New Advice for Eating Fish During Pregnancy And Why We Are Proposing It

Transcription

1 New Advice for Eating Fish During Pregnancy And Why We Are Proposing It Philip Spiller Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration

2 June 10, 2014 FDA and EPA Jointly: Issued draft updated fish consumption advice for pregnant & breastfeeding women, women who may become pregnant, and young children. Plus additional info accompanying the advice (in the form of Q & A). It would replace advice we last issued in FDA: Issued a quantitative assessment of net effects on fetal neurodevelopment from eating commercial fish during pregnancy. 2

3 The Challenge for FDA MeHg is a neurotoxin; in all fish in at least trace amounts (and always has been); The Challenge: are U.S. consumers being harmed from commercial fish containing MeHg, and if so, who and under what circumstances? 3

4 The Journey That question started out for us solely as a food safety matter But over time it evolved into a nutrition matter in addition to a food safety matter (as you will see). 4

5 Focusing on Prenatal Exposure MeHg can affect anyone if exposure is high enough. But the fetus can be especially sensitive (per extreme poisoning events in Japan & Iraq involving harm like cerebral palsy, mental retardation). Fortunately, no overt, clinical harm from prenatal exposure has been reported again. But are subtle, subclinical effects to children occurring here? If so, when, and how big are they? HOW TO FIND OUT? 5

6 FDA First Opts for Consumption Advice to Pregnant Women 2001: Safe to eat up to 12 oz/wk of fish during pregnancy. (But avoid 4 fish highest in MeHg: shark, swordfish, king mackerel and tilefish) 2004: 12 oz/wk ceiling retained: 4 fish to avoid retained; 6 oz ceiling on albacore tuna; Advice extended to young children 6

7 Advice was Issued as a Matter of Prudence We did not know how to calculate risk, i.e., likelihood and severity of harm Thus: Likelihood & severity over 12 oz: not estimated. -- Likelihood & severity at 12 oz: not estimated. -- Likelihood & severity) below 12 oz: not estimated. 01/15/2012 7

8 FDA Considered Quantitative Risk Assessment for MeHg (2004-5) To estimate: likelihood of neurodevelopmental harm; and severity of harm through range of U.S. exposures to MeHg that are occurring from mothers consumption of commercial fish during pregnancy. 8

9 But Then. Studies Published Beginning in 2004 Eating fish during pregnancy associated with better cognitive outcomes in offspring. Eating more than 12 oz/wk associated with better outcomes than eating less. Although MeHg could still apparently affect outcomes. Apparently could reduce the size of the benefit Apparently could sometimes cause the effect to be adverse 9

10 What Could Be Causing The Beneficial Relationships? Most of the studies just looked at eating fish The omega-3 fatty acids in the fish? Omega-3 fatty acids in combo with other nutrients? Bottom line: we re still not sure. But an association between benefits and eating fish keeps showing up. 10

11 New Questions for Us: 1. When is eating commercial fish during pregnancy beneficial to neurodevelopment and when is it adverse? 2. When beneficial, how big are the benefits? When adverse, how big are the deficits? We needed a new approach that would estimate overall, net effects from eating fish. 11

12 FDA Assessment Result for a Typical Commercial Fish 12

13 FAO/WHO Also Estimates Net Effects in a Risk-Benefit Assessment More than 70 species of fish: All beneficial through at least 24.5 oz/week. When MeHg assumed to be more toxic, most still net beneficial through at least 24.5 oz/week. But marlin, orange roughy, bigeye tuna, king mackerel, shark, swordfish are net adverse immediately under this assumption. 13

14 European Food Safety Agency Opinion July 2014 Scientific Opinion on the Health Benefits of Seafood (fish and shellfish) Consumption in Relation to Health Risks Associated with Methylmercury Conclusion: up to 3-4 servings per week during pregnancy has been associated with better functional outcomes of neurodevelopment in children compared to no consumption of seafood. 14

15 Potential Effect of All of This on Consumption Advice Focus in 2001 & 2004: How pregnant woman could minimize risk from MeHg without avoiding fish. How advice can be re-focused now: How pregnant woman could maximize benefit to the developing nervous system from fish while minimizing risk from MeHg. 15

16 Dietary Guidelines for Americans, 2010 (HHS/USDA) The refocus begins: Now includes a minimum consumption target: Pregnant women should eat 8-12 oz/wk. of varieties lower in MeHg. Other aspects of the recommendation are the same as in FDA/EPA 2004 advice. E.g., avoid same 4 high-mehg species. 16

17 FDA/EPA Draft Updated Advice Key Message: Eat 8-12 oz of a variety of fish each week lower in mercury. Also: Up to 6 oz/wk albacore Avoid shark, swordfish, king mackerel, tilefish from Gulf of M. Same advice for young children except smaller portions. Follow local advisories for locally caught fish 17

18 What s Next Comment period is running on the advice no closure date set yet. Meeting of FDA Risk Communication Advisory Committee in November. Assessment of Net Effects is final but comments always welcome 18

19 How to Find the Draft Updated Advice and the FDA Assessment They are both located under Spotlight on that page 01/15/