FDA Efforts: Trans Fat and Salt

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