FDA 101: Dietary Supplements

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

vitamin and mineral products

"botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.

enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.
People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.
If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.
How Are Supplements Regulated?

• You should know the following if you are considering using a dietary supplement.
• Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
• Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
• Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
• Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
• Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
• Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
• It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
• There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
• Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.
Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

microbiological, pesticide, and heavy metal contamination
absence of a dietary ingredient claimed to be in the product
the presence of more or less than the amount of the dietary ingredient claimed on the label
In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

• Let your health care professional advise you on sorting reliable information from questionable information.
• Contact the manufacturer for information about the product you intend to use.
• Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
• Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
• Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
• Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
• Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.
• Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.fda.gov/FDAgov/Food/DietarySupplements/Alerts/ucm111110.htm.
Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA Consumer Complaint Coordinator.

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Dietary Supplements

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

vitamin and mineral products

"botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.
People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.
Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.
If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.
Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.
Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

microbiological, pesticide, and heavy metal contamination
absence of a dietary ingredient claimed to be in the product
the presence of more or less than the amount of the dietary ingredient claimed on the label
In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

Let your health care professional advise you on sorting reliable information from questionable information.
Contact the manufacturer for information about the product you intend to use.
Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
Learn to spot false claims. If something sounds too good to be true, it probably is.
Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.fda.gov/FDAgov/Food/DietarySupplements/Alerts/ucm111110.htm.
Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA Consumer Complaint Coordinator.

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Dietary supplement

Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

 Bodybuilding supplement

A dietary supplement is either intended to provide nutrients in order to increase the quantity of their consumption, or to provide non-nutrient chemicals which are claimed to have a biologically beneficial effect.

Supplements as generally understood include vitamins, minerals, fiber, fatty acids, or amino acids, among other substances. U.S. authorities define dietary supplements as foods, while elsewhere they may be classified as drugs or other products.

There are more than 50,000 dietary supplements available. More than half of the U.S. adult population (53% – 55%) consume dietary supplements with most common ones being multivitamins.[1]

These products are not intended to prevent or treat any disease and in some circumstances are dangerous, according to the U.S. National Institutes of Health. For those who fail to consume a balanced diet, the agency says that certain supplements "may have value."[2] An exception is vitamin D, which is recommended in Nordic countries[3] due to weak sunlight.




According to the United States Food and Drug Administration (FDA), dietary supplements are products which are not pharmaceutical drugs, food additives like spices or preservatives, or conventional food, and which also meet any of these criteria:[4]

The product is intended to supplement a person's diet, despite it not being usable as a meal replacement

The product is or contains a vitamin, dietary element, herb used for herbalism or botanical used as a medicinal plant, amino acid, any substance which contributes to other food eaten, or any concentrate, metabolite, ingredient, extract, or combination of these things.[4]
The product is labeled as a dietary supplement.[4]
In the United States, the FDA has different monitoring procedures for substances depending on whether they are presented as drugs, food additives, food, or dietary supplements.[4] Dietary supplements are eaten or taken by mouth, and are regulated in United States law as a type of food rather than a type of drug.[5] Like food and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not; and rather than requiring risk–benefit analysis to prove that the product can be sold like a drug, risk–benefit analysis is only used to petition that food or a dietary supplement is unsafe and should be removed from market.[4]


The intended use of dietary supplements is to ensure that a person gets enough essential nutrients

Dietary supplements should not be used to treat any disease or as preventive healthcare.[7] An exception to this recommendation is the appropriate use of vitamins.[7]

Supplements may create harm in several ways, including over-consumption, particularly of minerals and fat-soluble vitamins which can build up in the body.[8] The products may also cause harm related to their rapid absorption in a short period of time, quality issues such as contamination, or by adverse interactions with other foods and medications.[9]


Main article: Vitamin
Vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[10] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals. Supplementation is important for the treatment of certain health problems but there is little evidence of benefit when used by those who are otherwise healthy.[11]

Dietary mineral

Main article: Mineral (nutrient)
Dietary elements, commonly called "dietary minerals" or "minerals", are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules.[citation needed]

Amino acids and proteins

Main articles: Amino acid and Protein (nutrient)
Amino acids are biologically important organic compounds composed of amine (-NH2) and carboxylic acid (-COOH) functional groups, along with a side-chain specific to each amino acid. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen, though other elements are found in the side-chains of certain amino acids.

Amino acids can be divided into three categories: essential amino acids, non-essential amino acids, and conditional amino acids. Essential amino acids cannot be made by the body, and must be supplied by food. Non-essential amino acids are made by the body from essential amino acids or in the normal breakdown of proteins. Conditional amino acids are usually not essential, except in times of illness, stress, or for someone challenged with a lifelong medical condition[citation needed].

Essential fatty acids

Main article: Essential fatty acids
Essential fatty acids, or EFAs, are fatty acids that humans and other animals must ingest because the body requires them for good health but cannot synthesize them.[12] The term "essential fatty acid" refers to fatty acids required for biological processes but does not include the fats that only act as fuel.

Bodybuilding supplements

Main article: Bodybuilding supplement
Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding and athletics. Bodybuilding supplements may be used to replace meals, enhance weight gain, promote weight loss or improve athletic performance. Among the most widely used are vitamin supplements, protein drinks, branched-chain amino acids (BCAA), glutamine, essential fatty acids, meal replacement products, creatine, weight loss products and testosterone boosters. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public their salience and frequency of use may differ when used specifically by bodybuilders.


Industry

In 2013, the global market of vitamins, minerals, and nutritional and herbal supplements (VMHS) was valued at $82 billion, with roughly 28 percent of that in the U.S., where sales increased by approximately $6 billion between 2007 and 2012.[13]

The vitamins and dietary supplements sector in the U.S. grew 4% in 2015, to reach US$27.2 billion. The U.S. market was highly competitive in 2015, as no single company accounted for more than a 5% share of value sales.[14]

Controversy

According to University of Helsinki food safety professor Marina Heinonen, more than 90% of dietary supplement health claims are incorrect.[15] In addition, ingredients listed have been found to be different from the contents. For example, Consumer Reports reported unsafe levels of arsenic, cadmium, lead and mercury in several of the protein powders that were tested.[16] Also, the CBC found that protein spiking (the addition of amino acid filler to manipulate analysis) was not uncommon,[17] however many of the companies involved challenged their claim.[18]

Adverse effects

Some products make extraordinary claims and contain active ingredients which may not have been proven effective.
Among general reasons for harmful effects of dietary supplements are: a) absorption in a short time; b) quality and contamination; and c) enhancing both positive and negative effects at the same time.[19] The number of incidents of liver damage from dietary supplements has tripled in a decade. Most of the products causing that effect were bodybuilding supplements. Some of the victims required liver transplants and some died. A third of the supplements involved contained unlisted steroids.[20] Mild to severe toxicity has occurred on many occasions due to dietary supplements, even when the active ingredients were essential nutrients such as vitamins, minerals or amino acids. This has been a result of adulteration of the product, excessive usage on the part of the consumer, or use by persons at risk for the development of adverse effects. In addition, a number of supplements contain psychoactive drugs, whether of natural or synthetic origin.[21][22]

Physical and chemical properties

Adulteration in North America
BMC Medicine published a study on herbal supplements in 2013. Most of the supplements studied were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[23][24]

An investigation by the New York Attorney General’s office reported in 2015 analyzed 78 bottles of herbal supplements from Walmart, Target, Walgreens and GNC stores in New York State using DNA barcoding, a method used to detect labeling fraud in the seafood industry. Only about 20% contained the ingredient on the label.[25][26]

Some supplements were contamined by rodent feces and urine.[27]



Society and culture
Public health
Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[28]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[29][30] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[31][32]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[33][34]:10

Legal regulation
United States
Main article: Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Regulation in European Union

The European Union's Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[35] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.


The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[
In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[38] referred to the European Court of Justice by the High Court in London.[

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[40] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[

Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.
Research
Effects of most dietary supplements have not been determined in randomized clinical trials and manufacturing is lightly regulated; randomized clinical trials of certain vitamins and antioxidants have found increased mortality rates.

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Nutrition and Supplements for Fitness and Health

Doctors say eating a well-balanced diet is the best way to get the nutrients your body needs. People who think they may need a little extra help often reach for food supplements. These are diet aids, such as vitamins, herbal extracts and fish oil. The companies that sell them suggest they’ll make people healthier. But scientists warn that some of these products actually can make people ill.

Drug stores, groceries and health food shops all sell these products. They’re known as supplements because they are not strictly needed for health. They just supplement — or add to — what people already eat.

They might contain nutrients that are otherwise available from foods. Or they might provide plant-derived materials that work in the same way that drugs do. This might be to boost immunity, increase metabolism (how the body uses energy) or improve how organs of the body work. The caffeine pills that people take to stay awake on long drives are one example of supplements. So are the zinc-based lozenges that people take to fight colds.

Explainer: Some supplements may not have what it takes
Most of these diet aids just provide more of something that is already in the diet. As such, these supplements are supposed to be as safe as food.

Yet each year, a new study finds, food supplements send more than 23,000 people across the United States to emergency rooms (ERs). Each patient had suffered some sort of bad reaction. Doctors refer to such reactions as adverse events. Some people developed chest pains or heart palpitations — a feeling that the heart is beating too fast or hard. Others got headaches or felt dizzy. Still others might have suffered stomach pains, nausea or vomiting.

The study tallying these reactions to food supplements appeared October 15 in the New England Journal of Medicine.

Unexpected number of teens and young adults affected

For the study, researchers collected 10 years of data. These came from the ERs at 63 U.S. hospitals. Supplements had sickened 3,667 of these ER patients, they found. Then the researchers used statistics — various math techniques — to scale up how many times this likely happened if all U.S. hospitals had experienced a similar trend.


The authors were comfortable analyzing these data and making these extrapolations to other hospitals. They all work at the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga., or for the U.S. Food and Drug Administration (FDA) in Washington, D.C. These are government agencies. CDC scientists and doctors make sure Americans receive safe, high-quality health care. The FDA, as its name implies, regulates the safety of food and drugs. For instance, it requires that prescription drugs and over-the-counter medicines (like cough syrups and aspirin) must be tested to show that they are safe and effective. Without tests that show that, FDA won’t let manufacturers sell these products.

Dietary supplements are considered neither foods nor drugs. So for a long while, no government agency had control over their safety or any claims made by the products’ makers. Then, in 1994, Congress wrote a law that ordered FDA to treat supplements like a special kind of food. Back then, FDA said it would assume that supplements are safe enough to sell without going through safety tests. And companies that created new supplements would only have to give FDA data showing why these products were likely to be safe.

The only statement a supplement maker could not make is that its product would cure a disease or condition. That would instantly turn the product into a “drug.” Then, as with other drugs, it would now need to go through strict testing and government controls.

healthy dinner

Andrew Geller is a CDC physician who led the new study. His team was concerned that supplements were not as safe as had been assumed. Why? In the past, he notes, “FDA has recalled supplements that contained unapproved ingredients or were contaminated.”(A recall is when a company must take back a product from stores, hospitals or consumers, usually because of problems with its safety or reliability.) “We didn’t know how many [other types of supplements] caused problems,” Geller says.

So his team reviewed the hospital data. They paid special attention to how old patients were, their symptoms and what supplements they had taken. Then the scientists used data from the studied hospitals to estimate what might be occurring nationally. Adverse events, they found, were not occurring just in older or unhealthy people. Young people were at risk, too.

“Adverse reactions to drugs are usually more common in older people,” noted Geller. “It was surprising," he said, that many adverse reactions to supplements showed up in young people. After all, he notes, these are the people one would expect to be healthiest.

About 11 in every 100 adverse reactions occurred in people between the ages of 5 and 19. Across the United States, that would translate to more than 2,500 ER visits every year by kids and teens. Another 28 out of every 100 adverse events occurred in young adults, aged 20 to 34. That would translate to nearly 6,500 more ER visits yearly. Heart symptoms, such as chest pain and heart palpitations, were the most common effects among young adults.

Not all supplements equally risky

More than half of all side effects that sent people under age 35 to the hospital came from two types of supplements: weight-loss aids and energy boosters.

Weight-loss products come in many forms. They include pills, bars, liquids and powdered-drink mixes. There is no standard formula that all brands share. There also is no consistent list of safe ingredients.

vitamin c 
The label on this bottle of vitamin C tablets notes that the evidence that this supplement reduces cancer risk is not conclusive. If a manufacturer were to make a claim that a product reduces cancer risk, that product would be regulated as a drug, not a supplement.
ROEL SMART/ISTOCKPHOTO
One popular brand of these products, Hydroxycut, includes supplements containing plant-based stimulants such as green-coffee-bean extract and caffeine. Those chemicals can rev up the body’s metabolism — how fast it burns energy. Burn enough and people should lose weight.

But in 2009, FDA ordered Hydroxycut to recall many of its products. Their use had been linked to 23 cases of liver damage. In one case, a 19-year-old boy died.

In a 2013 survey of U.S. high school students, the CDC found that more than 6 out of every 100 high school girls reported taking diet aids without first talking to a doctor. If that trend holds nationally, it would equal roughly 500,000 adolescent girls.

Ruth Milanaik is a pediatrician at Cohen Children’s Medical Center in Lake Success, N.Y. She worries about how diet aids affect teenage bodies. For example, she says Hydroxycut “raises your core body temperature to speed up your metabolism. But teens are growing fast already," she notes. "So making your system run faster can be harmful.”

The company that makes these diet aids says its products are now safe. Still, the products’ labels say these supplements should not be used by anyone under age 18.

Energy supplements also can contain a broad mix of ingredients. These can include caffeine, herbs that produce caffeine-like effects, vitamins and enzymes that are already in our bodies. Some also contain a lot of sugar, especially drinks and those supplements that come in the form of a snack bar.

Some users have complained to the FDA about problems they claim such energy supplements have caused them. Common symptoms include chest pain, the feeling of a racing heart and dizziness. In 2013, the American Medical Association called for a ban on advertising energy drinks to people under age 18 if those products contain “massive and excessive amounts of caffeine.”

These products likely contain stimulants, says the CDC’s Geller. “Symptoms like heart racing and chest pain are very similar to what you see in kids who have taken too much caffeine or … Ritalin.” That last drug, he notes, is a powerful stimulant used to treat ADHD (attention-deficit hyperactivity disorder).

Bulking up?

Pediatricians also worry about body-building supplements. These products promise to help users build muscle. That’s a common goal among teens who play sports, especially games where size is important, such as football.

One of the most popular sports supplements is creatine (KREE-uh-teen). The body already produces some creatine. In muscles, the compound helps produce a chemical called ATP, or adenosine triphosphate (Ah-DEN-oh-seen Try-FOS-fate). ATP carries and releases chemical energy that the body uses for many tasks. One example: ATP provides the energy to power muscle contractions during activities such as lifting weights.

protein supplements

Some supplements, such as creatine, are advertised to athletes and body-builders. But doctors worry that they may not be safe for anyone under age 18.
DAVID VAN DER MARK/FLICKR (CC-BY-SA 2.0)
“The more muscle your body has, the more creatine it makes,” says Milanaik. “But if you don’t have a lot of muscle mass yet and you take creatine, your body will try to get rid of it.” It would excrete the chemical as a waste. And in the process, she says, “That could damage your liver or kidneys.”

Milanaik led three recent studies in which college students posed as 15-year-olds. They called hundreds of health-food stores and pretended to shop for supplements. Girls asked about weight-loss supplements, including Hydroxycut. Boys said they were looking for creatine and products containing the hormone testosterone, which also supports muscle growth.

None of these products are recommended for users under age 18. But many sales clerks recommended them, or were willing to sell them to 15-year-olds, when the callers asked. These studies will be submitted to medical journals within the next few months.

“It’s a lesson that teens need to do their own research,” Milanaik now says. “Warning labels are there for a reason. Just because something comes from a vitamin shop or health food store doesn’t mean it’s good for you.”

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Nutritional Supplements

Nutritional supplements include vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet.

Nutritional supplements are used for many purposes.

 They can be added to the diet to boost overall health and energy; to provide immune system support and reduce the risks of illness and age-related conditions; to improve performance in athletic and mental activities; and to support the healing process during illness and disease. However, most of these products are treated as food and not regulated as drugs are.

The Natural Nutritional Foods Association estimated that in 2003 nutritional supplements amounted to a $19.8 billion market in the United States. By category, vitamins provided $6.6 billion in sales, herbs $4.2 billion, meal supplements $2.5 billion, sports nutrition products $2.0 billion, minerals $1.8 billion, and specialty and other products totaling $2.7 billion. The nutritional supplement industry provides a huge array of products for consumer needs.

Vitamins are micronutrients, or substances that the body uses in small amounts, as compared to macronutrients, which are the proteins, fats, and carbohydrates that make up all food. Vitamins are present in food, but adequate quantities of vitamins may be reduced when food is overcooked, processed, or improperly stored. For instance, processing whole wheat grain into white flour reduces the contents of vitamins B and E, fiber, and minerals, including zinc and iron. The body requires vitamins to support its basic biochemical functions, and deficiencies over time can lead to illness and disease.

Vitamins are either water-soluble or fat-soluble.

 Water-soluble vitamins dissolve in water and pass through the body quickly, meaning that the body needs them on a regular basis. Water-soluble vitamins include the B-complex vitamins and vitamin C. Fat-soluble vitamins are stored in the body's fatty tissue, meaning that they remain in the body longer. Fat-soluble vitamins include vitamins A, D, E, and K.

The amount of vitamins needed by the body has been the subject of much research. The U.S. government has published recommended dietary allowances (RDAs) for each vitamin for the general population. These figures can be used as guidelines, but individuals may have different needs depending on gender, age, and health conditions.
Vitamins can be natural or synthetic. Natural vitamins are extracted from food sources, while synthetic vitamins are formulated in laboratory processes. The only vitamin for which there is a noted difference between the natural and synthetic forms is vitamin E. The natural form is labeled d-alpha-tocopherol while the synthetic form is named dl-alpha-tocopherol, with the extra "l" signifying laboratory production. Natural vitamin E has been shown to be slightly more absorbable by the body than the synthetic version, although for other vitamins no significant differences in absorption have been noted.
Minerals
Minerals are micronutrients and are essential for the proper functioning of the body. Cells in the body require minerals as part of their basic make-up and chemical balance, and minerals are present in all foods. Minerals can either be bulk minerals, used by the body in larger quantities, or trace minerals, used by the body in minute or trace amounts. Bulk minerals include sodium, potassium, calcium, magnesium, and phosphorus. Trace minerals include iron, zinc, selenium, iodine, chromium, copper, manganese, and others. Some studies have shown that the amount of minerals, particularly trace minerals, may be decreasing in foods due to mineral depletion of the soil caused by unsustainable farming practices and soil erosion. Supplemental minerals are available in chelated form, in which they are bonded to proteins in order to improve their absorption by the body.

Herbal supplements are added to the diet for both nutritional and medicinal purposes. Herbs have been used for centuries in many traditional medicine systems, and as sources of phytochemicals, or substances found in plants that have notable effects in the body. Chinese medicine and Ayurvedic medicine from India, two of the world's oldest healing systems, use hundreds of herbal medications. Naturopathy and homeopathy, two other systems of natural healing, also rely on herbal preparations as their main sources of medication. The medicinal effects of herbs are getting scientific validation; about one-fourth of all pharmaceuticals have been derived directly from plant sources, including aspirin (found in willow bark), codeine (from poppy seeds), paclitaxel (Taxol), a patented drug for ovarian and breast cancer (from the Pacific Yew tree), and many others.
Herbs can supplement the diet to aid in overall health or to stimulate healing for specific conditions. For instance, ginseng is used as a general tonic to increase overall health and vitality, while echinacea is a popular herb used to stimulate the body's resistance to colds and infections. Herbs come in many forms. They can be purchased as capsules and tablets, as well as in tinctures, teas, syrups, and ointments.

Meal supplements
Meal supplements are used to replace or fortify meals. They may be designed for people with special needs, or for people with illnesses that may affect digestion capabilities and nutritional requirements. Meal supplements may contain specific blends of macronutrients, or proteins, carbohydrates, fats, and fiber. Some meal supplements consist of raw, unprocessed foods, or vegetarian or vegan options, or high protein and low fat composition. Meal supplements are available to support some popular diet programs. Meal supplements are often fortified with vitamins, minerals, herbs, and nutrient-dense foods.
Sports nutrition
Nutritional supplements may be designed to provide specialized support for athletes. Some of these consist of high-protein products, such as amino acid supplements, while other products contain nutrients that support metabolism, energy, and athletic performance and recovery. People engaging in intense athletic activity may have increased needs for water-soluble vitamins, antioxidants, and certain minerals, including chromium. Sports drinks contain blends of electrolytes (salts) that the body loses during exertion and sweating, as well as vitamins, minerals, and performance-supporting herbs.
Other nutritional supplements

Other nutritional supplements include nutrient-dense food products. Examples of these are brewer's yeast, spirulina (sea algea), bee pollen and royal jelly, fish oil and essential fatty acid supplements, colostrum (a specialty dairy product), psyllium seed husks (a source of fiber), wheat germ, wheatgrass, and medicinal mushrooms such as the shiitake and reishi varieties.
Specialty products may offer particular health benefits or are targeted for specific conditions. These products may consist of whole foods or may be isolated compounds from natural or synthetic sources. Examples include antioxidants, probiotics (supplements containing friendly bacteria for the digestive tract), digestive enzymes, shark cartilage, or other animal products, or chemical extracts such as the hormone DHEA (dehydroepiandrosterone) and coenzyme Q10, an antioxidant.
General guidelines
Considering average dietary needs and the prevalence of certain health conditions, some basic guidelines may provide the foundation for the effective use of nutritional supplements. First, a high quality, broad-spectrum multivitamin and mineral supplement, taken once per day, is recommended to provide a range of nutrients. This should contain the B-complex vitamins B6, B12, and folic acid, which may help prevent heart disease, and the minerals zinc and copper, which aid immunity. In addition to a multivitamin, antioxidants can be added to a supplementation routine. These include vitamin A (or beta-carotene), vitamin C, and vitamin E, and the mineral selenium. Antioxidants may have several positive effects on the body, such as slowing the aging process, reducing the risks of cancer and heart disease, and reducing the risks of illness and infection by supporting the immune system. Coenzyme Q10 is another antioxidant in wide usage, as studies have shown it may improve the health of the heart and reduce the effects of heart disease. Essential fatty acids, particularly omega-3, are also recommended as they are involved in many important processes in the body, including brain function. Calcium supplementation is recommended for the elderly and for women, to strengthen bones and prevent bone loss. Calcium supplements that are balanced with magnesium have a less constipating effect and are better absorbed.
After basic nutritional requirements are supported, supplements may be used to target specific needs and health conditions. For instance, athletes, men, women, children, the elderly, and vegetarians have differing needs for nutrients, and an informed use of supplements would take these differences into account. People suffering from health conditions and diseases may use specific supplements to target their condition and to support the body's healing capacity by providing optimal amounts of nutrients.
Recommended dosage
Dosages of nutritional supplements vary widely, depending on the product and individual needs. For vitamins and minerals, U.S. RDA's are essential guidelines. For other products, manufacturers' guidelines, consumer information sources such as nutritional books and magazines, and practitioners including nutritionists and naturopathic physicians may be consulted.
Precautions
Overall diet is an important first consideration for those considering nutritional supplementation. Healthy dietary habits can help optimize nutrition and the absorption of supplements, and nutritional supplements cannot substitute for a diet that is not nutritionally balanced in the first place. Supplements are best used moderately to supply any extra nutritional requirements. Sound diets contain a variety of wholesome foods. At least five servings per day of fruits and vegetables are recommended, as well as the inclusion of whole grains in the diet. Variety in the diet is important to provide a full range of vitamins and minerals. Overeating inhibits digestion and absorption of nutrients, while regular exercise contributes to sound nutrition, by improving metabolism and digestion. Drinking plenty of clean water prevents dehydration, improves digestion, and helps the body flush out impurities.
Generally, nutrients from food sources are more efficiently utilized by the body than isolated substances. For instance, fresh fruit and vegetable juice could be used to provide concentrated amounts of particular nutrients, such as vitamins A and C, to the diet. As another example, eating plenty of leafy green vegetables is a healthy option for those wishing to add calcium to the diet.
Vitamins and minerals are most easily digested with food. Fat-soluble vitamins should be taken with food that contains fat. Vitamins tend to work synergistically, meaning that they work together in order to be effective. For instance, vitamin E requires some of the B-complex vitamins and the minerals selenium and zinc for most effective absorption. Some minerals may not be absorbed or may inhibit each other when taken in improper ratios. Generally, a high quality, broad-spectrum vitamin and mineral supplement will be formulated to prevent unfavorable interactions.
Vitamin A can become toxic when taken in large amounts (over 100,000 International Units) on a daily basis over time, as can vitamin D. Substituting beta-carotene for vitamin A can alleviate this risk. Very large doses of minerals taken over long periods may have toxic effects in the body. Dosages far exceeding RDA's of vitamins are not recommended, nor are large doses of other supplements.
Consumers can make wise choices for nutritional supplementation by consulting professional nutritionists and naturopathic physicians. Nutritional supplements are best added into the diet slowly, starting with small dosages and working up to the manufacturers' recommended amounts over time. Also, some supplements, such as herbal medications that may stimulate processes in the body, are best taken intermittently, allowing the body occasional rest periods without the supplement. To avoid unfavorable interactions, nutritional supplements are best used moderately and individually, rather than taking handfuls of capsules and tablets for various needs and conditions at the same time. Finally, consumers should be wary of excessive or grandiose health claims made by manufacturers of nutritional supplements and rely on scientific information to validate these claims.
Side effects

Some nutritional supplements can cause upset stomach and allergic reactions, including rashes, flushing, nausea, sweating, and headaches.
Interactions

Herbal preparations and nutritional supplements may interact unfavorably with pharmaceutical drugs. For instance, some nutritional supplements recommended for nervous system function may not be recommended for those taking pharmaceutical antidepressants, such as taking 5-HTP, a nutritional supplement for the brain, or the herb St. John's Wort, with prescription antidepressants. Vitamin C should not be taken with aspirin, as it can irritate the stomach and limit absorption. Minerals should be taken in proper proportions to prevent unfavorable interactions; large amounts of zinc may deplete the body of the mineral copper, while too much calcium adversely affects the magnesium levels in the body. Balanced mineral supplements are recommended to alleviate these interactions.

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Food supplements

In the UK most products described as food supplements (such as vitamins, minerals or amino acids) are regulated as foods and subject to the provisions of general food law such as the Food Safety Act. If you sell food supplements you must register as a Food Business Operator (FBO) with the environmental health service at your local authority.
What is a food supplement
A food supplement is defined as ‘any food for the purpose of which is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination and is sold in dose form’. 

What is the role of the FSA?
food supplements

~~The FSA’s main role regarding food supplements is enforcement (setting enforcement policy, co-ordination and advice) with specific responsibility for:
• General food law, food safety legislation and food controls.
• Novel foods
• Chemical risk assessments
• Labelling requirements under the EU Food Information to Consumers Regulation (EU FIC) in Wales and Northern Ireland (Defra in England)
• Enforcement, Incidents and National Food Crime Unit (NFCU).

Local authorities are responsible for the enforcement of food supplements legislation in addition to general food law and food safety legislation. Trading standards officers generally undertake this role. Local authorities do not enforce legislation relating to medicinal products –MHRA is responsible for enforcement in this area .

Department of Health acts as the Competent Authority for the EU legislation on Food Supplements and coordinates policy across the devolved authorities and with other relevant government departments. FSA is responsible for the enforcement of these regulations with local authorities.

MHRA has responsibility for medicinal products (including enforcement) which includes traditional herbal medicines. Herbal substances can be used in both medicines and foods, but where the use is for a medical purpose (either by virtue of the mode of action or the claims that are made) then the MHRA may regard the product, (not the substance), to be medicine. The MHRA has a separate registration scheme, based on traditional use, for certain herbal medicines.
Herbal substances are referred to as botanicals under food law. Products may be considered by the MHRA Borderline Section on a case by case basis to determine whether if the product should be classified as a medicine. The MHRA’s Borderline Section only become involved where there may be doubt regarding a product’s regulatory status, either over the botanical itself, the entire formulation, or the presentation of the product. If a product is not considered medicinal product they typically default to being a food supplement. 

The regulatory landscape for food supplements is complex. The current legislative framework creates overlapping areas of responsibility between several different bodies:

• Food Standards Agency (FSA), Food Standards Agency Wales (FSAW) and Food Standards Agency Northern Ireland (FSANI)
• Food Standards Scotland (FSS)
• Department of Health (DH)
• Home Office (HO)
• Medicine and Healthcare products Regulatory Agency (MHRA)
• Local authorities (LA)
• Welsh Government (WG)

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Food supplements

National regulation on food supplements

The national regulation on food supplements is harmonised with the EU legislation on food supplements. Limits on the levels on vitamin and minerals are not harmonised in the EU and each country may have national limits.

Norway has set minimum and maximum levels conform to the recommended daily intake on minerals and vitamins. The levels are set in annex 1 to the regulation on Food Supplement.

Medicinal products or food supplements

Medicinal products are subject to the national legislation on medicinal products. What is defined as a medicinal product may vary in the European countries. The Norwegian Medicines Agency is responsible for administering the national legislation on medicinal products. 

Novel food

Note that there is a national prohibition on marketing novel food on the Norwegian market. Approval before marketing must be given. Approval is given by the NFSA.

In particular: herbs
Herbs may be classified as medicinal products. The Norwegian Medicines Agency is responsible for the classification of herbs. See the list of drugs and herbs (Forskrift om legemiddelklassifisering).

For your information: 

- Herbs marked with L are classified as medicine 
- Herbs marked with RL are classified as prescription drugs
- Food supplements containing ingredients marked L and RL, indicates that the product may be classified as a medicinal product or drug and the 
- Norwegian Medicines Agency must be contacted in order to classify the product. 
- Herbs marked with H – indicates that the food supplement is not a medicinal product or drug, and is therefore likely to be subject to the national food legislation. Note that this is not a final classification, but an indication only.

Other substances

There are no specific national requirements as to other substances in food supplements. The food businesses must ensure that food supplements are safe in accordance with Regulation (EU) no. 178/2002 article 14 which is incorporated into the national Food Act § 16.


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DIETARY SUPPLEMENTS WHAT YOU NEED TO KNOW

The majority of adults in the United States take one or more dietary supplements either every day or occasionally. Today’s dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.

The Dietary Supplement Label

All products labeled as a dietary supplement carry a Supplement Facts panel that lists the contents, amount of active ingredients per serving, and other added ingredients (like fillers, binders, and flavorings). The manufacturer suggests the serving size, but you or your health care provider might decide that a different amount is more appropriate for you.

Effectiveness

If you don’t eat a nutritious variety of foods, some supplements might help you get adequate amounts of essential nutrients. However, supplements can’t take the place of the variety of foods that are important to a healthy diet. Good sources of information on eating well include the Dietary Guidelines for Americansexternal link disclaimer and MyPlateexternal link disclaimer.

Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, calcium and vitamin D are important for keeping bones strong and reducing bone loss; folic acid decreases the risk of certain birth defects; and omega-3 fatty acids from fish oils might help some people with heart disease. Other supplements need more study to determine their value. The U.S. Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed.

Safety and Risk

Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of unexpected side effects, especially when taking a new product.

Supplements are most likely to cause side effects or harm when people take them instead of prescribed medicines or when people take many supplements in combination. Some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person’s response to anesthesia. Dietary supplements can also interact with certain prescription drugs in ways that might cause problems. Here are just a few examples:

Vitamin K can reduce the ability of the blood thinner Coumadin® to prevent blood from clotting.
St. John’s wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs’ effectiveness.
Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.
Keep in mind that some ingredients found in dietary supplements are added to a growing number of foods, including breakfast cereals and beverages. As a result, you may be getting more of these ingredients than you think, and more might not be better. Taking more than you need is always more expensive and can also raise your risk of experiencing side effects. For example, getting too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.

Be cautious about taking dietary supplements if you are pregnant or nursing. Also, be careful about giving them (beyond a basic multivitamin/mineral product) to a child. Most dietary supplements have not been well tested for safety in pregnant women, nursing mothers, or children.

If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088 or completing a form onlineexternal link disclaimer. In addition, report your reaction to the dietary supplement company by using the contact information on the product label.

Quality

Dietary supplements are complex products. The FDA has established good manufacturing practices (GMPs) for dietary supplements to help ensure their identity, purity, strength, and composition. These GMPs are designed to prevent the inclusion of the wrong ingredient, the addition of too much or too little of an ingredient, the possibility of contamination, and the improper packaging and labeling of a product. The FDA periodically inspects facilities that manufacture dietary supplements.

In addition, several independent organizations offer quality testing and allow products that pass these tests to display their seals of approval. These seals of approval provide assurance that the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. These seals of approval do not guarantee that a product is safe or effective. Organizations that offer this quality testing include:

U.S. Pharmacopeia
ConsumerLab.com
NSF International
Keep in Mind

Don’t decide to take dietary supplements to treat a health condition that you have diagnosed yourself, without consulting a health care provider.

Don’t take supplements in place of, or in combination with, prescribed medications without your health care provider’s approval.
Check with your health care provider about the supplements you take if you are scheduled to have any type of surgical procedure.
The term “natural” doesn’t always mean safe. A supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used. Certain herbs (for example, comfrey and kava) can harm the liver.
Before taking a dietary supplement, ask yourself these questions:
What are the potential health benefits of this dietary supplement product?
What are its potential benefits for me?
Does this product have any safety risks?
What is the proper dose to take?
How, when, and for how long should I take it?
If you don’t know the answers to these questions, use the information sources listed in this brochure and talk to your health care providers.

Talk with Your Health Care Provider

Let your health care providers (including doctors, pharmacists, and dietitians) know which dietary supplements you’re taking so that you can discuss what’s best for your overall health. Your health care provider can help you determine which supplements, if any, might be valuable for you.

Keep a record of the supplements you take in one place, just as you should be doing for all of your medicines. Note the specific product name, the dose you take, how often you take it, and the reason why you use each one. You can also bring the products you use with you when you see your health care provider.

Federal Regulation of Dietary Supplements

Dietary supplements are products intended to supplement the diet. They are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both dietary supplements and medicines.

In general, the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require premarket review or approval by the FDA. While the supplement company is responsible for having evidence that their products are safe and the label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed.

Dietary supplement labels may carry certain types of health-related claims. Manufacturers are permitted to say, for example, that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (like immunity or heart health). Such a claim must be followed by the words, “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.”

Manufacturers must follow certain good manufacturing practices to ensure the identity, purity, strength, and composition of their products. If the FDA finds a product to be unsafe or otherwise unfit for human consumption, it may take enforcement action to remove the product from the marketplace or work with the manufacturer to voluntarily recall the product.

Also, once a dietary supplement is on the market, the FDA monitors information on the product’s label and package insert to make sure that information about the supplement’s content is accurate and that any claims made for the product are truthful and not misleading. The Federal Trade Commission, which polices product advertising, also requires all information about a dietary supplement product to be truthful and not misleading.

The federal government can take legal action against companies and Web sites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.


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