Transcript Legal and Regulatory Issues Affecting Energy Shots and Beverages

Supply Side West 2009
Energy Shots and Beverages:
Growth, Innovation, Safety and
Regulation
Legal and Regulatory Issues
Affecting Energy Shots and
Beverages
Anthony L. Young
Kleinfeld, Kaplan & Becker LLP
[email protected]
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ENERGY BEVERAGE
WEBSITE
• http://www.screamingenergy.com/
• More than you ever would want to know,
but . . .
• Products that stretch the imagination of
even the most jaded marketeer
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ENERGY BEVERAGE
WEBSITE OCTOBER ENTRY
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Food or Dietary Supplement
• First Issue – What is it
• Marketer picks the category - food or
dietary supplement
• Nutritional Facts for food
• Supplement Facts for dietary
supplements
• Customers and retailers no longer
make a distinction
• 7-11 would know the difference?
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Energy Shots and Beverages
Focus on Particular Consumer
Needs
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Energy
Stimulation
Alertness
Focus
Attention
Stay awake
And more “energy”
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Energy Shot Ingredients
Besides SUGAR
• Caffeine, guarana and other caffeine
source ingredients
• Taurine
• L-carnitine
• B vitamins
• Ginseng
• Amino acids
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Taurine
• Not technically an amino acid but
referred to as one
• Supports neurological development and
helps regulate the level of water and
mineral salts in the blood
• Thought to have antioxidant properties
• Some studies suggest taurine
supplementation may improve athletic
performance
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B vitamins
• Important in cell metabolism
• Help convert food to energy
• Well known for energy support
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L-carnitine
• Synthesized in the liver and kidneys from
amino acids and stored in muscle
• Helps the body turn fat into energy
• May be difficult to formulate so that it
survives processing
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Ginseng and Ginkgo
• Ginseng reported to increase the body’s
resistance to stress (adaptogen)
• Ginseng is traditionally used as a
stimulant: thought to improve mental and
physical performance
• Ginkgo to enhance blood circulation
• Ginkgo to enhance memory
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Glucuronolactone
• Carbohydrate
• Produced by the metabolism of glucose
in the liver
• Structural component of most connective
tissues
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Milk Thistle Extract and Acai
• Milk Thistle historically used to treat liver
disease and to protect the liver against
toxins
• Acai has measured antioxidant
properties (contains anthocyanins and
flavonoids)
•
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ENERGY and Shot Claims
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Energy
Feel it in minutes
Energy for a specific period
Energy for a specific purpose
More energy
Claims are supported by energy
related professional sports
endorsements that reinforce ENERGY
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ENERGY and Shot Claims
• Some performance enhancment claims
• Red Bull, the 800 lb Gorilla in the
marketplace, appears to make some of
the more aggressive and specific claims
• All In is one to take in Vegas - it has an
interesting poker tie-in, instead of the
athlete ties of most energy beverages
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RED BULL Claims
– Increases performance
– Increases concentration and reaction speed
– Improves vigilance
– Improves emotional status
– Stimulates metabolism
– Vitalizes body and mind
– Developed for times of increased mental
and physical exertion
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Other Energy Drink Claims
• twice the buzz of a regular energy drink
• ideal for persons who need a boost but
aren’t afforded the most timely restroom
breaks
• scientifically formulated to provide an
incredible energy boost for those who
lead active and exhausting lifestyles
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ALL IN Claims
• All In delivers the ideal premium energy
drink to the fast moving world of poker.
• All In is a premium product…without
sugar, carbs, or excess calories.
• All in uses herbs, vitamins and amino
acids and provides a smooth, sustained
sharpening of focus and pure energy
every poker player needs.
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Other Energy Shot Products
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Dr. Chao - Herbal Lady Drink (PMS)
Dr. Chao - Herbal Adult Drink
Dr. Chao – Herbal 21 Drink
Dr. Chao – Herbal Stress Reliever
Drink
• Note for Blumenthal – no Herbal Guy
drink
• And no Herbal Lawyer Up drink either
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Herbal Lady Drink
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Energy Shots and Beverages
Labeled as Foods
• Nutrition Facts Box is limited to
nutrients – no place to display
functional non-nutrients – so taurine
and guarana cannot be included.
• On the Information Panel, non
nutrient ingredients must be included
only in the ingredients declaration for
the product.
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FDA Regulations Limit Health and
Nutrient Content Claims for Foods
and Dietary Supplements
• Nutrient content claim regulations
limit claims about the presence of
ingredients to FDA - recognized
nutrients.
• To tout the presence of ingredients,
the actual amount per serving must
be stated.
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First Amendment and FDA
• In 2002 FDA asked for comment on
those FDA claim rules believed to
infringe on truthful and not
misleading commercial speech.
• Nutrient content claim regulations
were identified as First Amendment
suspect – but this proceeding never
got off the ground, and now never
will.
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Nutritive Value - Food
• FDA defines nutritive value as value
in sustaining human existence by
such processes as promoting growth,
replacing lost nutrients, or providing
energy
• Physiological effect that provides a
benefit through growth or health
improvement probably meets the
definition
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Claims for Foods More Restrictive
than Dietary Supplements
• Health Claims – F and DS
• Qualified Health Claims – F and DS
• Structure Function Claims for foods
based on nutritive value effects or
taste or aroma of the food – F
• Structure Function Claims for dietary
ingredients based on demonstrated
effect on structure or function of the
body – DS
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Dietary Supplements in
Conventional Food Form
• May be in conventional food form but
must be represented as supplement
and not conventional food
• May not be represented as a meal or
meal replacement or snack
• May not be linked to a meal or
conventional food form
• Labels, labeling and advertising must
stay out of food arena
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New Ingredients for Energy
Shots
• New ingredients or novel forms of old
ingredients must meet regulatory
requirements for foods or
supplements
• New or novel food ingredients must
be GRAS or food additive approved
• Dietary ingredients must be old
ingredients or lawfully marketed new
dietary ingredients
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Ingredients In Energy Drinks
• Surprised to see that there is little
exotica in the ingredients
• Marketeers here appear to be looking for
marketing niches based on
endorsements, affiliations and packaging
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GRAS Substances for Food
Energy Shots
• § 402(a)(2)(C): adulterated if it contains an
“unsafe” food additive
• § 409: “unsafe” food additive is one not covered
by an FDA regulation, OR
• the substance is GRAS through common
knowledge throughout the scientific community
• Reasonable certainty that the substance is not
harmful under the specific intended conditions of
use – (reasonable certainty of no harm)
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Conditions of Use
• GRAS notifications to FDA must list the
foods for which the ingredient is intended
• 21 CFR Sec. 170.3
• Must describe and list proposed amounts
for the food category
• Many food ingredients are NOT GRAS for
all uses
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GRAS Self-Affirmation
• Scientific Procedures
– Generally available and accepted
scientific data
 Ordinarily published
 Corroborated by unpublished data
– Normally reviewed by expert panel
– OR
• Common use in food prior to 1958
• NO FDA REVIEW LEGALLY REQUIRED
FOR EITHER CATEGORY
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GRAS Self-Affirmation
• GRAS self-affirmation is a predicate
for the use of an ingredient in food
• Panel of Experts review and
conclusion is important to customers
• If FDA finds the ingredient and
questions its use, the GRAS SelfAffirmation package provides a
defensive conversation piece
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GRAS Self-Affirmation
• Largest ingredient customers (Coca-Cola,
Pepsi) may not accept GRAS selfaffirmation for an ingredient
• If FDA disagrees with the use of a selfaffirmed ingredient in food they may advise
customer that their products may be
adulterated.
• FDA may make products containing the
ingredient subject to seizure or injunction
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GRAS NOTIFICATION TO FDA
• Since mid-1997 GRAS Notification may
voluntarily be submitted to FDA
– Proposed Rule 62 FR 18938 4/17/97
– If successful, results in a “No-Question”
letter
– Replaces the old GRAS-affirmation
process
– Replaces a regulatory process that was
too long – required too much FDA buy-in
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FDA GRAS NOTIFICATION
WEBSITE
• FDA provides guidance to those
considering GRAS notification
• FDA provides chronology of GRAS
notifications and responses
• FDA response letters provide good
guidance on data requirements
• FDA provides guidance on estimating
total dietary intake of the substance
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Successful GRAS Notifications
• Pre-submission meeting with FDA with
Expert Panel Report as meeting baseline
• Listening carefully to what FDA says presubmission
• Some published data and information
• Data and information package presents
quality relevant data
• GRAS notification is written by someone
schooled in FDA data requirements and
FDA lines of inquiry
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Successful GRAS Notifications
• Panel of Experts ARE “qualified by training
and experience to evaluate the safety of the
substance under the conditions of use”
proposed
• The proposed conditions of use are not
controversial for the ingredient
• Panel of Experts addresses all relevant and
expected issues including any raised by
FDA pre-submission
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FDA Informal Responses
• FDA GRAS Notification review staff is
experienced and knowledgeable
• Review staff is not restrained from
asking questions to clarify the
submission
• Review staff will advise notifier if the
notification is going to receive an
unfavorable response
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Old Dietary Ingredients
• On the market prior to October 15,
1994
• Must be one of the defined dietary
supplement ingredient catagories
• Must not have been a new drug
ingredient – ephedrine HCl example
• And probably not on the market as a
drug
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New Dietary Ingredients
• Developed since October 15, 1994
• NDI premarket notification required
unless the ingredient is present in the
food supply and is used in a form in
which the food has not been
chemically altered
• If you claim it is new, different or
never before available, you need to
respect the NDI requirements
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Basic Safety Premise
• Reasonable expectation of safety
when used or consumed as directed
• Don’t test new product ingredients on
the customer
• How would you like to testify in court
that “you thought it was safe” but had
never sought to substantiate it.
• Have a reasonable basis that
ingredient combinations are safe.
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New Sheriff in Town
• With the changed Administration,
expect more concern around safety of
foods and dietary supplements
• The National Nanny is back in
residence, we will be told what is
good for us
• Expect some focus on large amounts
of SUGAR and CAFFEINE in products.
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Energy Shots are “Functional
Foods”
• Industry has said that no new regulatory
definition or distinct regulatory approach is
necessary for the evaluation of the safety
of ingredients added to ``functional foods'‘.
• More use of labeling and restrictions on
use was suggested for GRAS review of
functional ingredients.
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Energy Drinks Under
Scrutiny
• 12 year old reports results of study
conducted to see if energy drinks like
“Monster” delivered as intended.
Brendan D. O’Neil – future MD
• Caffeinated “Monster” against
decaffeinated Sprite
• “Monster” as compared with soday
had no significant effect on exercise
performance.
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Energy Drink Study Author
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Energy Drink Safety
• These products are being sold to
people who want a faster lifestyle, the
issue of the safety of caffeine, as well
as other ingredients will be raised
about this category.
• Similar to the sports supplement
model, the marketing is to a
population that makes itself
vulnerable.
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Caffeine
• Medline Plus says: It is recommended
that pregnant women consume less
than 300 mg of caffeine a day.
• Caffeine passes into breast milk in
small amounts and may build up in
the nursing baby.
• FFDCA Section 201(n) material
information for Moms – why NOT
require added caffeine to be labeled?
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Caffeine
• Major marketers of caffeine
containing beverages include the
amount of caffeine on their product
labels.
• Some energy shot product contain
caffeine amount labeling and a
caution regarding use by pregnant
women.
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Additional Energy Drink
Consideration
• Took a boat tour of the Chicago River
• First drink on the bar menu was Red Bull
and Vodka
• All foods should be compatible with all
foods – so mixing into cocktails is no
surprise
• But formulators should take the liquor
mixing into consideration
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WHERE’S THE ACTION?
• CALIF AG lawsuit against Kellogg's for
Immunity Claim on cereals – no surgical
mask for Tony the Tiger – Pvt lawsuits
follow
• Consumer class action against Danone
and over $30 million (note $ not Euros)
• Lawsuits over “natural” and the like
• Success has benefits, and a price
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FDA Functional Food Hearing
November 2006
• There was no support for a
requirement that companies that
market ingredients for addition to
``functional foods'' notify FDA prior to
introducing the ingredients into
interstate commerce.
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FDA Functional Food Hearing
• There appeared to be agreement that
data and information appropriate to
demonstrate that ingredients added to
conventional foods being marketed as
``functional foods'' meet the present
safety standard of ``reasonable
certainty of no harm'‘ and achieve
GRAS status.
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FDA Functional Food
Hearing
• Commentators did not support a
premarket notification process for
presentation of the scientific evidence
supporting structure/function claims
for ``functional foods'' and
ingredients, as recommended by IFT.
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FDA Functional Food Hearing
• There was agreement that
conventional foods being marketed as
``functional foods'' could be
adequately addressed through the
current regulations for food additives,
GRAS substances, and labeling
claims.
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THANK YOU
Tony Young
[email protected]
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Glossary of Terms
• Food – a food for man providing taste,
aroma or nutritive value, including chewing
gum.
• Dietary Supplement – a product for
ingestion, other than tobacco, intended to
supplement the diet that contains a
vitamin, mineral, herb/botanical, amino
acid, dietary substance, or concentrate,
metabolite, constituent or extract, or a
combination of those ingredients.
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GRAS
• GRAS – applies to food ingredients, GRAS
means Generally Recognized as Safe for
use in food by experts qualified by training
and experience to evaluate the safety of
such ingredients
• GRAS Self-Affirmation – a safety review by
experts for use by a company marketing or
using a food ingredient
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GRAS Basis
• Common use in food prior to 1958
when the Food Additive Amendments
were passed shows safety
• Scientific procedures which can mean
a variety of scientific information
ranging from in vitro tests, animal
studies, to human clinical studies,
some published, that show safety
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Dietary Ingredient
• Vitamin, mineral, herb/botanical,
amino acid, dietary substance, or
concentrate, metabolite, constituent
or extract
• If a dietary substance, FDA position is
that it must be an ingredient
consumed in the diet
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