1. The New York City Trans Fat Regulation: Preventing Heart Disease by Changing the Food Environment APHA - Washington, DC November 6, 2007
Lynn D. Silver, MD, MPH
Assistant Commissioner
Bureau of Chronic Disease Control & Prevention
Sonia Angell, MD, MPH
Gail Goldstein, MPH
Christine Johnson, MBA
Mary Bassett, MD, MPH
Thomas R. Frieden MD, MPH
New York City Department of Health & Mental Hygiene

2. Heart Disease Is New York City’s Leading Cause of Death
Heart disease is the number one cause of death in New York City, state, the country and the world
More than 19,000 New Yorkers died from heart disease in New York City in 2004.
Nearly one third were younger than 75 years old.
Source: The World Health Report, 2003, The World Health Organization (WHO).
Source: NYCDOHMH Bureau of Vital Statistics, 2004

4. What Is Artificial Trans Fat?
Partially Hydrogenated Vegetable Oil (“PHVO”) =
Hydrogen +
Vegetable Oil
Partially hydrogenated oils contain trans fat
Here’s a description of the process that makes artificial trans fat
Hydrogen is added to vegetable oil to make partially hydrogenated vegetable oil which contains trans fat.
The cis structure on the left is what the oil molecule looks like before being processed.
In partially hydrogenated oils, many – although not all – of the bent molecules become straight (trans).
These straight molecules (trans fat molecules) are able to stack more closely against one another, making the substance more solid and stable. Adding hydrogen also prevents the oil from becoming rancid as quickly.
Regular, plain versions of these same vegetable oils (soybean, corn, canola, etc.) do not contain trans fat.
VS.
Cis
Trans

5. Average daily intake 2.6% of total calories
Trans Fat in the Diet
Average daily intake 2.6% of total calories
(approx 5.8 grams)
79% Artificial
Source:
Partially
Hydrogenated
Vegetable
Oil
So what did we learn? First that while there is naturally occurring trans fat, most of the trans fat we eat, nearly 80%, is artificially made by a process called hydrogenation.
The rest is from small amounts of trans fat that are naturally found in meat and dairy such as beef, lamb, and in butter, cheese and other milk products, but these only account for 21% of the trans fat in our diet.
In the US 2.6% of daily calories from trans fat – 5.8 grams total. (80% of 2.6 = 2.08% or about 2% of trans fat in the diet comes from artificial trans fat)
21% Naturally Occurring
Source:
Meat and Dairy Products
Source: FDA Consumer magazine. September-October 2003 Issue. Pub No. FDA C

6. Trans Fat Is More Dangerous than Saturated Fat
Good (HDL) Bad (LDL)
Cholesterol Cholesterol
Trans fat
Saturated fat
To summarize this evidence in case I’ve lost any of you, trans fat increases your risk of heart disease and is more dangerous than saturated fat.
Trans fat, like saturated fat, raises bad (LDL) cholesterol.
- However, trans fat also lowers good (HDL) cholesterol.

7. Scientific Evidence: Replacement Studies
Here is a brief summary of the evidence which comes largerly from two lines of research: replacement studies and observational studies.
In replacement or feeding studies, people are fed different types of fats and the effects on their blood cholesterol levels are measured.
These studies provide the most conservative estimates of the effects of trans fat. In these studies, individuals are fed diets which are identical in every respect except for the kind of fats consumed; each diet is rich in a specific type of fat – saturated fat, trans fat, polyunsaturated fat, or monounsaturated fat. Participants rotate through each of these fat-specific diets. Blood cholesterol levels are measured after completing each diet, before participants start the next diet. Since it is difficult to draw conclusions from studies involving few participants, results from multiple smaller studies are often pooled – resulting in more accurate estimates of the impact of fat consumption.
By pooling 12 of these studies the authors of this study looked at the impact that three different diets have on LDL cholesterol (bad cholesterol) and HDL cholesterol (good cholesterol). The darkest bar shows what happens when saturated fat is replaced with trans fat, the clear bar, when mono-unsaturated fat is replaced with trans fat, and finally the teal blue bar (the right-most of each group), when polyunsaturated fat is replaced with trans fat.
From the group of bars on the left (the affect on LDL) and on the right (the affect on HDL) we can see that in every case, even with saturated fat, replacement with trans fat makes the LDL higher –that’s worse for the heart – and the HDL lower – also worse for the heart. So the effect of trans fat intake is even worse than saturated fat on your cholesterol levels.
Using this information and combining it with studies that look at the impact of cholesterol on coronary heart events, like heart attack, it has been estimated that the replacement of trans fat in the diet with heart-healthy alternatives will result in a decrease in coronary heart events of 6%. Even if replaced with saturated fats, which occurs less frequently and primarily in some baked goods, coronary heart disease would still be reduced.
Remember that replacement studies estimate only the impact that trans fat has on cholesterol. An increasing body of scientific literature is demonstrating that there are other mechanisms through which trans fat increases risk, including through increasing inflammatory markers and their affects on endothelial cell function, unaccounted for through this conservative method of studies.
Source: Mozaffarian et al NEJM, 2006.

8. Scientific Evidence: Observational Studies
Relative risk of coronary heart disease events associated with
substituting 2% of total daily energy of carbohydrates with trans fat.
Study N RR
Health Professionals Follow-up Study, 2005
38,461
1.26
Alpha-Tocopherol, Beta-Carotene CA Prevention Study
21,930
1.14
Nurses' Health Study, 2005
78,778
1.33
Zutphen Elderly Study
667
1.28
Above studies, pooled
139,836
1.23
Observational studies allow one to assess the impact of other mechanisms through which trans fat may increase cardiovascular risk. In observational studies, large groups of people are followed for many years and health outcomes, such as heart attacks, are studied in relation to their diet and lifestyle.
I list here 4 of a number of observational studies that have examined the impact of trans fat on cardiovascular risk. They estimate the relative risk of coronary heart disease associated with a substitution of 2% of total daily energy intake of carbohydrates with trans fat. This is roughly equal to the amount of artificial trans fat in the average US diet. So, what they are estimating here is the increase in relative risk for heart disease attributable to the artificial trans fat we eat.
For the Health Professionals Study, they found a relative risk of 1.26, meaning that for every increase in trans fat by 2% of total daily energy, the risk of ischemic heart disease went up 26%.
In another study, researchers combined, or “pooled”, all of these studies to estimate the impact they have on risk. Together, they estimate that the increased risk for a coronary heart event that results from substituting 2% of total daily energy of carbohydrates with trans fat is 23%.
As with any observational study, there are limitations. One important to note is that they are based upon the individual participant’s dietary recall which may not be complete, and that in these types of studies, the ability to control for all confounders is limited. Relationships found in observational studies are not always confirmed in randomized trials.
This initiative is supported even by the most conservative estimates which come from the replacement studies discussed in the slide before; however, as mentioned, estimates from the observational studies, which account for risk conferred by trans fat intake beyond their impact on lipids, suggest that the benefits will be much greater.
Data source: Mozaffarian et al NEJM, 2006.

9. Major Food Sources of Artificial Trans Fat for U.S. Adults
Data Source:

10. U.S. Department of Agriculture American Heart Association
Leading health organizations agree that trans fat intake should be strictly limited
Institute of Medicine
U.S. Department of Agriculture
American Heart Association
World Health Organization
As a result, leading health organizations agree that trans fat intake should be strictly limited. For example, the Institute of Medicine concluded in their report that trans fat intake should be kept “as low as possible.”
Other major recommendations came from the US government in their recent 2005 Dietary Guidelines for Americans. They recommend that dietary intake of trans fat be kept “as low as possible.”
The American Heart Association issued new guidelines in June 2006 recommending that trans fat intake be kept below 1% of total energy intake.
The Canadian Trans Fat Task Force – commissioned by the Canadian government – and the World Health Organization also have concluded that trans fat intake should be limited.

11. Denmark: 1st Country to Restrict Trans Fat
March 2003: Denmark issued new regulations limiting the amount of trans fat in all industrially processed foods.
Processed food can only contain 2% of trans fat for every 100 grams of fat.

12. Labeling in US Supermarkets, 2006
Starting in January 2006
Prior to January 2006
Ingredients:
Liquid Corn Oil, Partially Hydrogenated Soybean Oil, Salt, Vegetable Mono And Diglycerides And Soy Lecithin (Emulsifiers), Sodium Benzoate (To Preserve Freshness), Vitamin A Palmitate, Colored With Beta Carotene (Source Of Vitamin A), Artificial Flavor, Vitamin D3

13. Trans Fat Still Invisible in Food Service
Food labeling led to massive reformulation of grocery store products by 2006
BUT…restaurants & bakeries continued to widely use products containing trans fat

14. People Are Eating Out More

15. But in restaurants, operators are still stuck with just the Ingredients List and there’s no practical way for consumers to know what they’re eating.

16. Trans Fat Education Campaign 2005-2006
Survey:
Prevalence of use pre- and post-intervention
Materials distributed to:
200,000 to consumers
15,000 to distributors
30,000 to restaurants and other FSEs
Also…
Trans fat module in food safety courses
Information on inspection reports

17. % Restaurants Using Trans Fat Where Use Could Be Determined
Voluntary Campaign Proved To Be Ineffective % of Restaurants Known to be Using Trans Fat in Oils and Spreads
% Restaurants Using Trans Fat
Where Use Could Be Determined
in Oils and Spread

18. Like lead in paint, it’s invisible, dangerous, unnecessary and won’t be missed
Unavoidable in Restaurants: No way to know the trans fat content of food
Replaceable: Artificial trans fats are fully replaceable
Feasible: Phasing out trans fat is a feasible environmental policy to reduce heart disease in New York City

19. Why should a local health department address this?
As overseer of NYC's Health Code, the Board of Health has enacted countless measures to improve the well-being of New Yorkers over the years – including the nation’s first ban on interior lead paint, modern tuberculosis control provisions and, more recently, a plan for eliminating trans fat from restaurants.

20. NYC Board of Health: A History of Regulating the Food Environment

21. Sept 26th 2006 Board of Health: Proposal to Partially Phase-Out Artificial Trans Fat
Proposed restriction of trans fat to be phased in over 18 month period
Food served in manufacturers’ original packaging will be exempt
Applies to all NYC restaurants and mobile vending commissaries

22. There’s No Such Thing As Bad Press
Selection of Headlines from 2006 – Trans Fat Proposal

23. Summary of Comments and Testimony
Written comments received: 2,287
Public hearing participants: 53
Total support: 2,266
Total opposition: 74
Ratio PRO to CON: 31:1

24. Supporters: National Health Organizations
American Medical Association
American College of Cardiology
American Cancer Society
American Diabetes Association
American Academy of Pediatrics
National Hispanic Medical Association

25. Supporters: State and Regional Health Organizations
American Society of Hypertension - Eastern Regional Chapter
Empire State Medical Association (New York State Affiliate of the National Medical Association)
Medical Society of the State of New York
New York Academy of Medicine
NYS Chapter American College of Cardiology
NYS District of the American Academy of Pediatrics (AAP)

26. Supporters: Selected Local Organizations
Albert Einstein College of Medicine
Campaign for Bronx Health
Columbia University Medical Center
Columbia University’s Mailman School of Public Health
Community Health Care Association of New York State (CHCANYS)
Community Healthy Care Network
East Harlem Partnership for Diabetes Health and Prevention
GHI
Harlem Hospital Center
Harvard School of Public Health
Institute for Urban Family Health
Montefiore Medical Hospital
Morris Heights Health Center
Mount Sinai School of Medicine
New York Downtown Hospital
New York University School of Medicine
North General Hospital
Primary Care Development Corporation (PDCD)
Public Health Association of New York City
Staten Island University Hospital

27. Concerns Raised in Public Comments and Testimony
Health Impact
Regulatory Strategy
Feasibility

28. Regulation
July 1, 2007: oils, shortening, and margarine used for frying or as a spread must have with less than 0.5 grams of trans fat per serving.
Oils and shortening used to fry yeast dough and cake batter must comply with the second deadline.
July 1, 2008: all foods must have less than 0.5 grams of trans fat per serving.
Food served in manufacturers’ original, sealed packaging will be exempt
So what does the new regulation say?
There are two deadlines: enforcement deadlines have been staggered to ensure that restaurants can comply.
July 1, 2007
July 1, 2008
Food served in manufacturers’ original packaging will be exempt
WHY STAGGERED? WHY YEAST DOUGH? What is that?
The proposal applies to all NYC restaurants and mobile vending commissaries.

29. Technical Assistance to Restaurants and Bakeries
Helpline staffed by recognized culinary science experts
Website
Training for restaurant personnel
Materials, including a product resource list, brochures & case studies
All available in multiple languages

31. Challenges Topic was ‘new’ to consumers & public health professionals
Voluntary approach was not successful
Needed to learn about oil industry and food production
Widespread false perceptions about restricting food choice

32. Challenge: Keep Saturated Fat Down
Most trans fat replaced by healthy oils for frying and spreads
BUT baking requires some saturated fats…key challenge is minimizing saturated fats while preserving quality.

33. Strengths Projected significant impact on the #1 cause of death
Strong evidence base
Preceded by voluntary effort
Evaluation & enforcement utilized existing DOHMH infrastructure
Regulation: Health Code Amendment via Board of Health
Policy Design:
Changes the “default”
Benefits all citizens

34. Trans Fat Restriction: Success!
Approximately 1,500 inspections were completed from July 1 -28th. 95% of FSEs inspected during this period were in compliance with the first phase of NYC's regulation (frying & spreads.)
Violations were largely due to failure to order new products, particularly margarine replacement, and not due to technical difficulties with product reformulation or supply issues.

35. Trans Fat Regulation Spread

36. Shifting to a Healthier Food Environment NYC’s Approach to the Problem: Make healthy food the default, a not a niche “Healthy food” vs. “health food” 36

37. We need a new concept of food safety for the 21st Century
Traditional Concern: Food contamination, unsanitary practices
Today: Foodborne Pathogens still cause 5,000 deaths annually in the US and it is still a key concern
But the food industry has been tremendously successful in reducing the burden of foodborne pathogens 37

38. We need a new concept of food safety for the 21st Century
Today: Food is a major contributor to disease, but primarily through the ingredients that are supposed to be in it, not the bugs that aren’t. 38

39. The New Food Safety:
Making healthy food widely available and affordable
Nutrition Labeling
Improving the Nutritional Profile of Foods {trans fat, sodium, saturated fat & added sugar}
Reducing the Sale of Unhealthy Foods
Portion Size Reduction 39

40. Good Taste No Artificial Trans Fat
Good Health
Good Taste No Artificial Trans Fat
Your Will
Thank You