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2 years ago

What are the local/federal laws and regulations regarding the production of fresh/dried herbs, and herbal tinctures in the state of MO?

I'm interested in starting a small business growing medicinal and culinary herbs and producing herbal tinctures in the state of Missouri. Tinctures would be both alcohol and glycerin based.

I would like to know what regulations I would need to be aware of for both the production and distribution of these products.
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hapahaole | 2 years ago
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According to Rick Miller(http://www.richters.com/newdisplay.cgi?page=./QandA/Profiles/miller.html):

"There are no State of Federal laws dictating how someone might want to dry herbs, flowers, and foods on personal farms. There are rules and conditions for processing foods (something you might eat), when served directly to the public. That is where the stainless steel 2-sink regulations begin.

All States do have guidelines and requirements for COG, and they also have certification of manufacturing processes. This would include stainless steel throats on processing mills and other machinery for foods for use by the public. Drying processes have yet to be considered, but that most likely with be next."
http://www.richters.com/newdisplay.cgi?page=./QandA/Commercial/20090930-2.html&cart_id=111.100

The following databases might be useful:

US Patent and Trademark Office Patent Database
http://patft.uspto.gov/netahtml/PTO/search-bool.html

Code of Federal Regulations
Title 21, Volume 3
Revised as of April 1, 2009
CITE: 21CFR182.20
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 182 -- SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Subpart A--General Provisions
Sec. 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
(Input "182.20" to the "Title21 Part.Section (e.g., 862.1385)" text box)
Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:
Common name Botanical name of plant source
Alfalfa Medicago sativa L.
Allspice Pimenta officinalis Lindl.
Almond, bitter (free from prussic acid) Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Ambrette (seed) Hibiscus moschatus Moench.
Angelica root Angelica archangelica L.
Angelica seed Do.
Angelica stem Do.
Angostura (cusparia bark) Galipea officinalis Hancock.
Anise Pimpinella anisum L.
Asafetida Ferula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm) Melissa officinalis L.
Balsam of Peru Myroxylon pereirae Klotzsch.
Basil Ocimum basilicum L.
Bay leaves Laurus nobilis L.
Bay (myrcia oil) Pimenta racemosa (Mill.) J. W. Moore.
Bergamot (bergamot orange) Citrus aurantium L. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic acid) Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Bois de rose Aniba rosaeodora Ducke.
Cacao Theobroma cacao L.
Camomile (chamomile) flowers, Hungarian Matricaria chamomilla L.
Camomile (chamomile) flowers, Roman or English Anthemis nobilis L.
Cananga Cananga odorata Hook. f. and Thoms.
Capsicum Capsicum frutescens L. and Capsicum annuum L.
Caraway Carum carvi L.
Cardamom seed (cardamon) Elettaria cardamomum Maton.
Carob bean Ceratonia siliqua L.
Carrot Daucus carota L.
Cascarilla bark Croton eluteria Benn.
Cassia bark, Chinese Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia Cinnamomum burmanni Blume.
Cassia bark, Saigon Cinnamomum loureirii Nees.
Celery seed Apium graveolens L.
Cherry, wild, bark Prunus serotina Ehrh.
Chervil Anthriscus cerefolium (L.) Hoffm.
Chicory Cichorium intybus L.
Cinnamon bark, Ceylon Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese Cinnamomum cassia Blume.
Cinnamon bark, Saigon Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese Cinnamomum cassia Blume.
Cinnamon leaf, Saigon Cinnamomum loureirii Nees.
Citronella Cymbopogon nardus Rendle.
Citrus peels Citrus spp.
Clary (clary sage) Salvia sclarea L.
Clover Trifolium spp.
Coca (decocainized) Erythroxylum coca Lam. and other spp. of Erythroxylum.
Coffee Coffea spp.
Cola nut Cola acuminata Schott and Endl., and other spp. of Cola.
Coriander Coriandrum sativum L.
Cumin (cummin) Cuminum cyminum L.
Curacao orange peel (orange, bitter peel) Citrus aurantium L.
Cusparia bark Galipea officinalis Hancock.
Dandelion Taraxacum officinale Weber and T. laevigatum DC.
Dandelion root Do.
Dog grass (quackgrass, triticum) Agropyron repens (L.) Beauv.
Elder flowers Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon, tarragon) Artemisia dracunculus L.
Estragon (tarragon) Do.
Fennel, sweet Foeniculum vulgare Mill.
Fenugreek Trigonella foenum-graecum L.
Galanga (galangal) Alpinia officinarum Hance.
Geranium Pelargonium spp.
Geranium, East Indian Cymbopogon martini Stapf.
Geranium, rose Pelargonium graveolens L'Her.
Ginger Zingiber officinale Rosc.
Grapefruit Citrus paradisi Macf.
Guava Psidium spp.
Hickory bark Carya spp.
Horehound (hoarhound) Marrubium vulgare L.
Hops Humulus lupulus L.
Horsemint Monarda punctata L.
Hyssop Hyssopus officinalis L.
Immortelle Helichrysum augustifolium DC.
Jasmine Jasminum officinale L. and other spp. of Jasminum.
Juniper (berries) Juniperus communis L.
Kola nut Cola acuminata Schott and Endl., and other spp. of Cola.
Laurel berries Laurus nobilis L.
Laurel leaves Laurus spp.
Lavender Lavandula officinalis Chaix.
Lavender, spike Lavandula latifolia Vill.
Lavandin Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.
Lemon Citrus limon (L.) Burm. f.
Lemon balm (see balm)
Lemon grass Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf.
Lemon peel Citrus limon (L.) Burm. f.
Lime Citrus aurantifolia Swingle.
Linden flowers Tilia spp.
Locust bean Ceratonia siliqua L,
Lupulin Humulus lupulus L.
Mace Myristica fragrans Houtt.
Mandarin Citrus reticulata Blanco.
Marjoram, sweet Majorana hortensis Moench.
Mate Ilex paraguariensis St. Hil.
Melissa (see balm)
Menthol Mentha spp.
Menthyl acetate Do.
Molasses (extract) Saccarum officinarum L.
Mustard Brassica spp.
Naringin Citrus paradisi Macf.
Neroli, bigarade Citrus aurantium L.
Nutmeg Myristica fragrans Houtt.
Onion Allium cepa L.
Orange, bitter, flowers Citrus aurantium L.
Orange, bitter, peel Do.
Orange leaf Citrus sinensis (L.) Osbeck.
Orange, sweet Do.
Orange, sweet, flowers Do.
Orange, sweet, peel Do.
Origanum Origanum spp.
Palmarosa Cymbopogon martini Stapf.
Paprika Capsicum annuum L.
Parsley Petroselinum crispum (Mill.) Mansf.
Pepper, black Piper nigrum L.
Pepper, white Do.
Peppermint Mentha piperita L.
Peruvian balsam Myroxylon pereirae Klotzsch.
Petitgrain Citrus aurantium L.
Petitgrain lemon Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine Citrus reticulata Blanco.
Pimenta Pimenta officinalis Lindl.
Pimenta leaf Pimenta officinalis Lindl.
Pipsissewa leaves Chimaphila umbellata Nutt.
Pomegranate Punica granatum L.
Prickly ash bark Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L.
Rose absolute Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp.
Rose (otto of roses, attar of roses) Do.
Rose buds Do.
Rose flowers Do.
Rose fruit (hips) Do.
Rose geranium Pelargonium graveolens L'Her.
Rose leaves Rosa spp.
Rosemary Rosmarinus officinalis L.
Saffron Crocus sativus L.
Sage Salvia officinalis L.
Sage, Greek Salvia triloba L.
Sage, Spanish Salvia lavandulaefolia Vahl.
St. John's bread Ceratonia siliqua L.
Savory, summer Satureia hortensis L.
Savory, winter Satureia montana L.
Schinus molle Schinus molle L.
Sloe berries (blackthorn berries) Prunus spinosa L.
Spearmint Mentha spicata L.
Spike lavender Lavandula latifolia Vill.
Tamarind Tamarindus indica L.
Tangerine Citrus reticulata Blanco.
Tarragon Artemisia dracunculus L.
Tea Thea sinensis L.
Thyme Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white Do.
Thyme, wild or creeping Thymus serpyllum L.
Triticum (see dog grass)
Tuberose Polianthes tuberosa L.
Turmeric Curcuma longa L.
Vanilla Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Violet flowers Viola odorata L.
Violet leaves Do.
Violet leaves absolute Do.
Wild cherry bark Prunus serotina Ehrh.
Ylang-ylang Cananga odorata Hook. f. and Thoms.
Zedoary bark Curcuma zedoaria Rosc.
FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 21044, May 22, 1985

Code of Federal Regulations
Title 21, Volume 3
Revised as of April 1, 2009
CITE: 21CFR172.510
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart F--Flavoring Agents and Related Substances
Sec. 172.510 Natural flavoring substances and natural substances used in conjunction with flavors.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
(Input "172.510" to the "Title21 Part.Section (e.g., 862.1385)" text box.)
Natural flavoring substances and natural adjuvants may be safely used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their intended physical or technical effect and in accordance with all the principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, previously sanctioned for such use, or regulated in any section of this part.
Common name Scientific name Limitations
Aloe Aloe perryiBaker,A. barbadensisMill.,A. feroxMill., and hybrids of this sp. withA. africanaMill. andA. spicataBaker
Althea root and flowers Althea officinalisL
Amyris (West Indian sandalwood) Amyris balsamiferaL
Angola weed Roccella fuciformisAch In alcoholic beverages only
Arnica flowers Arnica montanaL.,A. fulgensPursh,A. sororiaGreene, orA. cordifoliaHooker Do.
Artemisia (wormwood) Artemisiaspp Finished food thujone free1
Artichoke leaves Cynara scolymusL In alcoholic beverages only
Benzoin resin Styrax benzoinDryander,S. paralleloneurusPerkins,S. tonkinensis(Pierre) Craib ex Hartwich, or other spp. of the SectionAnthostyraxof the genusStyrax
Blackberry bark Rubus,SectionEubatus
Boldus (boldo) leaves Peumus boldusMol Do.
Boronia flowers Boronia megastigmaNees
Bryonia root Bryonia albaL., orB. diociaJacq Do.
Buchu leaves Barosma betulinaBartl. et Wendl.,B. crenulata(L.) Hook. orB. serratifoliaWilld
Buckbean leaves Menyanthes trifoliataL Do.
Cajeput Melaleuca leucadendronL. and otherMelaleucaspp
Calumba root Jateorhiza palmata(Lam.) Miers Do.
Camphor tree Cinnamomum camphora(L.) Nees et Eberm Safrole free
Cascara sagrada Rhamnus purshianaDC
Cassie flowers Acacia farnesiana(L.) Willd
Castor oil Ricinus communisL
Catechu, black Acacia catechuWilld
Cedar, white (aborvitae), leaves and twigs Thuja occidentalisL Finished food thujone free1
Centuary Centaurium umbellatumGilib In alcoholic beverages only
Cherry pits Prunus aviumL. orP. cerasusL Not to exceed 25 p.p.m. prussic acid
Cherry-laurel leaves Prunus laurocerasusL Do.
Chestnut leaves Castanea dentata(Marsh.) Borkh
Chirata Swertia chirataBuch.-Ham In alcoholic beverages only
Cinchona, red, bark Cinchona succirubraPav. or its hybrids In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage
Cinchona, yellow, bark Cinchona ledgerianaMoens,C. calisayaWedd., or hybrids of these with other spp. ofCinchona. Do.
Copaiba South American spp. ofCopaiferaL
Cork, oak Quercus suberL., orQ. occidentalisF. Gay In alcoholic beverages only
Costmary Chrysanthemum balsamitaL Do.
Costus root Saussurea lappaClarke
Cubeb Piper cubebaL. f
Currant, black, buds and leaves Ribes nigrumL
Damiana leaves Turnera diffusaWilld
Davana Artemisia pallensWall
Dill, Indian Anethum sowaRoxb. (Peucedanum graveolensBenth et Hook.,Anethum graveolensL.)
Dittany (fraxinella) roots Dictamnus albusL Do.
Dittany of Crete Origanum dictamnusL
Dragon's blood (dracorubin) Daemonoropsspp
Elder tree leaves Sambucus nigraL In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor
Elecampane rhizome and roots Inula heleniumL In alcoholic beverages only
Elemi Canarium communeL. orC. luzonicumMiq
Erigeron Erigeron canadensisL
Eucalyptus globulus leaves Eucalyptus globulusLabill
Fir ("pine") needles and twigs Abies sibiricaLedeb.,A. albaMill.,A. sachalinesisMasters orA. mayrianaMiyabe et Kudo
Fir, balsam, needles and twigs Abies balsamea(L.) Mill
Galanga, greater Alpinia galangaWilld Do.
Galbanum Ferula galbanifluaBoiss. et Buhse and otherFerulaspp
Gambir (catechu, pale) Uncaria gambirRoxb
Genet flowers Spartium junceumL
Gentian rhizome and roots Gentiana luteaL
Gentian, stemless Gentiana acaulisL Do.
Germander, chamaedrys Teucrium chamaedrysL Do.
Germander, golden Teucrium poliumL Do.
Guaiac Guaiacum officinaleL.,G. santumL.,Bulnesia sarmientiLor
Guarana Paullinia cupanaHBK
Haw, black, bark Viburnum prunifoliumL
Hemlock needles and twigs Tsuga canadensis(L.) Carr. orT. heterophylla(Raf.) Sarg
Hyacinth flowers Hyacinthus orientalisL
Iceland moss Cetraria islandicaAch Do.
Imperatoria Peucedanum ostruthium(L.). Koch (Imperatoria ostruthiumL.)
Iva Achillea moschataJacq Do.
Labdanum Cistusspp
Lemon-verbena Lippia citriodoraHBK Do.
Linaloe wood Bursera delpechianaPoiss. and otherBurseraspp
Linden leaves Tilliaspp Do.
Lovage Levisticum officinaleKoch
Lungmoss (lungwort) Sticta pulmonaceaAch
Maidenhair fern Adiantum capillus-venerisL Do.
Maple, mountain Acer spicatumLam
Mimosa (black wattle) flowers Acacia decurrensWilld. var.dealbata
Mullein flowers Verbascum phlomoidesL. orV. thapsiformeSchrad Do.
Myrrh Commiphora molmolEngl.,C. abyssinica(Berg) Engl., or otherCommiphoraspp
Myrtle leaves Myrtus communisL Do.
Oak, English, wood Quercus roburL Do.
Oak, white, chips Quercus albaL
Oak moss Evernia prunastri(L.) Ach.,E. furfuracea(L.) Mann, and other lichens Finished food thujone free1
Olibanum Boswellia carteriBirdw. and otherBoswelliaspp
Opopanax (bisabolmyrrh) Opopanax chironiumKoch (true opopanax) ofCommiphora erythraeaEngl. var.Llabrescens
Orris root Iris germanicaL. (including its varietyflorentinaDykes) andI. pallidaLam
Pansy Viola tricolorL In alcoholic beverages only
Passion flower Passiflora incarnataL
Patchouly Pogostemon cablinBenth. andP. heyneanusBenth
Peach leaves Prunus persica(L.) Batsch In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor
Pennyroyal, American Hedeoma pulegioides(L.) Pers
Pennyroyal, European Mentha pulegiumL
Pine, dwarf, needles and twigs Pinus mugoTurra var.pumilio(Haenke) Zenari
Pine, Scotch, needles and twigs Pinus sylvestrisL
Pine, white, bark Pinus strobusL In alcoholic beverages only
Pine, white oil Pinus palustrisMill., and otherPinusspp
Poplar buds Populus balsamiferaL. (P. tacamahaccaMill.),P. candicansAit., orP. nigraL Do.
Quassia Picrasma excelsa(Sw.) Planch, orQuassia amaraL
Quebracho bark Aspidosperma quebracho-blancoSchlecht, or (Quebrachia lorentzii(Griseb)) Schinopsis lorentzii(Griseb.) Engl.
Quillaia (soapbark) Quillaja saponariaMol
Red saunders (red sandalwood) Pterocarpus san alinusL In alcoholic beverages only
Rhatany root Krameria triandraRuiz et Pav. orK. argenteaMart
Rhubarb, garden root Rheum rhaponticumL Do.
Rhubarb root Rheum officinaleBaill.,R. palmatumL., or other spp. (exceptingR. rhaponticumL.) or hybrids ofRheumgrown in China
Roselle Hibiscus sabdariffaL Do.
Rosin (colophony) Pinus palustrisMill., and otherPinusspp Do.
St. Johnswort leaves, flowers, and caulis Hypericum perforatumL Hypericin-free alcohol distillate form only; in alcoholic beverages only
Sandalwood, white (yellow, or East Indian) Santalum albumL
Sandarac Tetraclinis articulata(Vahl.), Mast In alcoholic beverages only
Sarsaparilla Smilax aristolochiaefoliaMill., (Mexican sarsaparilla),S. regeliiKillip et Morton (Honduras sarsaparilla),S. febrifugaKunth (Ecuadorean sarsaparilla), or undeterminedSmilaxspp. (Ecuadorean or Central American sarsaparilla)
Sassafras leaves Sassafras albidum(Nutt.) Nees Safrole free
Senna, Alexandria Cassia acutifoliaDelile
Serpentaria (Virginia snakeroot) Aristolochia serpentariaL In alcoholic beverages only
Simaruba bark Simaruba amaraAubl Do.
Snakeroot, Canadian (wild ginger) Asarum canadenseL
Spruce needles and twigs Picea glauca(Moench) Voss orP. mariana(Mill.) BSP
Storax (styrax) Liquidambar orientalisMill. orL. styracifluaL
Tagetes (marigold) Tagetes patulaL.,T. erectaL., orT. minutaL. (T. glanduliferaSchrank) As oil only
Tansy Tanacetum vulgareL In alcoholic beverages only; finished alcoholic beverage thujone free1
Thistle, blessed (holy thistle) Onicus benedictusL In alcoholic beverages only
Thymus capitatus(Spanish "origanum") Thymus capitatusHoffmg. et Link
Tolu Myroxylon balsamum(L.) Harms
Turpentine Pinus palustrisMill. and otherPinusspp. which yield terpene oils exclusively
Valerian rhizome and roots Valeriana officinalisL
Veronica Veronica officinalisL Do.
Vervain, European Verbena officinalisL Do.
Vetiver Vetiveria zizanioidesStapf Do.
Violet, Swiss Viola calcarataL
Walnut husks (hulls), leaves, and green nuts Juglans nigraL. orJ. regiaL
Woodruff, sweet Asperula odorataL In alcoholic beverages only
Yarrow Achillea millefoliumL In beverages only; finished beverage thujone free1
Yerba santa Eriodictyon californicum(Hook, et Arn.) Torr
Yucca, Joshua-tree Yucca brevifoliaEngelm
Yucca, Mohave Yucca schidigeraRoezl ex Ortgies (Y. mohavensisSarg.)
1As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007

WHO Good Manufacturing Process (GMP) Guidelines
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

US FDA Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm

Missouri Organic Association
http://www.missouriorganic.org/

Wild Crops Farm summer 2010 home distillars workshop series, "How to Make your Own Essential Oils and Hydrosols at Home" with George Frazier
http://www.missouriorganic.org/Events/OtherEvents.aspx

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garyallen's Avatar
garyallen | 2 years ago
15
Hello from St. Louis. I am not an attorney. You should at least talk with one before you start a business

A tincture MIGHT be a "new drug," as defined in Missouri Revised Statutes, Chapter 196:
Food, Drugs and Tobacco Section 196.010, which reads, in part:

(11) The term "new drug" means any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended or suggested in the labeling thereof; or any drug the composition of which is such that such drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions;

(12) The term "official compendium" means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them;

I think this is the actual Missouri Ag Law pertaining to on getting a license to produce the stuff:
http://www.moga.mo.gov/statutes/C100-199/1960000105.HTM

Missouri Revised Statutes
Chapter 196
Food, Drugs and Tobacco
Section 196.105

August 28, 2009

Provisions governing selling or delivering new drug.

196.105. 1. No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless:

(1) An application with respect thereto has become effective under 21 U.S.C.A. § 355; or

(2) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the department an application setting forth full reports of investigations which have been made to show whether or not such drug is safe for use; a full list of the articles used as components of such drug; a full statement of the composition of such drug; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; such samples of such drug and of the articles used as components thereof as the department may require; and specimens of the labeling proposed to be used for such drug.

2. An application provided for in subdivision (2) of subsection 1 shall become effective on the sixtieth day after the filing thereof, except that if the department finds after due notice to the applicant and giving him an opportunity for a hearing, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the department shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

3. This section shall not apply:

(1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs provided the drug is plainly labeled "For investigational use only"; or

(2) To a drug sold in this state at any time prior to the enactment of sections 196.010 to 196.120 or introduced into interstate commerce at any time prior to the enactment of the federal act; or

(3) To any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902 (U.S.C. 1934 cd. title 42. Chapter 4).

4. An order refusing to permit an application under this section to become effective may be revoked by the department of health and senior services.

Read all of Chapter 196 by section here: http://www.moga.mo.gov/STATUTES/C196.HTM

And if you want to read SEC. 505. USC §355 New Drugs from the FDA, read here:
http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

You may also want to poke around a site, "Missouri Agricultural Law Center (MALC)."
by Stephen F. Matthews, Professor Emeritus of Agricultural Law, University of Missouri
http://aglaw.missouri.edu/

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manywaters1's Avatar
manywaters1 | 2 years ago Report

Great Information!

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sincerelysandi's Avatar
sincerelysandi | 2 years ago
2
I'm not trying to win anything with this answer. I just found an article that I thought might be helpful about the business of selling herbs. It is at http://attra.ncat.org/attra-pub/PDF/gh-herb.pdf. I don't know anything about this subject so I'll butt out now. Just thought the article might be interesting to you!! Sandi

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manywaters1's Avatar
manywaters1 | 2 years ago
7
Ok, without listing all the herbs you wish to use, In the United States natural herbs are not illegal, unless one wishes to utilize them as a substance for mind altering, then there will be problems, common sense will help you in this arena, if if is illegal in Missouri to smoke it, don't use it... The most important thing is to disclose on anything you sell, or make for anything other than personal use, " The statements" *This product is not FDA approved.* Before using this and any organics products you should consult with your physician.* I am not a medical physician however these things have worked for me or a friend in the past.*
I would advise you to become extremely familiar with the side affects of any herbs you use & the precautions one should take if they are using more than one product. When you choose to grow & develop holistic tinctures & herbal medicines it is Your responsibility to Know, Know, Know your products & be confident they will be harmless to someone who uses them. ex: if I have rheumatoid arthritis will using Slippery elm bark for my sore throat affect my medications? & so forth..
Good Luck to You...

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garyallen's Avatar
garyallen | 2 years ago Report

I believe there are inherent risks to producing for consumption any type of medicinal cure, and I've laid out the applicable Missouri and Federal FDA guidelines. It's not enough for the manufacturer to know their trade--they may not know it. Someone needs to protect the consumer.

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