Lynn Silver, MD, MPH Cathy Nonas, MS, RD Thomas Merrill, JD May 12, 2009

Lynn Silver, MD, MPHCathy Nonas, MS, RDThomas Merrill, JD

May 12, 2009

Calorie Labeling Food Procurement

Guidelines Daycare Regulations

Pertaining to Physical Activity and Nutrition

Stairwell Prompts SPARK, Shape Up, School PE Healthy Bodegas, Health

Bucks Food & Fitness Partnership Green Cart Vegetable

Permits Calorie Awareness

Campaign

DOHMH has jurisdiction to regulate all matters affecting health in NYC

Board of Health may amend NYC Health Code or publish additional provisions for security of life or health

NYC Health Code has the force and effect of law

DOHMH program will articulate need for new law

Program and OGC draft proposed rule DOHMH asks Board of Health to

approve proposed rule for publication Public comments are received and

responded to DOHMH asks Board of Health to

adopt rule

66.4 million

25.1 million

31.1%

15.1%

0

20

40

60

80

100

1978 2001

# o

f O

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Ad

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s in

U.S

. (m

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ns

)

0%

5%

10%

15%

20%

25%

30%

35%

% o

f O

be

se

Ad

ult

s in

U.S

.

Number (millions) Percent

Data from CDC.

1.8 million more obese U.S. adults each year4% annual increase

1,233,000

987,000

21.7%

18.2%

900

1000

1100

1200

1300

2002 2004

# o

f O

be

se

Ad

ult

s in

NY

C (

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ds

)

17%

18%

19%

20%

21%

22%

% o

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Ad

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s in

NY

C

Number (thousands) Percent

Data from Community Health Surveys, 2002 & 2004.

0 0.5 1 5

12 25 125

04

8

12

Excess intake (% total)

Excess intake (kcal/d)

Rosenbaum M et al. N Engl J Med. 1997;337:396-408.

1 million

Energyintake(kcal/y)

1 million

Energyexpenditure

(kcal/y)

Change in body fat (lb/y)

Since the 1960s, expenditures for food eaten away from home have steadily increased.

Preliminary data from 7,308 customers purchasing for themselves only at 11 chains serving lunch

1977-1978 1994-1996

419

171

131

497

284

191

721 972

Increase of 251 calories (35%)

▪ The NLEA requires that a nutrition fact panel appear on the labeling of packaged foods

▪ The NLEA labeling requirements do not apply to food served in restaurants (21 USC 343(q)(5)(A)(i))

▪ When eating out, diners usually don’t have access to information that would allow them to make healthier choices

Crispy Classic

Premium Grilled

Southern Style Crispy

530 530 400

Regular food item

Calories and % daily

intake*

Larger food item

Calories and % daily intake*

Calorie difference

Item larger by

Regular cheese-burger

36018%

Triple Whopper w/cheese

1,23061.5%

870 242%

Chocolate shake(12 oz.)

44022%

Chocolate shake(32 oz.)

1,16058%

720 164%

Big Breakfast

72036%

Deluxe Breakfast

1,40070%

680 94%

* Based on recommended 2,000 daily calorie intake

To find out What patrons buy, and how many

calories What calorie information they saw

Conducted March-June, 2007Brief survey and collected receipts> 7000 customers from 275

randomly selected restaurants from 11 fast food chains

743

695

634

726

550

600

650

700

750

800

1 2 3 4

Did Not See Saw Cals Effect No Effect

Ca

lori

es

con

sum

ed

Who should have to post?Restaurants who had calorie information

What nutritional information should they have to post?Calories are most important when dealing with obesity

Where should the information have to be posted?On the menu or menu board

Approved for Publication by the Board of Health in September 2006

Received overwhelming support in public comment period

Enacted by the Board of Health in December 2006

Would have required any restaurant that had otherwise published calorie information to put that information at the point of purchase as of July 1, 2007

Federal Preemption Claim: proposed law is preempted by federal

regulation of nutrient content claims under NLEA

Compelled Speech, 1st Amendment Claim: proposed law violates commercial free

speech

(a) “No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce – …

(4) any requirement for nutrition labeling of food that is not identical to the requirement of section 343(q) of this title, except a requirement for nutrition labeling of food which is exempt under subclause (i) … of section 343(q)(5)(A) of this title, …”

21 USC § 343-1(a)(4)

“The bill does not preempt any State nutrition labeling requirements for restaurants.”

136 Cong. Rec. S16607-02, S16608 (10/24/90) (Sen. Metzenbaum)

“State requirements for the nutrition labeling of [restaurant foods] would not be preempted.”

FDA, Guidance for Industry, “A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods” (4/2008) (available at http://www.cfsan.fda.gov/dms/labrguid.htmlat), question 106

The statement “100 calories” is a nutrient content claim

The NLEA’s provisions about nutrient content claims apply to restaurants

The NLEA similarly preempts local regulation of nutrient content claims

A nutrition claim “made in the label or labeling of food which expressly or by implication –(A) characterizes the level of any nutrient”

21 USC § 343(r)(1)

“An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in food, e.g., ‘low sodium’ or ‘contains 100 calories.’”

21 C.F.R. § 101.13(b)(1)

Statements as to nutrient amounts are nutrient content claims when they are voluntarily made, but they are not nutrient content claims when they are mandated.

New York State Restaurant Association v. New York City Board of Health, 509 F. Supp.2d 351, 360-361 (SDNY 2007) (“NYSRA I”)

Although NYSRA I held that States may mandate calorie labeling, because Health Code § 81.50 applied only to restaurants that had voluntarily provided calorie information, it was found to be preempted.

In January 2008, the Board of Health adopted an amended version of Health Code § 81.50 that mandates labeling by any restaurant that is part of a chain of 15 or more nationally

April 16, 2008 – District Court rules in favor of defendants

April 18, 2008 – District Court denies NYSRA’s motion for stay of enforcement pending appeal

April 29, 2008 – Second Circuit denies motion for stay pending appeal and directs NYSRA to ask the FDA to file an amicus curiae brief pending appeal

May 29, 2008 – FDA files brief supporting City’s position June 12, 2008 – appeal heard by the Second Circuit July 19, 2008 – DOHMH begins seeking fines for

violations of Health Code § 81.50 February 17, 2009 – Court of Appeals affirms Judge

Holwell in NYSRA v. NYCBOH, 556 F.3d 114 (2d Cir. 2009)

Subway Menu Board

July 2007

Auntie Anne’s Menu Board

July 2007

Starbucks, 2008

Chipotle, 2008

McDonald’s; July 21, 2008

“Some restaurants have had their own sticker shock and started offering lighter options. Cosi had a nutritionist look for ways to save on every item. Switching to low fat mayo brought the Cosi Club from nearly 800 calories to 447… “Having to post this information in New York really focused us on paying attention as well” says Chris Carroll, the chain’s chief marketing officer”

- Wall Street Journal July 29, 2008

If information is used similar to how used in Subway survey, over the next 5 years: at least 150,000 fewer

New Yorkers would be obese, leading to

at least 30,000 fewer cases of diabetes,

and many other health benefits

Other Jurisdictions Follow Suit

San Francisco, CASanta Clara, CAPhiladelphia, PAKing County, WAWestchester County, NYSuffolk County, NYConnecticut, Massachusetts and New

York are all considering

What’s Next?

State legislation ala California’s Senate Bill 1420 preempting local menu labeling requirements?

Federal legislation: MEAL or LEAN?

Take Aways

Local initiatives can have national effect

Local initiatives can lead to federal action

Alliances are key Implementation: learning to live with

the restaurant industry