FTC Staff Comment Before the Food and Drug Administration In the Matter of Sunscreen Products for Over-the-Counter Human Use

V940006
COMMISSION AUTHORIZED
BEFORE 	THE
DEPARTMENT OF HEALTH AND 	HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
In 	The 	Matter 	of
Sunscreen 	Drug 	Products
for 	Over-the-Counter 	Human 	Use;
Tentative 	Final 	Monograph
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Docket 	No. 	78N-0038
Comments 	of 	the 	Staff 	of
the 	Bureau 	of 	Consumer 	Protection
of 	the 	Federal 	Trade 	Commission·
February 	7, 	1994
• These 	comments 	are 	the 	views 	of 	the 	staff 	of 	the 	Bureau 	of
Consumer 	Protection 	of 	the 	Federal 	Trade 	Commission. 	They 	do 	not
necessarily 	represent 	the 	views 	of 	the 	Commission 	or 	any
individual 	Commissioner. 	Inquiries 	regarding 	this 	comment 	should
be 	directed 	to 	Toby 	Levin 	(202-326-3156) 	or 	Susan 	Cohn 	(202-326-
3053) .

I. 	Introduction and 	Summary
On 	May 	12, 	1993, 	the 	Food 	and 	Drug 	Administration 	("FDA")
published 	its 	Tentative 	Final 	Monograph 	("TFM") 	on 	Sunscreen 	Drug
Products 	for 	Over-the-Counter Human 	Use 	and 	requested 	comments 	on
aspects 	of 	it. 1 	The 	108-page 	TFM 	summarizes 	the 	scientific
evidence 	about 	acute 	and 	long-term 	injuries 	associated 	with 	sun
exposure 	and 	concludes 	that 	sunscreens 	may play a 	significant
role 	in 	providing varying 	levels 	of 	protection 	from 	these 	harms.
Based 	on 	our 	experience 	in 	analyzing 	the 	effects 	of 	information
in 	consumer 	product 	markets 	and 	in 	considering 	regulations 	that
address 	information 	issues, 	the 	staff 	of 	the 	Bureau 	of 	Consumer
Protection 	of 	the 	Federal 	Trade 	Commission 	("FTC") 	offers 	the
following 	comments 	to 	assist 	FDA 	in 	its 	deliberations. 2
The 	FTC 	enforces 	sections 	5 	and 	12 	of 	the 	Federal 	Trade
Commission Act, 	prohibiting 	deceptive 	or 	unfair 	practices 	in 	or
affecting 	commerce 	and 	false 	advertisements 	of 	drugs 	and
cosmetics 	(and 	other 	items).3 	One 	of 	the 	FTC's 	major
responsibilities 	is 	to 	prevent 	unfair 	and 	deceptive 	advertising,
and 	one 	important 	application 	of 	that 	responsibility 	has 	been 	the
prevention 	of 	deceptive 	advertising 	of 	over-the-counter 	("OTC")
drug 	products. 	Advertising 	can 	effectively provide 	consumers
with 	useful 	information, 	enabling 	them 	to 	make 	informed 	choices
in 	purchasing 	and 	using 	products. 	The 	FTC 	has 	developed
considerable 	expertise 	in 	understanding 	the 	roles 	of 	advertising
1 	58 	Fed. 	Reg. 	at 	28194 	(1993) 	(to 	be 	codified 	at 	21
C.F.R. 	Parts 	352, 	700, 	and 	740) .
2 	These 	comments 	are 	the 	views 	of 	the 	staff 	of 	the 	Bureau
of 	Consumer 	Protection 	of 	the 	Federal 	Trade 	Commission. 	They 	do
not 	necessarily 	represent 	the 	views 	of 	the 	Commission 	or 	any
individual 	Commissioner.
3 	15 	U.S.C. 	§§ 	45, 	52. 	Under 	section 	12 	of 	the 	FTC 	Act,
the 	Commission 	has 	jurisdiction over 	the 	advertising 	of 	food,
drugs, 	devices, 	and 	cosmetics. 	The 	FTC 	also 	has 	concurrent
jurisdiction with 	FDA over 	the 	labeling 	of 	foods, 	OTC 	drugs,
devices 	and 	cosmetics. 	In 	addition, 	the 	FTC 	has 	statutory
authority 	to 	enforce 	a 	number 	of 	laws 	that 	mandate 	disclosure,
including 	the 	Federal 	Cigarette 	Labeling 	and Advertising 	Act, 	the
Truth 	in 	Lending 	Act, 	and 	the 	Energy 	Policy 	and 	Conservation 	Act,
which 	regulates 	appliance 	labeling, 	and 	to 	enforce 	several 	laws
relating 	to 	standard-setting, 	including 	the 	Wool 	Products
Labeling Act, 	and 	the 	Magnuson-Moss 	Warranty 	& FTC 	Improvement
Act. 	The 	FTC 	has 	also 	promulgated 	disclosure 	rules, 	such 	as 	the
R-Value 	Rule, 	which 	regulates 	thermal 	insulation 	labeling, 	the
Used 	Car 	Rule, 	which 	requires 	warranty 	disclosures, 	and 	the 	Care
Labeling 	Rule, 	which 	regulates 	clothing 	labeling.
1

and 	labeling 	in 	providing 	consumers 	with 	information 4 	and
regularly 	considers 	information 	issues 	in 	the 	context 	of 	OTC 	drug
advertising.
The 	FTC 	has 	had 	a 	longstanding 	interest 	in 	products 	claiming
to 	reduce 	the 	harms 	associated 	with 	ultraviolet 	light. 	The 	FTC
has 	entered 	four 	administrative 	consent 	orders 	against 	allegedly
false 	and 	deceptive 	health 	and 	safety 	claims 	for 	artificial
tanning 	beds, 	and 	one 	about 	sunscreen 	products. 	These 	orders
have 	been 	directed 	at 	claims 	that 	tanning 	with 	artificial 	tanning
beds 	does 	not 	contribute 	to 	the 	risk 	of 	developing 	skin 	cancer 	or
other 	harmful 	side 	effects 	associated 	with 	sun 	exposures 	and
that 	a 	sunscreen 	product 	blocks 	all 	of 	the 	harmful 	rays 	that
cause 	photoaging. 6 	In 	addition, 	the 	Commission 	has 	issued 	two
consumer 	education 	brochures 	about 	sunscreens, 	tanning, 	and 	the
risks 	of 	various 	types 	of 	skin 	damage 	associated 	with 	exposure 	to
ultraviolet 	rays.7 	The 	staff 	of 	the 	Commission 	continues 	to
monitor 	sunscreen 	advertising 	to 	ensure 	that 	consumers 	are 	not
misled 	by 	deceptive 	claims 	about 	the 	protective 	efficacy 	of 	these
products.
The 	FDA's 	goal 	in 	issuing 	the 	TFM, 	to 	provide 	accurate,
adequate 	information 	so 	consumers 	can make 	better-informed
choices 	in 	protecting 	themselves 	against 	sun-induced 	skin 	damage,
is 	important. 	The 	TFM 	recognizes 	the 	importance 	of 	craft:i.L:;:j
sunscreen 	labeling 	regulations 	that 	will 	encourage 	appropriate
use 	of 	protective 	products, 	yet 	not 	create 	a 	false 	sense 	of
security.8 	The 	TFM's 	proposed 	regulations 	address 	these
important 	goals. 	Some 	aspects 	of 	the 	TFM's 	labeling 	language
might, 	however, 	unintentionally 	lead 	consumers 	to 	believe 	that
4 	Relevant 	FTC 	staff 	research 	includes: 	P. 	Ippolito 	& A.
Mathios, 	Health 	Claims 	in 	Advertising 	and 	Labeling: 	A Study 	of 	the
Cereal 	Market 	(1989); 	M. 	Lynch, 	R. 	Miller, 	C. 	Plott 	& W. 	Porter,
Experimental 	Studies 	of 	Markets 	With 	Buyers 	Ignorant 	of 	Quality
Before 	Purchase: 	When 	Do 	'Lemons' 	Drive 	Out 	High 	Quality 	Product?
(1986); 	M. 	Frankena, 	M. 	Cohen, 	T.Daniel, 	L. 	Ehrlich, 	N. 	Greenspun
& D. 	Keenan, 	Alcohol, 	Advertising, 	Consumption, 	and 	Abuse, 	(1985)
S 	Sun 	Industries 	Inc., 	110 	F.T.C. 	511 	(1988); 	The 	Silver
Group, 	110 	F.T.C. 	380 	(1988); 	An-Mar 	International 	Ltd. 	Inc., 	112
F.T.C. 	72 	(1989); 	and 	Haverhills, 	C-3322 	(Jan. 	25. 	1991).
6 	Revlon 	Inc. 	and 	Charles 	Revson, 	Inc., 	Docket 	No. 	9231,
November 	17, 	1993.
7 	"Sunscreens," 	Facts 	for 	Consumers, 	April 	1990; 	"Indoor
Tanning," 	Facts 	for 	Consumers, 	March 	1993. 	FTC 	staff 	coordinated
with 	FDA 	staff 	in 	the 	development 	of 	each 	of 	these 	brochures.
8 	58 	Fed. 	Reg. 	at 	28288, 	TFM 	Comment 	53.
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sunscreen 	products, 	particularly 	low 	SPF 	products, 	provide
greater 	protection 	than 	may 	be 	the 	case. 	Consumers 	cannot 	judge
accurately 	for 	themselves 	what 	level 	of 	protection 	sunscreen
products 	provide 	against 	chronic, 	long-term 	skin 	injuries 	such 	as
premature 	skin 	aging 	and 	skin 	cancer, 	so 	they 	must 	depend 	on 	the
product 	labeling 	(or 	other 	sources) 	for 	information. 	This
necessary 	reliance 	on 	the 	labeling 	makes 	it 	particularly
important 	that 	FDA's 	regulations 	not 	unintentionally 	endorse
labeling 	language 	that 	may 	confuse 	consumers 	about 	how 	much
protection 	these 	products 	can 	provide.
Many 	of 	the 	issues 	addressed 	in 	this 	comment 	concern 	the
inferences 	that 	consumers 	may 	draw 	from 	the 	use 	of 	particular
terms. 	We 	are 	aware 	of 	no 	consumer 	perception 	studies 	or 	other
consumer 	research 	that 	would 	help 	determine 	what 	meaning 	the
TFM's 	proposed 	labeling 	terminology 	conveys 	to 	consumers.
Because 	of 	the 	importance 	of 	the 	potential 	health 	consequences 	if
consumers 	take 	unintended 	messages 	from 	sunscreen 	labeling
claims, 	we 	suggest 	that 	the 	FDA 	consider 	obtaining 	empirical
information 	on 	consumers' 	interpretation 	of 	the 	proposed
terminology before 	issuing 	its 	final 	monograph. 	The 	remainder 	of
this 	comment 	identifies 	proposed 	labeling 	terminology 	that 	we
believe 	may 	be 	susceptible 	to 	unintended 	interpretations, 	which
the 	FDA may 	therefore 	wish 	to 	consider 	evaluating 	through
consumer 	research.
II. 	Sunscreen 	Product 	Guide
The 	TFM 	requires 	that 	the 	labeling 	of 	all 	sunscreen 	products
include 	the 	following 	chart: 9
9 	TFM 	Comment 	43, 	at 	28217, 	and 	§ 	352.52(e) (4), 	at 	28298.
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RECOMMENDED 	SUNSCREEN PRODUCT
GUIDE
Sunburn 	and 	tanning
history
Always 	burns 	easily;
rarely 	tans
Always 	burns 	easily;
tans 	minimally
Burns 	moderately; 	tans
gradually
Burns 	minimally; 	always
tans 	well
Rarely burns; 	tans
profusely
Recommended 	sun
protection 	product
SPF 	20 	to 	30
SPF 	12 	to 	under 	20
SPF 	8 	to 	under 	12
SPF 	4 	to 	under 	8
SPF 	2 	to 	under 	4
The 	"Sunscreen 	Product 	Guide" 	thus 	identifies 	5 	categories 	of
skin 	types, 	based 	on 	sunburn 	and 	tanning 	experience, 	and
recommends 	specific 	SPF 	numbered 	products 	for 	each 	category.
This 	guide 	appears 	to 	reflect 	an 	intention 	on 	the 	part 	of 	the 	FDA
to 	provide 	information 	both 	to 	consumers 	who 	wish 	to 	use 	a
sunscreen 	product 	to 	assist 	tanning 	and 	to 	consumers 	who 	wish 	to
protect 	themselves 	from 	the 	skin 	injuries 	caused 	by 	the 	sun. 	The
staff 	of 	the 	Commission 	is 	concerned, 	however, 	that 	the
unintended 	effect 	of 	this 	guide 	may 	be 	to 	lead many 	consumers 	to
use 	and 	rely 	on 	products 	with 	relatively 	low 	SPF 	numbers,
believing 	that 	the 	products 	will 	provide 	a 	greater 	degree 	of
protection 	than 	may 	actually 	be 	the 	case.
For 	three 	of 	the 	five 	skin 	types 	identified, 	the 	guide
recommends 	reliance 	on 	products 	with 	SPF 	values 	of 	less 	than 	12.
As 	the 	TFM 	recognizes, 	the 	NIH 	Consensus 	Development 	Conference
Statement 	and 	the 	American 	Association 	of 	Dermatology both 	have
recommended 	that 	consumers, 	regardless 	of 	their 	skin 	type, 	use 	at
least 	an 	SPF 	15 	product 	to 	protect 	themselves 	from 	the 	harms
associated 	with 	exposure 	to 	the 	sun's 	rays.10 	We 	are 	concerned,
10 	See 	58 	Fed. 	Reg. 	at 	28221, 	TFM 	Comment 	45; 	Taylor, 	et
al., 	"Photoaging/photodamage 	and 	photoprotection," 	Journal 	of 	the
American Academy 	of 	Dermatology, 	Vol. 	1, 	No.1, 	Jan. 	1990 	at 	p. 	10.
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however, 	that 	this 	chart 	might 	imply 	to 	consumers 	that 	such
levels 	,f 	protection 	are 	unnecessary 	and 	perhaps 	even
undesirable. 11 	The 	guide's 	product 	usage 	recommendations 	will
carry 	great 	weight 	and 	credibility 	with 	consumers, 	because 	they
would 	be 	the 	mandated, 	standardized 	recommendations 	of 	the 	FDA,
rather 	than 	promotional 	language 	devised 	by 	the 	products'
promoters. 	Thus, 	consumers 	might 	assume 	that 	adhering 	to 	these
FDA 	recommendations 	will 	provide 	the 	level 	of 	protection 	from 	the
sun's 	rays 	believed 	to 	be 	appropriate 	by 	the 	relevant 	public
health 	community. 	If 	the 	chart 	is 	misinterpreted 	to 	be 	an
implicit 	endorsement 	of 	low SPF 	products, 	the 	proposed 	guide 	may
give 	consumers 	an 	unwarranted 	sense 	of 	security 	about 	the 	level
of 	protection 	low 	SPF 	products 	provide.
The 	guide's 	SPF-level 	recommendations 	are 	apparently 	based
on 	the 	likelihood 	of 	experiencing 	sunburn. 	Protection 	against
sunburn 	is 	clearly 	important 	to 	consumers; 	however, 	it 	is 	our
understanding 	that 	protection 	against 	sunburn 	may 	not 	necessarily
be 	correlated 	with 	protection 	against 	the 	longer 	term 	chronic
harms 	of 	sun 	exposure, 	such 	as 	skin 	cancer 	and 	premature 	skin
aging. 12 	Staff 	is 	concerned 	that, 	by 	focussing 	on 	sunburn 	and
protection 	from 	sunburn, 	the 	guide 	may 	unintentionally 	contribute
to 	a 	consumer 	misperception 	that 	exposure 	to 	the 	sun 	is 	risk 	free
as 	long 	as 	sunburn 	is 	avoided. 	Thus, 	the 	guide 	may 	imply 	that
use 	of 	the 	recommended 	sunscreens 	renders 	suntanning 	safe, 	an
implication 	that 	could 	encourage 	those 	who 	would 	like 	to 	tan 	to
believe 	that 	they 	can 	do 	so 	without 	risk 	of 	more 	serious 	skin
damage.
One 	aspect 	of 	the 	proposed 	labeling, 	the 	"sun 	alert" 	that
would 	be 	required 	on 	package 	labels, 	is 	intended 	to 	counter 	some
of 	the 	risks 	described 	here. 	This 	required 	language 	is:
SUN ALERT: 	The 	sun 	causes 	skin 	damage. 	Regular 	use 	of
sunscreens 	over 	the 	years 	may 	reduce 	the 	chance 	of 	skin
11 	Indeed, 	consumers 	might 	misconstrue 	the 	recommendations
to 	discourage 	them 	from 	using 	products 	with 	SPF 	values 	higher 	than
the 	upper 	end 	of 	the 	range 	correlated 	with 	their 	skin 	type. 	For
instance, 	consumers 	who 	believe 	they 	burn 	minimally 	and 	always 	tan
well 	may 	infer, 	incorrectly, 	from 	the 	chart's 	advice 	to 	use
sunscreen 	products 	with 	SPF 	values 	of 	4 	to 	under 	8, 	that 	products
with 	SPF 	values 	of 	8 	or 	higher 	are 	not 	recommended.
12 	See 	58 	Fed. 	Reg. 	at 	28232, 	28288; 	see 	also 	Donawho 	&
Wolf, 	J. 	Natl' 	Cancer 	Inst._ 	(Jan. 	19, 	1994) 	(study 	of
effectiveness 	of 	sunscreen 	in 	preventing 	tumors 	in 	sunscreen-
protected 	mice) .
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aging, 	some 	types 	of 	skin 	cancer, 	and 	other 	harmful 	effects
due 	to 	the 	sun. 13
If 	the 	FDA 	undertakes 	any 	consumer 	research 	about 	the 	language
that 	the 	TFM 	requires 	or 	authorizes, 	this 	"sun 	alert" 	should 	be
included 	to 	determine 	what 	messages 	or 	warnings 	consumers
understand 	from 	it. 	The 	FDA may 	also 	wish 	to 	consider 	the
scientific 	community's 	recommendation 	that 	consumers 	use 	at 	least
an 	SPF 	15 	product 	for 	protection. 14
III. 	Permitted 	Indications
The 	TFM 	authorizes 	some 	indication 	statements 	that 	may
convey 	protection 	claims 	that 	are 	more 	absolute 	than 	the 	FDA may
intend 	to 	allow. 	The 	TFM's 	discussion 	of 	labeling 	references 	to
skin 	cancer 	and 	premature 	skin 	aging 	makes 	clear 	that 	unqualified
sunscreen 	product 	claims 	regarding 	protection 	against 	these 	harms
would 	be 	deemed 	unacceptable. 	For 	instance, 	in 	explaining 	why
claims 	such 	as 	"[p]revent 	(or 	reduce) 	skin 	aging 	caused 	by
exposure 	to 	ultraviolet 	rays" 	would 	be 	objectionable, 	the 	TFM
states 	that" [t]he 	agency 	objects 	to 	the 	absolute 	term 	'Prevent
(or 	reduce)' 	used 	in 	this 	claim 	... 	The 	agency 	concludes 	that
a 	qualified 	statement 	is 	appropriate, 	and 	that 	the 	use 	of
absolute 	terms 	such 	as 	'prevent' 	is 	not 	justified 	in 	the 	l~~~lin:
of 	sunscreen 	drug 	products. ,,15 	The 	TFM 	also 	provides 	examples
of 	claims 	regarding 	protection 	against 	premature 	aging 	that 	the
FDA would 	deem 	acceptable. 	Each 	of 	these 	examples 	explicitly
includes 	the 	word 	"may" 	to 	qualify 	the 	protective 	benefits 	of
sunscreens:
(1) 	Sunscreen may 	reduce 	the 	chance 	of 	skin 	aging 	caused 	by
exposure 	to 	the 	sun.
(2) 	While 	biological 	aging 	is 	inevitable, 	sunscreen 	may 	help
protect 	skin 	from 	aging 	caused 	by 	exposure 	to 	ultraviolet
radiation 	from 	the 	sun.
(3) 	Skin 	can 	age 	prematurely 	from 	exposure 	to 	the 	sun.
Sunscreen 	may 	help 	reduce 	the 	chance 	of 	this 	type 	of 	aging.
(4) 	May 	help 	inhibit 	the 	signs 	of 	skin 	aging 	caused 	by
exposure 	to 	ultraviolet 	rays 	from 	the 	sun. 16
(emphasis 	added) .
13
at 	28298.
14
15
16
58 	Fed. 	Reg. 	at 	28286, 	TFM 	Comment 	51 	and 	§ 	352.52(e) (6)
See 	n. 	10, 	supra.
58 	Fed. 	Reg. 	at 	28287-88, 	TFM 	Comment 	52.
58 	Fed. 	Reg. 	at 	28287, 	TFM 	Comment 	52.
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The 	TFM/s 	discussion 	of 	claims 	regarding 	skin 	cancer
protection 	is 	similar. 	The 	two 	examples 	of 	skin 	cancer 	related
claims 	that 	are 	considered 	acceptable 	both 	include 	the 	qualifying
word 	"may":
(1) 	May 	reduce 	the 	chance 	of 	some 	kinds 	of 	skin 	cancers
caused 	by 	exposure 	to 	the 	sun 	that 	would 	otherwise 	appear 	20
years 	from 	now.
(2) 	Regular/ 	everyday use 	of 	this 	product 	from 	childhood 	on/
may 	reduce 	the 	chance 	of 	some 	types 	of 	skin 	cancers 	caused
by 	exposure 	to 	the 	sun. ,,17
(emphasis 	added) . 	The 	FDA 	states/
Because 	of 	the 	seriousness 	of 	skin 	cancer/ 	the 	agency
believes 	that 	sunscreen 	drug 	product 	labeling 	related 	to
skin 	cancer 	should be 	especially 	limited 	and 	carefully
stated. 	It 	is 	very 	important 	that 	the 	labeling 	of 	sunscreen
drug 	products 	not 	include 	any 	phrases 	or 	terms 	that 	may
induce 	a 	false 	sense 	of 	security 	in 	sunscreen 	users. 18
Thus, 	with 	respect 	to 	claims 	that 	specifically mention 	protection
against 	skin 	cancer 	or 	premature 	skin 	aging/ 	the 	FDA has 	clearly
indicated 	that 	lack 	of 	explicit 	qualification 	will 	render
labeling 	unacceptable.
The 	staff 	of 	the 	Commission 	concurs 	with 	the 	FDA/s
conclusion 	that 	claims 	that 	are 	not 	appropriately 	qualified 	may
induce 	in 	consumers 	a 	false 	sense 	of 	security. 	Some 	of 	the
indications 	specifically permitted 	in 	the 	TFM may/ 	however/
inadvertently 	allow 	such 	unqualified 	claims. 	For 	instance/ 	the
TFM 	would 	allow 	any 	product 	containing 	approved 	sunscreen
ingredients 	to 	bear 	a 	claim 	that 	it 	"shields 	from/" 	or 	"protects
from," 	or 	"filters," 	or 	"screens 	out" 	the 	"sun's 	rays/" 	or 	the
"sun/s 	harsh 	rays/" 	or 	the 	"sun's 	harmful 	rays" 	to 	"help 	prevent
skin 	damage. ,,19 	These 	phrases 	are 	not 	required 	to 	be 	qual if ied.
Such 	language 	may 	convey 	to 	many 	consumers 	a 	message 	that 	is
considerably 	less 	qualified 	than 	FDA may 	intend. 	The 	effect
would 	depend 	in 	part 	on 	the 	context 	in which 	a 	phrase 	is 	used.
For 	example, 	the 	phrase 	"shields 	from," 	in 	the 	context 	of 	"the
harmful 	rays 	of 	the 	sun," 	may 	evoke 	an 	image 	of 	complete
17
18
58 	Fed. 	Reg. 	at 	28288, 	TFM 	Comment 	53.
19 	58 	Fed. 	Reg. 	at 	28296 	(§ 	352.52 (b) (v) 	and 	(vi)). 	Such
claims 	would 	be 	allowed 	even 	for 	a 	product 	with 	an 	SPF 	as 	low 	as 	2.
7

protection, 	implying 	to 	consumers 	that 	use 	of 	the 	product 	will
provide 	complete 	protection 	from 	the 	sun's 	harmful 	rays.20
Although 	these 	approved 	indications 	do 	not 	specifically
refer 	to 	skin 	cancer 	or 	premature 	skin 	aging, 	they 	do 	permit
reference 	to 	the 	more 	general 	term 	"skin 	damage." 	Since 	"skin
damage" 	is 	broad 	enough 	to 	include 	all 	skin 	injuries 	associated
with 	exposure 	to 	the 	sun's 	"harmful 	rays," 	some 	consumers 	might
interpret 	it 	to 	encompass 	both 	skin 	cancer 	and 	premature 	skin
aging 	(as 	well 	as 	sunburn, 	the 	more 	immediate 	and 	temporary
effect 	of 	sun 	exposure). 	Thus, 	the 	staff 	of 	the 	Commission 	is
concerned 	that 	these 	approved 	indications 	may 	convey 	to 	consumers
just 	the 	type 	of 	unqualified 	messages 	that 	FDA 	seeks 	to 	avoid 	--
that 	use 	of 	sunscreen 	products 	will 	prevent 	skin 	aging 	or 	skin
cancer 	caused by 	exposure 	to 	the 	sun. 	We 	therefore 	recommend
that 	FDA examine 	carefully 	whether 	the 	use, 	without
qualification, 	of 	such 	terms 	as 	"shields 	from," 	"protects 	from,"
"filters 	out," 	and 	"screens 	out" 	with 	reference 	to 	the 	sun's 	rays
might 	convey 	an 	overstated message 	to 	consumers.
The 	TFM 	would 	also 	permit 	sunscreen 	labeling 	to 	state 	that
the 	product" [a]llows 	you 	to 	stay 	in 	the 	sun 	up 	to 	(insert 	SPF 	of
product 	up 	to 	30) 	times 	longer 	than 	without 	sunscreen
protection. ,,21 	While 	it 	appears 	that 	the 	intent 	of 	this
indication 	is 	to 	inform 	consumers 	how much 	sun 	exposure 	they 	can
incur 	before 	they 	will 	suffer 	a 	sunburn,22 	it 	may 	convey 	a 	much
more 	expansive 	meaning. 	Specifically, 	it 	may 	imply 	to 	consumers
that 	they 	can 	safely 	stay 	in 	the 	sun 	for 	the 	specified 	period 	of
time 	without 	risking 	any 	sun-induced 	skin 	injury. 	Consumers 	may
be 	led 	to 	believe 	that 	use 	of 	the 	product 	will 	prevent, 	for 	that
period 	of 	time, 	not 	only 	sunburn, 	but 	also 	any 	increased 	risk 	of
other 	sun-induced 	chronic, 	long-term 	skin 	damage, 	such 	as
premature 	skin 	aging 	and 	skin 	cancer. 	The 	FDA may 	therefore 	wish
to 	consider 	modifying 	this 	indication 	along 	the 	following 	lines:
"Allows 	you 	to 	stay 	in 	the 	sun 	without 	burning 	up 	to 	(insert 	SPF
of 	product 	up 	to 	30) 	times 	longer 	than 	without 	sunscreen
protection."
20 	Similarly, 	claims 	that 	a 	product 	"f il ters" 	or 	"screens"
out, 	or 	"protects 	from" 	the 	sun's 	rays 	may 	convey 	to 	consumers 	a
greater 	sense 	of 	safety 	than 	FDA 	intends.
21 	58 	Fed. 	Reg. 	at 	28296 	(§ 	352.52 (b) (1) (iii)).
22 	The 	two 	approved 	indications 	preceding 	this 	one
("Sunscreen 	to 	help 	prevent 	sunburn;" 	and 	"Filters" 	or 	"screens 	out
the 	sun's 	burning" 	or 	"harsh 	and 	often 	harmful 	rays" 	" 	to 	prevent
sunburn") 	and 	the 	one 	following 	it 	("Provides 	up 	to 	(insert 	SPF 	of
product 	up 	to 	30) 	times 	your 	natural 	protection 	from 	sunburn") 	are
all 	specifically 	linked 	solely 	with 	protection 	from 	sunburn. 	58
Fed. 	Reg. 	at 	28296 	(§ 	352.52 (b) (1) (i), 	(ii), 	and 	(iv)).
8

IV. 	~.T':-~ Protection 	Claims
The 	TFM 	does 	not 	include 	approved 	indications 	for 	protection
against 	UVA 	radiation, 	because 	the 	FDA 	has 	determined 	that 	there
is 	inadequate 	information 	for 	FDA 	to 	propose 	a 	method 	of
determining 	a 	sunscreen 	product's 	ability 	to 	protect 	against
it. 23 	The 	TFM 	discusses 	the 	subject 	and 	requests 	comment 	on
proposed 	labeling. 	The 	proposal 	would 	apply 	if 	(1) 	the
ingredient 	absorbs 	ultraviolet 	radiation 	up 	to 	360nm 24 	or 	above
and 	(2) 	the 	product 	containing 	the 	ingredient 	demonstrates 	UVA
protection 	using 	testing 	procedures 	that 	the 	FDA proposes 	be
developed. 25 	Under 	this 	proposed 	labeling, 	products 	that
satisfy 	these 	criteria 	would 	be 	allowed 	to 	use 	the 	following
indications: 	"Protects 	against," 	or 	"Absorbs," 	or 	"Screens 	out,"
or 	"Shields 	from" 	"UVA 	rays" 	or 	"UVA 	radiation."
The 	same 	concern 	described 	in 	§ 	III 	of 	this 	comment 	would
apply 	here. 	These 	broad 	safety-related 	te~ms such 	as 	"shields
from" 	may 	convey 	to 	consumers 	that 	the 	product 	provides 	complete
protection 	from 	UVA 	radiation, 	so 	that 	if 	they 	use 	the 	product
they 	need 	not 	be 	concerned 	about 	incurring 	any 	UVA-related 	skin
damage. 	Unless 	the 	products 	to 	which 	such 	claims 	are 	affixed 	can
in 	fact 	prevent 	any 	significant 	amount 	of 	potentially 	harmful 	UVA
rays 	from 	penetrating 	the 	user's 	skin, 	such 	unqualified 	claims
may 	well 	induce 	in 	consumers 	a 	false 	sense 	of 	security.26
23 	58 	Fed. 	Reg. 	at 	28233 	and 	28250, 	TFM 	Comments 	53 	and 	73.
24
to 	400
290 	to
28233,
Ultraviolet 	radiation
nanometers 	comprises 	the
320 	nanometers 	comprises
TFM 	Comment 	53.
from 	approximately 	320 	nanometers
UVA 	range, 	while 	the 	lower 	range 	of
the 	UVB 	range. 	58 	Fed. 	Reg. 	at
25 	In 	the 	interim, 	until 	the 	final 	UVA 	testing 	and 	labeling
regulation 	is 	issued 	and 	effective, 	products 	may 	bear 	UVA
protection 	claims 	provided 	(1) 	they 	absorb 	UVA 	and 	(2) 	they 	meet
the 	agency's 	enforcement 	policy which 	allows 	claims 	that 	appeared
in 	labeling 	prior 	to 	the 	beginning 	of 	the 	OTC 	drug 	review 	process.
58 	Fed. 	Reg. 	at 	28233, 	TFM 	Comment 	53.
26 	It 	is 	not 	clear 	from 	the 	FDA's 	proposal 	what 	percentage
of 	the 	specified UVA 	spectrum 	(to 	360nm or 	above) 	an 	ingredient
must 	be 	able 	to 	absorb 	in 	order 	to 	satisfy 	the 	criteria 	for 	UVA
protection 	labeling. 	It 	is 	not 	clear 	whether 	an 	ability 	to 	absorb
5 	or 	10 	or 	20 	percent 	of 	this 	range 	would 	qualify 	an 	ingredient 	as
an 	effective 	UVA 	protectant, 	or 	whether 	it 	must 	absorb 	close 	to 	100
percent 	of 	the 	UVA 	spectrum up 	to 	360nm 	in 	order 	to 	bear UVA
protection 	labeling. 	If 	a 	relatively 	low 	threshold 	would 	qualify,
then 	our 	concern 	would 	be 	particularly pertinent.
9

V. 	The 	PCDs
The 	TFM 	authorizes 	the 	use 	of 	a 	series 	of 	"Product 	Category
Designations" 	or 	"PCDs,,27: 	"Minimal 	Sun 	Protection 	Product" 	for
products 	with 	an 	SPF 	of 	2 	to 	under 	4; 	"Moderate 	Sun 	Protection
Product" 	for 	products 	with 	an 	SPF 	of 	4 	to 	under 	8; 	"High 	Sun
Protection 	Product" 	for 	products 	with 	an 	SPF 	of 	8 	to 	under 	12;
"Very 	High 	Sun 	Protection 	Product" 	for 	products 	with 	an 	SPF 	of 	12
to 	under 	20; 	and 	"Ultra 	High 	Sun 	Protection 	Product'· 	for 	products
with 	an 	SPF 	of 	20 	to 	30. 	The 	FDA may 	want 	to 	consider 	whether
the 	multiple 	superlative 	terms 	"high," 	"very 	high," 	and 	"ultra
high" 	may 	be 	confusing 	to 	consumers. 	These 	multiple 	superlatives
may 	unintentionally 	foster 	consumer 	confusion 	about 	the 	level 	of
protection 	each 	SPF 	provides. 	In 	spite 	of 	its 	limitations 28 ,
the 	SPF 	rating 	system 	has 	provided 	consumers 	with 	a 	clear 	basis
for 	comparing 	different 	products' 	levels 	of 	protection. 	If 	the
FDA 	concludes 	that 	additional 	verbal 	descriptors 	are 	nonetheless
desirable, 	staff 	suggests 	that 	the 	proposed 	descriptor 	scheme 	be
simplified 	so 	as 	not 	to 	include 	duplicative 	superlatives 	or 	terms
potentially 	subject 	to 	misinterpretation. 	Because 	the 	SPF 	number
is 	already 	available 	to 	help 	consumers 	compare 	products, 	staff
suggests 	that 	the 	FDA be 	cautious 	about 	authorizing 	additional
comparisons 	that 	may 	overstate 	the 	protection 	provided.
IV. 	Conclusion
Based 	on 	the 	Commission's 	extensive 	experience 	in 	analyzing
advertising 	claims 	the the 	likely 	implicit 	messages 	they 	may
convey, 	the 	staff 	of 	the 	Commission 	believes 	that 	the 	FDA's
proposal 	includes 	terms 	and 	phrases 	for 	labels 	that 	may,
unintentionally, 	misinform 	consumers 	about 	the 	level 	or 	type 	of
protection 	that 	sunscreen 	products 	provide. 	The 	FDA may 	wish 	to
conduct 	consumer 	research 	to 	learn 	how 	consumers 	interpret 	the
proposed 	language 	and 	to 	test 	whether 	modified 	language 	might
inform 	consumers 	more 	effectively and 	accurately. 	Many 	consumers
are 	very 	interested 	in 	protecting 	their 	skin 	from 	sun 	damage, 	as
evidenced 	by 	the 	tremendous 	increase 	in 	sales 	of 	sunscreens 	and
the 	proliferation 	of 	products 	containing 	sunscreens. 	It 	is 	thus
very 	important 	that 	the 	labeling 	information 	about 	the 	relative
protection 	provided by 	available 	OTC 	sunscreen 	products 	not 	be
deceptive 	or 	misleading. 	We 	appreciate 	the 	opportunity 	to
provide 	these 	comments 	and 	hope 	they 	help 	the 	FDA 	in 	providing
consumers 	with 	accurate 	and 	meaningful 	labeling 	information.
27
at 	28297.
58 	Fed. 	Reg. 	at 	28221, 	TFM 	Comment 	44; 	and 	§ 	352.52(e),
28 	The 	SPF 	value 	is 	based 	only 	on 	a 	measure 	of 	protection
from 	sunburn 	caused 	by 	UVB 	radiation.
10