STATES DISTRICT COURT 

SOUTHERN DISTRICT OF NEW YORK 

NEW YORK STATE RESTAURANT 

ASSOCIATION, 

Plaintiff, 

-against- : No.2007Civ. 57I0 (RJH) 

NEW YORK CITY BOARD OF HEALTH, 

NEW YORK CITY DEPARTMENT OF I 

HEALTH AND MENTAL HYGIENE, and 

Thomas R. Frieden, :DECLARATION OF DAVID B. 

In His Official Capacity as Commissioner ALLISON, Ph.D 

of the New York City Department of Health 

and Mental Hygiene, 

Defendants. 

David B. Allison, Ph.D declares Table of Contents for Report 

under penalty of perjury as follows: I , ,,~,,,, &Qualifications. 

B. Materials Reviewed and Relied Upon. 

C. Opinions to Be Offered and Propositions to Be 

Addressed. 

A. Backaround and Qualifications D. Standards of Evidence. 

E. Remarks on Propositions Supporting Concern 

I am a Professor in the Departments about Obesity. 

F. Remarks an Propositions Supporting Conjecture 

of Biostatistics, Nutrition that Providing Calorie Information at The Point Sciences, of Purchase In Restaurants (Espedally Fast Food 

Restaurants) Might Be Beneficial in Reducing 

Medicine, and Genetics, and Director of Obesity Levels. 

G. Is there Competent and Reliable Evidence that 

the National Institutes of Health-fvnded (A) Providing Restaurant Patrons with Calorie 

Information On Menu Items in Any Manner Will 

Reduce Individual or Population Levels of 

Obesity; and (B) That Doing So in the Manner Clinical Nutrition ResearchCenter at the Mandated by R81.50 Will Reduce Obesity More 

Effectively Than Will Providing Such Information 

University of Alabama at Birmingham. I am 

in Some Other Manner?? 

H. Are There Reasons to Conjecture That There 

Might Be Unintended Deleterious Effects of the 

also a Senior Scientist at the Center for City's Proposed Rule? 

I. Summary. 

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Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 1 of 31
and Effectiveness Research and Education at the University of Alabama at 

Birmingham. In my current position, and in previous positions, I have conducted 

extensive research on the causes, consequences, and treatment of obesity; on the 

development and evaluation of statistical methods; and on study design. I have played 

a major role in the design, analysis, and interpretation of studies involving weight loss 

- interventions. I received a Ph.D. in Psychology from Hofstra University in 1990 and am a 

licensed psychologist in the State of NY. 

I am currently Vice-President of NAASO: The Obesity Society, the largest and 

most prestigious academic society for the study of obesity in North America, and will 

become President in October 2008. 1 have authored, in whole or in part, over 300 

articles appearing in peer-reviewed journals. Many of these articles address nutrition, 

bbesity, weight-loss, study design, and statistical analysis. I have also edited, authored, 

or co-authored multiple text books and chapters in text books on the topics of nutrition, 

obesity, and weight-loss. I have served on the editorial boards of the journals Obesity, 

Obesity Reviews, Nutrition Today, International Journal of Obesity, International Journal 

of Eating Disorders and Evidence-Based Preventive Medicine. 

I previously served as an Associate ResearchScientist at the NIH-funded New 

York Obesity Research Center at Saint Luke's/Roosevelt Hospital Center and as 

Associate Professor of Medical Psychologyin Psychiatry at Columbia University in New 

York City. At the New York Obesity Research' Center, I was primarily involved with 

designing and conducting original research in human obesity and related areas, 

collaborating with other investigators on their projects, particularly with respect to data 

analysis, and training students, interns, and post-doctoral fellows with respect to obesity 

research projects. 

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have periodically served as a consultant to the Federal Trade Commission (FTC), 

the Food and Drug Administration (FDA), the United States Postal Inspection Service, 

and the United States Department of Justice on the validity of weight-loss product 

claims. In that capacity, I have reviewed numerous clinical research studies in order to 

determine whether efficacy claims are supported by the research. In 2006, 1 hosted, 

organized and spoke at a 2-day conference on Design, Analysis and Interpretation of 

Randomized Clinical Trials in Obesity. This conference was funded by the NIH through a 

grant on which I was the principal investigator. 

I have been elected as a fellow of the American College of Nutrition and of the 

American Statistical Association, and am a member of the New York Academy of 

Sciences. 

My experience, training, and research expertise qualify me to offer informed 

opinions on the evidential basis or lack thereof for claims that the New York City 

regulation requiring some restaurants that already provide their patrons with calorie 

information to post it in a specified manner will help reverse an epidemic of obesity 

among New York City residents. 

My curriculum vita is attached as Exhibit A and includes a more detailed 

description of my training and experience, and a listing of my publications. 

B. Materials Reviewed and Relied Upon. 

I have reviewed the NYC Board of Health's Notice of Adoption of Regulation 

81.50 and the studies cited in that Notice in support of the contention that the 

regulation will impact the amount of calories New Yorken consume and will thereby 

help prevent obesity. I have also reviewed the July 5, 2007 Declaration of Thomas R. 

Frieden, MD, MPH and many of the articles cited by Frieden in support of his supposition 

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Regulation 81.50 will have an effect in reducing obesity. I have also reviewed the 

amicus brief filed by the City of San Francisco Attorney's Office, and many articles cited 

therein. I have also conducted a review of the scientific articles bearing on the topic 

and have reviewed those that appeared most relevant and cite key'articles in the 

references to this document. 

C. Opinions to be Offered and Propositions to Be Addressed 

The issues under consideration are complex and there is a multiplicity of ideas 

involved. Hence to avoid any misconstrucrl, I wish to begin by clarifying not only what I 

see as the fundamental issues and what I will offer opinions on, but also what I will not 

address and which opinions I am not offering. 

C.1. Issues on Which I Will Not Opine. 

My goat is to provide an assessment of whether there is scientific evidence 

showing that Regulation 81.50 thereafter R8 1.50) will achieve the objective of reducing 

obesity levels among NYC residents and/or people that dine in NYC. This is an empirical 

question that can be addressed via a consideration of scientific evidence. In contrast, 

whether R81.50 is 'good,' legally defensible, fair, adverse to legitimateeconomic 

interests, or 'should' be adopted are questions of a legal and social nature and I will not 

be addressing those questions. I will attempt to provide scientific information that can 

be used as inputs in the social and legal decision making process. However, I am not 

offeling the opinion that (1)R81.50 should not be adopted; nor am I offering the 

opinion that /2) R81.50 should be adopted. 

0.2. Issues on Which I will Opine. 

I believe that the propositions or issues that are germane to the scientific basis or 

lack thereof for adopting R81.50 can be grouped into three categories: (1) Those that 

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concern about obesity and suggest that as a society we should be seeking 

ways to reduce obesity and/or the deleterious effects it causes. I address these 

propositions in section E of this report; (2) Those that support the conjecture that 

providing calorie information at the point of purchase in restaurants (especially fast 

food restaurants) might be beneficialin reducing obesity levels. I address these 

propositions in section F of this report; and (3) Those that, if true, would directly indicate 

that implementation of R81.50 would be beneficial in reducing obesity levels. I address 

these propositions in section G of this report. 

D. Standards of Evidence 

Before proceeding to an evaluation of relevant evidence, it is important to 

clarify the standard of evidence I will refer to herein. I refer to scientific evidence and by 

evidence I mean facts that could potentially lead to a reasonable conclusion that 

causation exists as opposed to facts that could lead one to conjecture or hypothesize 

about putative causation. Clearly, this standard requires that we ieek evidence 

generated using procedures generally accepted in the scientific community as 

capable of supporting valid conclusions as to causation. 

When evaluating outcome claims about interventions in humans, there are clear 

standards accepted by the biomedical research community. These standards are 

articulated in a number of publications relating to testing effects of interventions in 

general (e.g., Meinert et al., 1986), interventions for weight control (Allison et al;, 1997; 

Committee for Proprietary Medicinal Products, 1997; FDA, 1996; Gadbury et al., 2003; 

Anderson et a1.,1998), and in the legal context specifically (Green et al., 2000). 

Although there may be nuances to studying effects with one type of intervention 

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program, substance) as compared to another, the same general principles of 

sound experimental design, statistical analysis, and interpretation apply. 

A key point to consider when reviewing purportedly scientific opinions is the joint 

concept of objectivity and observability in the scientific process. The process leading to 

conclusions should be an objective one that is articulatable and observable and, 

therefore, can be checked and reproduced by other scientists as well as evaluated for 

validity. To illustrate this point, consider the fact that many scientific journals, including 

the prestigious Proceedings of the National Academy of Sciences, ask their peerreviewers to answer the following question when evaluating manuscripts that have 

been submitted for publication "Are the procedures described sufficiently well that the 

work can be repeated?" Simply stating that one has reviewed evidence and come to 

a conclusion without describing what the objective criteria for reaching such a 

conclusion are and showing that thosecriteria were met does not make something a 

valid scientific opinion. 

Types of Information that are Generally Accepted by the Scientific 

CqmmvnityasSufficient Evidence that an Intervention Aimed at Preventing 

Obesity Is Effective. 

With respect to assessing any possible effects of an intervention to reduce 

obesity, including both putative beneficial and deleterious effects, the ideal source of 

evidence would be one or more large randomized, controlled trials (RCTs) of the 

intervention, in a sample from the population of interest. Importantly, these RCTS must 

be well designed, well executed, and well analyzed. An RCT is a study in which humans 

are assigned to two or more conditions via a random process. Those conditions should 

ideally be identical in all respects except for the independent variable(i.e., 

'treatment') under study. The group getting the treatment or intervention is generally 

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to as the treatment or experimental group and the group that does not get the 

treatment in question is called the control group. After some a'ppropriate period, all 

subjects in each of the two groups are then measured on the outcome (i.e., 

dependent variable) and compared with respect to the outcome using an appropriate 

statistical test. 

However, for practical or ethical reasons, it is often impossible to conduct an RCT 

to address a particular question. In such situations, an observational (epidemiologic) 

study might be the best alternative, and evidencefrom such studies, though imperfect, 

would be the key evidence sought. In an observational study one studies people who 

were exposed (through their own choice or other circumstances) to the intervention of 

interest and compares them to people who were not so exposed. Observational 

epidemiologic studies cannot unequivocally demonstrate causality, but can document 

associations'. Associations observed in observational epidemiologic studies are more 

compelling with respect to possible inference to causation when the study is well 

designed, conducted, and analyzed. Again, one or more studies finding supportive 

results are not sufficient to support a claim if they are only a subset of a larger number 

of studies some of which obtain contradictory evidence and the weight of evidence is 

not supportive. 

Critically, because randomization is not used in observational epidemiologic 

studies, potential confounding-factors must be delineated, carefully measured, and 

carefully controlled for in the statistical analysis. Unlike: RCTs which can control for both 

In the field of statistics, two variables (e.g., a putative cause and a putative outcome) are said 

to be associated if and only if they are not independent. Two variables are independent if and 

only if the conditional distribution of one variable is identical for all levels of the other variable. 

Association differs from and does not necessarily imply causation. Causation means that one of 

the variables influences the other. 

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and unknown confounding factors, observational epidemiologic studies can 

only control for confounders' to the extent that the confounding variables can be 

effectively measured and for which the functional form of the relation between the 

potential confounding variable and the outcome can be effectively modeled in the 

statistical analysis. 

In evaluating the body of evidence bearing on whether a treatment or 

intervention is effective, it has become standard in 'evidence-based' medicine and 

public health to rank studies according to objective criteria that include consideration 

of whether the data comes from RCTs or observational studies, the consistency of the 

data, and other aspects of study design and methodology. One authoritative set of 

criteria is that used by the National Heart, Lung and Blood Institute in its "Clinical 

Guidelines on the Identification, Evaluation and Treatment of Obesity - The Evidence 

Report" (2000). Those criteria rate evidence from a series of well-designed RCTs that 

provide a ~consistent pattern of findings in the population for which a recommendation 

is made as "Category A" evidence. Where there are onlya few RCTs or findings are less 

than consistent, the evidence is ranked "Category B". Evidence from observational 

studies is rated 1Category C". Evidence based only on expert clinical judgment is rated 

2 Confounding and confounders have been defined as follows: 

confounder or confounding foctoc A cause of something being studied ( i.e a diseasej whose effect 

on that disease is mixed up with the effect (or non-effect) of another factor because the 

"confounder" is associated with that other factor. See "confounding". 

confounding: Epidemiologists use the term when the impact of two risk factors are associated with the 

same exposure and must be disentangled. Heavy alcohol consumption and smoking are both known 

to cause esophageal cancer. If people who drink also tend to smoke, then the effect of drinking will 

confound the effect of smoking and vice versa. Therefore one must correct for this confounding in the 

way the data are analyzed. Sometimes the non-effect of a factor which conveys no risk at all is 

confounded with the true effect of another factor. ... 

See: httn:/!www. dhs.ca. aov/ehib/em~RiskEvaluation/AT~·~endix8 .pdf 

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Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 8 of 31
as "Category D". These or similar categories have been applied in assessing the 

evidence that public health interventions aimed at improving diet or reducing caloric 

consumption among the general public have been shown to be efficacious (Faith et al, 

2007; see Seymour et al, 2004). 

E. Remarks on Prooositions SvDPortlna Concern about Obesity. 

The City, Dr. Frieden, and the amicus brief thereafter simply amicus) filed by the 

City of San Francisco Attorney's Office all offer a number of propositions, and evidence 

in support of those propositions that, if true, justify substantial concern about obesity 

and suggest that as a society we should be seeking solutions. These propositions can be 

summarized in the following points. 

Proposition El. During the last several decades, the prevalence of obesity 

increased substantially in the world, the nation, and in NYC and is now sufficiently 

high as torepresent a major public health concern. 

Proposition E2. Obesity has many deleterious effects for the individual iricluding 

reduced longevity, reduced quaiity of life, and reduced health and may also be 

costly to society. 

I believe that Propositions Pi and E2 are true and have indeed published many 

papers providing the evidence that would support them (see CV attached). Moreover, 

I believe that the evidence supporting these points has been well documented by the 

City, Dr. Frieden, and the amicus, and therefore I will not dwell on them further. I also 

agree with the apparent conclusion of the City, Dr. Frieden, and the amicus that 

accepting Propositions Ei and E2 justifies substantial concern about obesity and 

suggests that we should be seeking solutions. 

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Remarks on Propositions Suooortina Coniecture that Providinn Calorie 

Information at The Point of Purchase In Restaurants (Eseeclallv Fast Food Restaurantsl 

Minht Be Beneficial in Reducina Obesity Levels. 

The City, Dr. Frieden, and the amicus advance several other propositions that, if 

true, I believe support the conjecture that providing calorie information at the point of 

purchase in restaurants (especially fast food restaurants) might be beneficial.in 

reducing obesity levels. These propositions may be stated as follows. 

Proposition Pi. Obesity largely results from extended periods of positive energy 

balance (i.e., periods where energy intake exceeds energy expenditure). 

Proposition F2. On average, Americans eat more food in restaurants now tin both 

absolute calories and as a proportion of total caloric intake) than Americans did 

in the past. 

Proposition F3. Many of the foods served in restaurants are quite energy denses 

and quite high in absolute calories. 

Proposition F4. On average, Americans substantially underestimate the calories 

of food served in restaurants, largely as a function of large portion sizes. 

Proposition F5. Restaurants and restaurant food are contributing to the obesity 

epidemic in some manner that is above and beyond the contribution offered by 

any source of food energy. 

I accept all of Propositions F1 to F3 and think that they are sufficiently well 

documented (including in materials presented by the City, Dr. Frieden, and the amicus) 

to not merit further discussion. With respect to Proposition F4, I do believe that there are 

reasons to question it. People may not report their true beliefs about the calorie content 

3 Energy density refers to the energy ('calories') infoods divided by the weight (grams) of those 

foods. 

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foods they typically eat accurately in part because doing so may help to preserve 

their self-image and public personae as 'reasonable' eaters. We have previously shown 

evidence that would suggest this is the case (Muhlheim et al., 1998). Nevertheless, I 

suspect that even were this putative bias taken into account, patrons would still be 

shown to underestimate the caloric content of large restaurant land also large nonrestaurant) meals and food items. Thus, for the purposes of further discussion, Iwill 

accept the validity of Proposition F4. 

In contrast, the support for Proposition F5 is more open'to question. Clearly, 

acceptance of proposition Fl implies that any source of food energy consumed by 

humans is contributing to the obesity epidemic. This is as true for fresh fruits, vegetables 

and lean broiled fish as it is for French fries, ice cream, and refined sugar. But this 

statement is more tautological than informative. Acceptance of Proposition F1 does not 

ipso facto imply that restaurants and restaurant food are contributing to the obesity 

epidemic in some manner that is above and beyond the contribution offered by any 

source of food energy. 

Though acceptance of Propositions F1to F4 make it plausible that Proposition F5

is true, there are several reasons to retain some skepticism about the truth (or lack 

thereof) of Proposition F5. These include the following. 

(1) There are many plausible contributors to the obesity epidemic beyond 

restaurant food. My colleagues and I recently reviewed 10 of them in a widely 

discussed paper (Keith et al., 2006). Our thoughts have been echoed by other 

obesity researchers publishing in respected peer-reviewed journals (e.g., Astrup 

et al., 2006; Bray a Champagne, 2005; Eisenmann, 2006; Heindel, 2003; Jacobson 

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Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 11 of 31
al., 2007; Newbold et al., 2007) and there are additional putative contributors 

beyond the 10 we mentioned (c.f., Pasarica & Dhurandhar, 2007). 

(2) The evidence directly in favor of the unique role of restaurants as 

contributing to the obesity epidemic, is strictly from observational research, and 

more importantly, equivocal. The data cited in support of the unique role of 

restaurants rarely, if ever, stem from RCTs, and generally do not even include a 

consistent body of observational epidemiologic studies. I acknowledge that 

there are multiple epidemiologic studies showing a positive ('direct') association 

(not necessarily causation) between fast food and/or general restaurant 

consumption and overweight, obesity, of BMI (BMI denotes body mass index, a 

measure of relative weight [kg/mn] used as a proxy for adiposity). Some of these 

studies were cited by the City, Dr. Frieden, and the amicus and there are others 

still that support a positive or direct association that they did not cite (e.g., 

Schroder et at., 2007). Yet. there are also multiple studies thatdo not support this 

association (e.g., French et al 2001; Jeffery et al, 1998; Sanigorski et al., 2007). The 

findings of French et al. (2001) are especially interesting. In a sample of 4,746 

adolescents, "Overweightstatus was not significantly associated with FFFRU 

[frequency of fast food restaurant use] among males or females. Interestingly, 

BMI was significantly lower among males who reported using fast food 

restaurants three or more times per week, compared with those reporting less 

frequent fast food restaurant use. BMI was not significantly associated with FFFRU 

among females" (French et al., 2001, p. 1828). That is, in this large sample, not 

only was BMI not positively correlated with frequency of fast food restaurant use, 

but it was negatively correlated in males. 

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When correlations have been observed between fast food use and 

overweight, obesity, or BMI, such correlations are plausibly due to confounding. 

Fast food restaurants tend to be more prevalent in the poorest and most 

deprived neighborhoods (Block et al., 2004; Cummins et al., 2005; Reidpath et al., 

2002) and poverty and deprivation have been associated with obesity (Phipps et 

al., 2006). Moreover, fast food restaurant use has been associated with having 

soda and chips in the home (Boutelle et al., 2007), more TV and video viewing 

(Taveras et al., 2006), and lower income (French et al., 2000), all factors that 

have been proposed or shown to be associated with obesity. Thus, these factors 

may be confounding the association (if any) between fast food consumption 

and obesity. The plausibility of confounding by these factors is increased by the 

findings that: (a) At least one study found fast food patronage/consumption to 

be more strongly associated with BMI or BMI gain than is other restaurant 

consumption (Duffey et al., 2007) and yet other restaurants have not been 

shown to have consistently more nutritionally sound food (Saelens et al., 2007) 

and may even provide higher calorie meals to many patrons (Yamamoto et al., 

2006). This suggests the hypothesis that fast food patronageis correlated with BMI 

or BMI change more so than is other restaurant patronage because fast food 

patronage is a marker for lower socioeconomic status and/or other confounding 

factors. 

Given the forgoing points, I concur with Jeffery et al. (2006) who wrote 

"Available data on fast food use and obesity are far from conclusive, however. For 

example, the direction of causation is unclear, i.e., the menus and prices at "fast food" 

restaurants may result from the demands of an increasingly obese population rather 

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being a direct cause of obesity. It is also possible that a third variable, such as 

demographics and lifestyle characteristics (e.g.an aging population with smaller 

families and a higher percent of two income families), may cause both phenomena." 

Despite the reasons for skepticism about the truth of Proposition F5 I have offered 

above, I nevertheless believe that Propositions F1 to F3 are true, I accept proposition F4, 

and Proposition F5 is plausible. In turn, on this basis, I believe it is reasonable to 

conjecture that providing calorie information at the point of purchase in restaurants 

(especially fast food restaurants) might be beneficial in reducing obesity levels. 

However, I believe it is equally reasonable to conjecture that providing calorie 

information at the point of purchase in restaurants (including fast food restaurants) 

would have no beneficial effect on reducing obesity levels. This is because providing 

such calorie information may have little to no effect on reducing caloric intake in the 

restaurants affected by R81.50 (Yamamoto et al., 2006), patrons may compensate for 

any reduced caloric intake that does occur by increasing caloric intake or decreasing 

caloric expenditures in other settings (Foltin et al., 1992; King et al., 2007; Whybrow et al., 

2007), obesity-predisposed patrons may choose to frequent other restaurants not 

posting caloric information where overeating may be normative as they have been 

shown to do elsewhere (Stunkard & Mazer, 1978), or any effect of providing calorie 

information may be 'washed out' or overridden by the many other factors influencing 

body weight (Bray 8,Champagne, 2005). Of course, this is all just conjecture, but it is 

well-reasoned conjecturebased on the scientific literature. Given that one can 

reasonably conjecture in either direction, it is critical to turn to an assessment of the 

direct evidence (if any) that does or does not support the proposition that R81.50 will be 

effective in reducing obesity levels. 

Page 14 of31 

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Is there Competent and Reliable Evidence that (A) Providinn Restaurant Patrons 

with Calorie Information On Menu Items in Any Manner Will Reduce individual or 

Population Levels of Obesity: and (B~ That Doina So In the Manner Mandated by R81.50 

Will Reduce Obesity More Effectively Than Will Providinn Such Information in Some Other 

Manner? 

This question, which is key to assessing the evidentiary basis for Regulation 81.50, 

must be broken down into a number of components to properly analyze the relevant 

studies. 

First, one must distinguish between short and long-term effects". In the obesity 

field, it is well-established that it is far easier to influence weight for a short period of time 

than for a long one. We have substantial data showing that weight control interventions 

that successfully alter behavior over the short term - days, weeks, or even months - 

prove to demonstrate little to no efficacy over years (Hill et al., 2005). This may be 

related to 'set points' around which people maintain their weight, and the strong 

physiological signals that influence 'energy compensation' (Keesey, 1988). Studies show 

that altering caloric consumption or expenditure in one context can trigger 

compensatory consumption or expenditure in other contexts with no net change in 

weight (Foltin et al., 1992; King et al., 2007; Whybrow et al., 2007). 

Second, it is important to distinguish between (a) the effects of providing caloric 

information in any format versus providing no caloric information at all; from (b) the 

effects of providing caloric information in formats that would be compliant with R81.50 

versus some other format. 

4 A standard, promulgated by the Federal Trade Commission. is to consider 'long-term' to be at 

least 2 years in the field of weight loss and obesity. See: 

http://www.ftc.aov/os/ 1997~12/d9261.htm. FTC states that when claims about evidence of longterm effects are made "said evidence shall, at a minimum, be based upon the experience of 

participants who were followed for a period of at least two years...". 

Page 15 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 15 of 31
as my colleagues and I have recently discussed elsewhere (Faith et al., 

2007), it is important to not conflate outdome variables. Such outcomes include: (1) the 

patron's stated or actual evaluation of the desirability of high-calorie food; (2) the 

caloric content of the meal the patron actually orders and eats in naturalistic setting; 

and (3) the weight and obesity prevalence of the restaurant's patrons, which depend 

on their calorie consumption and expenditure from all sourcesthroughout multiple 

days. 

Studies which measure an individual's stated (or real) intentionswith respect to 

food purchase or consumption after receiving certain information are not necessarily 

indicative of what the individual will actually purchase and consume, especially over 

the long term and in natural settings. This can be because subjects do not actually 

know how they will behave in the future, because intentions are imperfect effecters of 

behavior, or because subjects know which answers experimenters want to hear and 

dutifully provide those verbal responses regardless of true intents or behaviors (Harnack 

et al., 2004).Studies which measure actual consumer purchase or consumption 

behavior are better, but are not yet as informative as studies which follow weight or 

obesity prevalence, since reduced consumption of calories in one setting may be 

counterbalanced by increased consumption or reduced expenditure in other setting as 

my colleagues and I have noted elsewhere ic.f., Faith et al., 2007). 

For ease of exposition, using the distinctions elucidated above, I break the 

question posed in this section into 16 specific related questions in the table on the 

following page and therein summarize the evidence regarding each. 

Page 16 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 16 of 31
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Table i, I have included every paper that the City, Dr. Frieden, and the amicus 

cited as supportive of the likely'8 efficacy of R81.50. In addition, I include several other 

papers that I was able to identify. I suspect there may be a few more papers available 

that could be uncovered with an exhaustive search, but I have been unable to identify 

any additional ones in the time available. 

For example, the primary support relied on by the City and by Dr. Frieden as 

evidence that R81.SO will 'likely' have its intendedeffect on obesity are three papers by 

Burton and colleagues (Burton et al., 2006; Kozup et al., 2003; Burton a Greyer, 2004). 

Those studies report on the impact of providing nutritional information on consumers' 

attitudes to restaurant meals and/or self-reported willingness or intentions to purchase 

foods andhave important methodological limitations. Perhaps most critically, they 

focus on- the effects of providing a different sort of nutritional information than that 

required by Regulation 81-50, and cannot provide evidence regarding the effects (or 

lack thereof) of the specific practices that would be mandated by R81.50. 

The 2003 and 2004 papers report several experiments on the effect of providing 

nutritional information to consumers regarding a hypothetical restaurant meal such as 

lasagna or pot roast. The authors report a positive'impact of providing information on 

the fat, saturated fat, calories-from-fat and cholesterol levels of the meals. The calorieonly information required by R81.50 was not tested. The 2006 study did give some 

'8 1 note that both Dr. Frieden and the amicus use the term 'likely' and are quite clear in there 

language that R81.50 is only likely to be effective. They never state that there is evidence 

showing that it will be effective. 

Page 19 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 19 of 31
calorie-only information and others the fat, cholesterol, etc information, and 

found no advantage to the calorie-only option. Each of the studies tested the impact 

of menu information by having subjects presented with a hypothetical menu complete 

a questionnaire on their subjective impressions after reading it, e.g., "How likely would 

you be to purchase this item given the information shown on the menu?" No meals 

were served, and actual purchases and consumption were not measured. Subjects' 

overall consumption and weight were not measured. Each study only measured the 

impact of information on a single occasion. Effects over days or weeks, and certainly 

impact on long-term weight management, was not tested. The studies focus on meals 

served at what the authors describe as "dinner house restaurants", Menu boards were 

not used to provide the nutritional information.Subject samples were not representative 

of the NYC population or the population of fast food diners, and response rates tended 

to be low suggesting concerns about generalizability of findings. The findings do not 

show that providing nutritional information at the type of restaurants generally subject 

to R81.50, and in the specific manner R81.50 requires, will be effective at all or more 

effective than alternative modes of providing nutritional information. 

In brief, there is reasonably persuasive evidence (level B) that providing caloric 

information (vs no calorie information) will change stated purchase intentions in the 

short term. Beyond that, there is no body of' data that showing that implementation of 

R81.50 would affect actual behavior or weight either in the short-term or long-term nor is 

there any body of evidence that the specific manner in which the R81.50 would require 

provision of caloric information would lead to better results in the short-term or longterm than any other method. Thus, I conclude that there is not competent and reliable 

evidence that providing restaurant patrons with calorie intormatfon on menu items will 

Page 20 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 20 of 31
individual or population levels of obesity. Nor is there evidence that the method 

of providing caloric information mandated by R81.50 will reduce levels of obesity more 

than the ~methods currently used by the affected restaurants to provide this information. 

This does not imply that there is competent and reliable evidence that providing 

restaurant patrons with calorie information on menu items will not reduce individual or 

population levels of obesity. It simply implies that there is insufficient evidence to draw a 

conclusion. 

H. Are There Reasons to Coniecture That There Miaht Be Unintended Deleterious 

Effects of the City's Proposed Rule? 

Intuition might suggest that, at worst, R81.50 could do no harm to the public 

health. Dr. Frieden seems to share this intuition when he writes "And even in the unlikely 

event the calorie labeling regulation had little or no impact on consumer food choices, 

it is likely to increase the number of lower-calorie, and reduce the number of highercalorie offerings these facilities provide. And even if the regulation neither changed 

consumer choices nor FSE offerings, there would be a salutary effect on increasing 

consumer awareness of calorie content." Nevertheless, it is important to note that the 

history of science, medicine, and psychology tells us that intuitions, even those of welltrained experts, are often wrong especially on issues involving human behavior (Dawes 

et al., 1989). 

To take just a few examples, few people would argue that we should not try to 

prevent post-traumatic stress disorder (PTSD) among NYC rescue workers, families, and 

direct victims after the tragedy of September 1 i, 2001, teen suicide, adolescent eating 

disorders, and childhood sexual abuse. And yet, in each of these areas, evidence has 

emerged that the well-intentioned and intuitively sound efforts of professionals may 

Page 2] 0/31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 21 of 31
some times done more harm than good (Carter et at., 1997; Callahan, 1996; Taal 

& Edelaar, 1997; McNally, 2003). 

Closer to the specific issue herein and highlighted in a recent Associated Press 

report entitled "Nutrition education ineffective'g," is a recent CDC-sponsored study 

(Centers for Disease Control and Prevention, 2006). In 2004-05 a program-was 

implemented to "1) increase student access to fresh fruit and vegetables, 2) increase 

the degree of student preference for fruit and vegetables, and 3) increase fruit and 

vegetable consumption." Participating schools distributed free fresh fruit and 

vegetables to school children accompanied by nutrition education activities. Results 

showed a decreased preference for fruit and vegetables, belief that they could eat 

more vegetables, and willingness to try new fruit and vegetables among 5th-grade 

students. In other words, for these children, the seemingly innocuous intervention 

seemed to make things worse. 

What harms (if any) might result from implementation of R81.50? That is difficult to 

predict. An interesting study by Boon et al. (2002) points to one possibility. Boon et al. 

found that when restrained eaters20, who constitute 50% of the population according to 

the definition Boon et al; used, were both distracted by being asked to perform a 

cognitive task and also presented with information that the food they were eating was 

high in calories, they were more likely to overeat. To the extent that many NY diners 

consume food from restaurants while in a state of distraction or performing distracting 

19 Nutrition education ineffective By Martha Mendoza, Associated Press. See: 

htto:llwww.usatodav.com/newslhealth/2007-07-04-fiahtinafat N.htm 

20 Restrained eaters are those thathabitually tend to eat less than they want despite the 

availability of food. 

Page 22 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 22 of 31
we might hypothesize that the belief that the food is especially high in calories 

would trigger disinhibited increased consumption. 

The study by Aaron et al. (1995) cited in Table 1 is especially germane. Aaron et 

ai. "examined the influence of nutrition information on nutrient intakes at lunch in a 

college cafeteria...Experimental subjects (EXP, n=65) ate all mid-day meals in a student 

cafeteria over two weeks with identical meal cycles. Information on the energy and fat 

content of food items was displayed in the cafeteria in week two. ...Unexpectedly, EXP 

subjects had significantly increased total energy, grams fat, grams carbohydrate and 

decreased grams protein and % energy from protein in week two vs. week one." Thus, 

Aaron et al's results were opposite to the intention of providing nutrient and calorie 

information and worsened subjects' diets. 

With respect to deleterious effects, other conceivabilities include (but are not 

limited to) creation of greater interest in foods seen as 'decadent' or 'forbidden' 

(Jansen et at., 2007), inadvertently encouraging patrons to consume lower calorie, but 

arguably less healthy choices (e.g., a food product that is largely refined sugar versus 

one that is largely protein), inadvertently encouraging patrons to consume lower 

calorie foods that subsequently lead to greater total caloric intake either because of 

poor satiating efficiency of the smaller calorie loads (Booth, 1988) and/or because of 

cognitively mediated reactivity to the label-induced perception of what one has eaten 

(Caputo a Mattes, 1993). 

The foregoing does not by any means prove that there will be deleterious 

outcomes if R81.50 is implemented, but it shows that the conjecture is reasonable. 

Page 23 of31 

Case 1:07-cv-05710-RJH Document 49 Filed 07/20/2007 Page 23 of 31
Summary. 

In summation I believe that (1) the body of scientific evidence clearly supports 

the merit of concerns about obesity and suggests that as a society we should be 

seeking ways to reduce obesity and/or the deleterious effects it causes. (2) Though 

there are some limitations to the evidence available, on balance, the evidence can 

support the conjecture that provision of information about the calorie content of foods 

at the point of purchase in restaurants might be beneficial in reducing obesity levels. 

That being said, the evidence can equally support the conjecture that such action 

would be ineffective and possibly even deleterious; and (3) There is not competent and 

reliable evidence that providing restaurant patrons with calorie information on menu 

items will reduce individual or population levels of obesity. Nor is there evidence that 

the method of providing caloric information mandated by R81.50 will reduce levels of 

obesity more than the methods currently used by the affected restaurants to provide 

this information. 

I declare under penalty of perjury pursuant to 28 U.S.C. ~ 1742 that the foregoing 

is true and correct. 

Executed on July 18, 2007 

David B. Allison, Ph.D. 

Page 24 oj~31 

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