An Introduction to Dietary Supplements

What are Dietary Supplements?

There is currently a great deal of confusion surrounding the use of dietary supplements. Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
Source: FDA

What are the implications to you as a health care professional and a consumer?

In order to be educated consumers and soon to be nurses it is important to realize the facts and myths about dietary supplements. In order to help provide the best care for your patients it is your responsibility to ask the questions, and provide the answers to many questions your patients might have. For example, a patient comes into the hospital for high cholesterol, and is prescribed Lipitor to lower their LDL levels. It is your responsibility, as a proactive nurse, to ask the patient what
medications they have taken to realize if there might be any contraindications for giving a certain drug. It is important to verbalize to patients that dietary supplements, including herbs, are considered drugs, and can result in adverse reactions. Now consider this patient believes they have mild signs of depression and researched that St. Johns Wort is a natural remedy to depression. This might be acceptable except for the fact that Lipitor is a category X drug, and that taking St. Johns Wort can lower the effectiveness of the birth control medicine they are currently taking.

Why is this a hot topic issue?

Dietary supplements are compounds that have been around for sometimes thousands of years, even before some of the more common medications that are available today; however the issue has never been more important than now. With the continuous rise of
medical errors it is important for consumer and health care providers to be aware of not only the facts about dietary supplements but the myths which we will elaborate on in this blog.

If the health care provider is aware of the common myths, they can be proactive in talking to their patients, and assessing their current ideas about dietary supplement and some of the risks involved. By acknowledging that patients consume dietary supplements, adverse reactions can be avoided not only in the hospital but in outpatient treatment as well. Consumers also need to be advised that dietary supplements do just that, supplement the diet, they are not intended to replace certain foods.


Are Dietary Supplements safe?

Some dietary supplements may be harmful under some conditions. For example, many herbal products and other "natural" supplements have real and powerful pharmacological effects that can cause harmful reactions in some people or can cause dangerous interactions with prescribed or over-the-counter medicines. It does not necessarily mean that supplements marketed as "natural" are safe and without side effects.

This begs the question: “If the dietary supplements that I can buy over-the-counter are not safe, then why are they not being monitored better?” The Food and Drug Administration's (FDA) review of the safety and efficacy of these products is significantly less than for drugs and foods. Consumers must be cautious about using any supplement that claims to treat, prevent or cure a disease. The FDA has approved very few claims for labeling. Exceptions are based on a review of certain scientific evidence gathered through research. An example is that claims about folic acid supplements taken during pregnancy and a correlated decreased risk of neural tube birth defects.

It is critical that we all read carefully and think critically about the claims we see on the packages of dietary supplements. As health care professionals, we should be especially vigilant about discovering and educating our patients about the concerns and warnings involved in self-medicating with dietary supplements.

Dietary Supplements: It's All Around Us

Dietary supplements are more than just vitamins and minerals. Dietary supplements consist of “herbals, botanicals, amino acids, and enzymes.” These supplements can come in the forms of “tablets, capsules, powders, energy bars, or drinks.” Most people turn to supplements because they do not consume the required nutrients from the foods they eat. “However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure diseases; therefore, manufacturers may not make such claims. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.”

"Certain active ingredients can have adverse outcomes on the body and combining these supplements with prescribed medicines could cause harmful effects, and in the worst case scenario, death. One must understand that consultation with a healthcare provider is very essential to using supplements for treatment. Listed below are examples of interactions that may occur between dietary supplements and medications:

Calcium and heart medicine (e.g., Digoxin), thiazide diuretics (Thiazide), and aluminum and magnesium-containing antacids.

Magnesium and thiazide and loop diuretics (e.g., Lasix®, etc.), some cancer drugs (e.g., Cisplatin, etc.), and magnesium-containing antacids.

Vitamin K and a blood thinner (e.g., Coumadin).

St. John's Wort and selective serotonin reuptake inhibitor (SSRI) drugs (i.e., anti-depressant drugs and birth control pills).

The FDA has not approved some of stated therapeutic effects stated with the use of some dietary supplements. “It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. When a product makes it to the public, the FDA has the authority to take action on any dietary supplement product that presents a significant or unreasonable risk of illness or injury.”

Source: Office of Dietary Supplements
National Institutes of Health
Bethesda, Maryland 20892 USA
Web: http://ods.od.nih.gov

Legislation and Dietary Supplement Manufacturers

The Dietary Supplement Health and Education Act of 1994 states what manufacturers can and can not do and defines what a dietary supplement is. The purpose of this is Act is to protect the many manufacturers of dietary supplements as well as the consumers.

Congress, through the FDA, has made many findings about the use and need of some dietary supplements. They found that ingesting certain amounts of nutrients or dietary supplements could prevent many chronic diseases and could lead to an overall healthy life. If people ingest these nutrients, dietary supplements, and begin living healthy life styles, it might one day lesson the need for expensive medical procedures. There is an increasing need for the public to be educated on the benefits of nutrients, dietary supplements and how to lead a healthy lifestyles. The United States will spend over 1 trillion on health care in 1994. There is estimation that of the 600 dietary supplement manufacturers in the United States that produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000. There is a need for the Federal Government to take action against unsafe products but there should not be unreasonable rules that will stop or slow the production of safe products and good teaching for the consumers.

A dietary supplement is defined as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above.”

It is up to the FDA to make sure that a dietary supplement is safe and unaltered before it can be released to the public. It must not have any alterations in any way or have an unreasonable risk of injury and/or illness to the consumer. The manufacturer of a dietary supplement may claim a benefit of the supplement to a common deficiency in the United States and the function of the structure of the dietary supplement. Statements made by the manufacturer of a dietary supplement must first have good evidence that can back up the information they are claming to be true. On the labeling of the product there must be a bold statement “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." The manufacturer must also label clearly the vitamins and minerals that make up the supplement and the percentage of each in the supplement.

This Act is a good way to protect people from harm of ingesting unsafe dietary supplements and harm from false hope that a dietary supplement can cure a disease. Dietary supplements are meant to aid in a healthy lifestyle, not to cure deficiencies.

Common Misconceptions of Dietary Supplements

Myth: Since dietary supplements are made from herbs and other natural substances they can’t harm you

However, that is just a common myth and in reality they cause many adverse effects such as allergic reactions and toxicity. On the contrary, some herbal medications can be beneficial, but it is the amount you intake that can affect you. If you are taking any medications, you must be aware of the possible effects.

Myth: All dietary supplements are the same and therefore they are all safe

“The truth is that the ingredients in dietary supplements can vary greatly in quality and efficacy.” “Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed” and it is the FDA’s responsibility to take action against any unsafe supplement (FDA.org) However, “manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements”. This concern is especially true for herbal supplements, since capsules and bottles may not have the same amount of the supplement. However, many people believe that because the supplements are natural, they are safe. This myth is false because they are many adverse reactions that can occur when taking dietary supplements and prescriptions or OTC drugs. For example, according to Consumer Health Care, women taking oral contraceptives shouldn’t take certain medicines, such as St. Johns Wort, because it makes the birth control less effective. To avoid any potentially dangerous drug interactions, the best thing to do is talk to a doctor or pharmacist for instruction. It is also extremely important for nurses to ask their patients if they are taking any dietary supplements, and to teach them about the drug-drug interactions that can occur when taking these drugs together.

http://www.cfsan.fda.gov/~dms/supplmnt.html

Myth: If I take vitamins, I do not have to eat very much.

However, the truth is that vitamins do not work on their own, rather they help release the energy within food. This is much like a car… a car without gas will not run, just like a body without calories will not be able to work to its full potential, unless there is enough energy from food for them to work on. We get our energy from calories, which come from carbohydrates, proteins, and fats not vitamins alone.

Myth: My doctor will think I’m foolish for taking dietary supplements, therefore I should not tell him/her

The truth is that doctors are aware of the value, as well as the dangers of herbs. For example, the effectiveness of St. Johns Wort for depression but the adverse affects it can cause with birth control. It is important for your healthcare provider to know what you are taking so that they are aware of any drug-drug interactions that may occur, and as nurses it is especially important to teach patients about dietary supplements, and ask questions during the assessment process.

By Keecha Harris, MPH, RD
Nutrition Coordinator, JCCEO Head Start and Early Head Start
Birmingham, AL

Some myths about dietary supplements

Most people fall for dietary supplements because they think that they are “not getting adequate amount of nutrients,” which might be true in some cases but not always. And once people get into the habit of supplements they don’t pay attention to their diet because they think that their pill is taking care of the required nutrient. The office of dietary claims that “in 2002,calcium supplements were the number one selling mineral supplement and the 3rd highest selling supplement overall in the U.S. nutrition industry totaling approximately $877 million in sales.” Calcium is readily available in dairy products and other foods such as cabbage and broccoli. Eating variety and healthy food can meet the daily required nutrient but no, we look for easier way to get out of the way hence most of us end up taking calcium pills rather than adding a yogurt in our diet. Also, there are people who believe in “more is better.” Is more always better???---I don’t think so. We know that there is a normal range for every thing in our body. It is true that calcium is good for bones and teeth but what if take it more than required? Toxicity, which results in hypocalcaemia, impaired kidney function, and decreased absorption of other minerals.

Majority of the supplements are self-prescribed and work on referral basis. Every individual has different body chemistry so the drug that worked for A may not always work for B. and to take medication without a physician’s advice is not always a good idea. The drug may not always have the therapeutic effect and may have side effects. One should be more concerned if taking two or more drugs for that might cause drug-to-drug interaction.

I have seen many athletes overdosing themselves with protein supplements. As college students we all know that it’s the carbohydrates that actually fuel our body with energy. So, we should actually look into our carbs if we need extra energy, not proteins. A research document by Prof. Linda B. Bobroff (Department of Family, Youth and Community Sciences, Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of Florida) states that “Even if you are an active person, you don't need protein or amino acid supplements. These supplements are unnecessary and can be dangerous!” she further explains that following the food pyramid and eating variety of food rich in different nutrients is a key factor for being fit and healthy.

Source:www.fda.org
www.edis.ifas.ufl.edu/FY470
http://ods.od.nih.gov/factsheets/Calcium_pf.asp

Thinking Twice Before You Take That Supplement

It seems that everywhere we look today there is a commercial or advertisement suggesting that every single American could lose inches in hours or turn on the “energy afterburners” all day long with no ill side effects. Would this not be a great world if all this were true, and evaluated by arguably the most trusted nutritional source in America, the FDA?

So what do you need to think of next time you take that dietary supplement?

Research has shown that most people who are considered “medically normal “(i.e no pre-existing medical conditions or abnormalities that could cause adverse side effects with supplement use) do not need to use dietary supplements to lose weight. As is always true in nutrition, a healthy and diverse diet coupled with exercise is all the body needs to return to homeostasis, function properly, and run efficiently for many years. Dietary supplement manufacturing companies know this, so they play off your emotions without informing you about possible ramifications of their product.

The following is a list of those who should consult with their physician before taking dietary supplements to aide weight loss: *#

1. Tobacco users
2. Frequent dieters
3. Those who are pregnant or nursing
4. High blood pressure patients
5. Post menopausal women
6. Non-dairy consumers
7. High fat diet patients
8. Those who are fighting a cold
9. Hazardous material handlers
10. Those who eat cured or pickled foods
11. Suffers of clinical PMS
12. Those who spend little time outdoors

As stated before, most people do not need to take dietary supplements to control their weight. They need only to change their lifestyle and eating habits. For many these are changes that are too great and require too much effort to start and follow through with. For these many, a pill is their “cure-all” and the only way out of being overweight. Next time you see that advertisement telling you that you could be the next top model by taking this pill, reconsider the under-lying motivation of that statement.

*# Source: The Right Dose. Hausman, Patricia. Rodale Press. 1987.