Transcript Document

Toward Closer Cooperation
in the New Decade?
FDA Issues
Martin J. Hahn
Hogan & Hartson, L.L.P.
NABCA 17th Annual Symposium
March 10, 2010
© 2009 Hogan & Hartson LLP. All rights reserved.
Outline
• What
is GRAS?
• What
is safety?
• Can
it be marketed in foods if it is
marketed in dietary supplements?
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Food Additive Defined
“The term ‘food additive’ means any substance the
intended use of which results or may reasonably be
expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the
characteristics of any food (including any substance
intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging,
transporting, or holding food; and including any
source of radiation intended for any such use)…”
FDCA Section 201(s)
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GRAS Exemption
• The
term ‘food additive’ excludes…. a substance
“generally recognized, among experts, qualified by
scientific training and experience to evaluate its
safety, as having been adequately shown through
scientific procedures (or, in the case of a substance
used in food prior to January 1, 1958, through either
scientific procedures or experience based on
common use in food) to be safe under the conditions
of its intended use.”
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What is GRAS?
• Generally
recognized as safe (GRAS)
• An
ingredient is GRAS and exempt from the food
additive definition and the premarket approval
requirements if
– Common
use in Foods: The food ingredient
has been used in the food supply for the same
use prior to 1958; or
– Scientific
Procedures: There are published
data, of the same type required to approve a
food additive, serving as the foundation for
general recognition of safety
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Dietary Ingredients
•
Dietary ingredients in dietary supplements are
exempt from the food additive definition
•
Dietary ingredients in dietary supplements are
deemed lawful if marketed in dietary
supplements or food prior to October 15, 1994—
FDA bears the burden in proving such dietary
ingredients are unsafe
• “New
dietary ingredients,” which are those
marketed for the first time after October 15,
1994, are subject to a premarket notification
program if they have no history of use in foods
or dietary supplements
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Why should you care about dietary
ingredients?
• There
are many dietary ingredients that
lawfully may be marketed in dietary
supplements that cannot lawfully be marketed
in foods because they are not approved food
additives and there are insufficient data to
support GRAS status
• The
first question you should ask is NOT,
whether you see the substance marketed in
supplements or energy drinks but whether
there are sufficient data to support the GRAS
status of the ingredient
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Quick Review
Food Additives: Must be approved by FDA
(which will issue a regulation); burden is on
petitioner to demonstrate safety
• GRAS
Ingredients: Exempt from food additive
definition and FDA approval; burden is on user
to demonstrate safety
• Dietary
Ingredients: Exempt from food additive
definition and FDA approval; burden is on FDA
to demonstrate they are unsafe
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“Reasonable Certainty of No Harm”
Safety Standard
•
“Safe” or “safety” means that there is a
reasonable certainty in the minds of competent
scientists that the substance is not harmful
under the intended conditions of use. It is
impossible in the present state of scientific
knowledge to establish with complete certainty
the absolute harmlessness of the use of any
substance. Safety may be determined by
scientific procedures or by general recognition
of safety.
•
21 C.F.R. 170.3(i)
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What type of safety studies?
Always/Usually Required
Sometimes/Rarely
Required
•
Genetic toxicity studies
•
•
Short-term toxicity tests with
rodents
One-year toxicity studies
with non-rodents
•
Chronic toxicity studies
•
Subchronic toxicity studies with
rodents
•
•
Subchronic toxicity studies with
non-rodents
Carcinogenicity studies
with rodents
•
Human Studies
•
Reproduction Studies
•
Developmental toxicity studies
•
Metabolism and Pharmacokinetic
studies
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Safety Analyses
•
FDA focuses its safety review on traditional animal toxicity
studies
•
Many foods can be safe for the general population or at
typical consumption levels but present concerns for
subsets of the population or at abuse levels
•
–
Water (hyper hydration for marathon runners)
–
Peanuts (anaphylaxis for peanut allergic)
–
Sulfites (trigger potentially severe reactions in sensitized people)
In unique situations, FDA historically has required
disclosures rather than challenge the safety
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Aspartame
• Aspartame
is a combination of two amino acids—
phenylalanine and aspartic acid
•A
small subset of the population has
phenylketonuria, a metabolic disorder that does not
allow for the metabolism of phenylalanine
• As
part of the approval, all products containing
aspartame must bear the statement,
“PHENYLKETONURICS: CONTAIN
PHENYLALANINE”
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Polydextrose
• Is
a bulking agent that is used in a wide variety of
foods, but it is only partially digestible
• If
a serving of a food contains more than 15 gram of
polydextrose, the label must state:
“Sensitive individuals may experience a laxative
effect from excessive consumption of this product”
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Olestra
 When
approved by FDA in
1996, the agency required a
warning.
 2005/6,
FDA amended the
regulation and removed the
need for the warning
statement after re-evaluating
the data
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Safety Quick Review
• GRAS
ingredients and food additives must
meet reasonable certainty of no harm under
intended conditions of use
• If
there are conditions of use or abuse that
could present potential safety issues, the
FDA precedent would support labeling rather
than a conclusion that an ingredient is not
GRAS
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Functional Ingredients Decision Tree
• Is
it an approved food additive for the intended
use?
• If
not, has it been reviewed by FDA as a
GRAS ingredient for the intended use?
• If
not, are there sufficient data to support the
GRAS status for the intended use?
• If
not, find another ingredient; if so, are there
warnings (or state laws) that should be
considered to ensure the safe use of the
ingredient?
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Caffeine
•
There are no food additive regulations or GRAS
authorizations for the use of caffeine in alcoholic
beverages
•
There are multiple published studies supporting the
safety of caffeine at relatively high levels that show
great promise in supporting the GRAS status
•
To the extent the science demonstrates that caffeine
can be safely consumed with alcohol in moderation, in
my view, FDA would be honoring earlier precedent if it
dealt with concerns involving abuses through the use
of a warning rather than a finding that it is not GRAS
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Other Functional Ingredients
• The
decision tree will work for other functional
ingredients
– Guarana
– Melatonin
– Taurine
– Ginseng
(Siberian vs. Panax)
– Valerian
Root
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Conclusions
• Remember
the decision tree—the functional
ingredient must be an approved food additive
or GRAS or it cannot be used
• Safety
evaluations and GRAS assessment
should focus on traditional toxicological data
• Issues
concerning abuse or misuse should be
handled through labeling rather than
conclusions that the ingredient is not GRAS
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Contact Information
Martin J. Hahn
Hogan & Hartson LLP
555 13th Street NW
Washington, DC 20004
[email protected]
202/637-5926 (direct)
202/637-5910 (fax)
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