미국 건강기능식품기준 및 규격 비교 조사

Comparison Research for Standards & Specification 미국

건강기능식품수출가이드_표지_1210.indd 21 2014-12-12 오후 1:47:57

목차

식이보충제 관련 규제 1. ····························································· 1

가 규제의 개관 . ········································································· 1

나 연방식품약품화장품법 . ······················································· 4

다 식이보충제 관련 법률 . ······················································· 5

라 현행우수제조관리기준 . (CGMPs) ········································ 6

식이보충제 표시 2. ······································································· 8

가 일반적인 표시관련 규제 . ··················································· 8

나 강조표시 . ············································································· 16

다 기타 라벨링 . ······································································· 23

라 라벨링 예시 및 관련 규정 . ············································· 25

신규식이원료 3. (NDI, New Dietary Ingredient) ··················· 33

가 신규식이원료의 정의 . ······················································· 33

나 신규식이원료의 신고내용 및 절차 . ······························· 36

다 접수된 신규식이원료 리스트 . ········································· 44

라 와 의 구분 . GRAS NDI ························································ 44

식이보충제 사후관리제도 4. ····················································· 50

가 문제점 보고 . ······································································· 50

나 의 관할권 . FDA ··································································· 51

별첨 식이보충제 관련 건강 및 교육법 1. (DSHEA)「 」 ······· 52

별첨 2. NNFA Dietary Ingredient List「 」 ······························ 75

별첨 모노그래프 리스트 3. USP 「 」 ········································· 84

별첨 식이보충제 원료 신고 포맷 4. FDA 「 」 ························· 89

별첨 접수된 리스트 5. NDI 「 」 ················································· 95

별첨 6. FDA MedWatch「 」 ····················································· 102

참고자료 ※

- 1 -

- 2 -

- 3 -

- 4 -

- 5 -

1) 별첨 식 보충제 건강 및 법 참조 1. (DSHEA)「 」

- 6 -

- 7 -

- 8 -

- 9 -

- 10 -

- 11 -

- 12 -

- 13 -

- 14 -

- 15 -

- 16 -

- 17 -

- 18 -

� 칼슘과 골다공증(21 CFR §101.72)

� 식이지 과 암(21 CFR §101.73)

� 나트륨과 고 압(21 CFR §101.74)

� 포 지 스 과 상심장질 험, (21 CFR §101.75)

� 소 함 곡 과채 암, (21 CFR §101.76)

� 소 특히 용 소 함 과채 곡 상심장질 험( ) (21 CFR §101.77)

� 과채 암(21 CFR §101.78)

� 엽산과 신경 결손(21 CFR §101.79)

� 당알 과 충 (21 CFR §101.80)

� 식품에 래 용 식이 소 상심장질 (21 CFR §101.81)

� 단 과 상심장질 험(21 CFR §101.82)

� 식 스 식 스타놀 에스 르 상심장질 (21 CFR §101.83)

�

�

- 19 -

등 상 계 강조 시 사용용어

A 높 (High) 에 충족 여 건강강조 시에 해당 다SSA .

B간

(Moderate)

강조 시를 뒷 침 는 과 증거가 있 나 이 증거는 증 것“ ,

이 아님(Evidence is not conclusive)”

C 낮 (Low)강조 시에 과 증거가 일부 있 나 이 증거는 이며 “

증 것이 아님(Evidence is limited and not conclusive)”

D매우 낮

(Extremely Low)

강조 시에 과 증거는 매우 이고 이를 뒷 침해 주“ ,

는 과 근거는 거 없 (Little scientific evidence supporting

this claim)”

- 20 -

- 21 -

- 22 -

- 23 -

- 24 -

- 25 -

- 26 -

- 27 -

- 28 -

- 29 -

- 30 -

- 31 -

- 32 -

- 33 -

- 34 -

2) 별첨 참조 2. NNFA Dietary Ingredient List「 」

3) 별첨 모노그래프 리스트 3. USP 「 」

월 일 이 에 미국에 매 이 있는 1994 10 15

식이보충 원료인가?

Yes No

식이보충 원료를 생산 는 데

변경사항이 있는가?

새 운 식이보충 (NDI)

일 식품 원료 사용 이

있는가?

No YesNo

새 운 가공 식이 원료

분 꾸어 버리는가?

다른 구조 또는 분( ,

추출 사용 새 운 시재료, )

신고자가 신고를 FDA NDI

는가?

No

Yes Yes No

식이보충 원료가 변경 ,

태 월 일 , 1994 10 15

이 에 매 이 있는가?

새 운 품 생산과 이

분 NDI

꾸어버리는가?

No

Yes Not Sure

이 DSHEA

식이원료 신고 NDI

요 없

생산과 에

변 가 를 NDI

만들어냈다면 NDI

신고가 이에 라

요 않 있

No Yes

신고가 NDI

요 않

NDI

신고가

요함

건조 얼림 건조 분 등 원료를 변 지 않는다* , , , .

- 35 -

식이보충 검증마크USP 식이보충 원료 검증마크USP

약 재료 검증마크USP 약 첨가 검증마크USP

- 36 -

- 37 -

- 38 -

- 39 -

- 40 -

- 41 -

- 42 -

- 43 -

4) 별첨 식 보충제 원료 신고 포맷 참조 4. FDA 「 」

- 44 -

5) 별첨 접수된 리스트 참조 5. NDI 「 」

- 45 -

- 46 -

- 47 -

- 48 -

- 49 -

새 안 NDI새 안 GRAS

데이 생 특징: ,

사용 이 안 연구,

데이 생 특징: ,

사용 이 안 연구, 연구 에

연구자료 요 없( )

명GRAS

가 ( )

자 단계

통보FDA자가 결

시 일75

시

- 50 -

- 51 -

6) 별첨 참조 6. FDA MedWatch「 」

- 52 -

식이보충 건강 법 (DSHEA)

- 53 -

- 54 -

- 55 -

- 56 -

- 57 -

- 58 -

- 59 -

- 60 -

- 61 -

- 62 -

- 63 -

- 64 -

- 65 -

( )

- 66 -

- 67 -

- 68 -

- 69 -

- 70 -

- 71 -

- 72 -

- 73 -

- 74 -

- 75 -

원료명

캡슐 타 원료 (Capsule & Tablet Ingredients)

#0 Red Opaque Conisnap capsule Ghatti gum

200 Bloom GMI gelatin Klucel LF

Ac-di-sol Methyl cellulose

Acacia (arabic gum) (arabia gum) Methyl-propyl parabens

Alanate 330 Myvacet 9-45K

Alginic acid, alginates Myvaplex 600 powder

Akoxyglycerol Natural lock capsules

Annatto Pharmaceutical glaze

Avicel PH-102 Polysorbate 80

Bentonite Povidone

Blue fim coat conc. C&KT733BL Pregel, starch NF starch 1500

Cab-O-Si1 M5 Proooticarb-MGI

Carbomer Reclaimed netting-0989 & 1109

Carbowax 3350 Sodium carboxmethylcellulose

Carmine dye #09350 Sodium lauryl sulfade

Carnauba Wax Sodium starch glycolate NF

Carnauba Wax Powder, NF Sorbitan

Cellulose Gum Sterotex K vegetable stearin

Cellulose, microcrystalline cellulose Superex S-3027, 2nd

Crospovidone, NF (PVPP) T dioxide/glycerin disper

Dipac DC Tableting Sugar Gran. Talc

Ditab Unmill DCP Dihydrate USP Titanium dioxide

Dri-Klear TR ultra mega II 1/o iron mix

Ethocel (10 cps) Transfer-98 TM

Foam Blest 10 Silicone compound Unidex 2034

Food Glaze Vegetable magnesium stearate

White film coating concentrate

아미노산 펩티드 (Amino Acids & Peptides)

Alanine Isoleucine

Arginine Lactalbumin

Arginine pyroglutamate Lactoglobulin complex

Aspartame Leucine

Aspartic acid Lysine (HCl)

Betaine anhydrous Methionine

Betaine HCl Milk Caseinate

Botanical protein N, N-Dimethylglycine

Casein N-Acetyl-Cysteine

Citrulline Ornithine

Cysteine Ornithine Alpha-Ketoglutarate (OKG)

Cystine Ornithine monohydrochloride

D, L-Methionine Pea Protein

D, L-Phenylalanine Phenylalanine

Egg Albumen Proline

Egg Albumin Rice protein

Egg protein isolate Serine

Gelatin bone 150 bloom Soy protein isolate, hydrolysate

Gelatin, hydrolyzed gelatin, bone hydrolyzed Sweet dairy whey powder

Glutamic acid, glutamic acid HCl Threonine

- 76 -

원료명

Glutamine Tryptophan

Glutathione Tyrosine

Glutathione peroxidase E Valine

Glycine Whey

Histidine Whey protein concentrate

지(Fats and Oils)

Alpha Linolenic acid (ALA) Omega 3 (Spray dried fish oil)

Arachidonic acid Orange oil 2 1/2 fold

Beta-sitosterol Palmitic acid

Black currant seed oil Parsley (Carum petroselinum) seed oil

Borage oil Peppermint oil

Borage oil powder Phosphatidic acid

Campesterol Phosphatidylcholine

Caprylic acid Phosphatidylethanolamine

Carrot Oil Phytosterols

Castor oil Pumpkin seed oil

Coconut oil Rosemary oil

Cod liver oil Safflower oil

Corn oil, winterized, USP Salmon oil

Dillweed oil Sardine oil

Docosahexaenoic acid (DHA) Skip jack liver oil

EFA (unrefined vegetable lipids)essential

fatty acidsSodium Caprylate

EPA (Eicosapentaenoic acid) Soy Lecithin

Evening primrose oil Soybean and Palm oil (Primex)

Fish body oil (EPA/DHA Vit E) Soybean oil

Fish liver oil Squalene

Flax oil Stearic acid

Gamma Linolenic acid (GLA) Sterol complete pramix

Hexacosanol Sulfated Castor oil

Intrinsic Glandular lipids Sunflower oil

Linoleic acid (Omega-6) Tetracosanol

Linolenic acid (Omega-3) Triacontanol

Medium Chain Tryglycerides Vegetable shortening

Octacosanol Vegetable squalene

Oleic acid (Omega-9) Vegetable stearic acid

Olive oil Wheat germ oil

Wheat germ oil 50% powder

식 (Botanicals)

Adzuki sprouts Guarana

Alfalfa seed; juice conc. Gum guggul, gugulipid

Alfalfa leaf powder Hawthorn berries

Aloe Hemp Agrimony (Eupatorium cannabrinum)

Aloe vera gel Hijiki seaweed

American Centaury herb Hops

American Centaury powder Horseradish

American ginseng (Panax quinquefolius) Horsetail rush

Ammi Majus Horsetail/Shave grass (Arvense equisetum)Angelica root Hydrangea

Apple cider Hydrastine

Apple cider vinegar, dry Irish Moss

- 77 -

원료명

Apple pectin Jalapeno peppers

Artichoke leaf (Cynara scolymus) Job's tears

Ashwagandha Juniper berries

Asparagus root Juniper berry extract

Asparagus root powder Kale powder

Astragalus Karwartake muchroom extract

Barberry root bark (Berberis vulgaris) Kava kava

Barley Kelp, kelp powder

Barley grass Kola nut

Beet juice powder Kombu (Laminaria species)

Beet leaves powder Kombucha

Beet root (Beta vulgaris rubra) Korean ginseng

Berberine Kudzu root powder

Bilberry (fruit ext.) lady's slipper root powder

Bissy nut Lavender

Black cohosh root powder Licorice root

Black currant powder Ligustrum berries

Black radish Madagascar centella asiatica

Bladderwrack Maple syrup

Blessed Thistle (herb) Marigold Pedals (Tagetes erecta)

Blue Cohosh (root) Marshmallow (Althaea officinalis)Blue vervain Milk Thistle (Silybum marianum)Boldo Millet

Boswellin Motherwort

Brazil wax Myrrh gum

Broccoli Orange (peel, pulp, oil)

Brussels Sprouts Orange powder

Buchu Pacific Nori

Buckthorn powder (Rhamnus frangula) Pacifica alaria (Alaria marginata)Butcher's Broom (Ruscus Aculeatus) Pagodabuds, Japan, PW Rutin

Butternut (bark) Papaya fruit powder

Cabbage Parsley leaf powder

Cabbage powder Passion flower/Passiflora

Caraway seeds Pau D'Arco

Carrot Pennyroyal

Carob Extract (St. John's bread) Peppermint

Cascara sagrada (bark) Pine Bark extract

Cat's Claw Plantain leaf

Cauliflower Pleurisy root

Cayenne (Capsicum fastigiatum) Prickly Ash (bark)

Celandine root Primrose

Celery Prune powder-dried (Prunus aractus)Celery leaf powder (Apium graveolins) Psyllium (husks, seed)

Chamomile (flowers) Pumpkin seed meal

Chaparral Pygeum africanum

Chickory root Quinoa

Chickweed Red Clover tops (Trifolium pratense)

Chili peppers Red Raspberry (leaves)

Chinese Dong Quai Red root/Jersey tea

Chinese Ephedra (Ma Huang) Rehmannia

Cider vinegar Reishi mushrooms

- 78 -

원료명

Cider vinegar powder Rhubarb root powder, juice powder

Cocoa Rice protein concentrate

Cocoa, natural, powder Rice syrup solids

Couch grass Rose hips (powder)

Cranberry fruit pocker Rosemary (leaves, extract)

Cranberry juice concentrate Safflower/Mexican Saffron

Cucumber ext (Cucumis sativae) Sage (Salvia officinalis)

Culvers root Sarsaparilla (root) (smilax officinalis)

Culvers root powder Sew palmetto (Serenoa serrulata)

Curcumin pod (Curcuma longa) Schizandra (berries)

Damiana(leaves) (Tumera aphrodisiaca) Scullcap herb powder

Dandelion (Taraxicum deins-leanis) Sea cucumber (Beche-de-mer)

Deodorized garlic powder Sea palm (Pastelsia palmaeformis)

Dioscorea villosa Senna leaves (Cassia angustifolia)

Dong Quai (Angelica sinensis) Shiitake mushroom extract

Dulse(sea vegetable)Siberian ginseng (Eleutherococcus

senticosus)

Echinacea (Angustifolia) Slippery Elm (bark)

Echinacea (Purpurea) Snake root

Emcosoy Soy

Ephedra herb & extract Spearmint

Eyebright Spinach

Fennel Spinach powder

Fenugreek (seeds) Squaw vine

Fever few (Tanacetum parthenium) SL Johnswort herb extract

Flaxseed meal Sterculia acuminata powder

Fo-ti (Polygonum multiflorum) Stevia (Stevia rebaudiana)

Garlic extract, aged (extract, powder) Strawberry concentrate

Garlic macerate Suma

Garlic sprouts Suma root powder

Gentian root Sunflower seed meal

Ginger (root) Teinshi ginseng

Ginkgo biloba Turmeric

Glycyrrhiza glabra Uva Ursi

Goldenseal (Hydrastis canadensis) Valerian (root)

Gotu Kola (Hydrocotyle asiatica) Vitex agnus castus

Grapefruit, whole, powder Watercress

Gravel root (Eupatorium purpureum) White oak (bark)

Greater Celandine extract White pond lily (Lilium tigrinum)

Green bell pepper White willow bark

Green onions Wild yam (root)

Green pepper Wood betony

Green pepper concentrate Yarrow

Green tea, extract, powder Yellow dock (root ext) (Rumex crispus)

Guar gum Yerba mate

Yucca

생 질(Biochemicals)

Alcohol(ethyl) Lipoic acid

Alpha-Ketoglutaric acid Lutein

Beta glucan Luteolin

Bioflavonoids Lycopenes

- 79 -

원료명

Carnitine Lycophyll

Carnitine HCl Lyxonic acid

Carnitine L-Tartrate Magnesium peroxide

Carnosine Malic acid

Carotenoids Maltodextrin

Cetyle Alcohol Mannitol

Charcoal carbon Melatonin

Chlorella growth factor Mucopolysaccharide

Chlorophyll N-Acetyl glucosamine

Chlorophyll, oil soluble, 8% Naringenin

Chlorophyllin Noncitrus bioflavonoids

Choline dihydrogen, citrate Para-amoni benzoic acid (PABA)

Choline bitartrate Phycocyanin

Chondroitin sulfate Phycoerythrin

Citric acid Polyethylene glycol

Coenzyme Q10 (ubiquinone) Polyphenols

Creatine monohydrate Polysaccharides

Creatine phosphate Procyanadins

Dimethyl glycine (DMG) Propylene glycol; esters of propylene glycol

Dimethylaminoethanol Pyridoxine ketoglutarate (PAK)

DNAPycnogenol (proanthocyanidin, pine bark

extract)

Ferulic acid Pytuvate

Frac Quercetin

Fructooligosaccharides (FOS) Rhamnose

Galactomannan RNA

Gamma Aminobutyric Acid (GABA) Rutin

Gamma Oryzanol Sodium carbonate

Glucosamine HCl Sodium chlorite

Glucosamine sulfate Sodium copper chlorophyllin

Glycerin Sodium sulfate

Grapefruit seed extract Sorbitan A

Hydroxycitric acid Sorbitol

Inosine Starch

Inositol Taurine

Inositol hexaniacinate Tetrose

Inositol (phophatide) Threonic Acid & Salts

Inulin Undecylenic acid

Isopropyl alcohol Urea

Isopropyl palmitate Xanthophyll

Kreb's cycle complex Xylonic acid & salts

Lecithin Zeathanthine / Zeaxanthin

효소 (Enzymes)

Amylases Malt powder

Aspergillus Orzae enzyme Mycozyme

Bromelain Pancreatin 4X, pancreatin 4NF

Catalase Pancrelipase

Cellulase Papain

Chymotrypsin Papaya enzymes

Distase Pepsin enzymes

Ficin Peroxidase

- 80 -

원료명

Galactosidase Phosphatase

Glucosidase Protease

Glutathione peroxidase Rennet

Lactase Rhizopus enzyme

Legumase Sucrase

Lipases Superoxide Dismutase (SOD)

Lysozyme Trypsin

Malt disease (maltase) Vegetable rennet

이 틱스 단 포 품 & (Probiotics & Single Cell Products)

Bifidobacterium bifidum Lactobacillus jugart/delbrueckii (bulgaricus)

Bifidobacterium infantis Lactobacillus plantarum

Bitidobacterium longum Lactobacillus rhamnosus

Bifidus adolescentis Saccharamyces boulardii

Blue green algae Spirulina

Brewer's yeast, debittered brewer's yeastStreptococcus faecium (Enterococcus

faecium)

Chlorella Streptococcus salivarius

D. salina algae Streptococcus thermophilus

Lactobacilus acidophilus Torula yeast

Lactobacillus casei Yeast powder, primary grown

질 미량원소 & (Minerals & Trace Elements)

Amino acid chelates Lysinates

Alpha ketoglutarates Magnesium (amino acid chelate)

Amino ethanol phsphates Magnesium aspartate

Arginates Magnesium carbonate

Ascorbates Magnesium citrate

Aspartates Magnesium ethanolamine phosphate

Boron Magnesium fumerate

Boron (boric acid) Magnesium gluconate

Boron (sodium borate) Magnesium glycerophosphate

Boron aspartate Magnesium glycinate

Boron chelate Magnesium hydroxide

Boron citrate Magnesium malate

Boron gluconate Magnesium oxide

Boron glycinate Magnesium protein chelate

Boron proteinate Magnesium serine phosphate

Calcium Magnesium silicate

Calcium (hydroxyapatite) Magnesium stearate

Calcium acetate Magnesium succinate

Calcium ascorbate Magnesium sulfate

Calcium aspartate Meleates

Calcium carbonate Manganese

Calcium caseinate Manganese amino acid chealte

Calcium chloride Manganese arginate

Calcium citrate Manganese ascorbate

Calcium citrate malate Manganese asparate

Calcium fumarate Manganese carbonate

Calcium gluconate Manganese citrate

Calcium glycerophasphate Manganese gluconate

Calcium hydroxide Manganese protein chelate

Calcium iodate Manganese sulfate

- 81 -

원료명

Calcium lactate Methionates

Calcium lysinate Molybdenum

Calcium malate Molybdenum amino acid chelate

Calcium malate lactate Molybdenum ascorbate

Calcium phosphate Molybdenum aspartate complex

Calcium phruvate Molybdenum yeast

Calcium serine phosphate Nickel

Calcium sodium caseinate Nickel sulfate

Calcium stearate Orotates

Calcium succinate Oyster shell powder

Calcium sulfate Phosphates

Calcium undecylenate Phosphorus (hydroxyapatite)

Carbonates Phosphorous protein chelate

Chromium Picolinates

Chromium asparate Platinum

Chromium (chromate) Potassium

Chromium (picolinate) Potassium amino acid chelate

Chromium chelate Potassium aspartate

Chromium chloride Potassium benzoate

Chromium dinicotinate Potassium bicarbonate

Chromium GTF Potassium caseinate

Chromium hydrolyzed protein Potassium chloride

Chromium nitrate Potassium citrate

Chromium polynicotinate Potassium gluconate

Chromium protein chelate Potassium glycerophosphoate

Chromium proteinate Potassium iodide

Chromium yeast GTF Potassium phosphate

Chromium yeast-free GTF Potassium protein chelate

Citrates Potassium sorbate

Cobalt Potassium succinate

Colloidal alkaline ash mineral conc. Potassium sulfate

Copper Potassium tartrate

Copper (cupric oxide) Proteinates

Copper (lysinate) Salt, sea

Copper amino acid chelate Selenium

Copper citrateSelenium (L-Selenomethionine,

selenocysteine, selenocystine)

Copper gluconate Selenium (sodium selenate)

Copper protein chelate Selenium amoni acid chelate

Copper sulfate Selenium ascorbate

Cupric sulfate Selenium chealte

Dicalcium phosphate Selenium Cysteine

Dolomoite Selenium Cystine

Egg shell powder Selenium hydrolyzed protein

Ferric ammonium citrate Selenium protein chelate

Ferric glycerophosphate Selenium selenite

Ferrochel iron bisglycinate Selenium yeast concentrate

Ferrous fumarate (coated) Seline

Ferrous lactate Silicon (silica) (sodium metasilicate)

Fluorine Silicon dioxide

Fumerates Silicon protein complex

- 82 -

원료명

Germanium Silver

Germanium (sesquioxide) Sodium molybdate powder

Gluconates Succinates

Glycerophosphates Sulfates

Glycinates Sulphur

Gold Tin (stannous chloride)

Histidinates Tri Boron complex

Hydroxyapatite Calcium Tricalcium phosphate

Iodine (kelp) Vanadium

Iron (bisglycinate) Vanadium amino acid chelate

Iron (citrate) Vanadium sulfate

Iron dextran chelate Vanadium protein complex

Iron (ferrous chelate) Zinc (amino acid chelate)

Iron (ferrous fumarate) Zinc (glycinate chelate)

Iron (ferrous gluconate) Zinc ascorbate

Iron (ferrous lactate) Zinc aspartate

Iron (ferrous lactate) Zinc citrate

Iron (ferrous sulfate) Zinc gluconate

Iron (peptonate) Zinc lysinate

Iron amino acid chelate Zinc oxide

Iron electrolytic Zinc picolinate

Iron picolinate Zinc protein chelate

Iron protein chelate Zinc succinate

Lithium Zinc sulfate

식 분 (Botanical Component)

Allicin Naringin

Caffeine Nettle Powder

Canadine Oat bran fiber

Carrageenan Oat bran flour

Carrageenan agar Oat flour

Casanthranol Oat grass powder

Catechins Oat straw powder

Citrus bioflavonoids Pea fiber

Citrus pecin powder Poplar bud extract

Corn bran Potato starch

Corn silk Rice bran powder

Corn solids, hydrolyzed Rye grass powder

Corn starch Senega extract

Diosgenin Soy fiber

Garcinia cambogia extract Soy polysaccharide

Garlic, oil Spearmint oil, natural

Glucomanna (Konjac root) Spelt grass powder

Glycyrrhetinic acid Tangerine extract

Grape seed extract Tea polyphenols

Grape skin extract Uva Ursi extract

Hesperidin complex hesperidin methyl

chalconeVegetable extracts

Jerusalem Artichoke Flour virgin orange bioflavonoids complex

Legume powder Wheat bran powder

Lemon bioflavonoid powder Wheat germ extract

Maitake powder Wheat germ toasted fine powder

- 83 -

원료명

Molasses, dried, D.C. Wheat grass; joice powder

Monoammonium glycyrrhizinate Wheat sprout conc. (enzyme active)

Moomiyo (Juniper berry) Whole brown rice powder

약품 (Drugs)

Acetaminophen Docusate sodium

Candex Ephedrin HCl

Chlorpheniramine Maleate USP Glyceron Guaiacolate (Guaifenesin)

Dextromethorphan Phenyltoloxamine citrate

Pseudoephedrine HCl

동 (Animal Derivatives)

Adrenal Liver

Bone marrow Liver, defatted

Bonemeal Liver protein fraction

Bovine cartilages Lung

Bovine tissue extract Lympathic

Brain Orchic

Chitosan Ox bile extract

Colostrum Oyster extract powder

Desiccated liver Pancreas

Desiccated liver granulation Parotid

Duodenal substance (bovine source) Pituitary

Eye Prostate

Gastrin mucin powder Shark cartilage

Green lipped sea mussel ext (Perna

canaliculus)Spleen

Heart Stomach

Hypothalamus Thymus

Japanese oyster extract Thyroid

Kidney Uterus

타민 (Vitamins)

Vit A (retinol, retinyl esters, fish oils, beta

carotene)Folic Acid

Vit B1 (Thiiamine Mononitrate, Thiamine

HCl, yeast)

Vit C (ascorbic acid, mineral ascorbates,

ascorbyl easters)

Vit B2 (Riboflavin) Vit C (calcium polyascorbate)

Vit B3 (Niacin, niacinamide, niacin complex)Vic D (ergocalciferol, cholecalciferol, fish

oil)

Pantothenic acid (Calcium Pantothenate)Vit C (D-alpha tocopheryl asetate, linoleate,

succinate, and d, I-forms)

Vit B6 (Pyridoxine HCl,

Pyridoxal-5-phosphate, Pyridoxal,

Pyridoxamine)

Vit E (d-beta, d-gamma, d-delta

tocopherols)

Biotin Vit K

Vit K1 (Phylloquinone, Phytonadione)

- 84 -

원 료 명

Acetylcysteine Guggul, Purified Extract

Acetyltyrosine, N- Guggul Tablets

S-Adenosyl-L-methionine Disulfate

TosylateHawthorn Leaf with Flower

Adenine Hawthorn Leaf with Flower, Powdered

Adenosine Histidine

Agar Horse Chestnut

Alanine Hose Chestnut, Powdered

Aloe Horse Chestnut, Powdered Extract

Alpha Lipoic Acid, see Lipoic Acid, Alpha Hydroxocobalamin

American Ginseng Iodine

American Ginseng, Powdered Isoleucine

American Ginseng, Powdered Extract Lactase

American Ginseng Tablets Leucine

Ammonium Molybdate Levocarnitine

Andrographis Levocarnitine Oral Solution

Andrographis, Powdered Levocarnitine Tablets

Andrographis, Powdered Extract Licorice

Arginine Licorice, Powdered

Arginine Hydrochloride Licorice, Powdered Extract

Arginine Capsules Licorice Fluidextract

Arginine Tablets Limestone, Ground

Ascorbic Acid Lipoic Acid, Alpha

Ascorbic Acid Oral Solution Lipoic Acid, Alpha Capsules

Ascorbic Acid Tablets Lipoic Acid, Alpha Tablets

Ashwagandha Root Lutein

Ashwagandha Root, Powdered Lutein Preparation

Ashwagandha Root, Powdered Extract Lycopene

Asian Ginseng Lycopene Preparation

Asian Ginseng Powdered Lycopene, Tomato Extract Containing

Asian Ginseng, Powdered Extract Lysine Acetate

Asian Ginseng Tablets Lysine Hydrochloride

Aspartic Acid Lysine Hydrochloride Tablets

Bacopa Magnesia Tablets

Bacopa, Powdered Magnesium Carbonate

Bacopa, Powdered Extract Magnesium Chloride

Beta Carotene Magnesium Citrate

Beta Carotene Capsules Magnesium Gluconate Tablets

Bilberry, Powdered Extract Magnesium Oxide

Biotin Magnesium Oxide Capsules

Black Cohosh Magnesium Oxide Tablets

Black Cohosh, Powdered Magnesium Phosphate

Black Cohosh, Powdered Extract Magnesium Sulfate

Black Cohosh Fluidextract Malabar-Nut-Tree, Leaf

Black Cohosh Tablets Malabar-Nut-Tree, Leaf Powdered

Boswellia serrata Malabar-Nut-Tree, Leaf Powdered Extract

Boswellia serrata Extract Manganese Chloride

Caffeine Manganese Gluconate

Calcium Acetate Manganese Sulfate

- 85 -

원 료 명

Calcium Acetate Tablets Maritime Pine

Calcium Ascorbate Maritime Pine Extract

Calcium Carbonate Menthol

Calcium Carbonate Lozenges Menthol Lozenges

Calcium Oral Suspension Methoinine

Calcium Carbonate Tablets Methylsulfonylmethane

Calcium Carbonate and Magnesia Tablets Methylsulfonylmethane Tablets

Calcium and Magnesium Carbonates Oral

SuspensionMilk Thistle

Calcium and Magnesium Carbonates Tablets Milk Thistle, Powdered

Calcium Chloride Milk Thistle, Powdered Extract

Calcium Citrate Milk Thistle Capsules

Calcium Citrate Tablets Milk Thistle Tablets

Calcium Glubionate Syrup Minerals Capsules

Calcium Gluceptate Minerals Tablets

Calcium Gluconate Tablets MSM, see Methylsulfonylmethane

Calcium Glycerophosphate Myrrh

Calcium Lactate Nettle, Stinging, see Stinging Nettle

Calcium Lactate Tablets Niacin

Calcium Lactobionate Niacin Tablets

Calcium Levulinate Niacinamide

Calcium Pantothenate Tablets Niacinamide Tablets

Calcium Pantothenate, Racemic Oatmeal, Colloidal

Calcium Phosphate, Dibasic Tablets Oleovitamin A and D

Calcium Phosphate Anhydrous, Dibasic Oleovitamin A and D Capsules

Calcium Phosphate Dihydrate, Dibasic Omega-3-Acid Ethyl Esters

Calcium Saccharate Omega-3-Acid Ethyl Esters Capsules

Calcium with Vitamin D Tablets Omega-3-Acid Triglycerides

Calcium and Vitamin D with Minerals

TabletsPancreatin

Capsaicin Pancreatin Tablets

Capsicum Panthenol

Capsicum Oleoresin Papain

Cascara Sagrada Pectin

Cascara Sagrada Extract Peppermint Spirit

Cascara Sagrada Fluidextract Phenylalanine

Cascara, Aromatic Fluidextract Phyllanthus amarusCascara Tablets Phyllanthus amarus, Powdered

Castor Oil Phytonadione

Castor Oil, Aromatic Phytonadione Tablets

Castor Oil Capsules Plantago Seed

Castor Oil Emulsion Potassium Acetate

Cat's Claw Potassium Bicarbonate

Cat's Claw, Powdered Potassium Bitartrate

Cat's Claw, Powdered Extract Potassium Carbonate

Cat's Claw Capsules Potassium Chloride

Cat's Claw Tablets Potassium Chloride Oral Solution

Centella asiatica Potassium Citrate

Centella asiatica, Powdered Potassium Citrate Tablets

Centella asiatica, Powdered Extract Potassium Gluconate

Centella asiatica Triterpenes Potassium Gluconate Oral Solution

- 86 -

원 료 명

Chamomile Potassium Gluconate Tablets

Charcoal, Activated Potassium Iodide

Chaste Tree Potassium Nitrate

Chaste Tree, Powdered Potassium Nitrate Solution

Chase, Tree, Powdered Extract Potassium Phosphate, Dibasic

Chlorophyllin Copper Complex Sodium Proline

Cholecalciferol Psyllium Hemicellulose

Cholecalciferol Solution Psyllium Husk

Choline BitartratePsyllium Hydrophilic Mucilloid for Oral

Suspension

Choline Chloride Pygeum

Chondroitin Sulfate Sodium Pygeum Extract

Chondroitin Sulfate Sodium Tablets Pygeum Capsules

Chromic Chloride Pyridoxine Hydrochloride

Chromium Picolinate Pyridoxine Hydrochloride Tablets

Chromium Picolinate Tablets Red Clover

Cod Liver Oil Red Clover, Powdered

Cod Liver Oil Capsules Red Clover, Powdered Extract

Copper Gluconate Red Clover Tablets

CoQ10, see Ubidecarenone Riboflavin

Cranberry Liquid Preparation Riboflavin Tablets

Crypthecodinium cohnii Oil Riboflavin 5'-Phosphate Sodium

Crypthecodinium cohnii Oil CapsulesS-Adenosyl-L-methionine Disulfate

Tosylate

Cupric Chloride Safflower Oil

Cupric Sulfate St. John's Wort

Curcumnoids St. John's Wort, Powdered

Curcuminoids Capsules St. John's Wort, Powdered Extract

Curcuminoids TabletsSAMe, see S-Adenosyl-L-methionine

Disulfate Tosylate

Cyanocobalamin Saw Palmetto

Crysteine Hydrochloride Saw Palmetto, Powdered

Cystine Saw Palmetto Extract

Dehydrocholic Acid Saw Palmetto Capsules

Dehydrocholic Acid Tablets Schizochytrium oil

Dexpanthenol Schizochytrium oil Capsules

Dexpanthenol Preparation Selenious Acid

DHA Algal Oil, see Crypthecodinium cohnii

Oil; see Schizochytrium OilSelenomethionine

Echinacea angustifolia Senna Leaf

Echinacea angustifolia, powdered Senna Fluidextract

Echinacea angustifolia, Powdered Extract Senna Pods

Echinacea pallida Senna Oral Solution

Echinacea pallida, Powdered Sennosides

Echinacea pallida, Powdered Extract Sennosides Tablets

Echinacea purpurea, Powdered Siberian Ginseng, see Eleuthero

Echinacea purpurea, Powdered Extract Slippery Elm, see Elm

Echinacea purpurea Aerial Parts Sodium Ascorbate

Echinacea purpuea Root Sodium Bicarbonate

Eleuthero Sodium Chloride

- 87 -

원 료 명

Eleuthero, Powdered Sodium Citrate

Eleuthero, Powdered Extract Sodium Fluride

Elm Sodium Fluride Tablets

Ergocalciferol Sodium Gluconate

Ergocalciferol Capsules Sodium Iodide

Ergocalciferol Oral Solution Sodium Phosphate, Dibasic

Ergocalciferol Tablets Soy Isoflavones, Powdered Extract

Eucalyptol Soy Isoflavones Capsules

Eugenol Soy Isoflavones Tablets

Ferrous Fumarate Stinging Nettle

Ferrous Fumarate Tablets Stinging Nettle, Powdered

Ferrous Gluconate Stinging Nettle, Powdered Extract

Ferrous Gluconate Capsules Taurine

Ferrous Gluconate Oral Solution Thiamine Hydrochloride

Ferrous Gluconate Tablets Thiamine Hydrochloride Oral Solution

Ferrous Sulfate Thiamine Hydrochloride Tablets

Ferrous Sulfate Oral Solution Thiamine Mononitrate

Ferrous Sulfate Tablets Thiamine Mononitrate Oral Solution

Ferrous Sulfate Threonine

Ferrous Sulfate Oral SolutionTomato Extract Containing Lycopene, see

Lycopene, Tomato Extract Containing

Ferrous Sulfate Syrup Trypsin, Crystallized

Ferrous Sulfate Tablets Tryptophan

Ferrous Sulfate, Dried Turmeric

Feverfew Turmeric, Powdered

Feverfew, Powdered Turmeric, Powdered Extract

Fish Oil containing Omega-3 Acids Tyrosine

Fish Oil containing Omega-3 Acids Capsules Ubidecarenone

Fish Oil containing Omega-3 Acids

Delayed-Release CapsulesUbidecarenone Capsules

Folic Acid Ubidecarenone Tablets

Folic Acid Tablets Valerian

Forskohlii Valerian, Powdered

Forskohlii, Powdered Valerian, Powdered Extract

Forskohlii, Powdered Extract Valerian Tablets

Garcinia cambogia Valine

Garcinia cambogia, Powdered Vinpocetine

Garcinia Hydoxycitrate, Powdered Extract Vitamin A

Garcinia indica Vitamin A Capsules

Garcinia indica, Powdered Vitamin A Oral Liquid Preparation

GarlicVitamin B6 Tablets, see Pyridoxine

Hydrochloride Tablets

Garlic, PowderedVitamin C Tablets, see Ascorbic Acid

Tablets

Garlic, Powdered Extract Vitamin E

Garlic Fluidextract Vitamin E Preparation

Garlic Delayed-Release Tablets Vitamin E Capsules

Ginger Vitamin E Polyethylene Glycol Succinate

Ginger, Powdered Vitamins, Oil-Soluble Capsules

Ginger Capsules Vitamins, Oil-Soluble Tablets

- 88 -

원 료 명

Ginger Tincture Vitamins, Oil-and Water-Soluble Capsules

GinkgoVitamins, Oil-and Water Soluble Oral

Solution

Ginkgo, Powdered Extract Vitamins, Oil-and Water Soluble Tablets

Ginkgo CapsulesVitamins, Oil-and Water Soluble with

Minerals Capsules

Ginkgo TabletsVitamins, Oil-and Water Soluble with

Minerals Oral Solution

Ginseng, see American Ginseng, see Asian

Ginseng; see Eleuthero

Vitamins, Oil-and Water Soluble with

Minerals Tablets

Glucosamine and Chondroitin Sulfate Sodium

TabletsVitamins, Oil-and Water Soluble Capsules

Glucosamine Hydrochloride Vitamins, Oil-and Water Soluble Tablets

Glucosamine TabletsVitamins, Oil-and Water Soluble with

Minerals Capsules

Glucosamine Sulfate Potassium ChlorideVitamins, Oil-and Water Soluble Minerals

Oral Solution

Glucosamine Sulfate Sodium ChlorideVitamins, Oil-and Water Soluble with

Minerals Tablets

Glucosamine and Methylsulfonylmethane

TabletsWheat Bran

Glucosamine, Chondroitin Sulfate Sodium,

and Methylsulfonylmethane TabletsZinc Acetate

Glutamic Acid Zinc Carbonate

Glutamine Zinc Chloride

Glutathione Zinc Citrate

Glycerin Zinc Citrate Tablets

Glycine Zinc and Vitamin C Lozenges

Goldenseal Zinc Gluconate

Goldenseal, Powdered Zinc Gluconate Tablets

Goldenseal, Powdered Extract Zinc Oxide

Grape Seeds Oligomeric Proanthocyanidins Zinc Oxide Neutral

Green Tea Extract, Decaffeinated Powdered Zinc Stearate

Guggul Zinc Sulfate

Guggul, Native Extract Zinc Sulfate Oral Solution

Zinc Sulfate Tablets

- 89 -

- 90 -

- 91 -

- 92 -

- 93 -

- 94 -

- 95 -

FDA

신고번원료명

일일허용 취량

인( )

RPT637 EXTRAfolate-S (6(S)-methyltetrahydrofolate calcium salt)™ 1000㎍

RPT636EXTRAfolate (6(R,S)-5-methyltetrahydrofolic acid, calcium ™ salt) 1000㎍

RPT632Puresta Oil (An astaxanthin-rich mixture of oil extract from the algae Haematococcus pluvialisand palm oil)

5.7-80mg (1-12mg

astaxanthin)

RPT626 Ethanol extract of Triticum vulgare (wheat) gluten lipids 350mg

RPT618 Sea Buckthorn Berry Juice [Brand: CharmaVi]10ml

(42.4mg Vitamin C)

RPT613Garlic Powder naturally enriched with organic selenium compounds (Derived from the bulbs ofAllium sativum) 50-200㎎

RPT609 GLA (gamma linolenic acid) from safflower (seed) oil1g (

400-800mg GLA)

RPT608 Lactobacillus paracasei GM080 (GMNL-32)1000mg

(100-200mg GMNL-32)

RPT607 Red Vine Leaf Extract (RVLE AS 195; Vitis viniferae) 360mg

RPT600 Golden Clam (Corbicula fluminea) Powder1050-2100

mgRPT595 Linalool Oil from Coriander (Coriandrum sativum) seed 420mg

RPT594Calcium Carbonate and Magnesium Carbonate derived from Maerl red algae [Brand: AlgaeCal]

2500mg (750mg calcium, 350mg

magnesium)RPT593 Solubilized Eggshell Membrane [Brand: Ovacore ]™ 500mgRPT590 Diosmin [Brand: Diosvein ]™ 500mg

RPT576Preparation containing a protease enzyme produced by fermentation of a culture of Aspergillus niger [Brand: PEP2COMFORT ]™

3000mg

RPT572 Polyphenols from extract of grape (Vitis viifera) 484mgRPT557 Chromium Propionate  1000㎍

RPT556 Ecklonia cava Kjellman Extract standardized to ~13% phlorotannins [Brand: SEAPOLYNOL] 

360mg (47mg

phlorotannins )

RPT480 Diamine Oxidase (DOA) derived from pig kidneys

12.762mg (0.9mg Diamine Oxidase)

RPT474Extract of rhapontic (Siberian) rhubarb (Rheum rhaponticum L.) root [Brand: ERr 731®] 4mg

RPT460 Lactobacillus reuteri RC-14 ;™  Lactobacillus rhamnosusGR-1™

5 x 10 -11 ⁹x 10 CFU ⁹

(2.5 x 10 -5.5 x ⁹10 CFU ⁹

Lactobacillus rhamnosusG

R-1 )™

- 96 -

FDA

신고번원료명

일일허용 취량

인( )

RPT410 Dried powder of dunaliella (Dunaliella bardawil) algae 100-300mg

RPT406Astaxanthin extract (from Haematococcus pluvialis, specific strain identified as confidential) as 10% oleoresin [Brand: AstaPure]

50mg (5mg astaxanthin)

RPT403Cantaloupe (Cucumis melo) melon (fruit) extract [Brand: Extramel®]

10-20mg (142 to 284

I.U. antioxidant enzymes, 1.8-3.6㎍ Vitamins A,E,C,

carotenoids)

RPT402Capsinoids in extracted oil of sweet chili pepper (Capsicum annum CH-19 Sweet (AMA) cultivar) fruit [Brand: CH-19 Sweet Extract]

3mg

RPT400Extract of lychee (Litchi chinensis) fruit and green tea (Camellia sinensis) leaf [Brand: Oligonol ]™ 200mg

RPT395 Potassium bicarbonate; Sodium bicarbonate

290mg potassium

bicarbonate, 110mg sodium

bicarbonate

RPT394 Sodium hydroxide and Potassium hydroxide 

67.20mg (50.35mg potassium hydroxide, 16.85mg sodium

hydroxide)

RPT393 Calcium carbonate Direct Compressible Grade (Spray Dried)

1200-1800mg

(444.444-666.666mg Calcium

carbonate)

RPT391 Omega-3 Phospholipids

500-1000mg (4㎍

Omega-3 PL)

RPT388Pomegranate (Punica granatum'Wonderful') fruit polyphenol extract [Brand: POMx] 1000mg

RPT378 Flax seed ligans (from Linum usitatissimum) [Brand: Beneflax™ Flax Lignan Extract]

86-1720mg (30-600mg

SDG)

RPT375Stearidonic acid-rich oil (botanical sourceEchium plantagineum L. seed) [Brand: Crossential Super Refined Echium Oil] 1g

RPT366 Psyllium hemicellulose fromPsyllium ovata husk 7.5gRPT358 Diosmin 500mg

RPT346Proprietary combination of minerals (calcium carbonate, magnesium hydroxide and potassium hydroxide) agglomerated by a patented process [Brand: Alka-Plex®]

2000-4000mg

RPT343Omega-3 phytosterol ester preparation (vegetable phytosterols; DHA and EPA fatty acid esters; and DHA/EPA enriched fish oil) 2.0g

- 97 -

FDA

신고번원료명

일일허용 취량

인( )

RPT339 Benfotiamine / Alpha-Lipoic Acid Combination

225-450mg (75-150mg Benfotiamine, 150-300 Alpha-Lipoi

c Acid)

RPT335A "symbiosis" of Streptococcus faecalis T-110,Bacillus mesentericus TO-A and Clostridium butyricum TO-A [BIO-THREE ]™

30mg Streptococcus feaecalis

T-110, 150mg Bacillus

mesentericus, 150mg

Clostridium butyricum

TO-A

RPT307 Kiwi Berry Extract (from Actinidia arguta fruit)

1200-2400mg

(600-1200mg

KiwiBerry extract

concentrate)

RPT303Purple corn extract (Zea mays); plant part = whole cob less leaf [Brand: Purple X®] 500mg

RPT300Kakadu plum (botanical source Terminalia ferdinandiana) fruit extract

100-800mg (15-360mg Vitamin C

RPT284 Licorice flavonoid oil (botanical source licoriceGlycyrrhiza glabra) root extract [Brand: Kaneka Glavonoid Rich Oil ]™ 600mg

RPT282Zeaxanthin Purified Concentrate (from Aztec marigold (Tagetes erecta) flower)

1 x 10^10 CFU

RPT280Zeaxanthin Purified Concentrate (from Aztec marigold (Tagetes erecta) flower)

12mg (3mg Zeaxanthin, 0.32 Lutein,

0.14mg epoxides)

RPT278Astaxanthin Complex (derived fromHaematococcus pluvialis) [Brand: Zanthin] 50mg

RPT276 Enzyme-treated Agaricus blazei mycelia 1-2g

RPT274 Astaxanthin (Haematococcus pluvialis) algae extract100-200mg (3.8-7.6mg astaxanthin)

RPT265 Alpha-cyclodextrin [Brand: FBCx ]™ 6g RPT262 Isomers of octadecadienoic acid 2.0gRPT246 Carnitine creatinate, monohydrate 20gRPT242 Milk protein hydrolysate [Brand: lactium ]™ 150-400mg

RPT2357-hydroxymatairesiol (HMR) (botanical source Norway spruce wood Picea abies) 50mg

RPT223Shea nut - 80% unsaponifiable matter (botanical source shea nut Butyrospermum parkii) extract, plant part not stated [Brand: SheaNature]

3.0g

RPT222 Shea nut - 50% unsaponifiable matter (botanical source shea nut Butyrospermum parkii) extract, plant part not stated [Brand: 6.0g

- 98 -

FDA

신고번원료명

일일허용 취량

인( )

BSP-201]

RPT209 Lactobacillus F19 (L. paracasei spp. paracasei strain F19)1 x 10⁹

CFU

RPT198Lactobacillus delbruekii spp. bulgaricus (as L. bulgaricus) [Brand: Biostim] 6-12g

RPT189 Conjugated linoleic acid (CLA) [Brand: Clarinol (78-82% ™ CLA)]

1.25-3.75g (1-3g CLA)

RPT173Reishi (Ganoderma lucidum) spore - processed [Brand: Lingzhi Master] 4.8g

RPT171Lactobacillus plantarum (ATCC 202195 strain) and fructooligosaccharide (FOS)

2 x 10 -16 ⁹x 10 CFU ⁹

Lactobacillus plantarum,

150-300mg FOS

RPT169 Humifulvate330mg (75mg

Humifulvate)

RPT163 Sesamin (botanical source sesame Sesamum indicum) lignan600mg (10mg

sesamin)

RPT148 3- acetyl-7-oxo-dehydroepiandrosterone [Brand: 7-Keto™ DHEA] 50mg

RPT145Krill dry fraction + freeze-dried krill [Brand: Neptune Krill Euphausia (Krill Aquateine/LyO-Krill Blend)]™ 300-900mg

RPT144 Lysate of Lactobacillus delbrueckiisubsp. bulgaricus 125-250mg

RPT142 Egg lecithin - (1) powder form; (2) liquid form; (3) other form not specified

(1) power form: 6.8g

(80mg docohexaeno

ic acid(DHA),

160mg arachidonic acid(ARA));

(2)liquid form:

1800mg (132.5mg

DHA, 146.25mg ARA); (3) other form: 1.5g (30mg DHA, 60mg

ARA)

RPT136(1) Cordyceps (Cordyceps sinensis) mycellia; (2) Wheat (Triticum aestivum) seed; (3) Licorice (Glycyrrhiza glabra) root; (4) American ginseng (Panax quinquefolius) root

(1) 1000-2000

mg (450-675mg Cordyceps

sinensis); (2)

700-1050mg Triticum asestivum;

- 99 -

FDA

신고번원료명

일일허용 취량

인( )

(3) 2000mg-30

00mg (40mg-60m

g Glycyrrhiza glabra); (4) 2000-3000

mg (360-540m

g Panax quinquefoliu

s)

RPT134 Zinc carnosine75mg (17mg

zinc)

RPT133 Freeze-dried krill [Brand: Neptune LyO Krill ]™ 300-900mg

RPT132 Krill dry fraction [Brand: Neptune Aquateine ]™ 300-900mgRPT131 Krill oil extract [Brand: Neptune Krill Oil Extract]™ 1-3gRPT130 Tuna oil [Brand: HiDHA®] 1g

RPT128 Iron protein succinylate [Brand: Iron-Aid ]™20-800mg (1-40mg

iron)

RPT119Astaxanthin (Haematococcus pluvialis) algae extract [Brand: AstaREAL] 1-2mg

RPT110Golden algae (botanical source Schizochytrium spp.) [Brand: DHA Gold®] 6g

RPT98Kombu fucoidan (botanical source seaweedKjellmaniella crassifolia) 200ml

RPT96 Zeaxanthin 5% TG 1mg

RPT95 L-5-methyltetrahydrofolate (L-5-methyl-THF) (derived from folic acid) 17mg

RPT92 S-adenosylmethionine (SAMe) 1600mgRPT91 Humifulvate (humic & fulvic acids) 75mgRPT89 Isoquercetin (quercetin-3-glocoside) 600mgRPT88 Type II collagen 60㎍

RPT86 Heme iron polypeptide (HIP)6-45mg

iron

RPT83 Diosmin complex

500mg (450mg diosmin, 50mg

hesperidin)RPT80 Troxerutin complex 500mgRPT77 Tall oil phytosterols 1.8g

RPT72 Red raspberry (Rubus idaeus) extract rich in ellagic acid, plant part not stated 25-50㎍

RPT66 S-adenosylmethionine (SAMe) 400mg

RPT65Haematococcus algae (Haematococcus pluvialis) [Brand: Aquaxan HD] 5mg

RPT63 D-ribose(1) powder:

60g (12g D-ribose);

- 100 -

FDA

신고번원료명

일일허용 취량

인( )

(2)tablet: 3g D-ribose

RPT59 Vincamine (botanical source lesser periwinkle Vinca minor) 20mg

RPT58 Huperzine A (botanical source toothed clubmoss Huperzia serrata)

5㎍ huperzine A

RPT55 Huperzine A (botanical source toothed clubmoss Huperzia serrata) 50-200㎍

RPT54 Plant stanol fatty acid esters 5g

RPT52 Reishi (Ganoderma lucidum) spore powder300-1800m

g

RPT50 Haematococcus algae (Haematoccoccus pluvialis)2mg

astaxanthinRPT48 Vinpocetine (botanical source lesser periwinkle Vinca minor) 30mgRPT47 Vinpocetine (botanical source lesser periwinkle Vinca minor) 5mgRPT46 Vinpocetine (botanical source lesser periwinkle Vinca minor) 10mgRPT44 Chicken sternal cartilage 200mgRPT40 Monacolin 8000F (Monacolin J) botanical sourceMonascus pilosus 500mgRPT39 Cordyceps (Cordyceps sinensis) mycellia 2.0-3.0gRPT38 Huperzine A (botanical source toothed clubmossHuperzia serrata) 50㎍RPT34 Vinpocetine (botanical source lesser periwinkle Vinca minor) 5mgRPT33 Imperata (Imperata cylindrica) root -RPT32 S-adenosylmethionine (SAMe) 40-1600mg

RPT31 Lactobacillus casei (clearans strain)1.5 x 10 -3 ⁹x 10 live ⁹

cellsRPT29 Seaprose-S (semi-alkaline protease from Aspergillus melleus) 30mgRPT28 Creatine-pyruvate 5-10mg

RPT27 Katsuobushi oligopeptide3g (5mg LKPNM)

RPT26 Ademetionine (SAMe) 500mg

RPT24 Galacto-oligosaccharides [Brand: Elix'or]

1) syrup: 16.5-33g; 2) powder: 12.5-25g

RPT23 Methyltetrahydrofolate (5-MTHF)400㎍

5-MTHFRPT22 Isopropoxy isoflavone 600mgRPT21 Alpha-D(-) ribofuranose (Ribose) 10-20gRPT19 S-adenosylmethionine (SAMe) 1200mgRPT17 DHA-rich oil [Brand: SeaGold ]™ 1gRPT16 Pinitol (botanical source Pinus spp.) 1000mg

RPT15 Huperzine A (botanical source toothed clubmoss Huperzia serrata) 50㎍

RPT14 7-keto DHEA acetate -RPT12 Vinpocetine (botanical source lesser periwinkle Vinca minor) 30mg

RPT11Rauvolfia vomitoria (as Rauwolfia vomitoria) root bark extract [Brand: Rovol V] -

RPT10 Flourensia cernua, plant part not stated5-15g

dyspepsia, 20-50g

- 101 -

FDA

신고번원료명

일일허용 취량

인( )

hydroalcoholic extract

RPT9Ribonucleic extract of Escherichia coli(nucleotide) [Brand: ReaL Build] 20mg

RPT8 Anacahuite (botanical source Cordia boissieri) wood syrup 3-4tsRPT7 Leucophyllum texanum, plant part not stated

RPT6 Debitterized fenugreek (Trigonella foenumgraecum) seed20-35g

fiber

RPT5 Pao pereira (Geissospermum vellosii) tree bark extract [Brand: Pao V] -

RPT4 Enzyme-peptidase [Brand: Serratiopeptidase] 30mgRPT3 Luo han guo (Siraitia grosvenorii) fruit extract 60-300mgRPT2 White sapote (Casimiroa edulis), plant part not stated -RPT1 Theobromine (botanical sourceCacao spp.) -

- 102 -

- 103 -

- 104 -

- 105 -

미국 건강기능식품 기준 및 규격 비교 조사Comparison Research for Standards & Specification

건강기능식품수출가이드_표지_1210.indd 22 2014-12-12 오후 1:47:57