Sample Proposal Submission

 

Title of Session:  
Bioactive Nutrients - Time for Tolerable Upper Intake Levels to Address Safety

 

Why is the session important/timely:  
Since bioactive compounds (sometimes referred to as “non-essential nutrients”) come from natural flora and fauna for the most part, they are assumed to be safe, but sometimes with putative and/or less-substantiated efficacy. As physiologically active constituents are identified and concentrated, efficacy is more pronounced and repeatable, but tolerable upper limits are needed to assuage potential toxicity. There is increasing interest by consumers, researchers, and regulators into the role that these compounds play in health maintenance and promotion, and even prolonging a productive quality of life. Research has rapidly emerged suggesting that a wide range of compounds and mixtures in and from plants (such as fruits and vegetables, tea and cocoa) and animals (such as fish) may exert substantial health benefits. There is interest in exploring the possibility of establishing recommended intakes or dietary guidance for certain bioactive substances to help educate consumers. A key aspect of establishing dietary guidance is the assessment of safety/toxicity of these substances.  Toxicologists need to be involved in both the development of the safety framework and in the evaluation of the science to establish maximum intake/upper limits.

 

Which sectors might be interested in this topic:  
Dietary Supplement and Nutritional Products Industry, Food and Functional Food Industry.
Regulators, Regulatory Scientists. Academicians and Researchers.

 

What is the specific scientific issue that you seek to address:  

  • Emerging science indicates bioactives have benefits, but how to help consumers, governments (regulators) make informed decisions?
  • Importance of safety/toxicology and establishing a tolerable upper intake level (UL) as part of intake recommendations and dietary guidance levels
  • Discussion of different approaches or frameworks that can be applied to the scientific literature in order to establish ULs for bioactive substances—classic nutrient risk assessment and other approaches will be discussed.

 

Which Regulatory Agency(s) is interested in the topic you have proposed:   
US Food and Drug Administration, Center for Food Safety and Applied Nutrition (FDA CFSAN); Health Canada, Natural Health Products Directorate (H-C NHPD), Marketed Health Products Directorate (H-C MHPD); European Food Safety Authority (EFSA); Global pharmacopeias.

 

What is the estimated session length: (i.e., half-day session, (4–5 speakers), quarter-day session (2–3 speakers):  
Half-Day (4 speakers and moderated panel discussion)

 

Provide a summary statement (not more than 150 words) that can be used on The Toxicology Forum's website:  
Research has rapidly emerged suggesting that a wide range of compounds and mixtures in and from plants (such as fruits and vegetables, tea and cocoa) and animals (such as fish) may exert substantial health benefits. Since most of these bioactive compounds come from nature, they are assumed to be safe, but sometimes with putative and/or less-substantiated efficacy. As physiologically active constituents are identified and concentrated, efficacy is more pronounced and repeatable, but tolerable upper limits are needed to assuage potential toxicity. There is interest in exploring the possibility of establishing recommended intakes or dietary guidance for certain bioactive substances to help educate consumers. A key aspect of establishing dietary guidance is the assessment of safety/toxicity of these substances. Toxicologists need to be involved in both the development of the safety framework and in the evaluation of the science to establish maximum intake/upper limits.

 

Who are the proposed speakers: (names, affiliations, and email addresses) To increase the competitiveness of your proposal, please indicate whether or not speakers have given an informal commitment to participate and proposed talk titles.
  

All confirmed unless listed as TBD

  • Dr. Barbara Winters, Campbell’s
    Past and Current Frameworks Used to Establish Tolerable Upper Intake Levels
  • Dr. John Erdman, Professor Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign
    Lutein: A Bioactive Case Study for Safety and Efficacy
  • Dr. Andrew Shao, V.P. Global Nutrition Policy, Herbalife
    EGCG: Friend or Foe?
  • Ms. Cara Welch (or other FDA CFSAN / H-C NHPD/MHPD speaker)      
    Safety of Bioactives: Application of Toxicology Decision-Making and Risk Assessment in Recommending Tolerable Upper Intake Levels for Bioactives
  • Dr. James Griffiths, V.P. Science & International Affairs, Council for Responsible Nutrition
    Emerging Interest in Dietary Guidance for Bioactive Substances and Efforts to Address Safety Frameworks to Date