`
`www.archive.org
`415.561.6767
`41584040391 e—fax
`
`Internet Archive
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`1. I am the Office Manager at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions, including the
`Library of Congress.
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 450 billion pages stored in the
`Internet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (i.e., a website address). If archived records for a URL are available, the visitor
`will be presented with a list of available dates. The Visitor may select one of those
`dates, and then begin surfing on an archived version ofthe Web. The links on the
`archived files, when served by the Wayback Machine, point to other archived files
`(whether HTML pages or images). If a Visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browseable by the Wayback Machine is
`compiled using software programs known as crawlers, which surf the Web and
`automatically store copies of web files, preserving these files as they exist at the point of
`time of capture.
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy] [Month in mm][Day in dd] [Time code in
`hh:mm:ss]/ [Archived URL]. Thus, the Internet Archive URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 am. and 28 seconds
`(1997/01/26 at 04:58:28). A web browser may be set such that a printout from it will
`display the URL of a web page in the printout’s footer. The date assigned by the Internet
`Archive applies to the HTML file but not to image files linked therein. Thus images that
`appear on a page may not have been archived on the same date as the HTML file.
`Likewise, if a website is designed with "frames," the date assigned by the Internet
`Archive applies to the frameset as a whole, and not the individual pages within each
`frame.
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`Internet Archive's records of the HTML files or PDF files for the URL and the dates
`
`specified in the footer of the printout (HTML) or attached coversheet (PDF).
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: {119117
`
`-
`
`'(i
`
`0
`
`3 figL
`
`Christopher Butler
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0001
`
`page 0001
`
`

`

`CALIFORNIA JURAT
`
`See Attached Document.
`
`A notary public or other officer completing this
`certificate verifies only the identity of the
`individual who signed the document to which this
`certificate is attached, and not the truthfulness,
`
`accuracy, or validity of that document.
`
`State of California
`
`County of San Francisco
`
`
`LAUREL KARR
`
`
`Notary Public - California
`San Francisco County
`tVNN
`
`Commission # 2172222
`
`
`My Comm. Expires Nov 17. 2020
`
`Subscribed and sworn to (or affirmed) before me on
`this
`
`X day $18221sz fill, by
`
`Christopher Butler,
`
`proved to me on the basis of satisfactory evidence to be
`the person who appeared before me.
`
`Signature'f g 5:: E [Lh-
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0002
`
`page 0002
`
`

`

`Exhibit A
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0003
`
`page 0003
`
`

`

`Purchase KRILL BILL Pure Neptune Krill Oil—FREE SHIPPING
`
`1 of 2
`
`Krill Bill 100% Neptune Krill Oil - the purest
`combination ofphospholipids,
`antioxidants, omega-3, omega-6, and omega-9
`fatty acids
`" Get Krilling and Start Living Again "
`
`100 %
`
`
`
`
`'
`
`-
`
`FREE SHIPPING
`inside USA
`i. [Ii-‘54 I
`I
`P P I
`
`.
`
`Neptune
`
`Each Serving (2 gel Pure
`caps) contains:
`
`Calories
`8.8 (6.3
`from fat)
`Total Fat (fatty
`acids)
`700 mg OIL
`Saturated Fat
`
`KRILL
`
`300 mg
`
`Sodium
`
`IU
`
`5 mg
`Vitamin A
`100
`Vitamin E
`0.5 IU
`omega-3 Fatty Acids
`300 mg
`
`EPA
`
`150 mg
`DHA
`
`9“ mg
`omega-6 Fatty Acids
`20 mg
`omega-9 Fatty Acids
`85,
`.mg
`PhosPhth'ds
`400 mg
`Astaxanthm
`1'5 mg
`
`CAUTION: If you
`have a seafood
`allergy or are
`taking a blood
`thinner, you
`Should consult
`your physician
`before taking Krill
`Oil
`
`500 mg ofpure
`NKO per gel
`cap
`go gel
`caps per bottle
`
`Suggested User
`Take 2 gel caps 21
`day with breakfast
`for one month.
`Then take 1 gel
`cap daily with
`breakfast
`
`thereafter.
`
`https://web.archive.0rg/web/2006071510371S/http://www.krillbill.Com280/purchaschtm
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0004
`
`page 0004
`
`

`

`Purchase KRILL BILL Pure Neptune Krill Oil—FREE SHIPPING
`
`2 of 2
`
`bottle $35 .97
`Purchase
`
`3 bottles
`
`$95.97
`Purchase
`
`6
`
`bottles $159.97
`Purchase
`
`Gluten—Free
`
`Sugar—
`Dairy—Free
`Free
`Starch—
`
`Free
`
`Yeast—Free
`
`Soy—Free Rice»
`Free Wheat—
`
`Egg—Free
`Free
`Preservative-Free
`
`Added Coloring—
`Free Added
`
`Flavor-Free
`
`bill@krillbill.com
`
`ARTHRITIS NEWSLETTER
`
`MORE
`
`SUPPLEMENTS
`
`REGULAR NEWSLETTER
`
`Solutions Unlimited Guarantee
`Privacy Policy
`We do not rent, sell. trade, or otherwise disclose 871 Englevifle Road I personally guarantee every product. We
`any information you give us. I am the only one
`-
`research, evaluate and use the products we offer
`who has access to your information. We have 3 Sharon Springs, NY you. If you ever have a problem - I want to hear
`firewall. antiaspyware, antiavirus software, and
`13459
`about it and make it right.
`are not online 24/7.
`PHONE
`518.284.2203
`FAX 303.568.2465
`
`Bi“ 21““
`
`Bill Ziese
`
`https://web.archiveorg/web/20060715 10371S/http://www.kri11bill.com:80/purchase.htm
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0005
`
`page 0005
`
`

`

`Specifications for KRILL BILL 100% Pure Neptune Krill Oil
`
`1 of 3
`
`Krill Bill 100% Neptune Krill Oil - the purest
`combination ofphospholipids,
`antioxidants, omega-3, omega-6, and omega-9
`fatty acids
`” Get Krilling and Start Living Again "
`
`Composition of Krill Bill 100%
`
`Pure Neptune Krill Oil
`(Do You Know What‘s in Your Fish Oil?)
`
`Standard Specification
`Component
`Phospholipid Profile per 100 grams
`
`Total Phospholipids
`Phosphatidylcholine
`
`Lysophosphatidylcholine
`
`>400 grams
`>30 grams
`0.4 - 2 grams
`0.4 - 2 grams
`
`0.4 - 2 grams
`
`Phosphatidylethanolamine
`Phosphatidylinositol
`
`Fatty Acids Profile per 100 grams
`
`>73 grams
`<30 grams
`>12 grams
`>32 grams
`>30 grams
`>15 grams
`>9 grams
`>0.4 grams
`1500 - 2500 mg
`>1.3 grams
`>6 grams
`>5 grams
`
` Acids
`
`Total Lipids as Fatty
`
`as Saturated
`as Monounsaturated
`as Polyunsaturated
`Total Omega-3 Fatty
`Acids
`as EPA
`as DHA
`as DPA
`Total Omega-6 Fatty
`Acids
`as Linoleic Acid
`
`FREE SHIPPING
`inside USA
`__
`
`-= L4 - Total Omega‘9 Fatty
`
`Pa yPaI
`
`Acids
`as Oleic Acid
`
`Antioxidants
`
`>150 mg per 100 grams
`Esterfied Astaxanthin
`trans Retinol (Vitamin A) >100 IU per gram
`
`https://web.archive.org/web/20060715 103809/http://www.krillbill.com/profilehtm
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0006
`
`page 0006
`
`

`

`Specifications for KRILL BILL 100% Pure Neptune Krill Oil
`
`2 013
`
`alpha-Tocopherol
`(Vitamin E)
`Cholecalciferol (Vitamin
`D)
`Selenium
`
`>05 IU per gram
`>10 IU per gram
`>30 pg per gram
`
`Minerals per 100 grams
`
`Calcium
`
`Magnesium
`Potassium
`Phosphorus
`
`Sodium
`
`Zine
`
`Total Arsenic
`inorganic Arsenic
`Cadmium
`
`Mercury
`
`Lead
`
`Copper
`Tin
`
`Antimony
`
`Aldrin
`BHC
`
`Chlordanes (alpha &
`
`gamma)
`DDD, DDE, DDT
`Dieldrin
`
`Heptachlor
`
`Toxaphene
`Dioxins & Furans
`Total PCB‘s
`
`>20 mg
`
`>1 mg
`>150 mg
`>1000 mg
`
`<300 mg
`
`>0.3 mg
`
`Heavy Metals
`
`<10 ppm
`50.1 ppm
`<0.1 ppm
`
`<0.1 ppm
`
`<0.15 ppm
`
`<5 ppm
`<10 ppm
`
`<1 ppm
`
`Organic Contaminants
`
`<0.01 ppm
`<0.01 ppm
`
`<0.01 ppm
`
`<0.01 ppm
`<0.01 ppm
`<0.01 ppm
`
`<0.01 ppm
`
`<0.15 ppt
`<0.5 ppb
`
`mg = milligrams
`
`
`
`Units
`
`l
`
`ppm=partspermillion
`
`
`pg = micrograms
`
`
`
`IU= Internafiunal
`
`ppb=partsperbillion
`
`ppt = parts per trillion
`
`;
`
`bill@krillbill.c0m
`
`ARTHRITIS NEWSLETTER
`
`
`MORE
`
`SUPPLEMENTS
`
`REGULAR NEWSLETTER
`
`https://web.archive.org/Web/20060715103809/http://www.krillbill.com/profilehtm
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0007
`
`page 0007
`
`

`

`Specifications for KRILL BILL 100% Pure Neptune Krill Oil
`
`3 of 3
`
`Solutions Unlimited Guarantee
`Privacy Policy
`We do not rent, sell, trade, or otherwise disclose 871 Englevflle Road I personally guarantee every product. We
`any information you give us. I am the only one
`research, evaluate and use the products we offer
`who has access to your information. We have 3 Sharon Springs, NY you. If you ever have a problem - I want to hear
`firewall, anti—spyware, anti-virus software, and
`13459
`about it and make it right.
`are not online 24/7.
`PHONE
`518.284.2203
`FAX 303.568.2465
`
`Bi" Ziese
`
`Bill Ziese
`
`https://web.archiveorg/web/20060715103809/http://www.krillbill.com/profilehtm
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0008
`
`page 0008
`
`

`

`Aquabource Products — Furcnasc Wllu Knll U11 Capsules
`
`1 01 l
`
`Home ' Healthy lelng - Knll Oll Products - Resources - Store ‘ SaleSv Conlacl Us
`
`Sihpppl' m1 firm
`0 Items
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`
`Welcome Guutl Would you like to lg laurself in? 01 would you prefer to create an account?
`
`Looking for more information on Aquasource Krill Oil”) gliggm
`
`
`Wild Antarctic Krill Oil
`.vp- \, ,‘,;,.»,
`
`
`
`4
`
`-
`
`hugn ln antlomdanls to help fight lhe aqmg process
`contains unique phospholipids
`nch mums cf Omega 3 fatty acids
`
`60 gel capsules USD $27.99m
`
`FREE SHIPPING
`
`
`
`
`
`
`
`
`1
`I
`
`Wlld Sockey‘. Salman Oil HEW?!
`0
`pure! 100% WIld sochays salmon oil
`I not blended with inlen’orfish cuts or omer salmon spaces
`-
`l'ICh source of Omega 3 law acids
`
`
`- Site Map . Legal - anacy Slalemenl
`
`180 - 508 mg gel upsules USD $19.39
`
`Wammg: those with known allergies to fish and seafood should cansull with their
`healthcare pmfessional as no studies have been done on those mm alleryres.
`
`Mid Antarctic Krill and Wild Sockeye Salmon Oil ls a dietary supplement onfy.
`
`Wednrzsnav .1 6 fix Hg :1 5t! 2006
`
`ropynght
`
`"004 AquaSource Produnls lm-
`
`https://web.archive.org/web/20060816050841/http://www.aquasourceproducls.com:80/sl0re/
`
`RIMFROST EXHIBIT 1076
`
`page 0009
`
`RIMFROST EXHIBIT 1076 page 0009
`
`

`

`-"I'f._l'1.;L'_ \
`kflli oil is high in antioxidants to help fight the aging process
`knit oil contains unique phospholipids
`krill oil is rich source of Omega 3 fatty acids
`
`Why Choose Antarctica Select Krill Oil?
`
`Nutritionists and Health Professronals readily agree that m: health benefits of Omega-35 are essential to people today, Young and old benefit
`from the powerful oil found in Antarctlw Seled, ridi in EPA and DHA. Antarctica Select is the best choice for you and your family in
`maintaining a wellrbalanced diet.
`
`Krill Oil has a higher oontent of Omega 3 tatty acids than fish oils and some antioxidants that are not found in other products ll will notcause
`gastrointestinal difficulty or aftertaste, it is suggested that the mercury content in fish oil may mnoel out any benefits derived from it, but krill
`oil is free of all ton‘c elements.
`
`Kn‘tl oil is free of pollutants such as mercury and other heavy metals. in addition to OmegaG (wefl known for it1§€"‘s effect upon
`cardiovascular health)‘ krill oil has powerful antioxidants. shown to be effective in preventing the common signs and symptoms oi aging, and
`phosphotipids, cniical for the maintenance of cell membranes and normal hormone regulation—something that ordinary fish oil does not have.
`
`Purging Antagjcg Select Krill Qfl
`
`Hit."
`
`Important Notice: This site is desrpned primarily as an educational resource and a product sales. tool
`
`it is not intended to provide medical adwce on personal heaith matters or [L guide treatment A-
`
`'Jt’thl" is
`
`Copyright I: 2004 AquaSource Products inc - Site Map - Legal - Privacy Statement
`
`Wild Antarctic Krill Oil - A rich source of Omega—3 and Antioxida...
`
`l of l
`
`Home - Healthy Livmg - Krill Oil Products - Resources - Store - Distributors- Contact Us
`
`Krill Oil
`
`Wild Antarctic Krill Oil - A Clean, Pure Source of Antietam: and Omega-3
`
`Wk‘t‘iL-f'fr.
`
`Only appropriately done by a qualified health prolessmnai
`
`https://web.archive.org/wcb/2006081605 lOlO/htip://www.aquasourceproducts.com:80/krill_oil.html
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0010
`
`page 0010
`
`

`

`Wild Antarctic Krill Oil — A rich source ol'Omega—3 and Antioxida...
`
`1 of 3
`
`lzD’-}{<3,D350u[cg
`
`LK TS INC
`
`. Healthy lemg - Knllel Products ~ Resoutces . Store « DISIHDUQDrS' Conlacl Us
`
`Home.
`
`FAQ: Regarding Krill on
`Mm lllflll?
`
`mwig-mdwwnmm,IlnmmnmtmlzmmmMWMflumanmdmammm
`hmwflicmmfifaflufiflmnfisudm15%highmfllflywmmmmmnufia!mmfldsmflmfmmmmmlm,ll
`WWMMuM,mm,mmnlswrynmfimnandammdmw
`mhmulmdfl
`
`inn-mm«9mmWMWOmmu-ummmmmmmmwmmwuwwmm
`am Mam-ass. lane and mm quantyi
`mmmmumnoHum?
`
`M WWI: demm IDtharwclu-iflod miw-mshwmaramm, swimmnm.
`asmwmuupnmymm "mm: hlgl'leraumflllas nfmaa‘dmnouwaPAmd DMMammmi
`Wmmdmh-mmmuflnm
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`-Mrynmma1mase
`-mmmm
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`wmmm
`muzmmemlim
`‘mmm
`-Remshkllp-'n
`-M:anmfimnimwlimesflml
`
`Dun-Alum all-c1 mmlcomah MMIW?
`
`MillisumdmmmmmnshaflmycancelmAwMswmmMImwismuafltnmm
`mnmmmmawmflsl
`Mitt malt: Ant-m filled dlfltronl mm m! fish oils?
`
`Mala-an Krill oi mammw 010“:va may add: than M1 all; as walla maniofidams mm In tamer prnmcls. ltwll
`mlmmmmmmmmamm.
`with"
`
`PM): Regarding Dietary SupplimeMa and Omega-33
`Whit. can I find infnmaflan abnui tilting nlturhl pmducls, a! dietary suppbmeflu?
`
`mun Sofa-a slanmg any supplement «1 (5 use to speak Mm yourer or pharmdsl. See our gyma; section for more mien-nation on
`m mung Omega-35 A: wall visit the FDA's muslin ragammg Diem Suppllmem: for l‘uflhet ManhattanWW
`WEI.“
`An In“. whmona m vlumlm and minerals or (Hug: than I menial he mm of m am taking Gauge-3 suppllme-nu?
`
`Answer. The amen-3 90!}qu am comma-1t: all foods and as sud! not blah: to inmau Mm drugs. M11 ll i: dilllcull 10 be and
`slum mere am so many drugs being lamahed all the time. ”you an; Iaklng any drug «at-tho mmmends‘llon ofa physician: a would be wise
`to m him or her men Hex! yuu «at. There are no Mum interactions with vitamins or minerals.
`
`Do I M1012!- mm E m an milling an Oman-3 supfiimncwmdm
`
`fins-rat: "banana mommanood'hmkadulfaflfinflf you are gahglnhhaun omega»: Emlmmfiw Selectmllflllan
`Whflfimfiammmtunwm.
`
`mm In lit. Mumndnd amuum all Drum-a I would bu consuming In my am?
`Amuse TimM Heaflmwwm has published ifs guide to taking OW3‘ See that: ”manna-hon at
`hgmamgflmgsenygnmgmmm. As well this wide is useful for fluent-res In proper consumption omeeua-El:
`W
`suck-mu.“
`Studies on Omegadc
`
`Thu Having amides are rota-ad m the benefits on cumming Omegads in our dietsv
`
`https://web .archive.org/web/200605061 15548/http://www.aquasourcepr0ducts.com:80/resourccshlml ?osCsid=ace4bb3df08470b03375b05984...
`
`RIMFROST EXHIBIT 1076
`
`RIMFROST EXHIBIT 1076 page 0011
`
`page 0011
`
`

`

`Wild Antarctic Krill Oil — A rich source of Omega—3 and Antioxida...
`
`2 of 3
`
`
`
`Diem
`
`towels of
`
`aanmdh nodsmmllmM b-
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`lmm‘mrlslroilnuhinv-s
`am n—S Fa Add: and {PM '
`of Sud
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`'
`
` unis”.
`Gloostry of Terms
`
`All terms below wars attainedMM aW encycirzpedia
`Aflflolldlnt!
`
`An antioxidant is a chem! that prevents the oxidation of (filler chemicala In Halogical water-n5, me normalm of urination (plus a
`minor mnln'butinn {rum ionizing radiationl pmduca highly reaches m radicals, These can readily read with and damagn other molaallos: in
`some case: We body uses this to ugh! lnlection. In 0mm cams, lire damage may be no me Wsm calls. The [3112me clam-amour
`eaally undisable communes in tho mam can "map up" free radicals before may damage newer use-1w mail“. The lullavvlng winning
`hm shown posiflva anfioxidam eflaus: Retinal (Wan-in A or beta—carotene), Ascorbic ldd Marlin C), Wamln E (monpnmi), Selenium.
`Amrflhm
`
`lmun&suppom’ng camlenoid. which can be use-0‘0 guard your cell membrane: film [ma raw-ml :l'amaga. main Is the dielrdcal ma!
`g'ms lobslers, shrill-m. and some crab: lheirred mlor when they are cooked.
`
`Wen-anal: acid mm;
`
`A polyun$amffile¢ fatty acid mused 0! 22 carbon atom: and six doubla Bonds. Because the firsl ml: band, as emailed hum rho melhyl
`lerminus,
`a! positian than, it belongs to me 0W3 group.
`
`Ekmoonuenok new (EPA)
`
`II is a lnngdaln polyunaamraeed fatty acid of the ry3 or omega-3 type. EFA is an all ch: polyunsamrnmd l'my
`A major componenl of fish Dll.
`acid containing 2.0 carbon: and 5 double hams.
`
`Emmr me Acids
`
`Fan}! adds trial are required in the human diet. Thls means may «anyml be syrflhasited by H10 mm mr lalh- m and must be
`obtained from food. 1'0953 fatty acids were originally desgnated as er1 F. unhl llwas realized mat they must be am with lha ills,
`Krill
`
`The Noam word for whale food. ll is also used as synonym for 64131131131565, m an shdmpike marina Mmiei. WHEN
`organisms of the plankton (zoaplankton). la the Elem sense ‘knfl’ is used as nornmun name liar file must spsaamla: spade: the ~1ch
`Krlfl lEupliallsfs superbal of tho Amaruic waters in the Southern Ocean, ll is an ermhaual'd. Krist in in large salads (Mlle-id men
`be primary ploduclion directly into a relafnrmy large animal. They grow in a length-ore an, weigh 2 gar-nus, and live probably fora years,
`Krill as me mslone species of tho ecosyslarn af Arum-Jim. andis an W! food organism far whales. seals, Leapard Seals. fur seals,
`Crammer Seals, squid. Ioefish penguins, albakosses and many olher birds. Thcir 1mm: in ashamed lo be between 100“ 300 Milan
`tonnes“ making E. superba pmhahly lhe mos! wmessful animal on me planet; ior mm, tho total non-krill yield hum dl mild fisheries
`is about 100 million lonnes per war. The fishery ul krill is on the order of 90.000 tunoes per year.
`Lin-olenic Ask!
`
`An 1&m‘bon polyunsaturated fatty acid with three double bonds. The isomer railed alpha-finalenic am. an Omega (any add, is easenla'll
`for all mmmals. Npharlil‘lolenic acid has been assoualecl wilh reduced cardiovaswlar risk Waugh reduced cardiac anythmlas and reduced
`carotid anenasdemsis; however. epidcmiolagy has also linked alpha—momma: and mm rapidly progressing prostate runner and macaw
`degeneration. Another isomer of llnolenlc add is gamma-linolenic add, an Omega-l5 fully acid Much is the pruduu at dasalurailan of Linolerc
`acid. This fatty acid is rare in food, and is sametimes taken as an all supplement because its elongation product, di-rlorm gamma linolenic
`acid, is an lmponanl constituent of cell membrane phospholids in its hale as precursor lo the series! eicosonoids.
`
`Omega-3
`
`Pofiunsalurated fatty acids found in certain fish harms, and in mammals snurces such a: flair seeds. walnuts, and canola oil. Omega-3 fatty
`adds are classed as essential fatty acids. The term 'amega—B‘ signifies lira: the firsl double bond in the man backbone of [he fatty acid,
`counting mm the and opp-agile the acid amup, mulls in the third carbon-carbon bond, Like all: polyunsatwmed fatty acids, the Omens
`fatty acids have mmimum 2 and maximum 6 double baunds in a carbon main that ranges from 18 until 22 carbon moms. Comon omega-3
`fatty acids in the hody ar: [alvha-ilinolenoc acid (18:3). eicosapemaenoic and (20:5) , dmnsahemenoic Add (2226). Gamma-Jimmie add is
`In omega-6 lalty add.
`
`Phosphollpids
`
`A phospholipid ls a lipid that is a primary component of cell membranes Phospholipids mnsisl of a water-soluble head (a positively charged
`(polar) pileup), linked to M0 walerJnsoluble nonpolar lails (by a negallvely charger! phosphate group), Balh tails mums! all a fatty add, each
`14—24 carbon groups long.
`H 1h ‘1‘
`
`it is not Intended to prowde medical advrce un pel>0nal health matters or to gwde treatment wnlcr: l5
`only appropnalelv done by a qualified health prof-
`
`ljopyngnl (r 2004 uqnasUwce Pronucls lnc - Slle Map - Legal . Privacy Slalemenl important NO’UCE This sue ls aeSlgned pllll‘lallly as an educational resource and a product sales lool
`RIMFROST EXHIBIT 1076 page 0012
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`Wild Antarctic Krill Oil - A rich source of Omega-3 and Antioxida...
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`FDA/CFSAN Overview of Dietary Supplements
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`1 of 6
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`U. S. Food and Drug Administration
`Center for Food Safety and Applied Nutrition
`
`January 3, 2001
`
`M11223 =
`
`IBM :-
`
`Overview of Dietary Supplements
`
`What is a dietary supplement?
`
`Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act
`(DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient"
`intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins,
`minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues,
`glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found
`in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other
`forms, such as a bar, but if they are, information on their label must not represent the product as a
`conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary
`supplements in a special category under the general umbrella of "foods," not drugs, and requires that
`every supplement be labeled a dietary supplement.
`
`What is a "new dietary ingredient" in a dietary supplement?
`
`The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary
`ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an
`ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the
`following substances:
`
`0 a vitamin,
`
`. a mineral,
`
`. an herb or other botanical,
`
`0 an amino acid,
`
`0 a dietary substance for use by man to supplement the diet by increasing the total dietary intake
`(e.g., enzymes or tissues from organs or glands), or
`o a concentrate, metabolite, constituent or extract.
`
`A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not
`sold in the US. in a dietary supplement before October 15, 1994.
`
`What is FDA's role in regulating dietary supplements versus the manufacturer's
`responsibility for marketing them?
`
`In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by
`President Clinton. Before this time, dietary supplements were subject to the same regulatory
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`FDA/CFSAN Overview of Dietary Supplements
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`requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic
`Act, created a new regulatory framework for the safety and labeling of dietary supplements.
`
`Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or
`distributes are safe and that any representations or claims made about them are substantiated by adequate
`evidence to show that they are not false or misleading. This means that dietary supplements do not need
`approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre—
`market review for safety data and other information is required by law, a firm does not have to provide
`FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its
`products .
`
`Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA
`before producing or selling them. Currently, there are no FDA regulations that are specific to dietary
`supplements that establish a minimum standard of practice for manufacturing dietary supplements.
`However, FDA intends to issue regulations on good manufacturing practices that will focus on practices
`that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the
`manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the
`dietary supplements it produces are safe and contain the ingredients listed on the label.
`
`When must a manufacturer or distributor notify FDA about a dietary supplement it
`intends to market in the U.S.?
`
`The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor
`notify FDA if it intends to market a dietary supplement in the US. that contains a "new dietary
`ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is
`reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food
`substance and is present in the food supply.
`
`There is no authoritative list of dietary ingredients that were marketed before October 15, 1994.
`Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is
`"new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary
`
`ingredient, were marketed before October 15, 1994. For more detailed information on new dietary
`ingredients, go to: http://wwwcfsan.fda.gov/~dms/ds-ingrd.html.
`
`What information must the manufacturer disclose on the label of a dietary
`supplement?
`
`FDA regulations require that certain information appear on dietary supplement labels. Information that
`must be on a dietary supplement label includes: a descriptive name of the product stating that it is a
`
`"supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list
`of ingredients; and the net contents of the product.
`
`In addition, each dietary supplement (except for some small volume products or those produced by
`eligible small businesses) must have nutrition labeling in the form of 3
`
`"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.
`
`Must all ingredients be declared on the label of a dietary supplement?
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`https://web.archive.org/web/20060513152744/http://vm.cfsan.fda.gov/~dms/ds-oview.html
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`FDA/CFSAN Overview of Dietary Supplements
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`Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient"
`statement beneath the panel. The types of ingredients listed there could include the source of dietary
`ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C),
`other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin,
`starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://wwwcfsanfdagov
`/~1rd/ffi7923a.html.
`
`Are dietary supplement serving sizes standardized or are there restrictions on the
`amount of a nutrient that can be in one serving?
`
`Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size
`or the amount of a nutrient in any form of dietary supplements. This decision is made by the
`manufacturer and does not require FDA review or approval.
`
`Where can I get information about a specific dietary supplement?
`
`Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means
`that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.
`If you want more detailed information than the label tells you about a specific product, you may contact
`the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be
`found on the label of the dietary supplement.
`
`Who has the responsibility for ensuring that a dietary supplement is safe?
`
`By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are
`safe before they are marketed. Unlike drug products that must be proven safe and effective for their
`intended use before marketing, there are no provisions in the law for FDA to "approve" dietary
`supplements for safety or effectiveness before they reach the consumer. Also unlike drug products,
`manufacturers and distributors of dietary supplements are not currently required by law to record,
`investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the
`use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for
`showing that a dietary supplement is "unsafe," before it can take action to restrict the product‘s use or
`removal from the marketplace.
`
`Do manufacturers or distributors of dietary supplements have to tell FDA or
`consumers what evidence they have about their product's safety or what evidence
`they have to back up the claims they are making for them?
`
`No, except for rules described above that govern "new dietary ingredients," there is no provision under
`any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the
`information they have about the safety or purported benefits of their dietary supplement products.
`Likewise, there is no prohibition against them making this information available either to FDA or to
`their customers. It is up to each firm to set its own policy on disclosure of such information. For more
`information on claims that can be made for dietary supplements, see (httQ://www.c[san.[dagov
`/~dms/hclaims.html).
`
`How can consumers inform themselves about safety and other issues related to
`dietary supplements?
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`FDA/CFSAN Overview of Dietary Supplements
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`It is important to be well informed about products before purchasing them. Because it is often difficult to
`know what information is reliable and what is questionable, consumers may first want to contact the
`manufacturer about the product they intend to purchase (see previous question "Where can I get
`information about a specific dietary supplement?"). In addition, to help consumers in their search to be
`better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making
`Informed Decisions And Evaluating Information —— http://wwwcfsan.fda.gov/~dms/ds—savvy.html
`(includes information on how to evaluate research findings and health information on-line) and Claims
`That Can Be Made for Conventional Foods and Dietary Supplements -— http://wwwcfsanfdagov
`/~dms/hc!ajms.html, (provides information on What types of claims can be made for dietary
`supplements).
`
`What is FDA's oversight responsibility for dietary supplements?
`
`Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and
`
`Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA‘s efforts to
`monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false
`or misleading claims) include obtaining information from inspections of dietary supplement
`manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory
`analyses of selected products, and adverse events associated with the use of supplements that are
`
`reported to the agency.
`
`Does FDA routinely analyze the content of dietary supplements?
`
`In that FDA has limited resources to analyze the composition of food products, including dietary
`supplements, it focuses these resources first on public health emergencies and products that may have
`caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or
`in violation of the law. The remaining funds are used for routine monitoring of products pulled from
`
`store shelves or collected during inspections of manufacturing firms. The agency does not analyze
`dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that
`the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and
`that the content matches the amount declared on the label. FDA does not have resources to anal