Transcript Food Label/Dietary Supplement Regulations

Food Label/Dietary Supplement
Regulations
NLEA
Nutrition Labeling and Education Act
passed by congress in 1990
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Regulations written 1993
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Manufacturer compliance Spring 1994
Exceptions
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Small business
Foods for immediate consumption, deli and
bakery items
Foods of no nutritional consequence
(spices/coffee/tea)
Infant formula/medical food
Small packages (require 1-800#)
Required Elements
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Serving size (common and g)
-standard reference sizes for 139
products
Servings/container
Total calories/calories from fat
Total fat (g)
Saturated fat (g)
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Cholesterol (mg)
Sodium (mg)
Total carbohydrate (g) (includes starch,
sugar, and fiber)
Dietary Fiber (g)
Sugars (g) (includes simple sugars from
natural and added sources)
Trans Fats (g)
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Will be listed after saturated fat
Will not have a %DV
Manufacturers must comply by Jan. 2006
Reference Values
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Generic Term = Daily Values (DVs)
2 sets of Daily Values
1. RDIs (Reference Daily Intakes) – label
standards for micronutrients
 Required: Vitamin A and C, iron, calcium
2. DRVs (Daily Reference Values) – label
standards for macronutrients, fiber, sodium,
cholesterol
 Based on a 2,000 kcal diet
 30% of kcals fat
 10% of kcals – saturated fat
 60% of kcals carbo.
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11-12 g fiber/1,000 kcals
2,400 mg sodium
300 mg cholesterol
Activity
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Estimate calorie needs
Healthy body weight (lb) X 10 = baseline calories
Baseline calories X
1.3 – sedentary
1.4 – light activity
1.5 – moderate activity
1.6 or more - active
Ingredients
Still listed by weight (descending order)
Changes:
 FDA-certified colors additives – use name
 Sources of protein hydrolysates revealed
 Caseinate identified as a milk derivative
 % real juice
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2 Types of Claims
1) Nutrient-Content Claims
2) Health Claims
Nutrient-Content Claims
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Highlighting and emphasizing something
about the nutritional content of the food
(fat, cholesterol, fiber, micronutrient, etc.)
Statements are well-defined.
Health Claims
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Approved statements that describe a
relationship between a food or substance in
food and a disease or condition
14 approved health claims
FDA requires SSA (significant scientific
agreement) in approving claims
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Food must also have at least 10% of DV for A, C, iron, Ca,
protein, fiber and no more than 20% of DV fat, sat’d fat,
cholestol, sodium
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In 1998 – President Clinton approved use
of “Authoritative Health Claim
Statements” for food labels
May use health claims from groups like
NIH, CDC, NAS
Raw Foods?
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Voluntary program for markets to provide
information if form of poster/brochures for
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20 most commonly consumed fruits/veges
20 most commonly consumed fish
22-23 categories of beef/poultry
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July 1994 – added safe handling of meat
instructions
How accurate are labels?
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Review results from 1996 study
Restaurants
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Are exempt from NLEA unless they make
claims about
Nutrient-content
Health claim
If customer inquires – they must provide
nutritional information
Other actions
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Slight changes in labeling of Olestra
products – no more warning label about GI
problems (pg 76-77 reader)
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Look for a grading system for health claims
(pg 83-86 reader)
Qualified Health Claims
B-D
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Review some examples
Dietary Supplements
Dietary Supplement Health and
Education Act
DSHEA (1994)
Congress passed law
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Regulations written (1997)
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Spring 1999
(new labels)
Provisions of Bill
1) Defined what a dietary supplement is
“is a product (other than tobacco) that is intended
to supplement the diet that bears or contains one
or more of the following dietary ingredients: a
vitamin, a mineral, an herb or other botanical, an
amino acid, a dietary substance for use by man to
supplement the diet by increasing the total daily
intake, or a concentrate, metabolite, constituent,
extract, or combinations of these ingredients”
2) Provides framework for assuring safety
Safety
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DSHEA does not require that supplements
are shown to be safe or effective before
they are marketed.
Manufacturers must notify FDA of intent to
market 75 days prior and submit info. that
supports their conclusion that a new
supplement can reasonably be expected to
be safe.
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True safety burden falls on FDA
FDA is only allowed to restrict a
supplement if it poses a “significant and
unreasonable risk” under the conditions of
use as stated on the label.
FDA must have substantial reports of
adverse effects before they may take any
action.
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Oct. 2001 - Sens. Orrin Hatch (R-Utah) and Tom Harkin
(D-Iowa) added an amendment (#2013) DSHEA
providing $1 million to FDA for safety enforcement
Sales: $17 billion in 2000
safe ty
sales
3) Provides for Good Manufacturing
Practices
Quality
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DSHEA gives FDA authority to establish good
manufacturing practices (GMPs)
In review - none currently exist
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March 2003 – proposed new regulations for the
establishment of current good manufacturing
practices (CGMPs)
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Does supplement contain what label claims
it has???
-What is appropriate dose for active
ingredient? (unclear)
-adulteration, substitution, contamination and
additives may be present but not listed on the
label
-have been some reports of outright fraud
Quality?
Consumer lab provides independent testing
of quality
http://consumerlab.com
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US Pharmocopeia – standards that overthe-counter drug companies use
http://www.usp.org/
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National Nutritional Foods Association
(NNFA) -- a trade organization
encompassing about 1000 producers as
well as retailers
http://www.supplementquality.com/testing/N
NFA-GMP-seal.html
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4) Established the Office of Dietary
Supplements and Alternative Medicine
of NIH
http://dietary-supplements.info.nih.gov/
5) Regulates Label Information
Required Elements
1) Product Name
 Must identify that product is a dietary
supplement
2) Serving size and daily dose
3) Ingredients List – in supplements fact box
and “other ingredients”
4) Percent Daily Value
 For nutrients with a DV – must show
mg/g amount and %DV
5) Claims
Claims
1. Nutrient - content claims
 must follow regulations as stated in NLEA
“High in calcium” - 200 mg or more/serving
“Excellent source of C” - 25 mg or more
“High potency” - 100% of DV for nutrients
2. Health Claims
 May use any of the 14 approved Health
Claims as stated in NLEA
 FDA required SSA (significant scientific
agreement) in approving claims
“Calcium reduces the risk of osteoporosis”
“Soluble fibers may reduce the risk of CHD”
“Plant sterols reduce the risk of heart disease”
“Folic acid reduces the risk of having a child
with a brain or spinal birth defect”
The Gray Zone
3. Structure/Function Claims
 Allowed to make claims about how the
supplement supports or promotes healthy
functioning of the body
 Claim must not suggest that the supplement
treats, prevents, or mitigates a disease
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Exemptions: common conditions
associated with natural states or processes
that do not cause significant or permanent
harm
e.g., hot flashes, mild memory problems,
hair loss associated with aging, acne
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Must carry disclaimer statement
“This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat,
cure, or prevent any disease”
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May sell a product with a claim as long as
FDA is notified within 30 days of market
Manufacturer determines if claim is
scientifically substantiated
Burden of proving inadequate
substantiation of claim in responsibility of
FDA.
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Helps maintain cardiovascular function
Protects against heart disease
Promotes healthy cholesterol level
Lowers cholesterol level
Promotes healthy joints
Reduces pain of arthritis
Supports regularity, healthy intestinal flora
Alleviates chronic constipation; laxative
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Promotes urinary tract health
Prevents urinary tract infections; improves
urine flow in men over the age of 50; diuretic
Reduces stress and frustration
Herbal prozac
Improves memory
Treats dementia
Center for Science in the Public
Interest (CSPI)
“this proposal was merely a futile bureaucratic
exercise in hairsplitting that did little to
protect the consumer.”
Recent Action
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December 2003 – Immediate consumer
safety alert on ephedra and rule to come on
banning the sale of ephedra-containing
products
Suggestions for the practitioners
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Direct link to FDA
http://www.cfsan.fda.gov/
Reliable sources on supplements
http://www.quackwatch.com/
http://www.supplementwatch.com/
http://www.herbalgram.org/
http://www.herbs.org/
http://www.herbmed.org/