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									      Food Additivies/Dietary
           Supplements
Are They Safe and Effective? How Do We Know?


               Mike Mangino
      Food Science & Technology - OSU
               August 5, 2008
            Mangino.2@osu.edu
                Additives

What’s in food?
Why is it there?
How do we know its safe?
Who decides if its safe?
What is the difference between an additive and
a supplement.
What is the function of most food additives?
              Food Additive

Any substance the intended use of which results or
may reasonably be expected to result, directly or
indirectly in its becoming a component or otherwise
affecting the characteristics of any food including any
substance intended for use in producing,
manufacturing, packaging, processing, preparing,
treating, transporting or holding food.
                    History
Most of the law we now follow was enacted in 1958.
Prior to that time the FDA had to prove that an
additive was harmful before it could force its removal
from food.
The 1958 act shifted the burden of proof.
Now industry has to prove that a substance is safe
before it can be used in food.
           FDA Philosophy

For something to be used a s a food or drug it
must meet two criteria
     1. It must be safe
     2. If must be effective
                 Supplements

Food Ingredients Compared to Dietary Supplement
Ingredients
Foods - pre-market approval required, products with
unapproved additives can be seized
Dietary Supplements - no pre-market approval, includes many
substances not legal to use in foods, harm must be
demonstrated before seizing products
              GRAS Additive

GRAS - Generally Recognized As Safe - originally
included 675 substances
GRAS review - each additive is reviewed by FASEB
and additives that are still considered safe on the basis
of the best experimental evidence are affirmed GRAS
            Affirmed GRAS

Acetic acid             Ferric chloride   Whey
Benzoic acid            Garlic
Caprylic acid           Helium            Lecithin
Linoleic acid           Maltodextrin      Niacin
Malic acid              Rapeseed oil      Salt
Potassium acid tartrate
Brown algae             BHT               Sucrose
L-Cysteine              Corn syrup        Vitamin A.
Wheat gluten            Cyclamate
              Acute Toxicity

These tests determine how toxic a single dose of an
additive is to rats.
The median lethal dose (LD50) is the amount of the
compound that will kill half of the animals within two
weeks after the dose is administered.
            Acute Toxicity

Compound         LD 50      154 lbs

Salt           3.75 g/kg    9.28 oz
BHT            3.20 g/kg    7.84 oz
DDT            0.50 g/kg    1.25 oz
Cyclamate      17.2 g/kg    42.4 oz
Solanine       0.042 g/kg   0.11 oz
         Short Term Toxicity

Normally in two species
Duration = 90 days
Determine
   Weight gain
   Food consumption
   Organ weights
   Complete blood profile
   Histopathological examination of organs
                 Teratogenicity

A teratogen is a compound that causes a miss-read in the DNA.

This causes birth defects and is not an inheritable change.

This often occurs in first few cell divisions after the egg is
fertilized.

These studies require the feeding of the compound prior to
conception and then examination of the fetuses.
Thalidomide
        Reproductive Studies

Three generations of animals
At least two litters per generation
Observe
Fertility                    Length of gestation
Live births                  Still births
Body weights                 Survival at 4 days
Gross abnormalities
      Chronic Feeding Studies
Two years in two species
Control group and test groups.
The highest dose level would generally be the highest dose that
would not reduce the life span of the animals.
These studies are conducted in parallel with the reproductive
studies discussed before.
These tests are used to determine the no effect dose. Also called
the     NO Effect Level ( NOEL)
          No Effect Level

The concentration that shows no affect in
the most sensitive species
Human exposure can not exceed 1/100 the
the no affect dose
Does not apply to carcinogens
               Biochemical

Determine fate of the compound in the animal.
            Absorption
            Distribution
            Storage
            Tissues accumulation
            Metabolism
            Enzyme profiles
                  Mutagenicity

Difficult to determine in intact animals
Exposure of human leukocytes in culture
Microbiological
Treated and untreated animals mated and fetuses examined
            Delaney Clause

Deals with carcinogens
Cannot add any substance to food if it induces cancer
when ingested by man or animal or if it is found, after
tests which are appropriate for the evaluation of the
safety of food additives to induce cancer in man or
animals.
          Ames Test
All carcinogens must be mutagens
Not all mutagens are carcinogens
Presumptive test
                   Bruce Ames

" I think that we got off on the wrong track.
We're concentrating almost exclusively on little bits of pollution
and man-made things and ignoring enormous amounts of natural
mutagens and carcinogens.
Many vegetables - including mushrooms, celery and parsnips,
contain ‘natural pesticides’ made by plants to protect against
insects.
Those pesticides contain chemicals that are more significant
carcinogens than man-made chemicals."
     Safety Considerations

Conversion to toxic compounds

Excretion in less toxic forms

Evidence of non-adsorption

Half-life and storage in tissue

Synergism and antagonism

Stress effect on different, sex, age and ethnic groups or
disease states.
       Problems with Safety

Impossible to determine absolute safety
Can’t use human subjects
Extrapolation from animals to humans
Extrapolation from large to small doses
Cost
Safety of additive maybe greater than food
Final decision comes down to judgment
Acceptable Applications

Improve nutritional value
Enhance quality
Reduce waste
Improve storage quality
Enhance acceptability
Facilitate preparation
Make food more available
   Unacceptable Applications

To disguise inferior products
To deceive the consumer
To provide otherwise desirable results that lower the
nutritional value
To replace good manufacturing practices
To use in amounts greater than are necessary
                   Additives

Listed on labels from most to least
Most of the additives are related to taste or flavor (but
flavor compounds may not be individually listed)
Only a limited number of preservatives are used
               Most Common

The most widely used additives based on weight of
usage are:
   – Sucrose
   – High fructose corn syrup
   – Dextrose (Glucose)
   – Salt
What do they have in common?
             The Dietary Supplement
                  Phenomenon
Big Business: $22.5 billion in sales in 2007 (NBJ website)

Popular Products: 14% of individuals surveyed had taken
  herbal product/supplement during previous week

Users: primarily self-initiated vs. practitioner-based

67% of regular supplement users would continue use even
  if FDA said products were not effective - ???

  Source: NAS Report (2005)
    Dietary Supplements - 2001 Sales
               Breakdown


 Vitamins - $5.8 billion

 Minerals - $1.2 billion

   Herbs/Botanicals - $4.1 billion

   Sports Nutrition - $1.5 billion

   Others (incl. combination products) - $3.8 billion
       Definition of Essential Nutrient

= A substance required for normal body functioning
  that cannot be synthesized by the body and must be
  obtained from a dietary source

Vitamins and minerals (usually as enzyme co-factors in
  physiological reactions)

Essential fatty acids (building blocks for fats)

Essential amino acids (building blocks for proteins)
                Adulteration

According to an FDA regulation: A food shall be
deemed adulterated if it bears a poisonous or
deleterious substance which may render it injurious to
health, but in the case that the substance is not an
added substance such food shall not be considered
adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it
injurious to health.
          Dietary Supplements

Dietary supplements fit into this definition. The FDA
tried to regulate them as a food if they were used as
herbal products consumed like foods and as food
additives or drugs if they were added to foods or sold
in capsules and advertised with claims. Congress
passed a law (see below) that stopped the FDA from
enforcing their rules and established a new set of rules
for supplements.
                          FDA

When the FDA tried to regulate supplements using the standard
that is used for foods and drugs the industry objected and
mounted a big advertising campaign. The FDA wanted two
things from those who marketed supplements as cures for an
illness. They wanted be assured that they were safe and they
wanted some proof that they worked. I am biased but I think
these are reasonable expectations. As a consumer I want the
products I buy to be safe and I want them to do what they
promise to do. After much lobbing by the supplement industry
congress passed a law that essentially told the FDA to treat
supplements as pure foods rather than as drugs are as additives.
    DSHEA (Dietary Supplement Health
       and Education Act – 1994)

   Assured American consumers access to products

   Defined dietary supplements

   Established regulatory framework

    • Food & Drug Administration (FDA)

    • As foods, not as drugs

   Established rules for what a label should contain

   Established ODS at NIH in the Office of the Director
       Definition of Dietary Supplement
= A product intended to supplement the diet that bears or contains
  one or more of the following ingredients:

A vitamin, mineral, amino acid, herb, other botanical;

A dietary substance for use to supplement the diet by increasing the
   total dietary intake

A concentrate, metabolite, constituent, extract, or combination of
   any ingredient describes above

Intended for ingestion in the form of a capsule, powder, soft gel, or
   gel cap and not represented as a conventional food or as a sole
   item of a meal or diet
        Definition of Dietary Supplement
                                (cont.)
   Structure/Function Claims

   May describe role of nutrient or dietary ingredient intended to
    affect a structure or function in humans

   Manufacturer is responsible for ensuring accuracy &
    truthfulness of these claims; since not approved by FDA,
    products must carry a disclaimer

   ―These statements have not been evaluated by the FDA. This
    product is not intended to diagnose, treat, cure, or prevent any
    disease.‖
 Claims requiring FDA approval

Lowers cholesterol
Maintains healthy lung function in smokers
Provides relief of chronic constipation
Suppresses appetite to treat obesity
Supports the body's anti-viral capabilities
Relief of persistent heartburn or acid indigestion
Helps reduce difficulty in falling asleep
Helps restore sexual vigor, potency and performance
 Claims that do not require FDA approval


Helps maintain normal cholesterol levels
Maintains healthy lung function
Provides relief of occasional constipation
Suppresses appetite to aid weight loss
Supports the immune system
Relief of occasional heartburn or acid indigestion
For relief of occasional sleeplessness Arouses sexual desire
Improves memory            Improves strength
Promote digestion         Boosts stamina
For common symptoms of PMS
 Claims that do not require FDA approval


For hot flashes         Helps you relax
Helps enhance muscle tone or size
Relieves stress
Helps promote urinary tract health
Maintains intestinal flora
For hair loss associated with aging
Prevents wrinkles
For relief of muscle pain after exercise
To treat or prevent nocturnal leg muscle cramps
          How are Dietary Supplements
                  Regulated?

Food rules apply; ingredients are presumed safe based on history of
  use in humans and, if sold in U.S. before Oct 1994, FDA review
  before marketing is not required

Manufacturers do not have to provide FDA evidence of efficacy or
  safety before marketing; once on the market, FDA must prove
  that a product is not safe in order to restrict its use or remove it

By contrast, for drug products, a manufacturer must obtain FDA
  approval by providing evidence of both safety and efficacy before
  marketing
  What are Americans using? Product Rate of Use

                               Echinacea (40.3)
                               Ginseng (24.1)
                               Gingko (21.1)
                               Garlic (19.9)
                               Glucosamine (14.9)
                               St. Johns wort (12.0)
                               Peppermint (11.8)
                               Fish oils (11/7)
                               Ginger (10.5)
                               Soy (9.4)




Source: NIH NCCAM (2004)
  How Many People are Using Dietary
        Supplements Today?


Estimated 40-55% of Americans use supplements on a
  regular basis, >100 million people

Estimated 69% use vitamin & mineral supplements;
  24% use herbal supplements

Users predominantly adult women 42-55% and adult
  men 30-42%
  How are Consumers Using Herbals ?


Of those taking herbals:

36% are using instead of prescription medication

31% are using with a prescription medication

48% are using instead of an OTC medication

30% are using with an OTC medication
            Herbs: Myths and Reality

Natural is not equal to safe

Used for thousands of years is not equal to effective & safe

Herb as a plant is not the same as a capsule or tablet

All brands of herbs are not the same
     Summary of HHS
    Actions on Specific
       Supplements
FDA Advisories
St. John’s Wort – Feb. 2000 (CDER, Public health)
Aristolochic acid – Apr. 2001 (CFSAN, consumers)
Kava – Mar. 2002 (CFSAN, consumers)
Androstenedione – Mar. 2004 (FDA warning to manufacturers)

Bans
Ephedra – Feb. 2004
         T-Bomb IIT-Bomb II

T-BOMB II is so effective at jacking your
Testosterone levels to the max, many are calling this
male hormone optimizing formula "the most
significant development in Pro-Testosterone
Technology since prohormones! "It's the ONLY
"prohormone-free" Testosterone formula available that
simultaneously optimizes pure Testosterone levels in
the blood, increases "Free Testosterone", improves the
Testosterone to estrogen ratio and maximizes the
anabolic effects of pure Testosterone. Never before
has a Testosterone formula attacked the physiology of
the human hormonal profile from so many angles!
         NOZ Full Throttle

NOZ Full Throttle contains Creatine Ester
Orotate, Isoleucine KIC, Glycine Ethyl Ester
(GEE), Citrulline Ethyl Ester Malate, Alanyl-L-
Glutamine-Dipeptide, Glycerol Monostearate,
K-R-Alpha-Lipoic-Acid and Beta-Alanine
               Nitrix
      Rapidly Blow Up Muscles
L-Arginine AKG - The Premier NO Booster! BSN has taken
vaso-muscular volumization to the next level by developing a
premier NO booster that ensures optimum NO production over
current NO boosters. L-Arginine Alpha Keto-Glutarate
(AAKG) has the unique ability to improve the conversion
process of Arginine into NO. However, the NO boosting power
of this specific amino acid is heavily dependent upon the
bonded ratio of L-Arginine to AKG. After months of extensive
research BSN has developed a precise bonded ratio of L-
Arginine to AKG. This ratio promotes an increase in NO
production over standard bonded versions of L-Arginine AKG.
BSN's proprietary AAKG technology makes Nitrix the world's
premier NO booster
            Mega Hoodia

Fueled by Hoodia gordonii, the plant's most
popular and effective species, new Mega
Hoodia from NOW delivers a powerful 20:1
concentrate of pure Hoodia.
        Hydroxycut Hardcore

Hydroxy citrate Garcinia cambogia fruit
Caffeine
Side effects
Increased blood pressure     Increased heart rate
Headache, dizziness          Loss of appetite
Restlessness                 Nose bleeds
Blurred vision
acne
                         St. John’s Wort
Claims: Today, used for depression, anxiety, sleep disorders; traditionally to
   treat mental disorders, nerve pain & malaria, as a sedative & balm for
   wounds, burns & insect bites.

Science: Not a proven therapy for depression; NCCAM is studying use for
   minor depression

Side Effects: Interactions w/medications— indinavir (HIV infection),
   irinotecan (cancer), cyclosporine (organ transplant), digoxin (heart
   muscle contractions), warfarin (anticoagulant), birth control pills;
   w/some antidepressants may increase nausea, anxiety, headache &
   confusion
                 FDA PUBLIC HEALTH ADVISORY
                       February 10, 2000



Subject: RISK OF DRUG INTERACTIONS WITH ST
JOHN’S WORT AND INDINAVIR AND OTHER DRUGS

Dear Health Care Professional:
The NIH conducted a study that showed a significant drug
interaction between St John's wort (Hypericum perforatum),
an herbal product sold as a dietary supplement, and
indinavir, a protease inhibitor used to treat HIV infection…
concomitant administration substantially decreased
indinavir plasma concentrations…
                              CONSUMER ADVISORY
                                 April 11, 2001

FDA WARNS CONSUMERS TO DISCONTINUE USE OF BOTANICAL
PRODUCTS THAT CONTAIN ARISTOLOCHIC ACID


The FDA is advising consumers to immediately discontinue use of any
botanical products containing aristolochic acid… Consumption has been
associated with permanent kidney damage, sometimes in kidney failure
requiring kidney dialysis or kidney transplantation. Some patients have
developed certain types of cancers, most often in the urinary tract.
                            Kava
KAVA-CONTAINING DIETARY SUPPLEMENTS
 MAY BE ASSOCIATED WITH SEVERE LIVER
 INJURY
 The FDA is advising consumers of the potential risk of
 severe liver injury associated with the use of kava-
 containing dietary supplements…promoted for relaxation
 (e.g., to relieve stress, anxiety, and tension), sleeplessness,
 menopausal symptoms and other uses.
                   Take Home Messages
Natural does not equal safe

Dose matters (even essential nutrients can be toxic in sufficient
   quantities)

Buyer beware – know what you are consuming to protect your health
   & wallet

Check out these government websites:

    http://www.cfsasn.fda.gov/~dms/supplemnt.html

    http://ods.od.nih.gov/health_information/health_information.aspx
What are Ramen Noodles?

              .
       How are they made?

Mix dough
Extrude
Dry partially
Fry
Cool
Package
Ramen Noodles

       Noodles: Enriched flour
       (wheat flour,niacin,
       reduced iron, thiamin
       mononitrate, riboflavin,
       folic acid), partially
       hydrogenated soy oil, salt,
       soy sauce (water, wheat,
       soybeans, salt), potassium
       carbonate, sodium
       phosphates, sodium
       carbonate, turmeric.
              Ramen Sauce

Sauce mix: Salt, dehydrated soy sauce (wheat,
soybeans salt, maltodextrin),sugar, monosodium
glutamate, lactose, beef flavor(dehydrated beef
extract, cooked beef powder),autolyzed yeast extract,
caramel color, natural flavors, spices, hydrolyzed corn,
soy and wheat proteins, dehydrated vegetables (onion,
garlic),beef fat, disodium inosinate, disodium
guanylate.
Marshmallows
          Marshmallows

Corn syrup, sugar, modified food
starch, water, gelatin, artificial vanilla
flavor, tetrasodium pyrophosphate,
Blue 1
Dried Potatoes
    Topco Scalloped Potatoes

Dehydrated potato with preservative (sodium bisulfite),
enriched flour (niacin, iron, thiamin mononitrate, riboflavin,
folic acid), food starch - modified, salt, maltodextrin, whey,
corn syrup solids, partially hydrogenated soy oil with emulsifier
(mono and di glycerides) cheddar cheese(milk, cheese culture,
salt, enzymes), hydrolyzed corn and soy protein, monosodium
glutamate, buttermilk, reduced lactose whey, dextrin,
dehydrated celery, sugar, corn starch, soy flour, chicken fat,
natural and artificial flavor, autolyzed yeast extract, disodium
phosphate, dehydrated onion, spice, color (paprika, yellow 6
lake, yellow 5 & 6, turmeric), dehydrated garlic, sodium
caseinate, blue cheese (cultured milk, salt, enzymes), lactic
acid, citric acid, disodium guanylate, disodium inosinate.
Slim Jim
       Slim Jim Ingredients

Beef, mechanically separated chicken, water,
salt, corn syrup, dextrose, flavorings, spice,
paprika, hydrolyzed corn gluten, soy and wheat
gluten proteins, sodium nitrite, lactic acid
starter culture.
                 Slim Jim

Mix ingredients
Grind
Stuff into casings
Ferment
Cook and Dry
                   Dasani - Pure?

Ingredients: water, magnesium sulfate, potassium chloride, salt
           Dasani - Pure?

Who regulates water?
  – EPA
  – FDA - bottled


Where could you find the rules?
                        Dasani - Pure?

Code of Federal Regulations (CFR)
21 CFR 165.110
Can ingredients be added to bottled water?
Bottled water is defined in 21 CFR 165.110 as water that contains no added ingredients, except
for optional antimicrobial agents or fluoride. Therefore, firms cannot add any other ingredients
to their bottled water products and still call it "bottled water" (or "mineral water" or "purified
water"). The name of a product with ingredients added must include the added ingredient, such
as "bottled water with minerals added" or "bottled water with raspberry flavor." The resulting
product is a multicomponent beverage and must bear an ingredient list on the label or labeling.
If the water ingredient is highlighted as a bottled water, such as spring water, the water
ingredient must comply with FDA's bottled water regulations.

								
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