FOOD LAWS AND REGULATIONS

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FOOD LAWS AND REGULATIONS
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FOOD AND DRUG ACT OF 1906

• First food protection legislation.
• Regulated the safety,whole-someness of food.
• Signed by Pres. Theodore Roosevelt June 30, 1906
• Became effective January 1, 1907.

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FOOD AND DRUG ACT of 1906

• Prohibited misleading and false statements on
  food and drug labels
• Defined adulterated foods
• Provided no true enforcement powers Allowed
  ONLY for publication of Federal investigation
  results

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FOOD MEAT INSPECTION ACT 1907

• Provided for meat inspection. Gave USDA the
  authority to prevent false or misleading labeling
  on meat and meat products

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GOULD AMENDMENT 1913

• Requires manufacturer to declare net weight
• BUTTER STANDARD AMENDMENT 1923
• Defined butter in fat set standard for all
  producers

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1938 FEDERAL FOOD, DRUG AND COSMETIC ACT

• Signed by President Franklin Roosevelt, still in
  use today
• Established standard of identity
• Prohibits false or misleading labeling
• Prohibits transport or dealing in food which may
  be injurious

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1938 FFDCA

• Requires listing any food additive
• Established standard for quality
• Authorizes recall of products which may be
  harmful
• Authorizes inspection of establishments producing
  products for Interstate shipment and all
  pertinent records. Provides for civil and
  criminal penalties for any violations

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1938 FFDCA

• Established Regulations for thermal food
  processing
• 1. Classifies food product by acidity to
  determine thermal processing requirements
• 2. Regulates types of packaging and packaging
  requirements
• 3. Sets requirements for record keeping and
  recall procedures
• 4. Determines processor liability

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1954 PESTICIDE CHEMICALS AMENDMENT

• Established the FDA as responsible for setting
  safety tolerance for registered pesticides for
  raw agricultural products

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POULTRY PRODUCTS INSPECTION ACT 1957

• Provided for inspection and regulation of poultry
  products. Gave USDA authority included
  preventing false or misleading label

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1958 FOOD ADDITIVE AMENDMENT
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1958 Food Additive Amendment

• Defined food additive direct or indirect
• Shifted burden of proof of safety from government
  to industry and Required all food additives to
  receive FDA approval prior to use

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1958 Food Additive Amendment

• Established 3 categories of food additives
• 1) Generally recognized as safe (GRAS)
• 2) Non-GRAS approved
• 3 Not approved

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1958 Food Additive Amendment

• Contains DELANEY CLAUSE (Anti-cancer Clause)
  which states any substance causing cancer in
  laboratory animals or man must be banned.

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Delaney Clause Requirements

• Efficacy testing Each food additive must be
  tested to determine
• 1) If it does what the manufacturer claims and at
  what level.
• 2) If it is anti-nutritive (ex binding to
  vitamins so the body cannot absorb them).
• 3) Change the texture or flavor of food product.
• 4) If it is altered during processing.

1958 Food Additive Amendment
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Risk Benefit analysis

• Determine the risk vs benefit of approval
  Using Exposure and the critical factor which is
  the amount of substance and who is exposed. Ex
  children, elderly, or immune compromised.
• Benefits Ex Prevent C botulinum from growing
  or producing toxin
• Risk Possibility of forming cancer

1958 Food Additive Amendment
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1960 COLORING AMENDMENT

• Require color safety certification

FAIR PACKAGING AND LABELING ACT 1966

• Gave FDA power over regulation of package size,
  provision of label information and measure of
  content.

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1972 FEDERAL ENVIRONMENTAL CONTROL ACT

• Established the U. S. Environmental Protection
  Agency .
• Removed authority for setting pesticide and
  agricultural chemical residues from jurisdiction
  of the Food and Drug Administration to the EPA.
• Today the EPA sets the tolerances (legal levels)
  and FDA enforces them in both raw and processed
  foods.

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1990 NUTRITIONAL LABELING AND EDUCATION ACT (NLEA)

• List all substances added no matter amount
• List ingredients for standardized products
• Juice in fruit/vegetable juices
• Define serving sizes serving size will be
  defined based on product category (dips, sauce,
  meal, main dish) - in household and metric
  measures.

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NLEA

• Define descriptors such as low-fat or light
  (lite)
• NUTRIENTS Total calories, calories from fat,
  total carbohydrates, sugars, dietary fiber,
  protein, sodium, Vit A, Vit C, calcium, and iron.
  
• Requires that all are listed by weight and
  "Percent of daily value" Must also include amount
  of fat, saturated fat and cholesterol.

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• Explanation that the ingredient list is in
  descending order by weight
• Identification of individual protein hydrolysates
  
• Identification of caseinate as milk derivative in
  non-dairy products
• Declare sulfites and MSG (if added directly or
  contained as a component of a protein
  hydrolysate)

NLEA
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FDA Approved Health Claims

• Calcium and osteoporosis
• Sodium and hypertension
• Fat, cholesterol and cardiovascular disease
• Folic acid neural tube defects
• Oat and soluble fiber and heart disease
• Fiber and cancer
• Dietary Fat and cancer
• Dietary sugar alcohol and dental caries

NLEA
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HEALTH CLAIMS NOT ALLOWED

• Antioxidant Vitamins and cancer
• Zinc immune function in elderly
• Omega-3 fatty acids and heart disease
• Fat and cancer
• Nutrient levels effects health claims Foods
  containing 45 mg cholesterol cannot contain any
  health claims.

NLEA
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Dietary Supplement Health and Education Act 1994

• Defines Dietary Supplements and Health Claims for
  Dietary Supplements and places the labeling
  requirements under the NLEA.
• Puts dietary supplements of vitamins, minerals,
  herbs and similar nutritional supplements under
  the same restrictions as all other foods with
  regards to health claims

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• "Dietary supplement" - a product other than
  tobacco, intended to supplement the diet that
  contains at least one or more of the following
  ingredients A vitamin a mineral an herb or
  other botanical an amino acid a dietary
  substance for use to supplement the diet by
  increasing the total dietary intake or a
  concentrate, metabolite, extract, or combination
  of any of the previously mentioned ingredients.

Dietary Supplement Health and Education Act 1994
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• A product labeled as a dietary supplement. It is
  intended for ingestion in tablet, capsule,
  powder, softgel or liquid form.
• Cannot be represented as a conventional food and
  is not represented for use as a sole item of a
  meal.
• Includes products such as an approved new drug,
  certified antibiotic or licensed biologic. May be
  a "dietary supplement" even if marketed in
  conventional food form.

Dietary Supplement Health and Education Act 1994
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• If herbs or botanicals are used the portion of
  the plant must be identified. Such as root,
  leaves, or bark.
• Label may NOT make any claims with regards to
  specific diseases. Such as "Cures" "For treatment
  of" .

Dietary Supplement Health and Education Act 1994
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Antioxidant Nutrient Claims

• Ascorbic acid, Vitamin E and beta-carotene only.
  Allow for terms such as good, source, more and
  high.

Dietary Supplement Health and Education Act 1994
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High Potency Claim

• Must contain 100 of the RDI or DRV for
  individual nutrients.
• May not be used for dietary ingredients for which
  no RDI has been established.
• Multi-vitamin formulas are required to contain
  100 of RDI for 11 nutrients in order to make a
  claim.

Dietary Supplement Health and Education Act 1994
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May 10, 1994 Federal Register, NLEA

• Determined the requirements for food to use the
  term "Healthy" or any derivative such as health,
  healthful, healthfully, healthier, healthiest,
  healthily and healthiness. Foods must meet the
  definitions of "low Fat", "Low Saturated Fat",
  "Low Cholesterol" and "Low Sodium". Most
  important being fat and cholesterol levels.

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August 2, 1996, Federal Register, NLEA

• Restaurants lose nutrient content and health
  claims exemptions. If a restaurant make a claim
  they must provide Nutrient Facts to prove it.

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August, 3, 1996, Food Quality Protection Act

• Allows for risk benefit analysis of pesticides in
  processed food products stricter guidelines for
  raw food products especially those consumed on a
  regular basis by children or the elderly.
• Removes pesticides found in processed foods from
  being considered as food additives.