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FDA's Comprehensive Strategy on Trans Fat and Salt Labeling Regulations

This document outlines the FDA's efforts related to trans fat and salt labeling, exploring developments from 2003 to 2008. It discusses the requirements for trans fat disclosures, consumer research on understanding nutrient claims, and the analysis of methodologies for detecting trans fat levels. The document also delves into sodium labeling regulations, including public comments and scientific evaluations to set Daily Values (DVs) for sodium. The aim is to ensure clearer labeling, promote consumer understanding, and enhance public health nutrition.

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FDA's Comprehensive Strategy on Trans Fat and Salt Labeling Regulations

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  1. FDA Efforts: Trans Fat and Salt Julie Moss, PhD, RD Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutrition, Labeling and Dietary Supplements

  2. Trans Fat • 2006 • Requires a trans fat amount without a %DV • Incentive for industry to decrease the trans fat content of foods

  3. Trans Fat: ANPRM 2003(68 FR 41507; July 11, 2003) • Claims • Disqualifying/disclosure levels • Coincide with saturated fat limits? • New trans fat claims • Possible footnote/disclosure statement • DV • format • method for determination • Consumer Research

  4. Trans Fat: ANPRM 2007(72 FR 62149; November 2, 2007) • Goal: Update daily values and mandatory nutrients • Questions from the 2003 ANPRM are being asked again regarding a DV so these issues can be considered in the context of the entire Nutrition Facts and Supplement Facts labels • Comments accepted until April 30, 2008

  5. Trans Fat Consumer Research • Data is collected, analysis to follow: • Evaluating consumer understanding of varying product characteristics (sat fat and cholesterol levels) having trans “free” and “reduced” nutrient content claims • Evaluating consumer understanding of various footnote options (e.g., Intake of trans fat should be kept low) • Evaluating effectiveness of various DV formats (trans fat DV combined with saturated fat, no trans fat DV)

  6. Trans Fat Analysis GC methods: • FDA, AOCS and commercial labs to look at detection limits • Will know more later this Spring

  7. Trans Fat Analysis IR methods: • Qualitative id at low levels (0.5% total fat) • Anal Bioanal Chem (2007) 389:87–92 • J Amer Oil Chem Soc (2007) 84:339–342 • Develop improved method to quantify low levels (below 0.5 g/serving) • To be published • Validation study through international labs • Australia, Switzerland, Germany, Canada, China, US

  8. Next Steps for Trans Fat Use… • ANPRM Comments • Science • Consumer Research …to develop a strategy to determine further rulemaking for trans fat labeling, e.g., claims, disqualifying/disclosure levels, DV or footnote statement

  9. Salt: Labeling • Nutrient content claims (free, low, lightly salted, healthy, etc.) • Health claims • Low sodium & BP • Good K, Low NA & BP/stroke • Disclosure/disqualifying criteria • Nutrition Facts label with a DV

  10. Salt: ANPRM 2007(72 FR 62149; November 2, 2007) • Should the DRV for sodium be based on the UL for sodium (2,300 mg/day) as suggested by the Dietary Guidelines for Americans or should it be based on the AI (1,500 mg/d using the population-coverage approach)? • If the UL should be used, should it be adjusted using the same approach (population-weighted or population-coverage) as the other DRIs? • Comments accepted until April 30, 2008

  11. Salt: GRAS • Salt is regulated as a GRAS ingredient per 21 CFR 182.1 • FDA has commented previously on salt’s GRAS status and has chosen labeling, rather than ingredient regulation, to encourage lower sodium intakes (per 1982 Policy Notice).

  12. Salt: Public Hearing • November 29, 2007 • Goal • Re-examine FDA’s current framework of policies regarding salt and Na • Discuss potential, future approaches as requested in a petition from CSPI • Information and comments accepted until March 28, 2008

  13. Next Steps for Salt • Reviewing comments to ANPRM on updating the daily values for labeling • Reviewing information and comments from the public hearing • Respond to the petition from CSPI

  14. Trans Fat or Labeling: Julie.Moss@fda.hhs.gov Salt: Richard.Bonnette@fda.hhs.gov THANK YOU

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