FTC Staff Comment Before the Food and Drug Administration Concerning Proposal to Amend Rules Governing Health Messages on Food Labels

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COMMISSION AUTHORIZED
Comments 	of 	the 	Bureaus 	of 	Competition,
Consumer Protection 	and 	Economics 	of 	the
Federal 	Trade 	Commissio~
Submitted 	to 	the
Food 	and 	Drug 	Administration
Department 	of 	Health 	and 	Human 	Services
In 	Response 	to 	a 	Request 	for
Comments 	on 	its 	proposal 	to
Amend 	the 	Rules 	Governing
Health Messages 	on 	Food Labels 	and 	Labeling
Docket 	No. 	85N-0061
[52 	FR 	28843]
Dockets 	Management 	Branch 	[HFA-305]
Food 	and 	Drug 	Administration
Room 	4-62, 	5600 	Fishers 	Lane
Rockville, 	MD 	20587
* 	These 	comments 	represent 	the 	views 	of 	the 	Federal 	Trade
Commission's 	Bureaus 	of 	Competition, 	Consumer 	Protection 	and
Economics 	and 	not 	necessarily 	those 	of 	the 	Commission 	itself 	or
any 	individual 	Commissioner. 	However 	the 	Commission, 	with
Commissioners 	Bailey 	and 	Strenio 	dissenting, 	has 	voted 	to
authorize 	the 	staff 	to 	submit 	these 	comments 	to 	you.
Commissioners 	Bailey and 	Strenio 	do 	not 	disapprove 	of 	FDA's
proposed 	rule 	but 	wish 	to 	disassociate 	themselves 	from 	the
reasoning 	set 	forth 	in 	the 	Commission 	staff's 	comment.

I. 	INTRODUCTION
In 	its 	Notice 	of 	Proposed Rulemaking,l 	the 	Food and 	Drug
Administration 	(FDA) 	has 	requested 	comments 	on 	the 	revision 	of
its 	rules 	governing 	health 	claims 	on 	food 	labels. 	The 	revised
rules 	would 	permit 	food 	manufacturers 	to 	include 	health
information on 	labels 	as 	long 	as 	the 	information 	is_truthful,
supported by valid 	evidence 	and 	consistent 	with 	generally
recognized 	medical 	and 	nutritional 	principles. 	If 	health 	claims
are 	made, 	however, 	the 	label 	must 	also 	include 	certain 	additional
nutritional 	information.
Rapidly 	accumulating 	scientific 	evidence 	indicates 	that 	diet
has 	an 	important 	influence 	on 	health. 	The 	FDA's 	proposed
revision 	to 	its 	rules 	will 	allow 	food 	manufacturers 	to 	provide
consumers 	with 	truthful 	information 	on 	the 	relationship 	between
diet 	and 	health. 	By removing 	current 	restrictions 	on 	the 	food
marketers' 	ability 	to 	communicate 	health 	information 	to
consumers, 	the 	FDA's 	revision 	will 	make 	an 	important 	contribution
to 	the 	public's 	welfare.
The 	Federal 	Trade 	Commission 	is 	a 	law 	enforcement 	agency
charged with 	prosecuting violations 	of 	Sections 	5 	and 	12 	of 	the
1 	52 	Fed. 	Reg. 	28843 	(1987) 	(to 	be 	codified 	at 	21 	C.F.R.
Part 	101).
1

Federal 	Trade 	Commission Act, 	which prohibit 	deceptive 	or 	unfair
practices 	in or 	affecting commerce. 2 	One 	of 	the 	FTC's 	major
efforts 	is 	to 	regulate 	national 	advertising 	in 	a 	way 	that
protects 	consumers 	from 	deception, 	but 	at 	the 	same 	time 	does 	not
chill 	or 	prevent 	dissemination 	of 	truthful 	ads. 	The 	FTC 	has
developed 	widely 	accepted 	standards 	for 	the 	regulation of
deceptive 	advertising with minimum 	disruption 	to 	the
dissemination 	of 	truthful 	information. 3 	We 	support 	~he FDA's
proposal 	to 	adopt 	an 	approach 	to 	the 	regulation 	of 	labeling 	that
reflects 	the 	same 	objectives.
This 	comment 	discusses 	how 	the 	FDA 	can 	assure 	itself 	that
its 	regulations 	are 	stringent enough 	to 	protect 	consumers 	from
deceptive 	information 	but 	not 	so 	restrictive 	as 	to 	stifle
dissemination 	of 	truthful 	information. 	Our 	main 	suggestion 	is
that 	a 	more 	flexible 	standard 	for 	substantiation 	of 	health 	claims
would 	benefit 	consumers 	by 	increasing 	the 	amount 	of 	information
available 	without 	jeopardizing consumers' 	health. 	In 	light 	of
2 	15 	U.S.C. 	S 	45 	~~. 	The 	FTC 	has 	concurrent
jurisdiction with 	the 	FDA 	over 	the 	advertising 	of 	food, 	and 	has
concurrent 	jurisdiction with 	the 	FDA 	and 	the 	Department 	of
Agriculture 	over 	the 	labeling 	of 	food. 	The 	FTC 	also 	has
statutory 	authority 	to 	administer 	a 	number 	of 	laws 	that 	mandate
disclosure 	such 	as 	the 	Federal 	Cigarette 	Labeling 	and 	Advertising
Act, 	Truth 	In 	Lending Act, 	Energy 	Policy 	and 	Conservation Act
(appliance 	labeling). 	In 	addition, 	the 	FTC 	has 	promulgated
disclosure 	rules 	such 	as 	the 	R-Value 	(thermal 	insulation
labeling) 	and 	Care 	Labeling 	rules.
3 	The 	Commission's 	approach 	has 	been 	cited with 	approval 	in
Supreme Court 	decisions 	articulating 	the 	reach 	of 	the 	First
Amendment 	to 	commercial 	speech. 	~ 	Zauderer v. 	Office 	of
Disciplinary Counsel, 	105 	S.Ct. 	2265, 	2279 	(1985).
2

the 	FTC's 	successful 	experience with 	reliance 	on 	proprietary
data, 	we 	also 	suggest 	that 	the 	FDA 	consider 	accepting 	proprietary
data 	as 	substantiation 	for 	health 	claims. 	Finally, 	we 	question
whether 	it 	is 	necessary 	to 	establish 	a 	committee 	to 	draft 	model
health 	claims 	when manufacturers 	are 	permitted, 	under 	the
proposed 	rules, 	to 	devise 	their own, 	adequately 	supported, 	health
claims 	for 	labels. 	In 	sum, 	we 	support 	the 	FDA 	on 	this 	important
proposal, 	but 	suggest 	that 	FDA 	revise 	the 	proposed 	substantiation
standard 	to 	make 	it 	consistent with 	the 	more 	flexible
substantiation 	standard 	used 	by 	the 	FTC 	to 	evaluate 	claims 	in
food 	advertising.
II. 	Benefits 	of 	Allowing 	Truthful 	Health 	Claims 	on 	Food
Labeling
A. 	Consumers 	Want 	Nutritional 	Information
A growing 	body 	of 	evidence 	indicates 	that 	important 	links
exist 	between 	diet 	and 	health. 	As 	a 	result, 	government
guidelines 	point 	to 	relationships 	between 	high 	dietary
cholesterol 	and 	saturated 	fat 	diets 	and 	increased 	risks 	of 	heart
disease,4 	sodium 	intake 	and 	hypertension,S 	and 	low-fat, 	high-
4 	~,~, 	u. 	S. 	Dep'ts. 	of 	Agriculture 	and 	Health 	and
Human 	Services, 	Dietary Guidelines 	for 	Americans 	15. 	(2d 	ed.
1985).
5 	~. 	at 	21.
3

fiber 	diets 	and 	reduced 	risks 	of 	some 	forms 	of 	cancer. 6 	The
importance 	of 	these 	concerns 	to 	consumers 	is 	reflected 	in 	the
substantial 	interest 	consumers 	expre~s in 	receiving more
nutritional 	information. 	A 1985 	national 	survey 	reportedly 	found
that 	68% 	of 	consumers 	surveyed wanted more 	information 	about
nutrition. 7 	The 	General 	Accounting 	Office 	has 	reported 	that
Americans 	believe 	that 	good diets 	are 	important 	but 	are 	confused
about 	nutrition 	and 	lack 	information on how 	to 	eat 	healthfully.8
Consumers 	appear 	to 	be 	responding 	to 	available 	information by
changing 	their 	dietary 	habits. 	The 	USDA's 	1985 	national 	food
survey 	found 	that 	American women 	are 	consuming 	60% 	more 	skim 	and
low-fat 	milk 	than 	they 	did 	in 	1977, 	29% 	more 	grain 	and 	roughly
30% 	less 	meat 	and 	eggs. 9 	These 	changes 	presumably 	reflect
increasing 	awareness 	and 	concern 	about 	the 	relationship 	between
diet 	and 	health. 	Indeed, 	an 	FDA 	telephone 	survey 	in 	1986 	found
6 	~,~, 	U. 	S. 	Dep't. 	of 	Health 	and 	Human 	Services,
Diet, 	Nutrition 	& Cancer 	Prevention 	5 	(1984).
7 	Lord, 	Health 	Claims 	in 	Food Advertising, 	27 	J. 	of
Advertising 	Research 	11 	(1987) (citing 	results 	of 	"The Gallup
Study 	of 	Changing 	Food 	Preparation 	and 	Eating Habits").
8 	Government 	Accounting 	Office, 	What 	Food 	Should Americans
Eat? 	Better 	Information Needed 	on 	Nutrition 	Quality of 	Foods,
Pub. 	No. 	CED-80-68 	1 	(April 	30, 	1980).
9 	U.S. 	Dep't. 	of 	Agriculture, 	Nationwide 	Food 	Consumption
Survey 	Continuing 	Survey 	of 	Food 	Intakes 	By 	Individuals, 	Women
19-50 	and 	Their 	Children 	1-5, 	Day 	(1985).
4

that 	61% 	of 	those 	surveyed 	reported eating 	differently 	because 	of
health 	concerns. 10
Allowing manufacturers 	to 	combine 	general 	health 	information
with 	information 	on 	their 	products' 	characteristics 	is 	likely 	to
increase 	the 	manufacturers' 	incentives 	to 	supply 	health
information. 11 	The 	producers 	of 	low-salt 	foods, 	for 	example,
could 	use 	marketing 	claims 	to 	explain 	how 	salt 	consumption 	is
related 	to 	existing 	hypertension. 	However, 	any 	particular
manufacturer may 	be 	reluctant 	to 	supply 	general 	health
information 	because 	the 	information 	supplied 	also 	benefits 	its
competitors 	at 	no 	cost 	to 	them. 	Therefore, 	there 	may 	be
disincentives 	for 	a 	manufacturer 	to 	supply 	some 	types 	of 	health
information. 	Thus 	allowing 	manufacturers 	to 	make 	health claims
about 	nutrients 	contained 	in 	their 	particular products 	should
encourage 	the 	dissemination 	of 	information.
B. 	Benefits 	From 	the 	Advertising 	of 	Health 	Claims
Even 	though 	health 	claims 	are 	not 	the 	predominant 	themes 	in
food 	advertising, 	advertising 	has 	played 	an 	important 	role 	in
10 	Remarks 	of 	James 	T. 	Heimbach, 	Head 	Consumer 	Research
Staff, 	FDA, 	at 	the 	Journalist 	Conference 	on 	Food 	Safety 	and
Nutrition 	(October 	1986 	and October 	1987).
11 	A review 	of 	nutritional 	advertising, 	~, 	~, 	ads
cited 	at 	notes 	13-19, 	indicates 	that 	typically 	advertising
relates 	the 	nutritional 	information 	to 	the 	individual 	brand 	or
product 	advertised.
5

informing 	consumers 	about 	the 	relationship 	between 	diet 	and
health. 	In 	the 	early 	1970's, 	for 	example, 	food 	manufacturers
were 	advising 	consumers 	to 	reduce 	cholesterol 	levels 	by
substituting polyunsaturated 	fats 	for 	some 	saturated 	fats. 12
Similarly, 	other 	advertisers 	promoted egg 	substitutes 	as 	a 	way 	to
help meet 	the 	American Heart 	Association's 	then-recommended
levels 	of 	dietary 	cholesterol 	intake. 13 	More 	recently, 	following
Kellogg's 	highly 	successful 	advertising 	and 	labeling 	campaign
discussing 	the 	National 	Cancer 	Institute's 	recommendations 	on
high-fiber 	low-fat 	diets, 	several 	food 	manufacturers 	have 	begun
more 	aggressive 	marketing 	strategies 	based 	on 	the 	relationship
between 	diet 	and 	health. 	For example, 	other 	cereal
manufacturers, 	such 	as 	General 	Mills, 	began making claims 	for
fiber. 14 	Quaker 	Oats 	has 	undertaken 	a 	campaign 	that 	describes
the 	benefits 	of 	oatmeal 	as 	part 	of 	a 	low-fat, 	low-cholesterol
diet. 1S 	The 	California 	Prune 	Board employed 	a 	campaign 	that
informs 	consumers 	that 	prunes 	are 	a 	good 	source 	of 	fiber 	and
12 	One 	example 	is 	the 	Promise Margarine 	campaign 	that 	ran
in major 	newspapers 	and 	magazines 	in 	1973. 	~,~, 	Potomac
Magazine, 	May 	27, 	1973.
13 	~ advertising 	for 	Fleischmann's 	Egg 	Beaters 	in 	the
Wall 	Street 	Journal, 	March 	21, 	1973. 	The 	use 	of 	this
advertisement, 	as 	well 	as 	the 	others 	in 	this 	comment, 	are 	for
illustration purposes 	only 	and do 	not 	suggest 	approval 	or
disapproval 	of 	their 	content.
14 	General 	Mills' 	television 	ad 	for 	Fiber-One 	that 	ran 	in
1986 	and 	1987.
15
1987. Quaker 	Oats' 	advertisement 	in 	Newsweek, 	September 	14,
6

explained how 	a 	high-fiber, 	low-fat 	diet 	may 	reduce 	the 	risk 	of
contracting 	some 	types 	of 	cancer. 16 	Another 	cereal 	manufacturer
has 	begun 	to 	advertise 	that 	its 	Shr~dded Wheat 	product was 	rated
the 	highest 	by Consumer 	Reports 	primarily because 	the 	product 	was
a 	source 	of 	fiber 	and 	had 	no 	added 	sugar or 	salt. 17
Other 	food 	advertisements 	have 	sought 	to 	correct 	consumers'
misimpressions 	about 	diet 	and 	health. 	For example, 	a 	newspaper
advertisement 	for 	Promise 	Spread 18 	explains:
Many 	grocery 	shoppers 	believe 	that 	any 	product
labeled 	"no cholesterol" 	is 	"good 	for 	your
heart" 	and 	poses 	no 	risk 	of 	increasing 	the
amount 	of 	cholesterol 	in 	the 	blood. 	Many
shoppers 	also 	assume 	that 	"no 	cholesterol"
means 	no 	saturated 	fat. 	But, 	both 	assumptions
are 	totally 	wrong, 	since 	a 	product 	labeled 	"no
cholesterol" 	may, 	in 	fact 	contain 	a 	large
amount 	of 	saturated 	fat.
In 	sum, 	at 	least 	some manufacturers 	have 	found 	advertising 	to 	be
an 	effective 	vehicle 	for 	providing 	health 	information 	related 	to
their 	products 	to 	consumers.
16 	Advertising 	by 	the 	California 	Prune 	Board, 	Better Homes
and Gardens, 	January 	1987.
17 	Nabisco 	Brands' 	television 	advertising 	for 	Shredded
Wheat, 	January 	1987.
18 	Promise 	advertisement, 	USA 	Today, 	May 	6, 	1987, 	at 	7A.
7

C. 	AdditiQnal 	Benefits 	frQm 	an 	FDA 	PQlicy AllQwing
Truthful 	Health 	Claims 	Qn 	FQQd 	Labels
The 	FDA's 	revisiQns 	Qf 	its 	fQo~ labeling 	regulatiQns 	will,
allQw 	fQQd 	manufacturers 	tQ 	prQvide 	mQre 	infQrmatiQn on 	fQQd
labels. 	Accurate 	health 	infQrmatiQn Qn 	labels 	could prQduce
substantial 	CQnsumer 	benefits. 	InfQrmatiQn 	cQnveniently 	placed
Qn 	labels 	WQuld 	significantly 	reduce 	the 	CQst 	tQ 	CQnsumers 	Qf
searching 	fQr 	health 	infQrmatiQn 	and 	Qf 	identifying 	prQducts 	that
can 	be 	assQciated 	with 	specific 	health 	benefits. 	As 	a 	result,
cQnsumers 	are 	likely 	tQ 	becQme 	better 	infQrmed 	and 	make 	healthier
chQices 	from 	amQng 	available 	fQQds.
Recent 	studies 	indicate 	that 	many 	CQnsumer 	purchasing
decisiQns 	are 	made 	in 	stQres,19 	and 	that 	CQnsumers 	use
infQrmatiQn 	presented 	clearly 	and 	cQnveniently 	at 	the 	PQint-Qf-
purchase 	in making 	thQse 	decisiQns. 	MQre 	specifically, 	a 	1981
study 	Qf 	Giant 	FQQd 	StQres' 	"Special 	Diet 	Alert" 	prQgram, 	which
flagged 	items 	lQW 	in 	SQdium, 	calQries, 	fat 	and chQlesterQI 	with
shelf 	markers, 	indicated 	that 	CQnsumers 	did 	use 	that 	infQrmatiQn
in making 	purchasing decisiQns. 20 	Indeed, 	31% 	Qf 	the 	shQppers
19 	Results 	Qf 	PQint-Of-Purchase Advertising 	Institute 	Study
as 	repQrted 	in 	Advertising Age, 	OctQber 	S, 	1987, 	at 	93. 	The
Institute 	repQrtedly 	fQund 	that 	tWQ 	Qut 	Qf 	three 	supermarket
purchase 	decisiQns 	are 	made 	while 	shQpping.
20 	A cQmparisQn 	Qf 	stQres 	emplQying 	the 	prQgram with 	stQres
that 	did 	nQt 	revealed 	that 	sales 	Qf 	the 	flagged 	items 	were
greater 	in 	the 	stQres 	using 	the 	shelf 	markers 	than 	in 	the 	cQntrQl
stQres. 	Schucker 	and 	Levy, 	DivisiQn Qf 	CQnsumers 	Studies, 	Center
FQr 	FQQd 	Safety 	& Applied 	NutritiQn, 	Special 	Diet 	Alert:
EvaluatiQn 	Of 	A Successful 	In-StQre 	PrQgram 	(September 	1984).
8

interviewed 	reported 	using 	the 	shelf 	markers 	when 	they 	shopped. 21
These 	studies 	suggest 	that 	having 	health messages 	available 	on
labels 	may 	help 	facilitate 	more 	infqrmed 	purchasing decisions.
Finally, 	the 	new 	rule 	may 	help 	bring 	about 	more 	informative
advertising. 	Although 	the 	preamble 	to 	the 	FDA's 	proposed 	rule
clearly 	states 	that 	the 	rule's 	requirements 	"apply 	to 	health
claims 	made 	on 	food 	labels, 	but 	not 	to 	health 	claims 	made 	in 	food
advertising," 	the 	FDA's 	former 	ban 	on 	labeling claims 	may 	have
had 	at 	least 	some 	chilling effect 	on 	advertising 	claims 	as
well. 22 	Thus, 	the 	FDA's 	revisions 	may 	encourage 	health 	claims 	in
advertising 	as 	well 	as 	in 	labeling.
While 	the 	effects 	of 	shelf 	markers 	may 	differ 	from 	the 	effects 	of
labels, 	the 	results 	suggest 	that 	consumers 	will 	use 	in-store
information 	to 	make 	purchasing 	decisions.
21
22
,rg. 	at 	3.
[The 	FDA] 	took 	the 	position 	that 	any 	product
for 	which 	drug 	claims 	were 	made 	in
advertising 	became 	a 	drug 	as 	well 	as 	a 	food,
whose 	label 	must 	bear 	the 	adequate 	directions
for 	use 	required 	for 	a 	drug 	under 	Section 	502
(A) 	of 	the 	FD&C 	Act. 	This 	position, 	commonly
referred 	to 	as 	the 	"squeeze 	play," 	was 	upheld
by 	the 	courts. 	More 	recently, 	FDA 	took 	the
position 	that 	a 	nutrition 	claim made 	solely
in 	advertising 	is 	sufficient 	to 	trigger
mandatory 	nutrition 	labeling 	under 	the 	FD&C
Act) .
Hutt, 	Goyernment 	Regulation 	of 	Health 	Claims 	in 	Food 	Labeling 	and
Adyertising, 	41 	Food 	Drug 	Cosmo 	L. 	J. 	3, 	25-26 	(1986)(footnotes
omitted) .
9

In 	summary, 	truthful 	health 	information 	in 	both 	food
labeling 	and 	advertising offers 	a 	powerful 	means 	of 	providing
consumers 	with 	information 	that 	may enable 	them 	to 	improve 	their
health. 	Manufacturers 	may 	respond 	to 	the 	greater opportunity 	to
use 	truthful 	health claims 	in marketing 	their 	products 	by
devoting 	additional 	resources 	to 	producing 	information 	about 	diet
and 	health. 	Moreover, 	allowing 	food 	manufacturers 	greater
latitude 	to 	emphasize 	the 	health 	benefits 	of 	their products 	is
likely 	to 	increase 	demand 	for 	products 	with 	those 	benefits 	and
thus 	increase 	incentives 	to 	produce 	such 	products. 23 	The 	FDA's
action 	in 	removing 	its 	prior 	ban 	on 	such 	information 	on 	food
labels 	can 	thus 	lead 	to 	a 	healthier 	population.
D. 	Risk 	Of 	Injury 	From 	Deceptiye 	Health 	Claims
From 	a 	public 	policy 	standpoint, 	it 	is 	important 	to 	balance
the 	benefits 	and 	the 	risks 	of 	allowing 	food 	manufacturers 	greater
latitude 	to 	make 	health 	claims 	on 	labels. 	The most 	important
risk 	is 	that 	some 	deceptive 	claims 	will 	also 	be made. 	Deceptive
health 	claims 	can 	harm consumers 	in 	three 	different 	ways. 	First,
in 	some 	instances, 	the 	claim may 	directly 	injure 	consumers 	by
persuading 	them 	to 	change 	their 	diet 	in 	a 	way 	that 	actually
23 	In 	fact, 	a 	recent 	Newsweek 	article 	reported 	that, 	in
response 	to 	the 	public's 	concern 	about 	saturated 	fat 	consumption,
HThe 	meat 	industry 	is 	feverishly 	developing 	less 	fatty 	cuts 	of
beef 	and 	pork, 	and 	supermarket 	shelves 	are 	laden with 	low-fat
dairy 	products." 	Controllin~ 	Cholesterol, 	Newsweek, 	October
19, 	1987, 	at 	97.
10

injures 	their 	health. 	Second, 	the 	claim may 	indirectly 	injure
consumers' 	health 	by 	leading them 	to 	refrain 	from making 	changes
in 	their 	diets 	that 	would 	help 	them r 	or 	by 	encouraging 	them 	not
to 	seek 	effective 	medical 	treatment. 	Finally, 	deceptive 	claims
may 	injure 	consumers 	economically 	if 	they 	pay 	a 	premium 	price 	for
the 	food, 	or 	if 	they 	purchase 	items 	they 	otherwise 	would 	not
because 	of 	the 	deceptive 	claims.
The 	market 	itself 	currently provides 	some 	safeguards 	against
misleading 	and 	potentially 	harmful 	claims. 	For 	example, 	if 	one
manufacturer makes 	a 	bogus 	claim, 	competitors 	can 	react
swiftly.24 	Other 	information 	suppliers, 	especially 	the 	media,
are 	also 	likely 	to 	help dispel 	resulting misconceptions. 	And,
manufacturers 	whose 	success 	depends 	upon 	their 	good 	reputations
may 	also 	be 	restrained 	from 	making exaggerated 	claims 	for
particular products 	for 	fear 	of 	tarnishing 	their 	reputations.
However, 	because 	the 	truthfulness 	of 	health 	claims 	is 	often
difficult 	or 	impossible 	for 	consumers 	to 	evaluate 	even 	after
purchase 	and 	use 	of 	a 	product, 	market 	safeguards 	may 	offer
insufficient 	protection 	against 	some 	harmful 	health 	claims. 	The
regulation of 	health 	claims 	should be 	designed 	to 	identify 	and
deter 	claims 	that 	are 	likely 	to 	be 	harmful. 	Because 	the
24 	They 	may 	complain 	to 	the 	FTC, 	run 	comparative
advertising 	countering 	the 	misinformation, 	seek 	a 	preliminary
injunction under 	the 	Lanham Act, 	15 	U.S.C. 	SI125(a), 	or 	file 	a
complaint 	with 	the 	National 	Advertising 	Division 	of 	the 	Council
of 	Better 	Business 	Bureaus, 	an 	industry 	self-regulatory body.
11

potential 	benefits 	and 	risks 	of 	particular 	claims 	vary widely, 	we
believe 	that 	this 	can 	best 	be 	accomplished 	by 	a 	flexible 	approach
to 	evaluating 	individual 	claims 	rat~er than 	a 	rigid 	rule 	that
applies 	to 	every 	possible 	claim. 25 	This 	is 	particularly 	true 	for
the 	area 	of 	deceptive 	health 	claims 	on 	food 	labeling because 	some
unsubstantiated claims 	could 	result 	in 	health 	injury while 	others
present 	only ~ minimis 	risks 	of 	economic 	harm. 26
III. 	COMPARISON OF THE 	FTC'S 	APPROACH 	TO ADVERTISING 	OF
HEALTH 	CLAIMS 	TO THE 	FDA'S 	PROPOSED 	FOOD 	LABELING 	RULE
A. 	The 	FTC 	Approach
The 	Federal 	Trade 	Commission Act 	prohibits 	unfair 	and
deceptive 	acts 	or 	practices. 27 	The 	Commission's 	deception 	and
advertising 	substantiation policy 	statements 28 	have 	made 	it 	clear
25 	We 	recognize 	that 	fixed 	regulatory 	standards 	may 	be
appropriate 	remedies 	for 	some 	problems. 	For 	example, 	a 	fixed
standard might 	be more 	effective 	than 	a 	flexible 	standard when
the 	likely 	consequences 	of 	allowing 	(or 	prohibiting) 	an 	action
are 	not 	apt 	to 	vary much 	from 	case 	to 	case, 	such 	as 	regulations
setting 	tolerance 	limits 	for 	toxins 	in various 	foods 	or 	drinking
water. 	However, 	a 	fixed 	standard 	appears 	inappropriate 	for
health 	claims 	because 	the 	consequences 	may 	vary 	significantly.
26
27
See 	discussion 	infra 	note 	43.
15 	U.S.C. 	S 45 	et 	seQ. 	(1982).
28 	Both 	statements 	have 	been 	adopted 	in 	Commission
decisions. 	Deception 	Policy Statement, 	appended 	to 	Cliffdale
Associates, 	Inc., 	103 	F.T.C. 	163, 	174-84 	(1983); 	Ad
Substantiation 	Policy Statement, 	appended 	to 	Thompson Medical
Company, 	104 	F.T.C. 	648, 	839-42 	(1984), 	aff'd 	791 	F.2d 	189 	(D.C.
Cir. 	1986).
12

that 	advertising claims 	must 	not 	mislead 	consumers 	and 	must 	be
substantiated 	if 	they 	are 	to 	pass 	muster 	under 	the 	FTC 	Act. 	In
determining whether 	a 	claim misleads 	or 	deceives 	consumers, 	the
Commission 	evaluates 	the 	overall 	impression 	created by 	the 	ad 	and
considers 	how 	reasonable 	consumers 	read 	or 	perceive 	the 	claim 	in
the 	context 	of 	the 	ad. 29 	With 	regard 	to 	determining 	the
appropriate 	level 	of 	support 	for 	a 	claim, 	the 	Commission 	employs
a 	flexible 	substantiation 	doctrine 	that 	it 	has 	found 	to 	be 	an
effective, 	but 	not 	overly 	restrictive, 	means 	of 	assessing 	the
adequacy 	of 	such 	support.
Under 	the 	Commission's 	ad 	substantiation 	doctrine, 	claims
must 	be 	supported by 	the 	level 	of 	substantiation 	they
communicate, 	either 	expressly or 	impliedly, 	to 	the 	reader 	or
listener. 	Thus, 	if 	an ad 	claims 	a 	particular 	level 	of
substantiation, 	~, 	that 	six major 	studies 	support 	the
existence 	of 	a 	particular 	diet/health 	relationship, 	then 	that
amount 	of 	evidence must 	indeed 	substantiate 	the 	claim. 30 	When 	an
advertisement 	expressly 	or 	impliedly 	claims 	that 	there 	is 	a
consensus 	of 	opinion 	that 	a 	diet/health 	claim 	is 	true, 	then 	this
consensus 	must 	exist. 	Similarly, 	where 	a 	manufacturer 	has
substantiating evidence 	that 	is 	subject 	to 	some 	limitation 	or
29 	~ Cliffdale, 	103 	F.T.C. 	at 	177-79.
30 	In 	the 	example 	used 	above, 	the 	six 	studies 	relied 	upon
would 	have 	to 	be 	conducted 	and 	evaluated 	in 	an 	objective 	manner
by 	persons 	qualified 	to 	do 	so, 	using 	procedures 	generally
accepted 	in 	science 	to 	yield 	accurate 	and 	reliable 	results. 	~
generally 	Thompson Medical, 	104 	F.T.C. 	at 	825-28.
13

qualification, 	the 	claim 	is 	allowed 	provided 	it 	is 	appropriately
qualified 	so 	that 	the 	limited nature 	of 	the 	substantiation 	is
apparent 	to 	consumers 	and 	the 	advertisement 	does 	not 	imply 	to
consumers 	that 	a 	higher 	level 	of 	substantiation exists. 31
In 	the 	most 	typical 	kind 	of 	advertising, 	however, 	where 	no
express 	or 	implied 	level 	of 	support 	is 	claimed, 	the 	Commission
examines 	several 	factors 	to 	determine 	what 	type 	of 	~reasonable
basis" 	the 	advertiser 	should 	have 	for 	the 	claim. 32 	In
particular, 	the 	Commission 	considers: 	(1) 	the 	type 	of 	claim; 	(2)
the 	type 	of 	product;33 	(3) 	the 	benefits 	of 	a 	truthful 	claim; 	(4)
31 	Likewise, 	if 	there 	is 	substantial 	inconsistency 	in 	the
evidence, 	it 	may 	be 	necessary 	for 	a 	manufacturer 	to 	disclose 	the
existence 	of 	contrary 	evidence 	in 	order 	to 	ensure 	that 	consumers
are 	not 	misled. 	~ 	National 	Commission 	on 	Egg 	Nutrition, 	88
F.T.C. 	89 	(1976) 	aff'd 	570 	F.2d 	157 	(7th 	Cir. 	1977), 	cert. 	denied
439 	u.s. 	821 	(1978). 	Of 	course, 	where 	such 	disclosure 	is
necessary 	to 	prevent 	consumers 	from 	being misled, 	the 	disclosure
must 	be 	legible 	and 	understandable 	to 	ensure 	that 	the 	overall
message 	communicated 	is 	accurate. 	In 	short, 	the 	disclosure 	must
be 	effective. 	See 	generally 	Cliffdale, 	103 	F.T.C. 	179-81 	and
cases 	cited 	therein.
32 	This 	requirement 	is 	based 	on 	the 	well-established
proposition 	that 	objective 	claims 	convey 	to 	consumers 	that
advertisers 	possess 	some 	reasonable 	amount 	of 	support 	for 	the
claim. 	Firestone 	Tire 	& Rubber 	Co. 	v. 	FTC, 	481 	F.2d 	246, 	250-51
(6th 	Cir.) 	cert. 	denied, 	414 	U.S. 	1112 	(1973); 	~ alaQ
Cliffdale, 	103 	F.T.C. 	at 	175, 	n. 	5.
33 	With 	respect 	to 	the 	first 	two 	factors, 	the 	Commission
considers 	whether 	the 	product 	involved 	raises 	health, 	safety, 	or
other 	special 	concerns, 	whether 	the 	claims 	at 	issue 	are 	specific
or 	general, 	and 	whether 	consumers 	are 	capable 	of 	evaluating 	the
claims. 	Thompson Medical, 	104 	F.T.C. 	at 	822-23.
14

the 	cost 	of 	developing 	substantiation 	for 	the 	claimi34 	(5) 	the
consequences 	of 	a 	false 	claimi35 	and 	(6) 	the 	amount 	of
substantiation experts 	in 	the 	field 	believe 	is 	reasonable. 36
These 	six 	factors 	allow 	the 	Commission 	to 	weigh 	carefully
the 	potential 	benefits 	from 	the 	dissemination 	of 	information 	if
it 	turns 	out 	to 	be 	true 	against 	the 	potential 	harm 	that 	may
result 	if 	the 	information 	turns 	out 	to 	be 	false. 	The 	reasonable
basis 	standard 	thus 	deals 	with 	uncertainty 	as 	to 	the 	existence 	of
the 	diet/health 	relationship, 	not 	by 	simply 	prohibiting 	all
claims 	based 	upon 	uncertain data, 	but 	by 	evaluating 	the 	value 	and
risk 	that 	attend 	dissemination 	of 	the 	information 	and 	by 	setting
the 	required 	level 	of 	substantiation 	accordingly. 	In 	sum, 	the
six 	criteria 	are 	part 	of 	a 	balancing 	analysis 	that 	enables 	the
Commission 	to 	consider 	not 	only 	the 	likelihood 	that 	a 	particular
claim 	is 	true, 	but 	also 	to 	weigh 	the 	likely consequences 	of
allowing 	claims 	based 	on 	the 	available 	substantiation.
34 	The 	third 	and 	fourth 	factors 	are 	often 	considered
simultaneously. 	This 	ensures 	that 	the 	level 	of 	substantiation
expected 	of 	the 	advertiser 	is 	not 	likely 	to 	prevent 	consumers
from 	receiving 	potentially valuable 	information. 	rd. 	at 	823.
35 	In 	considering 	the 	fifth 	factor, 	all 	adverse 	effects,
including 	potential 	economic 	and 	health 	injury, 	are 	taken 	into
account. 	rd. 	at 	824-25.
36 	Under 	the 	sixth 	factor, 	the 	Commission 	looks 	to 	what 	the
scientific 	or medical 	community would 	require, 	as 	evidenced 	by
such 	sources 	as 	FDA 	regulations, 	expert 	opinion 	and/or expert
panel 	reports, 	to 	substantiate 	the 	claim. 	rd 	at 	825-26.
15

Under 	this 	flexible 	approach, 	the 	required 	level 	of
substantiation rises 	with 	the 	potential 	for 	consumer 	injury
should 	the 	claim 	turn 	out 	to 	be 	false. 	For example, 	where 	the
particular product 	claim 	raises 	concerns 	about 	possible 	injury 	to
the 	health 	or 	safety of 	consumers 	or 	will 	be 	difficult 	or
impossible 	for 	consumers 	to 	assess 	for 	themselves, 	the 	Commission
requires 	a 	relatively 	high 	level 	of 	substantiation. 3 ?
B. 	The 	FDA's 	Reyised 	Rule
FDA's 	revised 	rule 	is 	in 	large measure 	consistent 	with 	the
FTC's 	approach 	to 	regulating 	the 	advertising 	of 	health 	claims.
First, 	the 	rule 	prohibits 	claims 	that 	are 	not 	truthful 	or 	are
misleading. 	Similarly, 	the 	FTC 	Act, 	which 	prohibits 	deceptive
acts 	or 	practices, 	proscribes 	claims 	which 	are 	misleading 	or
untruthful.
Second, 	the 	rule 	requires 	that 	a 	claim be 	supported 	by
valid, 	reliable, 	scientific 	evidence; 	that 	this 	evidence 	be
derived 	from 	well-designed 	and 	conducted 	studies 	consistent 	with
generally-accepted 	scientific 	procedures 	and 	principles; 	and 	that
the 	studies 	be 	performed 	and 	evaluated by 	persons 	qualified 	by
expertise 	and 	training 	in 	appropriate 	disciplines. 	These
requirements 	also 	parallel 	well-established 	principles 	under 	the
37 	Ia 	at 	822.
16

FTC's 	ad 	substantiation 	doctrine. 	Commission 	orders 	often
require 	that 	advertisers 	possess 	"reliable 	and 	competent"
evidence 	to 	substantiate 	their 	representations, 	and 	typically
define 	such evidence 	as 	"those 	tests, 	analyses, 	research,
studies, 	or 	other evidence 	conducted 	and 	evaluated 	in 	an
objective manner 	by 	persons 	qualified 	to 	do 	so, 	using 	procedures
generally 	accepted 	in 	the 	profession 	to 	yield 	accurate 	and
reliable 	results.,,38
Third, 	the 	rule 	requires 	that 	the 	claim must 	be 	consistent
with 	generally-recognized medical 	and 	nutritional 	principles 	for
a 	sound 	dietary 	pattern. 	This 	also 	seems 	consistent 	with 	the
Commission's 	application 	of 	its 	deception 	policy. 	A health 	claim
that 	is 	unqualified 	as 	to 	the 	strength 	and 	source 	of 	its 	support
and 	is 	inconsistent 	with 	generally-recognized medical 	and
nutritional 	principles 	would 	be 	deceptive. 39 	Moreover, 	the 	very
nature 	of 	the 	epidemiological 	evidence 	currently 	supporting
38 	PharmTech Research, 	Inc., 	103 	F.T.C. 	448, 	459 	(1984).
~ ~ 	Porter 	& Dietsch, 	Inc., 	90 	F.T.C. 	770, 	868, 	885, 	aff'd
603 	F.2d 	294 	(7th Cir. 	1979) 	(company whose 	claims 	were 	not
supported 	by 	a 	reasonable 	basis 	consisting of 	"competent
scientific 	tests" 	placed 	under 	order 	requiring 	such
substantiation).
39 	In 	National 	Commission 	on 	Egg 	Nutrition, 	88 	F.T.C. 	89
(1976), 	the 	Commission 	successfully 	challenged 	as 	deceptive
advertising 	for 	eggs 	that 	claimed 	there 	was 	absolutely 	no
scientific 	evidence 	that 	eggs 	increased 	the 	risk 	of 	heart 	attack,
that 	characterized evidence 	that 	eggs 	increased 	the 	risk 	of 	heart
disease 	as 	a 	"myth," 	and 	that 	asserted 	that 	cholesterol 	was 	not
all 	that 	bad 	for 	you. 	The 	Commission 	found 	these 	ads 	deceptive
because, 	by 	failing 	to 	inform 	consumers 	of 	the 	inconsistencies 	in
the 	evidence 	supporting 	the 	position 	stated, 	the 	ads 	were 	likely
to mislead 	consumers.
17

health 	claims 	for 	food 	products 	(~, 	studies 	which may 	analyze
certain 	foods 	in 	the 	context 	of 	a 	total 	dietary 	regimen)
virtually 	requires 	that 	the 	advice 	be 	consistent with 	nutritional
principles 	for 	a 	sound 	total 	diet 	in 	order 	to 	avoid misleading
consumers.
C. 	Differences 	Between The 	FTC 	Policy And 	FDA's
Revised 	Rule
1. 	Amount 	Qf 	Substantiation Required
FDA's 	revised 	rule 	does 	not 	explicitly 	set 	forth 	the 	amount
of 	substantiation 	that 	would 	be 	required 	to 	support 	a 	health
claim 	on 	a 	food 	label. 	However, 	the 	preamble 	to 	the 	regulation
sets 	out 	what 	could 	be 	construed 	to 	be 	a 	very 	restrictive
standard. 	In 	discussing 	the 	revised 	rule's 	requirement 	that 	the
claim be 	based 	on valid 	scientific 	test 	data 	obtained 	by 	using
proper 	testing 	procedures, 	the 	preamble 	states 	that 	labeling
claims 	must 	"reflect 	the 	weight 	of 	scientific 	evidence" 	and 	that
preliminary 	results 	must 	be 	confirmed. 	If 	these 	statements, 	by
stressing 	that 	study 	results 	must 	be 	internally 	consistent 	and
internally 	confirmed, 	are 	mere 	elaboration on 	the 	section's
general 	requirement 	that 	the 	claim 	be 	based 	on 	scientific 	data
18

that 	is 	valid and 	reliable, 	then 	the 	provision 	parallels 	the
FTC's 	approach 	to 	advertising 	regulation. 40
However, 	the 	preamble 	could 	also 	be 	read 	to 	indicate 	that
the 	FDA will 	interpret 	the 	rule 	to 	prohibit 	any 	claim supported
only 	by 	preliminary 	evidence, 	even 	if 	the 	preliminary 	nature 	of
such 	evidence 	is 	expressly cited 	or explained. 	Further, 	it 	is
possible 	that 	the 	general 	"weight of 	the 	scientific_evidence"
standard 	could be 	interpreted 	like 	the 	1985 	interim 	"consensus"
guidelines 	announced 	by 	FDA 	staff. 41 	If 	these 	two
interpretations 	are 	intended 	and 	are 	incorporated 	into 	the 	text
of 	the 	revised 	rule, 	then 	the 	revised 	rule 	will 	continue 	to 	ban
some 	health 	claims 	that 	are 	supported 	by competent 	and 	reliable
scientific 	evidence 	simply because 	the 	findings 	are 	preliminary,
or 	because valid, 	reliable, 	scientific 	evidence 	has 	not 	yet
40 	Similarly, 	the 	results 	of 	one 	study 	that 	contradict 	the
results 	of 	a 	number 	of 	other 	studies 	may 	simply 	reflect 	a 	false
positive 	result 	and 	not 	be 	appropriate 	substantiation 	unless
those 	results 	are 	confirmed.
41 	Remarks 	of 	Joseph 	P. 	Hile, 	Associate 	Commissioner 	for
Regulatory 	Affairs 	before 	the 	Food 	and 	Drug 	Law 	Institute 	(March
1985). 	In 	his 	remarks, 	Mr. 	Hile 	suggested 	that 	a 	"consensus" 	of
the 	scientific 	community would 	be 	needed 	to 	substantiate 	health
claims 	on 	labels.
The 	preamble 	to 	the 	revised 	rule 	does 	not 	use 	the 	term
consensus, 	instead employing 	the 	term 	"weight 	of 	the 	scientific
evidence." 	The 	amount 	of 	evidence 	needed 	to 	satisfy 	this
standard 	is 	not 	explained 	in either 	the 	preamble 	or 	the 	revised
rule. 	It 	is 	therefore 	possible 	that 	this 	standard 	could 	also 	be
interpreted 	to 	require 	that 	a 	consensus 	of 	the 	scientific
community exist 	before 	the 	"weight of 	the 	scientific 	evidence"
is 	established.
19

become 	known 	and 	therefore 	generally 	accepted 	in 	the 	medical
community.
If, 	of 	course, 	the 	FDA 	has 	concerns 	about 	the 	safety 	of
either 	the 	product 	being promoted, 	or 	the 	dietary 	advice 	being
given, 	then 	a 	higher 	level 	of 	substantiation 	is 	appropriate. 42
If, 	however"the 	FDA 	is 	merely 	concerned 	that 	consumers 	not 	be
misled 	about 	the 	underlying 	strength 	of 	the 	substan~iation for
the 	claim and 	the 	weight 	that 	consumers 	should 	attach 	to 	it, 	then
there 	are 	more 	flexible 	formulations, 	such 	as 	the 	FTC's
substantiation 	doctrine, 	that 	would 	achieve 	that 	goal.
The 	revised 	rule 	will 	allow 	the 	FDA more 	flexibility 	in
determining 	whether 	claims 	are 	adequately 	substantiated 	than 	the
42 	In most 	cases, 	however, 	it 	is 	unlikely 	that 	the 	FDA 	will
have 	concerns 	about 	whether 	a 	food 	is 	a 	safety 	or 	a 	health
hazard, 	or 	that 	the 	nature 	of 	the 	claims 	being made 	for 	a
otherwise 	harmless 	product 	renders 	their very 	consumption 	a
health 	risk. 	Thus, 	for 	example, 	when 	FTC 	officials 	commented 	on
the 	Kellogg's 	All-Bran 	ad 	in 	1985 	they 	noted 	that 	they 	were 	aware
of 	no 	grave 	health 	or 	safety 	risks 	that 	flowed 	from 	choosing 	AII-
Bran 	over 	another 	breakfast 	cereal.
In 	contrast, 	there 	are 	instances 	where 	consumption 	of 	the
food 	as 	advertised 	does 	raise 	health 	or 	safety concerns. 	In
Estee, 	Inc., 	for 	example, 	the 	Commission 	alleged 	claims 	that
Estee's 	advertising 	encouraged 	diabetics 	to 	consume 	foods 	without
adequate 	substantiation 	about 	how 	those 	foods 	affected 	blood
sugar 	levels. 	Estee, 	Inc., 	102 	F.T.C. 	1804 	(1983). 	In 	such
cases, 	the 	health 	or 	safety 	risk 	obviously 	demands 	a 	high 	level
of 	substantiation. 	Indeed, 	the 	Commission 	has 	repeatedly
stressed 	that 	a 	high 	level 	of 	substantiation 	is 	required 	for
claims 	involving 	consumer 	health 	or 	safety. 	~ Thompson
Medical, 	104 	F.T.C. 	at 	822. 	However, 	in 	the 	food 	advertising
area, 	cases 	that 	involve 	health 	or 	safety 	threats 	seem 	to 	be 	the
exception 	rather 	than 	the 	rule. 	The 	flexible 	substantiation
doctrine 	used 	by 	the 	Commission would 	allow 	the 	FDA 	to 	deal
firmly 	with 	these 	cases 	without 	jeopardizing 	truthful 	claims.
20

agency 	has 	enjoyed 	in 	the 	past. 	The 	FDA's 	experience 	with 	the
regulation 	of 	cholesterol 	claims 	on 	food 	labels 	is 	illustrative.
Although 	evidence 	existed 	from 	as 	early 	as 	1957 	that 	low-fat,
low-cholesterol 	diets 	were 	associated with 	reductions 	in 	the 	risk
of 	heart 	disease, 	FDA 	rules 	precluded 	the 	use 	of 	this 	information
on package 	labels. 43 	At 	that 	time 	FDA 	officials 	had 	no 	means 	of
predicting 	the 	strength 	of 	the 	evidence 	that 	would 	ultimately
accumulate 	on 	the 	relationship 	between cholesterol,-saturated 	fat
intake 	and 	health. 44 	In 	the 	early 	1970's, 	the 	FDA 	began 	to
permit 	the 	labeling 	of 	fatty 	acid 	content 	but 	not 	more 	explicit
health 	claims. 	Since 	then 45 	the 	relationship 	between
43 	Hutt, 	GQvernment 	RequlatiQn 	Qf 	Health 	Claims 	in 	FQod
Labelinq 	and 	Advertising, 	41 	FOQd 	Drug 	CQsm ..L.J. 	3 	(1986).
44 	Medical 	authQrities 	nQW 	widely 	accept 	that 	a 	high
chQlesterQl 	level 	is 	an 	impQrtant 	risk 	factQr 	fQr 	heart 	attack
and 	strQke 	and 	that 	limiting 	dietary 	intake 	of 	chQlesterol 	and
saturated 	fat 	can 	play 	an 	impQrtant 	role 	in 	lowering 	chQlesterQl
levels. 	American 	Heart 	AssociatiQn, 	The 	American 	Heart
Association 	Diet, 	An 	Eating 	Plan 	FQr Healthy Americans 	(1985).
Indeed, 	new 	guidelines 	fQr 	physicians 	released 	by 	the 	NatiQnal
ChQlesterQl 	EducatiQn 	PrQgram, 	an 	arm 	Qf 	the 	NatiQnal 	Health,
Lung 	and 	BIQQd 	Institute, 	recQmmend 	dietary 	mQdifications
(restrictions 	Qf 	fats 	tQ 	30 	percent 	Qf 	tQtal 	calQries, 	saturated
fats 	tQ 	10 	percent 	Qf 	tQtal 	calQries 	and 	chQlesterQI 	to 	300
milligrams 	daily) 	fQr 	persQns 	with 	cholesterQl 	levels 	abQve 	200
as 	Qne 	step 	in 	reducing 	chQlesterQI 	levels 	and 	so, 	the 	risk 	Qf
heart 	disease. 	~,~, CQntrQlling 	ChQlesterol, 	Newsweek,
OctQber 	19, 	1987, 	at 	95.
45 	In 	1973, 	the 	FDA 	adQpted 	regulatiQns 	permitting 	labels
to 	include 	specific 	numerical 	informatiQn 	about 	cholesterol 	and
fat 	levels. 	The 	regulations 	restrict 	the 	infQrmatiQn 	to 	CQntent
infQrmatiQn 	and 	a 	required 	statement 	that 	the 	information 	is
prQvided 	fQr 	individuals 	mQdifying 	their 	dietary 	fat 	intake 	Qn
the 	advice 	of 	a 	physician. 	All 	Qther 	health 	claims 	were
prohibited 	by 	the 	regulatiQns. 	~ 	21 	C.F.R. 	S 	101.25. 	In 	1986,
the 	FDA 	propQsed 	tQ 	modify 	these 	regulatiQns. 	FQod Labeling,
Definitions 	of 	CholesterQI 	Free, 	Low 	CholesterQI 	and 	Reduced
CholesterQI, 	51 	Fed. 	Reg. 	42584 	(1986)(tQ 	be 	cQdified 	at 	21
21

cholesterol, 	saturated 	fat 	and 	an 	increased 	risk 	of 	heart 	disease
has 	gained 	broad 	acceptance. 46 	However, 	the 	history of 	the 	FDA's
past 	approach 	is 	instructive. 	On 	the 	question of 	diet 	and
health, 	it 	will 	often be 	the 	case 	that 	fully 	confirmatory 	data
are 	not 	available 	until 	some 	time 	after 	the 	association 	has 	begun
to 	be 	established. 	This 	being 	the 	case, 	we 	think 	consumers 	would
be 	better 	off 	with 	a 	policy 	that 	permits 	carefully qualified
truthful 	information 	about 	diet-health 	relationships 	than with 	a
policy 	that 	prohibits 	such claims.
It 	is 	important 	to 	balance 	the 	desire 	for 	certainty 	against
lost 	benefits 	of 	truthful 	claims 	if 	an 	inflexible 	standard 	is
used. 	The 	FTC's 	substantiation 	doctrine 	offers 	an 	alternative 	of
addressing 	questions 	that 	may 	arise 	in 	the 	future, 	balancing 	as
it 	does 	the 	benefits 	of 	a 	truthful 	claim with 	risks 	of 	a 	false
one. 	In 	fact, 	in 	recent 	years 	the 	Commission 	has 	applied 	its 	ad
substantiation 	standards 	to 	cholesterol 	and 	fatty 	acids. 	The
Commission 	has 	both 	allowed 	truthful 	advertising 	about 	the
C.F.R. 	Part 	101).
46 	The 	claims 	made 	in 	the 	past 	about 	the 	relationship
between cholesterol, 	saturated 	fat 	and 	heart 	disease 	were
prohibited by 	the 	FDA's 	regulations 	specifically 	governing
cholesterol 	and 	fat 	labeling 	(21 	C.F.R. 	S 	101.25) 	(under which
virtually 	all 	cholesterol 	and 	fat-related 	health 	claims 	had 	been
effectively 	prohibited). 	The 	FDA 	indicated 	in 	the 	1986 	notice
proposing 	changes 	to 	its 	current 	cholesterol 	labeling 	rules 	that
an upcoming 	revised 	health claims 	rulemaking 	would 	address 	and
set 	out 	the 	FDA's 	policy 	regarding 	health 	claims 	including
cholesterol/fat 	health 	claims. 	51 	Fed. 	Reg. 	at 	42587. 	Thus, 	the
proposal 	that 	is 	the 	subject 	of 	this 	comment 	would 	govern 	these
claims 	if 	they 	were made 	today.
22

relationship 	between 	cholesterol, 	saturated 	fat 	and 	heart
disease, 	as 	well 	as 	taken 	action where 	necessary 	to 	correct
misstatement. 47
2. 	Eyidence 	Must 	Be 	Publicly Ayailable
The 	FDA's 	revised 	rule 	also 	differs 	from 	the 	Commission's
substantiation 	policy 	in 	that 	it 	does 	not 	permit 	reliance 	on
proprietary data 	to 	support 	claims. 	The 	requirement 	that 	the
data 	be 	publicly 	available 	has 	benefits 	and 	drawbacks.
One 	benefit 	of 	such 	a 	restriction may 	be 	that, 	to 	the 	extent
that 	manufacturers 	conduct 	research 	and 	release 	it 	in 	order 	to
make 	claims, 	the 	public 	will 	gain 	access 	to 	additional
information. 	Moreover, 	a 	substantiation 	standard 	incorporating
such 	a 	requirement 	will 	probably 	require 	fewer 	FDA enforcement
resources 	because 	the 	data 	will 	be 	subject 	to 	the 	review 	and
criticism of 	the 	scientific 	community 	before 	it 	is 	used 	as
substantiation, 	thus 	providing 	the 	FDA 	with 	a 	better basis 	on
which 	to 	assess 	labeling 	claims. 	In 	addition, 	because 	of 	the
peer 	review 	and 	criticism 	that 	publicly 	available 	research 	will
face, 	such 	research 	is 	likely 	to 	be more 	rigorously 	tested 	and
carefully 	performed 	than 	in-house 	proprietary 	research.
47 	~,~, 	National 	Commission 	on 	Egg 	Nutrition, 	88
F.T.C. 	89 	(1976).
23

There 	are, 	however, 	costs 	associated 	with 	an 	absolute
prohibition on claims 	based 	on 	proprietary 	information. 	In
particular, 	the 	benefits 	to 	a 	firm 	of 	investing 	in 	research 	are
eroded when 	the 	research 	results 	are 	made 	available 	to
competitors 	as 	a 	basis 	for 	parallel 	claims 	by 	them. 	Firms
therefore 	might 	not 	make 	beneficial 	health 	claims 	that 	can 	be
substantiated 	by 	proprietary 	research 	if 	in 	doing 	so 	they 	are
required 	to 	make 	that 	research 	data 	public. 48 	If 	PFoprietary
research 	cannot 	be 	used 	as 	a 	basis 	for 	health 	claims, 	firms 	may
decide 	to 	invest 	less 	in 	such 	health 	research 	than 	they 	might
otherwise 	have 	done. 	Either 	action 	could 	be 	detrimental 	to
consumers.
3. 	The 	Nutritional 	Labelin~ ReQuirement
The 	FDA's 	rule 	requires 	that 	food 	labels 	with 	health 	claims
must 	also 	contain complete 	nutritional 	labeling. 	This
requirement 	is 	different 	from 	the 	FTC's 	approach 	with 	respect 	to
food 	advertising, 	which 	is 	to 	require 	disclosure 	of 	additional
information 	only when 	thefailure 	to 	provide 	it 	would 	be 	unfair 	or
deceptive. 	The 	FDA's 	proposed 	revision 	has 	both 	benefits 	and
costs 	which 	should 	be weighed.
48 	It 	is, 	of 	course, 	clear 	that 	the 	FDA 	itself 	would 	need
access 	to 	any 	proprietary 	data 	on which 	a 	firm 	relied 	and 	to 	any
proprietary 	data 	that 	did 	not 	support 	the 	claim.
24

The 	FDA's 	across-the-board 	nutritional 	labeling 	requirement,
which 	would be 	automatically 	triggered 	by 	a 	health 	claim 	on 	the
label, 	would 	provide 	consumers 	with more 	information concerning
health 	claims. 	Thus, 	this 	requirement 	addresses 	concerns 	that
consumers 	will 	be 	misled 	by 	labeling 	that 	does 	not 	disclose
nutritional 	flaws.
However, 	the 	nutritional 	labeling 	requirement 	may 	raise 	the
cost 	of 	making 	health claims. 	These 	costs 	might 	deter
manufacturers 	from making 	some 	beneficial 	claims. 	Moreover, 	the
goal 	of 	providing 	protection 	against 	potentially misleading
claims 	might 	be 	better 	attained 	through means 	other 	than 	the
proposed 	across-the-board 	nutritional 	labeling 	requirement. 	For
example, 	disclosure 	of 	additional 	information 	including
disclosure 	of 	relevant 	nutritional 	flaws 	-- 	could 	be 	required 	on
a 	case-by-case 	basis 	in 	those 	instances 	where 	deception 	would
exist 	without 	the 	disclosure. 49 	Alternatively, 	in 	a 	regulatory
environment 	in 	which 	competitors 	are 	free 	to make 	adequately
substantiated comparative 	health 	claims, 	the 	market 	might 	provide
adequate 	incentives 	for 	competitors 	to 	supply 	useful 	information
49 	~,~, 	Adria 	Laboratories 	Inc., 	103 	F.T.C. 	512, 	524-
25 	(1984) (Cornmission 	required 	manufacturer of 	a 	non-aspirin
product 	with 	side 	effects 	similar 	to 	aspirin 	to 	disclose 	such
fact 	whenever 	it 	made 	representations 	that 	the 	product 	contained
no 	aspirin 	or made 	representations 	that 	compared the 	product 	to
aspirin).
25

about 	the 	nutritional 	attributes 	of 	competing 	products 	if
consumers 	desired 	to 	receive 	the 	information. SO
4. 	Health Message 	Committee
The 	preamble 	to 	the 	FDA's 	proposed 	revision 	to 	its 	rule 	on
health 	claims 	states 	that 	the 	Assistant 	Secretary 	for 	Health
intends 	to 	establish 	a 	standing 	Public 	Health Service 	Committee
to 	draft 	model 	health messages 	for 	food 	labeling. 	Such model
messages 	might 	have 	been 	an 	aid 	to 	compliance 	if 	FDA 	adopted 	the
more 	vaguely-worded consensus 	standard 	it 	had 	originally
proposed. 	However, 	the 	FDA 	has 	not 	adopted 	that 	approach, 	and 	we
hope 	that 	the 	FDA will 	further 	clarify the 	current 	standard 	in
response 	to 	these 	comments. 	Such 	revisions 	would 	make 	regulatory
guidance 	in 	the 	form 	of 	model 	messages 	much 	less 	necessary. 	More
importantly, 	although 	the 	preamble 	expressly 	states 	that 	food
manufacturers 	are 	not 	required 	to 	use 	the 	model 	messages, 	there
is 	at 	least 	some 	risk 	that 	manufacturers 	will 	use 	the
standardized messages 	exclusively 	in 	order 	to 	avoid 	the
possibility 	of 	having 	to 	undergo 	costly 	revisions 	of 	their
labels. 	If 	so, 	the 	model 	message 	may 	interfere 	with 	ordinary
competitive 	forces 	that 	would otherwise 	lead 	food 	marketers 	to
make 	health messages 	as 	noticeable 	as 	possible. 	Standardized
50 	~,~, 	the 	Promise 	Margarine 	advertisement 	discussed
at 	footnote 	19.
26

messages 	may 	decrease 	the 	diversity of 	the 	messages, 	which may 	in
turn 	decrease 	the 	possibility 	that 	the 	consumer will 	notice 	the
information 	and 	understand 	it. 51
This 	is 	not 	to 	say 	that 	the 	government 	cannot 	serve 	other
important 	functions 	to 	encourage 	better 	dissemination 	of 	health
information. 	For 	example, 	it 	may 	participate 	in 	joint 	promotions
such 	as 	Kelloggs' 	and 	the 	National 	Cancer 	Instituters 	All-Bran
campaign. 	Similarly, 	the 	Public 	Health 	Service 	committee 	might
serve 	an 	important 	coordinating 	function 	in 	helping 	develop
jointly 	sponsored 	public 	health 	campaigns.
IV. 	CONCLUSION
We 	support 	FDA's 	action 	in 	proposing 	revisions 	to 	its 	rules
regarding 	health 	messages 	on 	food 	labeling 	because 	it 	will
encourage 	the 	dissemination 	by 	food 	manufacturers 	of 	important
information 	about 	the 	relationship 	between 	diet 	and 	health. 	We
do 	recommend, 	however, 	that 	FDA 	adopt 	a 	more 	flexible 	standard
than 	it 	has 	proposed 	for 	the 	substantiation of 	health 	claims 	that
adjusts 	the 	level 	of 	substantiation 	to 	the 	type 	of 	claim. 	We
51 	This 	was 	the 	case 	in 	the 	single mandated 	health 	warning
in 	cigarette 	advertising. 	~ 	Federal 	Trade 	Commission, 	Staff
Report 	On 	The 	Cigarette 	Advertising 	Investigation, 	pp. 	4-10 	to 	4-
12 	(1981). 	In 	addition, 	the 	currently 	required 	disclosure 	that
cholesterol 	content 	information 	nis 	provided 	for 	individuals 	who
on 	advice 	of 	a 	physician 	are 	modifying 	their 	dietary 	intake 	of
fat n 	may 	diminish 	the 	attention 	given 	to 	this 	information 	by
ordinary 	consumers 	who 	are 	not 	under 	a 	doctor's 	care. 	21 	C.F.R.
§ 	101.25(d).
27

also 	suggest 	that 	FDA 	consider 	accepting 	proprietary 	data 	as 	well
as 	publicly available 	data 	as 	substantiation 	for 	health 	claims.
Finally, 	we 	question 	the 	necessity or 	advisability of 	a 	committee
to 	draft 	model 	health 	claim messages.
28