6 hours of nutrition education in school. The Internal Journal of Adolescent Medicine and Health assessed the basic nutrition knowledge of graduating physicians. The physicians answered only 52% of the questions correctly. In residency programs, it was found physicians only received ~2.8 additional hours in nutrition. The FDA assigns a medication as prescription only based on safety of the ingredient. So, before we look at WHO is qualified to prescribe, let’s look at IF it’s even needed?

Why Do We Need Confidence in Our Supplements?

Each year, 23,000 people visit the Emergency Department for adverse effects resulting from dietary supplements. Most are attributed to fitness and weight management supplementation resulting in cardiovascular injury. The rest of the majority result from unsupervised children consuming micronutrients such as heavy metals leading to toxicity or choking on tablets. So, if you use the supplement as intended and from a reputable company without harmful contaminants, is it always safe?
We are always told to tell our physician what supplements we consume, but why? Most commonly claimed adverse effects are attributed to supplement/drug interactions, weight loss supplements and ingestion of harmful additives or unwanted contaminants. Problems that arise from common adverse supplement/drug interactions are mostly attributed to the absorption or metabolism of the drug. A well-known example is St. John’s Wort. St. Johns’s Wort increases the metabolism of many drugs in the liver. By increasing drugs metabolism, the drug will not be as effective to the patient. The most commonly known example is St. John’s Wort decreasing birth control pills effects.
Many herbal supplements can cause adverse effects in patients taking blood thinners, increasing bleeding and bruising in patients. We will dive into adverse effects more when we dive deeper into herbal supplementation. With knowledge of the supplement and its interactions and known adverse effects, we can avoid these problems. What about unknown contaminants and potencies of the supplements?

Seals of Approval

Companies can use independent agencies to test their products, providing more confidence in their products. Their products’ labels are then adorned with the lab approved seal. Two common seals you will see on supplement labels are USP and NSF. U.S. Pharmacopeia, USP, and National Sanitation Foundation, NSF, test products for potency, harmful contaminants, the absorption and bioavailability of the active ingredient in a specified time, and sanitation. Both agencies charge companies $3,000 to $15,000 dollars on supplement products depending on the number of claimed active ingredients on the labels. The USP goes a step further by testing the quality control of the product testing products already on the shelves for sale throughout the year.
Consumerlabs and UL Standards also do manufacturer provided testing.

The Problems with Contaminants

The FDA has a list of ingredients that are banned in dietary supplements called the FDA Dietary Supplement Ingredient Advisory List. These ingredients are noted as “potentially unsafe”. Most of the ingredients are related to body mass and weight loss is banned because they can cause heart problems. The Journal of American Medical association analyzed the FDA supplement database for contaminant reports in sexual dysfunction supplements, weight loss, and body building supplements finding 776 different supplements contaminated by unapproved ingredients. In 2016, the FDA put a warning on 36 different weight loss supplements that had hidden the ingredient sibutramine in them. Sibutramine is a discontinued appetite suppressant that can cause serious heart problems. You can find more of these ingredients on the FDA Dietary Supplement Ingredient Advisory List.
The FDA banned ingredients all have large amounts of direct evidence causing the patient harm. Yet, there are ingredients that companies add to products that aren’t banned but have shown potentially harmful in studies. So why do companies add them?

Why Add Additives?

Additives are used in supplements to increase shelf-life, as binding agents, for coloring/flavor, and for lubrication to prevent sticking to the machinery used in manufacturing the product. Although many are not banned by FDA, it does not mean they are safe in our supplements. The European Union has banned artificial colors that have shown potential to increase cancer risk, allergies and hyperactivity in children. Panera Bread and Whole Foods have banned the use of sodium benzoate a common preservative that increases cancer risk. Other additives to look out for are Magnesium Stearate, Titanium Dioxide, and Sodium Benzoate. Artificial Colors to avoid are Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6. Many animal studies have shown these additives increase cancer risk.

The most increasingly popular form of supplementation is gummy vitamins. The gummy vitamin has shown beneficial for people with swallowing issues, especially children. With the potential benefits of children taking their vitamins, comes with sugar or sugar substitutes. Sugar, or sugar substitutes, are used as an additive to make the supplement taste better. Along with all the known problems added sugar causes, sugar can also block absorption of Vitamin C, Calcium, and Magnesium. This doesn’t look good for the calcium chewable vitamins companies that advertised to woman for bone health, does it?

People’s desire for optimum health and the known effect that lifestyle choices have on chronic disease outcomes has made the supplement market a multi-billion-dollar industry. The need to have confidence in our products’ claims, safety and absorption are all important factors for deciding to take supplements. So, who really needs them? And with all the forms and types of supplements out there, what is best? Be sure to look out for more in our supplement series!

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Confidence In Your Supplements