Dietary Supplements

Background Information

What is a dietary supplement?

As defined by Congress in the Dietary Supplement Health and Education Act , which became law in 1994,
a dietary supplement is a product (other than tobacco) that

is intended to supplement the diet;

contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals;
amino acids; and other substances) or their constituents;
is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
is labeled on the front panel as being a dietary supplement.

What is a new dietary ingredient?

A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary
supplement before October 15, 1994. The U.S. Food and Drug Administration (FDA) requires specific safety
information from a manufacturer intending to market a dietary supplement containing a new dietary
ingredient. This information is not required for older dietary supplement ingredients.

Are dietary supplements different from foods and drugs?

Although dietary supplements are regulated by the FDA as foods, they are regulated differently from other
foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is
based on its intended use. Most often, classification as a dietary supplement is determined by the
information that the manufacturer provides on the product label or in accompanying literature, although
many food and dietary supplement product labels do not include this information.

Table of Contents

What is a dietary supplement?

What is a new dietary ingredient?
Are dietary supplements different from foods and drugs?
What claims can manufacturers make for dietary supplements and drugs?
How does FDA regulate dietary supplements?
What information is required on a dietary supplement label?
Does a label indicate the quality of a dietary supplement product?
Are dietary supplements standardized?
What methods are used to evaluate the health benefits and safety of a dietary supplement?
What are some additional sources of information on dietary supplements?
Disclaimer
What claims can manufacturers make for dietary supplements and
drugs?

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug
manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such
claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims : a health
claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a
food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related
condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a
product. A structure/function claim is a statement describing how a product may affect the organs or
systems of the body and it can not mention any specific disease. Structure/function claims do not require
FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting
the product on the market . Product labels containing such claims must also include a disclaimer that
reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat,
cure, or prevent any disease."

How does FDA regulate dietary supplements?

In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement
ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for
their safety before they are marketed because they are presumed to be safe based on their history of use by
humans. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer
must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and
provide information on how it determined that reasonable evidence exists for safe human use of the
product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the
marketplace for safety reasons.

Unlike drug products, there are no provisions in the law for FDA to "approve" dietary supplements for safety
or effectiveness before they reach the consumer. Once a dietary supplement is marketed, FDA has to prove
that the product is not safe in order to restrict its use or remove it from the market. In contrast, before
being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing
evidence that it is both safe and effective.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not
meet this requirement, FDA may remove the product from the marketplace or take other appropriate
actions.

What information is required on a dietary supplement label?

FDA requires that certain information appear on the dietary supplement label:

General information
 Name of product (including the word "supplement" or a statement that the product is a supplement)
Net quantity of contents
Name and place of business of manufacturer, packer, or distributor
Directions for use

Supplement Facts panel

Serving size, list of dietary ingredients, amount per serving size (by weight), percent of Daily Value
(%DV), if established
If the dietary ingredient is a botanical, the scientific name of the plant or the common or usual
name standardized in the reference Herbs of Commerce (1992 edition) and the name of the plant
part used
If the dietary ingredient is a proprietary blend (i.e., a blend exclusive to the manufacturer), the
total weight of the blend and the components of the blend in order of predominance by weight

Other ingredients

Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders; listed by
weight in descending order of predominance and by common name or proprietary blend

The label of the supplement may contain a cautionary statement but the lack of a cautionary statement
does not mean that no adverse effects are associated with the product.

Does a label indicate the quality of a dietary supplement product?

It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality
control depends on the manufacturer, the supplier, and others in the production process.

In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements
and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure
quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of
their dietary supplements. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the
addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides,
heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.

Are dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their
products. In some cases, standardization involves identifying specific chemicals (known as markers) that can
be used to manufacture a consistent product. The standardization process can also provide a measure of
quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory
definition exists in the United States for standardization as it applies to dietary supplements. Because of
 this, the term "standardization" may mean many different things. Some manufacturers use the term
standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient
for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement
label does not necessarily indicate product quality.

What methods are used to evaluate the health benefits and safety of a
dietary supplement?

Dietary supplements are not required by federal law to be tested for safety and effectiveness before they
are marketed, so the amount of scientific evidence available for various supplement ingredients varies
widely. Some ingredients in dietary supplements have been carefully evaluated. For example, scientists
know that calcium and vitamin D are important for keeping bones strong and reducing bone loss. Other
supplements, such as many herbal products, need more study to determine their value.

Scientists can use several approaches to evaluate dietary supplements for their potential health benefits and
risks. They may investigate history of use, conduct laboratory studies using cell or tissue cultures, and
experiment with animals. Studies on people (e.g., individual case reports, observational studies, and clinical
trials) provide the most direct evidence of a dietary supplement's effects on health and patterns of use.

What are some additional sources of information on dietary

supplements?

Medical libraries are one source of information about dietary supplements. Others include Web-based
resources such as PubMed and FDA . For general information on botanicals and their use as dietary
supplements please see Background Information About Botanical Dietary Supplements.

Disclaimer

This fact sheet by the Office of Dietary Supplements provides information that should not take the place of
medical advice. We encourage you to talk to your healthcare providers (doctor, registered dietitian,
pharmacist, etc.) about your interest in, questions about, or use of dietary supplements and what may be
best for your overall health. Any mention in this publication of a specific brand name is not an endorsement
of the product.

Reviewed: June 24, 2011

Obesity and overweight

Fact sheet N311
Updated January 2015

Key facts
Worldwide obesity has more than doubled since 1980.
 In 2014, more than 1.9 billion adults, 18 years and older, were overweight. Of these over 600 million were
obese.
39% of adults aged 18 years and over were overweight in 2014, and 13% were obese.
Most of the world's population live in countries where overweight and obesity kills more people than
underweight.
42 million children under the age of 5 were overweight or obese in 2013.
Obesity is preventable.

What are overweight and obesity?

Overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health.
Body mass index (BMI) is a simple index of weight-for-height that is commonly used to classify overweight and
obesity in adults. It is defined as a person's weight in kilograms divided by the square of his height in meters
(kg/m2).
The WHO definition is:
a BMI greater than or equal to 25 is overweight
a BMI greater than or equal to 30 is obesity.
BMI provides the most useful population-level measure of overweight and obesity as it is the same for both
sexes and for all ages of adults. However, it should be considered a rough guide because it may not correspond
to the same degree of fatness in different individuals.
Facts about overweight and obesity
Some recent WHO global estimates follow.
In 2014, more than 1.9 billion adults, 18 years and older, were overweight. Of these over 600 million were
obese.
Overall, about 13% of the worlds adult population (11% of men and 15% of women) were obese in 2014.
In 2014, 39% of adults aged 18 years and over (38% of men and 40% of women) were overweight.
The worldwide prevalence of obesity more than doubled between 1980 and 2014.
In 2013, 42 million children under the age of 5 were overweight or obese. Once considered a high-income
country problem, overweight and obesity are now on the rise in low- and middle-income countries, particularly
in urban settings. In developing countries with emerging economies (classified by the World Bank as lower- and
middle-income countries) the rate of increase of childhood overweight and obesity has been more than 30%
higher than that of developed countries.
Overweight and obesity are linked to more deaths worldwide than underweight. Most of the world's population
live in countries where overweight and obesity kill more people than underweight (this includes all high-income
and most middle-income countries).
What causes obesity and overweight?
The fundamental cause of obesity and overweight is an energy imbalance between calories consumed and
calories expended. Globally, there has been:
an increased intake of energy-dense foods that are high in fat; and
an increase in physical inactivity due to the increasingly sedentary nature of many forms of work, changing
modes of transportation, and increasing urbanization.
Changes in dietary and physical activity patterns are often the result of environmental and societal changes
associated with development and lack of supportive policies in sectors such as health, agriculture, transport,
urban planning, environment, food processing, distribution, marketing and education.
What are common health consequences of overweight and obesity?
Raised BMI is a major risk factor for noncommunicable diseases such as:
cardiovascular diseases (mainly heart disease and stroke), which were the leading cause of death in 2012;
 diabetes;
musculoskeletal disorders (especially osteoarthritis - a highly disabling degenerative disease of the joints);
some cancers (endometrial, breast, and colon).
The risk for these noncommunicable diseases increases, with an increase in BMI.
Childhood obesity is associated with a higher chance of obesity, premature death and disability in adulthood. But
in addition to increased future risks, obese children experience breathing difficulties, increased risk of fractures,
hypertension, early markers of cardiovascular disease, insulin resistance and psychological effects.
Facing a double burden of disease
Many low- and middle-income countries are now facing a "double burden" of disease.
While they continue to deal with the problems of infectious disease and under-nutrition, they are experiencing a
rapid upsurge in noncommunicable disease risk factors such as obesity and overweight, particularly in urban
settings.
It is not uncommon to find under-nutrition and obesity existing side-by-side within the same country, the same
community and the same household.
Children in low- and middle-income countries are more vulnerable to inadequate pre-natal, infant and young
child nutrition. At the same time, they are exposed to high-fat, high-sugar, high-salt, energy-dense,
micronutrient-poor foods, which tend to be lower in cost but also lower in nutrient quality. These dietary patterns
in conjunction with lower levels of physical activity, result in sharp increases in childhood obesity while
undernutrition issues remain unsolved.
How can overweight and obesity be reduced?
Overweight and obesity, as well as their related noncommunicable diseases, are largely preventable. Supportive
environments and communities are fundamental in shaping peoples choices, making the healthier choice of
foods and regular physical activity the easiest choice (accessible, available and affordable), and therefore
preventing obesity.
At the individual level, people can:
limit energy intake from total fats and sugars;
increase consumption of fruit and vegetables, as well as legumes, whole grains and nuts;
engage in regular physical activity (60 minutes a day for children and 150 minutes per week for adults).
Individual responsibility can only have its full effect where people have access to a healthy lifestyle. Therefore,
at the societal level it is important to:
support individuals in following the recommendations above, through sustained political commitment and the
collaboration of many public and private stakeholders;
make regular physical activity and healthier dietary choices available, affordable and easily accessible to all -
especially the poorest individuals.
The food industry can play a significant role in promoting healthy diets by:
reducing the fat, sugar and salt content of processed foods;
ensuring that healthy and nutritious choices are available and affordable to all consumers;
practicing responsible marketing especially those aimed at children and teenagers;
ensuring the availability of healthy food choices and supporting regular physical activity practice in the
workplace.
WHO response
Adopted by the World Health Assembly in 2004, the WHO Global Strategy on Diet, Physical Activity and
Health describes the actions needed to support healthy diets and regular physical activity. The Strategy calls
upon all stakeholders to take action at global, regional and local levels to improve diets and physical activity
patterns at the population level.
The Political Declaration of the High Level Meeting of the United Nations General Assembly on the Prevention
and Control of Noncommunicable Diseases of September 2011, recognizes the critical importance of reducing
unhealthy diet and physical inactivity. The political declaration commits to advance the implementation of the
WHO Global Strategy on Diet, Physical Activity and Health, including, where appropriate, through the
introduction of policies and actions aimed at promoting healthy diets and increasing physical activity in the
entire population.
WHO has developed the "Global Action Plan for the prevention and control of noncommunicable diseases 2013-
2020" which aims to achieve the commitments of the UN Political Declaration on NCDs which was endorsed by
Heads of State and Government in September 2011. This Action Plan aims to build on the WHO Framework
Convention on Tobacco Control and the WHO Global Strategy on Diet, Physical Activity and Health. The plan
will contribute to progress on 9 global NCD targets to be attained in 2025, including a 25% relative reduction in
premature mortality from NCDs by 2025 and a halting of the global obesity rates to those of 2010.
To better inform and develop a comprehensive response to childhood obesity in particular, WHOs Director-
General established the high-level Commission on Ending Childhood Obesity (ECHO), which comprises 15
accomplished and eminent people from a variety of relevant backgrounds. The Commission will review, build
upon and address gaps in existing mandates and strategies, raise awareness and build momentum for action to
address childhood obesity.