rbST and Organic Labeling

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rbST and Organic Labeling

• Michelle Albee Matto
• Health Claims Workshop
• October 28, 2003

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Organic and rbST labeling

• Not health claims, but statements that must be
  truthful, not misleading and comply with
  regulation or guidance.
• Can be used to attract attention of specific
  consumers.
• May be used in conjunction with health claims, as
  long as all requirements to use all claims are
  met.

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USDAs National Organic Program
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USDAs National Organic Program

• Dairy fastest growth in organic food category
  57.9 increase over 5 years
• Milk, yogurt, cheese, pudding, ice cream, butter
• Organic farms increased 12 per year
• Retail sales of organic foods were 6 billion and
  growing
• Organic crop land has doubled in the last 5 years

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USDAs National Organic Program

• Organic Food Protections Act 1990 - part of the
  Farm Bill
• Required USDA to develop national standards for
  organically produced products
• Assure consumers consistency and uniformity in
  production, processing and labeling
• USDAs National Organic Program (NOP)

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USDAs National Organic Program

• Final Rule published Dec. 2000
• Implementation by Oct. 21, 2001 for packages
  entering the market
• Directs USDA to accredit agents that certify
  production and handling
• Certifying agents (50 state and private) act
  consistently and impartially

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USDAs National Organic Program

• Certification of any operation the produces of
  handles agricultural products that are labeled
  100 Organic, Organic or Made with Organic
  Ingredients
• Exceptions
• Farms and firms making less than 5000/yr.
• Retailers that do not process or repack
• Food with less than 70 organic ingredients

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USDAs National Organic Program

• Prohibited practices for organic products and
  ingredients
• Using ionizing radiation
• Using sewage sludge application - fertilizer
• Using sulfites, nitrates or nitrites
• List of excluded methods and processing aids
• List of allowed synthetic substance

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USDAs National Organic Program

• Livestock Standards - Milk
• Raised under organic management last 3rd
  gestation
• Utilize 100 organic feed, except vitamins and
  minerals - last 3 months (conversion 9 months
  with 80 organic feed)
• Animal access to outdoors, pasture for cows
• Allow vaccines and treatment for sick animals
• No growth hormones or prophylactic antibiotics

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USDAs National Organic Program

• Labeling and Marketing
• Based on of Organic Ingredients
• 100 Organic - only exception salt and water
• Organic - at least 95 organically produced
  ingredients, others are non-agricultural
• Use of USDA seal and certifying agent on PDP and
  advertising

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USDAs National Organic Program

• Labeling and Marketing
• Made with Organic Ingredients
• Contain at least 70 organic ingredients
• of organic content and certifying agent may be
  used on PDP
• USDA organic seal cannot be anywhere on the
  package

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rbST Claims
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rbST Claims

• FDA allowed for use of rbST in dairy cows in
  1993.
• Guidance issued February 7, 1994
• FDA found no significant difference between milk
  from cows treated with rbST and cows not treated
  with rbST.
• Companies that use milk from untreated cows may
  label, as long as statements are truthful and not
  misleading. (Need proper context)

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rbST Claims

• FDA Guidance, cont.
• Recommended label statement
• From cows not treated with rbST. No significant
  difference has been shown between milk derived
  from rbST-treated and non-rbST treated cows.
• Context can also be established with other
  statements regarding the companys reason not to
  use milk from cows treated with rbST (an overall
  explanation of organic milk)

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rbST Claims

• FDA replied to Monsanto request for information
  on rbST labeling in Dec. 2002
• Statements cannot allow consumers to conclude
  that milk from untreated cows is safer or of
  higher quality than other milk.
• Dont use rbST-free or hormone free.
• Statements must be presented with context.
• Claims must be substantiated.

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rbST Claims

• FDA warning letter issued to 4 companies on
  September 12, 2003
• Letters stated No Hormones and Hormone Free
  are false and misleading
• All milk naturally contains hormones
• Milk cannot be processed to remove hormones
• May voluntarily disclose milk from cows not
  treated with rbST, must not be misleading

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Organic and rbST Claims

• All claims must be truthful and not misleading.
• Organic labeling must follow USDA National
  Organic Program rules.
• rbST labeling must be presented in proper context
  and cannot allow consumers to believe one kind of
  milk is healthier or safer.

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Questions?