Download One Newark Center, Newark, New ... Main No. (973) 642-8800 Fax Nos. (973) 642-8194/8546

One Newark Center, Newark, New Jersey 07102-&O
Main No. (973) 642-8800
Fax Nos. (973) 642-8194/8546
Internet: Http://www.shu.eduflaw/
Mar. 14,200O
Christine J. Lewis, Ph.D.
Acting Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition ’
Food and Drug Administration
Washington, D.C. 20204
Dear Acting Director Lewis;
I received your Mar. 3 fax about a public meeting on April 4 relating to the
implementation of Pearsonv. Shalalaand another issueon health claims. I have classon April 4
and will not be able to attend.
I made comments about the implementation of Pearsonin my March 25, 1999 Testimony
to the House GovernmentReform Committee. I have encloseda copy in caseyou can include it
in the record of input for the meeting. I also have expandedmy views in a section in an article on
Constitutionalizing Food and Drug Law which is to be published shortly in 74 Tulane Law
Review SlS(2000).
I hope this is of assistance.
Sincerely yours,
Margaret ‘Gilhoo[ey i
Professor of Law“‘, ’
The Catholic University in New Jersey - founded in 1856
6L
SCHOOL OF LAW
FACULlY
One Newark Center, Newark, New Jersey 07102-&O
Main No. (973) 642-8800
Fax Nos. (97’3)642-8194/ 8546
Internet: Http//www.shu.edu/law/
TESTIMONY OF PROF. MARGARETGILHOOLEY OF
SETON HALL
LAW SCHOOL
HEARING OF THE HOUSECOMMITTEEON GOVERNMENT
REFORM
ON DIETARY SUPPLEMENTS,MARCH25, 1999
I am Margaret
Gilhooley.
I teach at Seton Hall Law School and
was a member of the Commission on Dietary
appreciate
the opportunity
carrying
out its
claims.
claims
to Identify
and function
Under FDA's proposed
general
maintain
references
references
tentatively
regards
cardiovascular
and "helps
maintain
I believe
to bodily
conditions,
to
rules
to
body
functions
function,
a healthy
that
claims
I
FDA is
dietary
but not disease
diseases,
or
** "inhibits
but
disease
not
more
functions.
a claim that
cholesterol
can still
and especially
members
specific
as appropriate
DSHEApermits
(63 Fed. Reg. 23624),
systems
FDA's criteria
organs and functions
Commission
on DSHEA and whether
Disease Claims.
to make structure
include
Labels.
intent.
1. Criteria
supplements
to testify
Supplement
Thus, FDA
a supplement '*helps
platelet
aggregation,"
level."
are too narrow.
General
imply
to prevent
disease
refer
bodily
usefulness
so when the
normally
receive
disagreed
about
claims
medical
appropriate
1
The Catholic University in New Jersey - founded in 1856
references
to
attention.
claims
The
for
.
.
.
.^.”
.. . . .
.-
.
supplements,
and some of us found
,__
I
VroublingVV
_
,_
I
.‘<,-
j
and ItProblematic"
claims:
llostensibly
actually
relating
state m
liver,
with
(emphasis
added).
my view,
function
major
or systems (e.g.
implies
relates
be misled
increases.
I think
supplement
conditions
disease
the
FDA proposal
claims
that
and functions
and beyond the ability
2. Need to Identify
The FDA proposal
function**
product
llimproves
for
one
supplement
for
in
the
of
own experience,
the potential
‘ ~.~,.'~.~.".rgi.~."~
" .I.,,
to
to
role
the
associated
a dietary
of
any meaningful
to restrict
maintenance
of
bodily
with the occurrence
"Dietary"
as an appropriate
not be viewed as an appropriate
not
to
which would be a disease.
an Understandable
affect
cardiovascular
beyond the ability
absentmindedness."
There are no foods that
36-37
of
of the consumer to evaluate.
recognizes
statement
P.
needs to be revised
relate
closely
circulatory)
normal"
to a matter
the consumer to assess from their
organs (e.g.
a need to use the product
an abnormality
when a claim
that
abnormal
conditions.
to \'lmaintain
claims)
an abnormality,
Moreover,
functions'
mentioning
clinical
a claim
(or similar
prevent
statements
and prostate)
associated
In
bodily
imply the need to remedy an underlying
or unhealthy
heart,
to 'normal
claim
supplement
sense.
2
'@structure
a claim
In my view this
for
that
and
the
claim should
a lVdietarvV1 ingredient,
absentmindedness,
a dietary
Relationship.
and this
claim
ingredient
or
That
should
claim
is
a dietary
not
be
.._, v,.
,__
._-
permissible
for
the
same reason
supplement
to be an "oral
the
is
claim
simply
that
contraceptivel*
not
one for
a claim
on
a dietary
would not be permissible-the
effects
of
a "dietary"
ingredient.
The FDA rule
supplements
should preclude
unless
the
claim
relationship.
Products
but
go beyond that
when they
claim,
the
statement
ingredient
the effects
that
the supplement
produced
claim
should
that
a calming
it
3. Health
in achieving
energy,
like
the process
be the
dietary
for
"the
health
approach,
concept
claims
supplements.
are
has found constitutionall
Under
unconstitutional
the
oldietarylf
supplements,
and function
of
like
the
dietary
those associated
dietary
claim would be
effects
For example,
like
those
a supplement
might
has a wak&up effect
like
for
Supplements.
approval
of fairness"
the
coffee
or
of health
foods
already
difficulties
decision,
to allow
3
should
foods,
and
the
for
adopted
by the D.C. Circuit
164 F.3d 650 (D.C. Cir.
in failing
claims
and
under which the requirements
FDA had
and legal
court
The Commission
and conventional
same for
While
decision
Pearson v. Shalala,
role
source for
supplements
P. 34-35.
a recent
effects
and Dietary
recommended that
supported
the
for
tea.
Claims
same for
to
An appropriate
in the diet.
effect
as dietary
to make a structure
is a substitute
provides
claims
had an understandable
relate
of foods.
by foods
and function
can be sold simply
in the diet
with
structure
Court
dietary
this
of Appeals
with FDA's actions.
1999).
FDA
supplements
regulations
are
to make a health
._
claim
.. .
-._
,..
.I^
e.
I
.
.
.,
even when there
support
the claim,
about
the
so long
determining
or
decision
on the label
that
agreementof
to
the
support
that
evaluating
a claim,
inform
supports
consumers.
supplements
possible
better
not comment upon
but will
make on
not be adequate
agreement."
point
out
remand
in
In my view,
claims.
consideration
is "no significant
claim.
scientific
The level
is
in
needs to be given
important
of
to
disclaimers
scientific
scientists
to inform
in
supplements.
concluded
but also
that
a cancer risk.
Doesn't
consumers is
decision
not
only
there
that
the
was tra hint
See ffStudies
Forestall
to end a
The study was
Cancer
New York Times, p. A 16, Jan. 16, 1996.
of
Find Beta
or
Heart
Disclaimers
may
to convey the information.
of Appeals
articulation
supporting
to particular
investigators
were not helpful
The Court
to
to adequately
of beta carotene
Used by Millions,
Disease,"
,.,‘.
a disclaimer
the
I will
Cancer Institute's
harm" in increasing
Carotene,
simply
when
of
to
_.
agreement
bears
limits
;I,
_
an adequate disclaimer
a claim
by the National,
early
scientific
have
there
of using
of the effects
ended
_^
and should be disclosed in order to adequately
.,.,a.‘s+,x
.I_
The difficulties
illustrated
^_,
..-.
of the decision,
disclaimers,
to stating
agreement
..
--~-.
other
FDA will
what constitutes
to the other
.._,.,..
of FDA approval.
consumers with respect
addition
)-..-_
as the supplement
law aspects
important
study
.-,..
^
is no significant
and the lack
the constitutional
inform
_
inconclusiveness
evidence,
the
.
of
was also
the
concerned
meaning
The Commission report
of
that
"significant
has a discussion
4
FDA provide
a
scientific
that
may be of
. .._..
,.
._..
.
__
.-
.L.l
-
4.)
. .
.,
.
some assistance.
The report
can be improved,
including
workshops.
P.
34-35.
scientific
literature
scientific
evidence
judgment.
to support
claims
The report
that
claims,
difficult
found
The decision
and well-documented
support
inadequate.
4. Safety
a body of
they
of
are not,
doing
nature
of
experimentation
make the
of
existence
in determining
of
whether
explanations
lacking
in
the importance
for
explanation
each claim,
if
the
supplements
however,
are safe--as
subject
food ingredients.
that
for
scientific
of FDA making a
and providing
agency finds
Consumers use dietary
or FDA approval
a product
indicates
in
make the evaluation
claims
of the evidence
assume the
recognition
of other
difficulty
found in‘ade~ate‘*FDA8s
Substantiation.
The supplements
report
is
and matters
of direct
important
highlights
a full
show that
the
also
particular
examination
safety
there
because of the chronic
and
agreement
careful
general
that
and
support.
agency
because
notes
uncertainties
recognized
health
The Court of Appeals
support.
conferences
the ways of evaluating
involves
also
scientific
is sufficient
why the
also
See p. 31. These, factors
more
significant
there
scientific
and the inappropr$ateness
many claims.
the
by holding
the FDA process
P.31.
the conditions,
for
out ways that
concerning
The Commission
research
pointed
safe
supplements
as
foods.
to the requirements
provides
assurance
for
of the
FDA bears the burden of proof
poses a significant
the difficulties
risk.
and resource
5
the
to
The Commission
burdens
involved
in
_._
meeting
this
standard.
Supplement
manufacturers
affirmative
obligation
supplements
are
manufacturer
should
the supplement
not
involve
should
safe.
If
they
report
that
is
otherwise.
only
finished
drug
the
active
decision
emphasizes
purpose
to the basis
purpose
indicates
that
against
ingredients
the
determining
purpose
marketing
such as those
to
research
supplements
in Taxol:
6
exclusion
applied
a supplement
new drug.
cases,
that
The
and
law in place with
drug intent.
exclusion
suggests
A commentary on DSHEA
covers flingredientsff
of
"an
FDA, by rule,
and prior
the existing
may have been broader.
to protect
in
supplements
unless
of the definitional
the exclusion
prevent
1659 (D. Utah 1999).
an approved
language,
as leaving
and detail
Congress'
had a wider
for
textual
to
the
the Committee is
this
and not
of
that
dietary
found that
ingredient
the
Lexis
of
products,
warning
Court decision
as a new drug"
The court
contains
The length
definition
approved
provides
views Congress'
the
of
measure.
I understand
1999 U.S.Dist.
the
the safety
recommended in
this
in views on the District
from
that
by FDA. I
FDA require
testing,
that
Such a measure would
but FDA has not acted on this
DSHEA excludes
respect
on the label
approval
that
Pharmanex v. Shalala,
to
do safety
has not been substantiated.
interested
article
needed to establish
do not
put a warning
5. Pharmanex v. Shalala.
also
have a legally-enforceable
to do the testing
pre-market
Commission
deception,
P. 22.
and that
investment,
containing
Congress
and to guard
botanical
,
“Under this
provision,
ingredients
drugs would not be dietary
supplement
purpose behind the provision
drug
ingredients
natural
the
of
time
another
bona fide
new
investment
into
use in new drugs.[Footnote]
was that
anti-neoplastic
ingredients....The
as research
negotiations
concern
taxophen,
for
marketed as new
was to protect
as well
ingredients
first
leading
to
the
abortifacient
agents derived
enactment,
ingredients
from botanicals,
might be marketedias
dietary
Bass & Young, DSHEA:A Legislative
At
and
such as
supplements.ff
History
See
and Analysis
36
(1996).
The provision
marketing
of these
labeling
supplements
supplement
drug sold
review
has the
by
and all
a manufacturer's
additional
provides
intent.
and approval
that
active
the
can be considered
Congress may have believed
was needed in the unusual
same
of the
a forum to consider
the factors
ingredient
of the Supreme Court
was to expand FDA's ability
and the
impact
authority
to regulate
impact
review
case in which a
found in a marketed
new
prescription.
The impact
Court
FDA regulatory
of the product
in determining
this
for
of
the
to regulate
Pharmanex
a supplement
may need further
cases cited
decision
products
is
as a drug.
consideration
in
by the District
to
as drugs,
narrow
This difference
determining
FDA's
in
Congress'
intent.
6. Determining
whether
FDA is
DSHEA's intent.
carrying
out
the
7
Finally,
there
intent
of
is debate about
DSHEA.
But
the
..,
underlying
DSHEA is
.,,,..
_
an enigma.
various
agree that
does not have this
a
* .“..a
,... r
while
.
j .,..
in my view,
limit
:
.-
issue
I believe
authority
to
.,
are ambiguous,
safety,
criteria
. “.....S.
that
substantiate
authority
further
._
inappropriate
authority,
a full
_“I
against
give FDA stronger
provide
_,.,,I..
guard
FDA has that
of the hearing.
__I
Thus,
clear
record
sic
ways.
DSHEA and provide
I ask that
. .
The provisions
do more to
will
_
is hard to resolve
ensure that manufacturers
all
,,.
,._
,.,
reason why it
interpreted
should,
-“.,.
and can be
FDA can,
I recognize
under DSHEA.
Congress should
inappropriate
copy of my testimony
be included
%.._S.
,,._.
8
and to
that not
If
FDA
revisit
claims
I would be glad to answer questions
Thank you.
and
and
of supplements.
information.
,
is because
claims,
to ensure the safety
.“.
in the
or to
._