Food Label/Dietary Supplement Regulations

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Food Label/Dietary Supplement Regulations
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NLEA

• Nutrition Labeling and Education Act
• passed by congress in 1990
• ?
• Regulations written 1993
• ?
• Manufacturer compliance Spring 1994

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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)

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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)

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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)

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Trans Fats (g)

• Will be listed after saturated fat
• Will not have a DV
• Manufacturers must comply by Jan. 2006

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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

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• 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

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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

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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

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Nutrient-Content Claims

• Highlighting and emphasizing something about the
  nutritional content of the food (fat,
  cholesterol, fiber, micronutrient, etc.)
• Statements are well-defined.

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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, satd 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

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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

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• July 1994 added safe handling of meat
  instructions

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How accurate are labels?

• Review results from 1996 study

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Restaurants

• Are exempt from NLEA unless they make claims
  about
• Nutrient-content
• Health claim
• If customer inquires they must provide
  nutritional information

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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)

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Qualified Health ClaimsB-D

• Review some examples

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Dietary Supplements
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Dietary Supplement Health and Education Act

• DSHEA (1994)
• Congress passed law
• ?
• Regulations written (1997)
• ?
• Spring 1999
• (new labels)

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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

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• 2) Provides framework for assuring safety

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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.

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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

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• 3) Provides for Good Manufacturing Practices

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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)

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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

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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/

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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/NNFA-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/

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• 5) Regulates Label Information

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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

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• 4) Percent Daily Value
• For nutrients with a DV must show mg/?g amount
  and DV

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• 5) Claims

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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

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• 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

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• 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

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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

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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.

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Recent Action

• December 2003 Immediate consumer safety alert
  on ephedra and rule to come on banning the sale
  of ephedra-containing products

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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/