product profile

PRODUCT PROFILE
Contents
1
Introduction
2
Marketing Summary
3
Research Monograph
4
Scientific Summary & Current Use
6
Product Label
7
Approved Claims
8
Safety Cautions & Assessment
9
Age Guidelines for Use/Shelf Life
10
Glossary
11
References & Additional Resources
PRODUCT PROFILES
who we are...
Agel Vision
The Global Leader in Suspension Gel Technology
based Nutritional Products
Agel Purpose
AGEL and our Product Profiles in Innovation,
Research, Quality and Safety provide the necessary
components for a confident, well-informed
community of empowered team members
through:
• Safe and beneficial products
• Clear and organized information
FLX
• Compliance to well-defined systems
1
Marketing Summary
Four supplements for healthy joints
Maintain Your Flexibility
Healthy joints can help you maintain an active lifestyle. Joint stiffness from exercise and
the normal activities of an active life can be a big annoyance, which is why maintaining
healthy joints is essential.
Four supplement ingredients for healthy joints
There are four supplement ingredients touted for their healthful effects on joints:
Chondroitin Sulfate is a part of a large protein molecule that gives cartilage elasticity*.
Glucosamine is an amino sugar that is believed to assist in cartilage formation and the
repair and in the lubrication of the joints*. Methylsulfonylmethane (MSM) is a biologically
active form of sulfur shown to be effective at supporting joint health*. And Celadrin® is
a proprietary combination of esterified fatty acids that has been shown to promote joint
health and ease minor or temporary discomfort due to the normal activities of an active
life*. Many pills contain one or even two of these supplements, but FLX contains all four.
FLX
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended
to diagnose, treat, cure, or prevent any disease.
Research MONOGRAPH
Product History
& Traditional Use
Joint issues can be immediate and cause acute distress
or they can be long term and result in chronic discomfort.
The Agel approach to joint health is to couple historical
use of nutritional joint ingredients with recent research
discoveries to formulate a comprehensive product to
address the structure of the joint (cartilage, collagen,
bone) along with the function of the joint (flexibility,
durability, range of motion). The dietary ingredients in FLX
flx ingredient
are unique for Agel. The FLX ingredients are not derived
from botanical sources. FLX ingredients are premier
extracts and purified natural substances. The historical
use of FLX ingredients typically date back to the 1960s,
although glucosamine has a history that goes back to
chemical investigations in the 19th century. In keeping
with the Agel approach, FLX builds upon that established
nutritional research to create a superior dosage delivery
form (Suspension Gel Technology) that provides a
comprehensive blend of four ingredients to support joint
structure and function. A historical background of FLX
ingredients is provided below.
traditional use*
nutrient type
Chondroitin Sulfate
Protein Cartilage
Enhanced durability of cartilage
Glucosamine
Sugar Amine Macromolecule
Nutrient & System Strengthen
Celadrin Complex
Fatty Acid Complex
Blood Builder
MSM
(methylsulfonylmethane)
Sulfur
Nutritional element of the body’s
connective tissues
Chondroitin Chondroitin was first extracted,
Celadrin First introduced and discovered by Harry
purified and analyzed in the 1960s. It is a naturally
occurring molecule in the body that is derived from
natural sources of cartilage. It was first extracted
and purified in the 1960s. Chondroitin sulfate works
synergistically and has a history of use for strengthening
W. Diehl, PhD in the 1960s, Celadrin complex is a blend
of esterifed fatty acids in a base of fatty acids. Celadrin
functions in joints supporting range of motion, flexibility,
and performance.*
the durability of the cartilage matrix*
Glucosamine Glucosamine was initially
prepared in 1876 by Georg Ledderhose by the hydrolysis
of chitin with concentrated acid. It is a natural product
derived from the exoskeletons of shrimp and crawfish. It
works synergistically with chondroitin to strengthen and
to stimulate the production of cartilage.*
compound. The term, “organically bound” refers to the
nature of the configuration of sulfur with carbon groups
to create a more readily available and absorbable
compound. Sulfur plays a major role as a component in
the body’s structural elements (bone, cartilage, collagen)
as well as the biochemical pathways of amino acids,
proteins, and enzymes that build the structural elements
of the joint ingredients.
FLX
MSM A naturally occurring organically bound sulfur
3
*Traditional has not been verified by modern scientific research.
Scientific Summary
& CURRENT USE
AGEL® FLX is innovative by providing four synergistic dietary ingredients into one suspension
gel technology based supplement for enhanced bioavailability and delivery. A truly unique and
comprehensive approach. The four dietary ingredients are:
Celadrin
Chondroitin Sulfate
•
Also called cetylated fatty acids or esterified
fatty acids or cetyl myristoleate
•
•
Celadrin is a proprietary blend of cetylated fatty
acids
•
Celadrin complex is a blend of esterifed fatty
acids in a base of fatty acids oil
•
Celadrin is integrated into plasma triglycerides,
fatty acids, phospholipids and cholesterol
throughout the body
•
GRN
FLX
4
Celadrin functions in joints, range of
motion, softening of tissues, flexibility, and
performance
•
A typical daily dosage in clinical studies is 5001000 mg
•
FLX provides 750 mg per serving
Naturally occurring molecule in the body
•
Derived from natural sources of cartilage
•
First extracted and purified in the 1960s
•
Strengthens and fosters durability of the
cartilage matrix
•
Strengthens the linkages of disulfide bridging
(bonding) in collagen
•
A typical daily dosage in clinical studies is
1000-1200 mg
•
FLX provides 1200 mg per serving
•
A small molecule that is critical to the larger
complex chondroitin sulfate
•
Works synergistically with chondroitin to
strengthen cartilage
•
MSM
•
A source of bio-available sulfur to the body
•
A naturally occurring organic bound sulfur
compound
•
Also called methylsulfonylmethane and
dimethylsulfone
•
Sulfur plays a major role in the body’s
structural elements (bone, cartilage,
collagen)
•
Sulfur plays a major role in the biochemical
pathways of amino acids, proteins, and
enzymes.
•
Sulfur plays a major role in the biochemical
pathways of amino acids, proteins, and
enzymes.
•
A typical daily dosage is 500-1500 mg
•
FLX provides 400 mg per serving
Derived from the exoskeletons of shrimp and
crawfish
•
A typical daily dosage in clinical studies is
1500 mg
•
FLX provides 1500 mg per serving
Complementary
Products
FLX RUB Topical gel rub for external
application. Comforting and soothing to joints.
FLX POD A convenient bulk size dosage form of
FLX gel (same formulation).
Ω-3 Research has demonstrated that fish oil
combined in formulations with FLX ingredients
have synergistic benefits to joints and structural
elements of the body.
FLX
Glucosamine
5
Product Label
Serving Size: 1 Packet (21g) Servings Per Container: 30
Amount Per Serving
Calories
Calories from Fat
Total Fat
Total Carboydrates
Sugars
Sodium
Celadrin® Oil
Glucosamine HCL
Chondroitin Sulfate
MSM
% Daily Value *
45
10
1g
9g
5g
50 mg
750 mg
1500 mg
1200 mg
400 mg
2%
3%
†
2%
†
†
†
†
* Percent Daily Values are based on a 2,000 calorie diet.
† Daily Value not established.
Other Ingredients: Water, Fructose, Citric Acid, Sodium
Chloride, Xanthan Gum, Guar Gum, Natural Flavoring,
FLX
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Agel® FLX is about joint
health. FLX uses Celadrin®,
Glucosamine, Menthyl Sulfonyl
Methane, and Chondroitin for
lubrication, cushioning, and natural
maintenance of flexibility. FLX’s
ingredients and convenient singleserve packaging are the solution
for lifestyles in motion.*
Nutritional Supplement
Patent Pending Suspension Gel Technology.
* This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure or prevent any disease.
Approved Claims
Key Ingredients
Glucosamine, Chondroitin, MSM (methyl-sulfonyl-methane or dimethyl sulfone), Celadrin® Oil
(esterified fatty acid complex).
approved
not approved
Promotes relief of temporary knee, ankle and
shoulder discomfort associated with exercise or
physical labor**.
Relieves joint pain associated with exercise.
Helps the body cope with temporary stiffness and
lack of mobility associated with exercise or other
strenuous physical activity**.
Relieves stiffness and pain associated with
exercise and arthritis.
Promotes flexibility as the body recovers from
exercise or manual labor**.
Prevents stiffness even after a heavy workout or
manual labor
Promotes the overall joint health and
functionality**
Repairs worn or injured knees, ankles and
shoulders.
Notes
Agel label claim submitted claim submitted to FDA is as follows: Agel FLX is about
joint health. FLX uses Celadrin, Glucosamine, and chondroitin for lubrication, cushioning,
and natural maintenance of joint flexibility. FLX’s convenient single-serving packaging and
ingredients are the solution for lifestyles in motion**
FLX
•
7
**These statements have not been evaluated by the Food and Drug Administration. This product is not
intended to diagnose, treat, cure, or prevent any disease.
Safety Cautions
& ASSESSMENT
1
2
Contains: An ingredient derived from shellfish. Do not take this product if you are
allergic to shellfish or any other ingredient listed on the label in Other Ingredients.
Glucosamine sulfate is derived from shellfish.
Pregnant or lactating women (or those planning pregnancy) should consult their
physician prior to using this product.
are planning a surgery, disclose use of FLX and all other dietary supplements
3 Iftoyou
your physician.
4
5
6
7
8
FLX
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A dosage of one FLX packet a day can be safely used by most people.
FLX is intended for adult use. It is not intended for use in young children. Consult
with your health care professional prior to using in young children.
MSM in daily dosages of 2.6-6 grams (2,600mg to 6,000mg) have been used safely
research investigations up to 12 weeks. MSM is classified as GRAS (Generally
Regarded as Safe) by FDA.
Chondroitin sulfate has been used safely in short and long term research studies
lasting two months to 6 years.
Glucosamine sulfate has been used safely in multiple short and long term clinical
trials lasting 4 weeks to 3 years.
Key Ingredients
Celadrin, Glucosamine HCl, Chondroitin Sulfate, MSM
Age Guidelines
FOR USE
age group class
approximate age
use recommendation
Newborn
Birth to one month of age
Not recommended for use
Infant
One month to 2 years
Not recommended for use
Child
2 years to 12 years
Not recommended for use
Adolescent
12 years to 17 years
Check physician before use
Adult
17 years and older
1-2 packets daily or as needed
Agel Guidelines
•
Individual conditions should be considered when considering use, including weight,
sex, pre-existing medical conditions, sensitivity or allergic reactions to ingredients, use
of prescription medication or other drugs.
•
The adult use recommendation for adults is 1-2 packets daily or as needed. The term
“or as needed” denotes that individuals may select more than 2 packets daily based
on individual need, however, the daily maximum dosage recommended is 4 packets.
•
Individuals should begin Agel product use with one Agel product at the lowest dosage
and increase dosage and add other complementary Agel products as needed.
Agel FLX has a shelf life of 12 months when stored under
ambient conditions.
FLX
Product Shelf Life
9
Glossary
Cartilage An elastic soft tissue that composes
Organic Compounds A term used
most of the skeleton of embryos and young
animals and becomes to a large degree converted
to bone in older animals.
to describe a branch of chemistry dealing with
carbon based compounds. The use of organic
compounds in chemistry should not be confused,
or is not synonymous with natural “organic”
foods. Organic foods are cultivated under strict
requirements to assure that they are produced
without synthetic inputs.
Celadrin® A dietary ingredient used in
Agel FLX and other dietary supplements for joint
functions. Composed of fatty acids in esterfied
or cetylated form. Celadrin® is a specific type of
naturally occurring fats.
amino sugar molecule. It is a dietary ingredient in
Agel FLX and other dietary supplements for joint
function.
for life. Sulfur in organic form (bound to carbon)
is present in some vitamins (biotin and thiamin),
many enzymes and selected antioxidant
molecules. Sulfur is a component of proteins and
provides mechanical strength to keratin.
Collagen A fibrous protein that occurs in
Suspension Gel Technology
animals as the primary constituent of connective
tissue and bones.
A patent pending, innovative and efficient
nutritional dosage delivery system from Agel. The
unique nature of SGT comes from a proprietary
blend of low-glycemic ingredients, including water,
xanthan gum, guar gum that creates a delivery
system to uniformly distribute and deliver bioactive
ingredients for optimal availability to the body.
Chondroitin sulfate Is a sulfur containing
Glucosamine An amino sugar and
precursor in the biochemical pathway to sugar
based proteins and fats.
Keratin Sulfur containing filerous protiens that
form the basis of epidermis and other tissues.
Methylsulfonylmethane (MSM)
Also referred to as dimethyl sulfone. Sulfur is
bonded to two methyl groups. MSM is a source of
sulfur in bioavailable form.
FLX
10
Sulfur A chemical element that is essential
References
•
•
Bourgeois P, Chales G, Dehais, J, et al.
Efficacy and tolerability of chondroitin sulfate
1200 mg/day vs chondroitin sulfate 3 x 400
mg/day vs placebo. Osteoarthritis Cartilage.
1998; 6(supplement A):P25-30.
•
Deal CL, Moskowitz RW. Nutraceuticals as
therapeutic agents in osteoarthritis. The
role of glucosamine, chondroitin sulfate, and
collagen hydrolysate. Rheum. Dis Clin.North
Am. 1999;25:379-395.
•
Diehl HW, May EL. Cetyl Myristoleate isolated
for Swiss albino mice: an apparent protective
agent against adjuvant arthritis in rats. J.
•
Pharm Sci. 1994; 83:296-9.
•
Hathcock JN, Shao A. Risk assessment
for glucosamine and chondroitin sulfate.
Regulatory Toxicology and Pharmacology 47
(2007) 78-83.
•
•
•
Hesslink R, Armstrong D, Nagendran MV,
Sreevatsan S, Barathur, R. Cetylated Fatty
Acids Improve Knee Function in Patients
with Osteoarthritis. Journal of Rheumatology
(2002) 29: 1708-12.
Jellin JM, Gregory PJ, et al. Pharmacist’s
Letter/Prescriber’s Letter Natural Medicines
Comprehensive Database. 11th Edition.
Stockton, CA: Therapeutic Research Facility.
2009
Lippiello L, Woodward J, Karpman R,
Hammad TA. In Vivo Chondroprotection
and Metabolic Synergy of Glucosamine and
Chondroitin Sulfate. Clinical Orthopaedics
and Related Research. 2000; 381:229-240.
Methylsulfonylmethane (MSM). Monograph.
Altern. Med. Rev. 2003 Nov; 8(4):438-41.
Review.
The United States Pharmacopeial
Convention. USP Dietary Supplements
Compendium The Authoritative Reference
2009-2010 1st Edition. Rockville, MD. 2009.
Woolley, Cole. Ageless Nutrition 2nd Edition.
Orem UT: Nutritional Sciences LLC. 2005.
FLX
•
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If you would like to review associated publications
in more detail we suggest you use PubMed, the
information portal provided by the US National
Library of Medicine and the National Institutes of
Health. PubMed is a service of the U.S. National
Library of Medicine that includes over 17 million
citations from MEDLINE and other life science
journals for biomedical articles back to the 1950s.
To find a reference on PubMed, copy the reference
for the article you want to read from the Agel
references (or website) page and paste it in the
“Search PubMed for” entry box on the following
web page: http://www.ncbi.nlm.nih.gov/sites/
entrez?db=pubmed
Some studies are subject to copyright or are
otherwise not available to the general public. The
following sites may allow access to a portion of
these studies and other related information:
•PubMed database: www.pubmed.gov
•US Office of Dietary Supplements:
www.ods.od.nih.gov
If you would like more scientific information on
FLX, go to the Agel website (www.agel.com) under
“products”.
FLX
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Additional Rescources
Agel Product Profiles and Organization
Agel Suspension Gel Technology FAQ
US Regulatory Requirements
European (EU) Regulatory Requirements
Agel Primary Use for All Agel Products
Responsible Use of Agel Nutritional Supplements
Agel Compliant Claim Guidelines for All Products
Agel Product Shelf Life (All Products)
Agel Quality (QA/QC 2011)
Product Profiles Listing of Item Numbers and
Release Dates
Product Certification (Halal and Kosher Lists)
Agel Glossary (All Products)