What you must know about dietary supplements and its legal regulations

Abstract

Dietary supplements are products intended to supplement the diet, and are not drugs for disease treatments. They are vitamins, minerals, herbals, botanical, amino acids, enzymes, metabolites and many other products. Some supplements play an important role in health, for example calcium and vitamin D are important for keeping bones strong, and folic acid is important for pregnant women to prevent certain birth defect in their babies. Dietary supplements are available in the market in the form of tablets, capsules, soft gels, gel caps, powders, drinks and energy bars. These dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing as required for prescription drugs or over-the counter drugs, but manufacturers must register their manufacturing facilities with the FDA and are responsible to having evidence that their dietary supplement products are safe and label claims are not misleading.
With a few well define exceptions dietary supplements such as per-workout for athletics and weight loss products may only be marketed to support structure or function of the body, without claiming to treat a disease or condition, and must include a label that highlight “These statements have not been evaluated by FDA and this product is not intended to diagnose, treat, cure, or prevent any diseases”

Full text

Cronicon
OPEN ACCESS EC NUTRITION
Review Article
What you must know about Dietary Supplements and its Legal Regulations
Osama O Ibrahim*
Consultant Biotechnology, Bio Innovation, Gurnee, Illinois, USA
*Corresponding Author: Osama O Ibrahim, Consultant Biotechnology, Bio Innovation, Gurnee, Illinois, USA.
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
Received: June 22, 2018; Published: July 27, 2018
Abstract
Dietary supplements are not drugs to treat diseases but are products intended to supplement diets. They are vitamins, minerals,
amino acids, proteins, enzymes, metabolites, herbal/botanical plants and many others. Some supplements plays an important role
in health such as calcium and vitamin D to keep bones strong [1], and folic acid for pregnant women to prevent certain birth defect
in new born children [2]. Dietary supplements are marketed in the form of tablets, capsules, soft gels, gel caps, powders, drinks and
energy bars. There is no need for dietary supplements to be approved by the U.S. Food and Drug Administration (FDA) before mar-
keting as in the case of prescription and over counter drugs, but dietary supplements manufacturers are responsible to register their
manufacturing facilities with FDA and to demonstrate that their manufactured products are safe and label claims are not misleading.
Keywords: Dietary Supplements; Dietary Supplements Ingredient; Herbal Supplements; Botanical Supplements; DSHES; FDA; TCA; GMP
Dietary Supplements Health and Education Act (DSHEA) were passed by United State Congress in the year 1994 to provide a
regulatory framework for the safety of dietary supplements.
Introduction

and are taken by mouth in different forms (pills, capsules, tablets or liquid). Dietary supplements are nutrient compounds includes vita-


These ingredients of dietary supplants are sold individually or in combination. In United States there are over 50,000 marketed dietary
supplements consumed daily by over 50% of American population. Multivitamins and menials are the most commonly consumed dietary
supplements especially for people failed to consume a balanced diet. The total market size of dietary supplements in North America alone
was estimated in the year 2016 for about $37 billion [8] and is rising due to the awareness towards calorie reduction, weight loss, and the
ss.
Dietary Supplements Health and Education Act (DSHEA) [9] were passed in the year 1994 by United States Congress to provide a
       
(other than tobacco) intended to supplement the diet and must be labeled as dietary supplements. DSHEA granted the United States Food
and Drug Administration (FDA) the authority to establish dietary supplement regulations, for manufacturing, health claims, labeling and
to encourage research on these supplements. Plus, DSHEA gave to Federal Trade Commission (FTC) a division of FDA the authority to
regulate dietary supplements advertising.

552
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
It is against United States Federal regulations for dietary supplements manufacturers to claim that their products prevent or treat any

effect. The FDA enforces these regulations, and prohibits the sale of dietary supplements or ingredients that are harmful, or not manufac-
tured according to Good Manufacturing Practices (GMPs) standard.
Similar to food manufacturers there is no need for government approval to manufacture or sell dietary supplements, and there is no
required clinical trials to be sold as pharmaceutical drugs. Dietary supplements manufacturers have the responsibility not the govern-

In summary dietary supplements regulations are different than the regulations of conventional foods and pharmaceutical drugs. The
FDA role for dietary supplements begins after the product enters the market place and have the authority to remove any dietary supple-
ment from the market if demonstrated to be unsafe.
Dietary supplements
Multivitamins and minerals

include herbs, hormones or drugs [10].
Vitamins are supplements that people used to boost their energy level, and some minerals plays role as enzymes cofactors in metabolic
pathways for energy.

a. -
tial vitamins of Thiamin (B12), niacin (B3  6), Pantothenic acid, Folic acid, Cyanocobalamin
(B12), and Biotin. Vitamin C, (L-ascorbic acid), is present in some foods, and available as a dietary supplement. Unlike most
animals, human is unable to synthesize [13] vitamin C so it is an essential in our diet for the biosynthesis of collagen, L-


b. -
sumed 
helping eyes adjust to light. Vitamin A also, plays role in bone growth, tooth development, reproduction, cell division, gene
-
rous [16] by increasing the small intestine absorption rate of these minerals, to maintain healthy bones. Vitamin D also play
-
sential fatty acids from destruction [17] Vitamin K plays an essential role in normal blood clotting, promoting bone health,
and helping proteins biosynthesis for blood, bones, and kidneys [18].
Minerals does not provide energy or calories for the body, but are needed in small amounts to keep healthy body, and for other func-
tions such as enzymes activity. Human body does not synthesize minerals, and must be obtained from foods, or from dietary supplements.
These minerals are Ca, Mg, Cr, Zn, Se, K, Fe, Mn, I, P, and Cu. Calcium (Ca) function is to keep bones and teeth strong and, supporting skeletal
structure. Calcium also, play roles in cell signaling, blood clotting, muscle contraction and nerve function [19]. Iron (Fe) is an essential
element for red blood cells production (hemoglobin) and muscle cells structure (myoglobin) [20].

553
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.

D per day during the pregnancy and breast feeding, to maintain proper levels of calcium and phosphorus [21] in their body, and should

calcium during pregnancy only by doctor advice.
Global market of vitamins and minerals is over $9 billion per year [23] and are available in the market in packages contain at least 10
vitamins and 10 minerals with the recommended 100% daily value (DV) and below the tolerable dose as determined by FDA.
Fibers

   
lower blood cholesterol, alleviate irritable bowel syndrome, reduce the risk of colon cancer, and increase feelings of satiety [24]. However,

and other medical problems [25]. To avoid such implications, the American Dietetic Association (ADA) recommends that the average adult

Fatty Acids
Essential fatty acids, are polyunsaturated short carbons chain that our body cannot synthesize and must ingested for good health. The
two known polyunsaturated fatty acids that essential for human are alpha-linolenic acid (ALA) and linoleic acid. The body convert alpha
        



signaling and necessary for the production of hormones and neurotransmitters. Selecting of right fatty acids in dietary supplement could
help in improving a range of health conditions such as cardiovascular, diabetes and neurological function.
Conjugate fatty acids (CFA) is an isomer of linoleic acid (LA) and are naturally present in meat and dairy products. Average daily intake
of conjugated fatty acids for most people is less than one gram per day mainly from meat and dairy products [32]. Conjugated fatty acids

-
 
the evaluations of physiological bioactivity of conjugated fatty acids on lifestyle-related diseases in humans and animals are necessary.
Protein and amino acids
Protein is amino acids linked together in a chain by peptide linkages and is one of the three macronutrients for energy (carbohydrates,
-
     
growth, increase body weight gain, increase lean muscle mass, and increase strength and power.
Amino acids are primary source of nitrogen for the body and are essential source for muscle growth, immune systems, enzymes, and

that cannot be synthesize in the body and must obtained from foods or from dietary supplements. These essential amino acids are phenyl
alanine, threonine, methionine, tryptophan, lysine, leucine, isoleucine, and valine. The rest of known 20 amino acids are non-essential

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What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
amino acids.
-
age label especially for essential amino acids and for branched chain amino acids (BCAAs). Branched chain amino acids are leucine, iso-
leucine and valine. The daily requirement intake of leucine is 40 milligram per kilogram body weight, and for both isoleucine and valine
daily requirements intake is 10 - 30 milligram per kilogram body weight for each. Protein supplements claims including branched chain
amino acids (BCAAs) is for stimulating the synthesis of muscle proteins.
Marketed protein supplements contain about 20 - 30 grams of protein per serving and It is important to highlight that high dose of
daily protein intake could have side effects such as: nausea, thirst, bloating, cramps, fatigue, headache, reducing appetite and increasing
bowl movements [34].
L- Glutamine supplement
L-Glutamine is one of the 20 building block amino acids in proteins and is the major amino acid in body muscles protein, making about
61% of skeletal tissue [35]. L-Glutamine is not essential amino acid, but it can be essential in the time of intense athletic training or in the
case of gastrointestinal disease. Bodybuilders should take about 10 to 15 grams of L-glutamine per day [36]. To minimize breakdown of

in the body.
Creatine supplement
Creatine is a nitrogenous organic chemical compound synthesized by the body muscle motions and is marketed as a supplement for
athletics. Creatine supply body cells with energy in the form of Adenine Tri Phosphate (ATP). The recommended maintenance dose of
creatine for athletes is in the range of 5 to 10 grams per day [37]. Creatine is marketed in the form of monohydrate, ethyl, hydrochlo-
ride, magnesium chelate, malate, nitrate and gluconate. Creatine supplement claims for athletics are to improve muscle growth, improve


creatine as dietary supplement [38] and should consult with a physician before taking creatine supplement with medications.
Herbal supplements
    
                
tablets, capsules, powders; tea bags; and in other forms. Total sale of herbal supplements is $7.5 billion per year in United States alone

Chamomile and Peppermint, are used for digestion and considered safe [40] with mild action. Herbal supplement Kava reported to have

 
manufacturers must follow Good Manufacturing Practices (GMP) to ensure that they are consistently manufactured and meet quality
standards.
Food and Drug Administration (FDA) considers some herbal supplements are worthless or unsafe. Some concerns about the safety
of herbal supplants because they are unregulated, may contain additives or contaminants, may cause allergic reaction, may interact with


555
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
Ginseng: Refers to the roots of Asian plant Panax ginseng. The active chemical compound in this plant that is being studied for poten-
tial use in medicine is ginsenoside (C42H72O14


Ginseng as dietary supplements should be standardized to contain about 4 - 5% of the active chemical compound ginsenoside [42].
Ginkgo: The plant Ginkgo biloba is the best-selling herbal supplements in United States. There are about 40 chemical compounds in

-

Ginkgo might help people with Alzheimer. The recommended daily intake of Ginkgo supplements is in the range of 120 to 240 milligrams

drugs and consulting a physician is recommended.
Hydroxyl citric acid:6H8O8Garicinia cambogia.
Garicinia
    

1,200 milligrams per day.
Enzymes
Enzymes sources as dietary supplements are from animals such as pepsin, trypsin and chymotrypsin, from plants such as bromelain,
papain, and diastase, and from microbial such as amylases, proteases, and lipases. Most enzymes supplements commercially used as
-
bined with herbals (botanicals) or other dietary supplements.
Coenzyme Q10
Coenzyme Q10 (CoQ10
present in mammalian cells (mitochondria), participates in metabolic pathways which generates energy in the form of ATP. It is also act
10 found in vital organs that require high energy,
     10 from food
sources is about 3 - 6 milligrams per day. CoQ10 has become a popular natural supplement produced from yeast with claims to boost en-

Antioxidants



vitamins A, C, and E.
Metabolites
Primary metabolites, are intermediate small chemicals substances found inside cells from metabolic pathways, it can be recognize and

cells, control metabolism, and have useful biological functions in cells. Secondary metabolites are organic compounds that secreted as

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What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.

the body in maintaining better balance.
Examples for primary metabolites are:
a. Pyruvate: Pyruvate is a natural substance in the body generated from carbohydrates metabolic pathway [48]. Calcium
pyruvate (C6H6Ca06i) is the pyruvate supplement that is used for weight-loss and its recommended intake is about 5 grams
per day.
b. Glucosamine sulfate: (C6H5N09S) is naturally present in the body for building tendons, ligaments, and cartilage, plus, it is
the 
intake about 1000 to 2000 milligrams per day [50].
Dietary Supplements Regulations in united states

Before the year 1990, Food and Drug Administration (FDA) regulated dietary supplements that only contains essential nutrients to pro-
tect public from mislabeling and unsafe products. In the year 1990 Nutrition Labeling and Education Act included herbs as dietary supple-
ments, and in the year 1994, Congress passed the Dietary Supplements Health and Education Acts (DSHEA) a legislation provided regula-
tory framework for assuring the safety of dietary supplements.

and herbs and granted the U.S. Food and Drug Administration (FDA) the authority to regulate dietary supplements processing, health
        
claims.
In summary DSHEA recommendations are [51]:
a. No need for dietary supplements manufacturers to receive FDA approval before marketing their products.
b. 
of 
c. Dietary supplements manufacturers and distributers are responsible to meet DSHEA, and FDA all safety and labeling re-
quirements before marketing their products.
d. The role of FDA authority on dietary supplements begins after the product enters the marketplace.
e. Dietary supplement manufacturers and distributers are responsible to inform FDA with any serious adverse events that are
reported to them by consumers or health care professionals on their marketed products
f. 
g. Labeling claims for dietary supplements are allowed as long it does not diagnose, prevent, treat or cure diseases.
h. FDA is responsible for dietary supplements labeling claims, including packaging, inserts, and other promotional materials
distributed at the point of sale.
i. Federal Trade Commission (FTC) is responsible for dietary supplements advertising, including prints, broadcast ads, cata-
logs, and any similar direct marketing materials.
j. All dietary supplements claims must meet both FDA and FTC requirements.

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Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
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• Calcium and osteoporosis.
• Sodium and hypertension.
• Folic acid and neural tube pregnancies.
• Fibers and cancer.
• Fruits and vegetables and cancer.
• Dietary fat and cancer.
• Soy protein and coronary heart disease.
• Omega-3-fatty acids and heart disease
• Saturated fats and cholesterol and coronary artery disease
• Sugar alcohols and dental caries
• Vitamins B (folic acid, B6, and B12) and heart disease.
Domestic and foreign manufacturers of dietary supplements are responsible to apply Good Manufacture Practice (GMP) for their
production process, packaging, labeling and distribution. Dietary supplements manufacturers are also responsible to ensure that their
-

herbicides, fertilizer, and harmful microorganism., developing shelf life and storage conditions for each product, and having reliable docu-

GMP requirements for dietary supplements are [53]:
• Design plants that easy facilitate maintenance and cleaning.
• Develop Hazard Analysis Control Points (HACCP) for each dietary supplant production process.
• 
• Having proper standard manufacture operations.
• Having quality control procedures.
• 
• Store dietary supplement ingredients under proper conditions.
• 
light, and sanitation to protect and assure products quality and activity.
• Maintain records keeping for one year past the shelf life date or for two years after the distribution of last batch of dietary
supplement.
• Must have a proper handling of consumer complains.
Dietary supplements manufacturers are also responsible to have a valid good sanitation practice for product and non-product contact
surfaces. 
Labels and advertise regulations [54]
Labels on dietary supplement packages should listed accurate quantity of contents, complete list of ingredients, ingredients safety in-
formation, the part of plant used in the case of herb supplements, and list of nutrition information including serving size, and percentage

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Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
of daily value (DV). Labels information should show, the name and place of the business, and a disclaimer stated that “this product is not
intended to diagnose, treat, cure, or prevent any diseases”.
Advertising including prints, broadcast ads, catalogs, and any other marketing materials are under the responsibility of Federal Trade

Discussion
Dietary supplements are available in different forms such as pills, capsules, powders, tablets or liquids and can be purchase without
a physician prescription. More than 50% of American population are taking daily or occasion one or more dietary supplements to make
sure that they are getting enough essential nutrients and to maintain or improve their health. Majority of Americans consumers do not
need to take these dietary supplements because, they are getting all of required nutrients from eating a variety of healthy foods.
In United States there are over 50,000 marketed dietary supplement and some of these dietary supplements have side effects, when
they are taken with prescription or over counter drugs. Plus, dietary supplements could have side effects for people with health condi-
tions, and consultations with health care providers or physicians are always recommended.

in dietary supplement supports bone health, and the intake of vitamin D with calcium in dietary supplement helps the body to absorb

in good health. Iron in dietary supplement is needed for women during pregnancy, and breastfed infants, to prevent anemic due to blood
loss. The daily intake of 400 micrograms folic acid in dietary supplement is important for all women of childbearing age to prevent birth
defect. Research evidence suggested that vitamin B12 keeps nerves and blood cells healthy [55] and the main source of vitamin B12 is from
the daily intake of meat and dairy products. In the case of vegetarians they should consider taking vitamin B12 as dietary supplement to
make sure of getting vitamin B12

omega-

a week or two before the surgery as recommended by health professions and physicians.
Despite the important of plants in medicine, FDA considers some herbal remedies are worthless or harmful because herbal supplants
are unregulated, sometime mislabeled, may contain additives or contaminants, may cause allergic reaction, may interact with prescrip-

Hypericum perforatum a native plant of Europe and Asia is marketed under trade
name St. -

     

or purity.
Before 1994 Food and Drug Administration (FDA) only protected the public from mislabeled and unsafe dietary supplements of es-
sential -

 
marketed dietary supplements are different in regulations from prescription and over-the-counter drugs that must be approval by FDA

559
What you must know about Dietary Supplements and its Legal Regulations
Citation: Osama O Ibrahim. “What you must know about Dietary Supplements and its Legal Regulations”
.
EC Nutrition 13.8 (2018): 551-
562.
   
their products, but they must follow certain Good Manufacturing Practices (GMP) to ensure the identity, purity, strength, and composi-
tion of their marketed dietary supplements. Manufacturers are also responsible for the safety of their products, the truthful of their label

FDA responsibilities are after dietary supplements inter marketplace, to monitor the safety and to make sure that the information on
labels and packages insert are accurate and claims made for these products are truthful and not misleading. The responsibility of Federal

not misleading.
It is important to highlight that FDA has the authority to take an action if marketed dietary supplement poses a direct health threat to
consumers. Their enforcements are only after dietary supplement was marketed and adverse health effects have already occurred.
Several independent organizations offer quality testing for marketed dietary supplements and allow to pass International standard
analytical tests to display their seals of approval on marketed dietary supplements. These seals of approval provide assurance that mar-
keted dietary supplements are properly manufactured, contains ingredients listed on the label, and does not contain harmful levels of
contaminants. However, these seals of approval still does not guarantee that marketed dietary supplements are safe or effective.
Finally consumers of dietary supplements are responsible for their own safety by selecting supplements with reliable ingredients and
informa-
chase supplements from retail stores not from the internet, consult the physician on the safety of a supplement before purchasing, stop

Conclusion
There are thousands of dietary supplements in the market and many are non-effective or even some might cause harm than good, as
in the case of some herbal supplements. Since there are little known about the safety of dietary supplements, consumers should consult
with their personal physician and purchase dietary supplements with reliable and safety ingredients.
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Volume 13 Issue 8 August 2018
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