FDA Efforts: FDA Efforts: Trans Fat and SaltTrans Fat and Salt

Julie Moss, PhD, RDJulie Moss, PhD, RDFood and Drug AdministrationFood and Drug Administration

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied NutritionOffice of Nutrition, Labeling and Dietary SupplementsOffice of Nutrition, Labeling and Dietary Supplements

Trans FatTrans Fat

20062006

Requires a trans fat Requires a trans fat amount without a amount without a %DV%DV

Incentive for industry Incentive for industry to decrease the to decrease the transtrans fat content of foodsfat content of foods

Trans Fat: ANPRM 2003Trans Fat: ANPRM 2003(68 FR 41507; July 11, 2003)(68 FR 41507; July 11, 2003)

ClaimsClaims Disqualifying/disclosure levelsDisqualifying/disclosure levels Coincide with saturated fat limits?Coincide with saturated fat limits? New trans fat claimsNew trans fat claims

Possible footnote/disclosure statementPossible footnote/disclosure statement

DV DV formatformat method for determinationmethod for determination

Consumer ResearchConsumer Research

Trans Fat: ANPRM 2007Trans Fat: ANPRM 2007 (72 FR 62149; November 2, 2007)(72 FR 62149; November 2, 2007)

Goal: Update daily values and mandatory Goal: Update daily values and mandatory nutrientsnutrients

Questions from the 2003 ANPRM are Questions from the 2003 ANPRM are being asked again regarding a DV so being asked again regarding a DV so these issues can be considered in the these issues can be considered in the context of the entire Nutrition Facts and context of the entire Nutrition Facts and Supplement Facts labelsSupplement Facts labels

Comments accepted until April 30, 2008Comments accepted until April 30, 2008

Trans Fat Consumer ResearchTrans Fat Consumer ResearchData is collectedData is collected, analysis to follow:, analysis to follow:

Evaluating consumer understanding of varying product Evaluating consumer understanding of varying product characteristics (sat fat and cholesterol levels) having characteristics (sat fat and cholesterol levels) having transtrans “free” and “reduced” nutrient content claims “free” and “reduced” nutrient content claims

Evaluating consumer understanding of various footnote Evaluating consumer understanding of various footnote options (e.g., Intake of options (e.g., Intake of transtrans fat should be kept low) fat should be kept low)

Evaluating effectiveness of various DV formats (Evaluating effectiveness of various DV formats (transtrans fat DV combined with saturated fat, no fat DV combined with saturated fat, no transtrans fat DV) fat DV)

TransTrans Fat Analysis Fat Analysis

GC methods: GC methods:

FDA, AOCS and commercial labs to look FDA, AOCS and commercial labs to look at detection limitsat detection limits

Will know more later this SpringWill know more later this Spring

TransTrans Fat Analysis Fat Analysis

IR methods:IR methods:1.1. Qualitative id at low levels (0.5% total fat)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

2.2. Develop improved method to quantify low Develop improved method to quantify low levels (below 0.5 g/serving)levels (below 0.5 g/serving)

• To be publishedTo be published

3.3. Validation study through international labsValidation study through international labs• Australia, Switzerland, Germany, Canada, China, Australia, Switzerland, Germany, Canada, China,

USUS

Next Steps for Trans FatNext Steps for Trans Fat

Use…Use…ANPRM CommentsANPRM CommentsScienceScienceConsumer ResearchConsumer Research

……to develop a strategy to determine further to develop a strategy to determine further rulemaking for rulemaking for transtrans fat labeling, e.g., fat labeling, e.g., claims, disqualifying/disclosure levels, DV claims, disqualifying/disclosure levels, DV or footnote statementor footnote statement

Salt: LabelingSalt: Labeling

Nutrient content claims (free, low, lightly Nutrient content claims (free, low, lightly salted, healthy, etc.)salted, healthy, etc.)

Health claimsHealth claims Low sodium & BPLow sodium & BP Good K, Low NA & BP/strokeGood K, Low NA & BP/stroke

Disclosure/disqualifying criteriaDisclosure/disqualifying criteria

Nutrition Facts label with a DVNutrition Facts label with a DV

Salt: ANPRM 2007Salt: ANPRM 2007 (72 FR 62149; November 2, 2007)(72 FR 62149; November 2, 2007)

Should the DRV for sodium be based on the UL Should the DRV for sodium be based on the UL for sodium (2,300 mg/day) as suggested by the for sodium (2,300 mg/day) as suggested by the Dietary Guidelines for Americans or should it be Dietary Guidelines for Americans or should it be based on the AI (1,500 mg/d using the based on the AI (1,500 mg/d using the population-coverage approach)?population-coverage approach)?

If the UL should be used, should it be adjusted If the UL should be used, should it be adjusted using the same approach (population-weighted using the same approach (population-weighted or population-coverage) as the other DRIs?or population-coverage) as the other DRIs?

Comments accepted until April 30, 2008Comments accepted until April 30, 2008

Salt: GRASSalt: GRAS

Salt is regulated as a GRAS ingredient per Salt is regulated as a GRAS ingredient per 21 CFR 182.121 CFR 182.1

FDA has commented previously on salt’s FDA has commented previously on salt’s GRAS status and has chosen labeling, GRAS status and has chosen labeling, rather than ingredient regulation, to rather than ingredient regulation, to encourage lower sodium intakes (per 1982 encourage lower sodium intakes (per 1982 Policy Notice).Policy Notice).

Salt: Public HearingSalt: Public Hearing

November 29, 2007November 29, 2007

GoalGoal Re-examine FDA’s current framework of Re-examine FDA’s current framework of

policies regarding salt and Napolicies regarding salt and Na Discuss potential, future approaches as Discuss potential, future approaches as

requested in a petition from CSPIrequested in a petition from CSPI

Information and comments accepted until Information and comments accepted until March 28, 2008March 28, 2008

Next Steps for SaltNext Steps for Salt

Reviewing comments to ANPRM on Reviewing comments to ANPRM on updating the daily values for labelingupdating the daily values for labeling

Reviewing information and comments from Reviewing information and comments from the public hearingthe public hearing Respond to the petition from CSPIRespond to the petition from CSPI

THANK YOUTHANK YOU

Trans Fat or Labeling: Trans Fat or Labeling: Julie.Moss@fda.hhs.govJulie.Moss@fda.hhs.gov

Salt: Salt: Richard.Bonnette@fda.hhs.govRichard.Bonnette@fda.hhs.gov