Foods referred to as Functional Foods

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Foods referred to as Functional Foods
NUTRITION ROUNDTABLE

• Ritu Nalubola, PhD
• Julie Moss, PhD RD
• Office of Nutrition, Labeling, and Dietary
  Supplements
• Center for Food Safety and Applied Nutrition
• December 12, 2008

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Functional Foods Public Hearing

• On December 5, 2006, FDA held a public hearing
• to share its current regulatory framework for the
  safety evaluation and labeling of conventional
  foods being marketed as functional foods.
• to solicit comments on how FDA should regulate
  these foods under the agency's existing legal
  authority.

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Functional Foods Public Hearing

• At the public hearing, FDA invited comments on
  seven specific issues/questions regarding
  ingredients, labeling, and overall regulatory
  framework for functional foods.
• FDA took into account recommendations of the GAO,
  ILSI, IFT, and a citizens petition from CSPI.
• Fifteen individuals from trade associations,
  health organizations, academia, a law firm, and
  consumers made oral presentations at the hearing.
  We also received 31 written comments following
  the hearing.

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Issues addressed in Questions in the Federal
Register

• Overall regulatory framework for evaluation of
  safety of functional foods ingredients
• Safety Assessment of Functional Foods
  Ingredients
• Notification of Marketing and Label Disclaimers
  related to Structure/Function Claims
• scientific findings from non-governmental groups
  and a notification program
• nutritive value and labeling claims
• incentives to stimulate research into functional
  foods

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Issue 1

• Re Overall regulatory framework for evaluation
  of safety of functional foods ingredients
• Need for a regulatory definition and a distinct
  regulatory approach to the evaluation of the
  safety of ingredients added to functional foods
• Legal authority under which FDA could create this
  new definition and distinct regulatory approach
• Pre-market notification of ingredients added to
  functional foods
• Scientific and legal basis for your position

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Issue 2

• Re Safety Assessment of Functional Foods
  Ingredients
• Types of data and information that would be
  appropriate to demonstrate that ingredients added
  to functional foods meet the safety standard of
  reasonable certainty of no harm
• Scientific and legal basis for your position
• Partnering with interested stakeholders regarding
  the development of appropriate recommendations or
  other information related to the safety
  assessment

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Issue 3

• Re Notification of Marketing and Label
  Disclaimers related to Structure/Function Claims
• Notification within 30 d of marketing a food
  bearing a structure/function claim
• Requirement to include the disclaimer on foods
  bearing a structure/function claim
• Scientific basis (e.g., consumer studies)
• Legal authority under which FDA could require
  notification within 30 d of marketing or
  requirement to include a disclaimer

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Issue 4

• Re scientific findings from non-governmental
  groups and a notification program
• Use of findings from non-governmental groups,
  such as the IFT recommended GRAE panels, to
  support labeling claims
• Pre-market notification for review of scientific
  evidence for structure/function claims for
  functional foods and ingredients (as
  recommended by IFT)
• Existing legal authority under which FDA could
  institute a premarket notification process
• Scientific and legal basis

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Issue 5

• Re nutritive value and labeling claims
• FDAs interpretation of Nutrilab v. Schweiker to
  limit claims based on nutritive value (or other
  food attributes such as taste and aroma)
• Is the agencys approach adequate or inadequate?
• IFT report's recommendation or other alternatives
• Scientific and legal basis

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Issue 6

• Re incentives to stimulate research into
  functional foods
• FDA incentives to manufacturers to conduct
  further research on emerging substance/disease
  relationship
• Scientific basis (e.g., consumer research)
• Existing legal authority under which FDA could
  provide such incentives

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Issue 7

• Re functional foods and their current
  regulatory status as a conventional food
• Adequate existing regulations for food additives,
  GRAS substances, and labeling claims
• If insufficient, scientific and legal basis