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Food Label/Dietary Supplement Regulations. NLEA. N utrition L abeling and E ducation A ct passed by congress in 1990  Regulations written 1993  Manufacturer compliance Spring 1994. Exceptions. Small business Foods for immediate consumption, deli and bakery items

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slide2
NLEA

Nutrition Labeling and Education Act

passed by congress in 1990

Regulations written 1993

Manufacturer compliance Spring 1994

exceptions
Exceptions
  • 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
Required Elements
  • Serving size (common and g)

-standard reference sizes for 139

products

  • Servings/container
  • Total calories/calories from fat
  • Total fat (g)
  • Saturated fat (g)
slide6
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
Trans Fats (g)
  • Will be listed after saturated fat
  • Will not have a %DV
  • Manufacturers must comply by Jan. 2006
reference values
Reference Values
  • 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
slide10
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.
slide11
11-12 g fiber/1,000 kcals
  • 2,400 mg sodium
  • 300 mg cholesterol
activity
Activity

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
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
2 types of claims
2 Types of Claims

1) Nutrient-Content Claims

2) Health Claims

nutrient content claims
Nutrient-Content Claims
  • Highlighting and emphasizing something about the nutritional content of the food (fat, cholesterol, fiber, micronutrient, etc.)
  • Statements are well-defined.
health claims
Health Claims
  • 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
    • 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
slide17
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
Raw Foods?
  • Voluntary program for markets to provide information if form of poster/brochures for
  • 20 most commonly consumed fruits/veges
  • 20 most commonly consumed fish
  • 22-23 categories of beef/poultry
how accurate are labels
How accurate are labels?
  • Review results from 1996 study
restaurants
Restaurants
  • Are exempt from NLEA unless they make claims about
  • Nutrient-content
  • Health claim
  • If customer inquires – they must provide nutritional information
other actions
Other actions
  • Slight changes in labeling of Olestra products – no more warning label about GI problems (pg 76-77 reader)
  • Look for a grading system for health claims (pg 83-86 reader)
qualified health claims b d
Qualified Health ClaimsB-D
  • Review some examples
d ietary s upplement h ealth and e ducation a ct
Dietary Supplement Health and Education Act

DSHEA (1994)

Congress passed law

Regulations written (1997)

Spring 1999

(new labels)

provisions of bill
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”

safety
Safety
  • 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.
slide30
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.
slide31
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
quality
Quality
  • DSHEA gives FDA authority to establish good manufacturing practices (GMPs)
  • In review - none currently exist
    • March 2003 – proposed new regulations for the establishment of current good manufacturing practices (CGMPs)
slide34
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

quality35
Quality?
  • Consumer lab provides independent testing of quality

http://consumerlab.com

  • US Pharmocopeia – standards that over-the-counter drug companies use

http://www.usp.org/

slide36
National Nutritional Foods Association (NNFA) -- a trade organization encompassing about 1000 producers as well as retailers

http://www.supplementquality.com/testing/NNFA-GMP-seal.html

slide37
4) Established the Office of Dietary Supplements and Alternative Medicine of NIH

http://dietary-supplements.info.nih.gov/

required elements40
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”

slide41
4) Percent Daily Value
  • For nutrients with a DV – must show mg/g amount and %DV
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

slide44
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
slide45
“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
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
slide47
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
slide48
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”

slide49
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.
slide50
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
slide51
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
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
Recent Action
  • December 2003 – Immediate consumer safety alert on ephedra and rule to come on banning the sale of ephedra-containing products
suggestions for the practitioners
Suggestions for the practitioners
  • 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/