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How to Start a Food Business We package a lot of food products into stick packs Kaj pouches and are often asked by entrepreneurs for resources on how to start a food business. We typically refer them to the Food and Drug Administration. Here is a summary of the FDA’s guidelines for starting your own food business. Be sure to visit their website for specific information. A link is at the bottom of this page. How to Start a Food Business Introduction To open a food business there are some requirements you will need to meet. The requirements include those that apply to all food businesses and those that apply to a specific food product (for instance sea food or juice). To know for sure what requirements you should meet for your facility, you could discuss it with the FDA District Office and state and local regulatory agencies that have jurisdiction. Food Businesses Subject to FDA Regulation FDA only regulates foods and food ingredients introduced into or offered for sale in interstate commerce. But foods like meat, poultry, and certain processed egg products are regulated by USDA. Requirements governing what FDA regulates: - Federal Food, Drug, and Cosmetic Act (FFD&C Act) - Title 21 of the Code of Federal Regulations (21 CFR) - Public Health Service Act (several provisions of this act provide FDA with important statutory authority, such as the authority to issue regulations for the control of communicable diseases) - Laws enforced by FDA Food Facility Registration In the United States, facilities that manufacture, process, pack or hold food intended for human or animals must register with the FDA before starting these activities. Requirements governing food facility registration: - Public health security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) - 21 CFR section 1.225 - Food Safety Modernization Act (FSMA) Resources - Food facility Registration - Facility Registration Under the Food Safety Modernization Act (FSMA) - Food Defense Guidance Documents & Regulatory Information Recordkeeping Every person or business involved in the manufacture and distribution of food must make available upon request, records required by the FDA. You may consult Title 21 of the Code of Federal Regulations to determine what records you require for your facility. Requirements governing recordkeeping: - Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism 2002) - 21 CFR Part 1, Subpart J - Food Safety Modernization Act Resources - Establishment and Maintenance of records - Records and Records Access under the Food Safety Modernization Act (FSMA) Good Manufacturing Practice Requirements Recent cGMP regulations require that food offered for sale or introduced into interstate commerce be produced under safe and sanitary conditions. Requirements governing cGMP: - 21 CFR Part 110 - Resources - Good Manufacturing Practices (GMPs) for the 21st Century –Food processing - Commodity Specific Information Labeling Food manufacturers must develop labels that meet legal food labeling requirements. Requirements governing the labeling of foods: - Federal Food, Drug, and Cosmetic Act (FFD&C Act) - Fair Packaging and Labeling Act - Nutrition and Labeling and Education Act - FDA’s regulations on food labeling- 21 CFR 101 Resources - Food Labeling and Nutrition Overview - Food Allergens information Developing labels - Manufactures may choose a commercial laboratory to test the food nutrient content. - United States Department of Agriculture’s Food Nutrient Database can be used to develop nutrient information for products. - Manufacturers can consult FDA’s Nutrition Labeling Manual. Reporting Registered facilities should report when there is probability that an article of food may cause adverse health consequences or death. FDA’s Reportable Food Registry has information on how to report these situations. Preventive Controls Unless specifically exempted by FSMA, the owner, operator, or agent in charge of a facility must evaluate the hazards that could affect manufactured food. Preventive controls should then be implemented to prevent such hazards. In addition, records of this monitoring should be maintained regularly. Inspections Investigators with FDA’s Office of Regulatory Affairs (ORA) inspect FDA regulated facilities. FDA inspects food facilities depending on the risk level of the product. Additional Information Under FFD&C Act and FDA’s regulations any person or business that handles food must provide products that are safe, sanitary and labeled according to federal requirements. For more information, visit: U.S. Food and Drug Administration.
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Conas a Tosaigh Gnó Bia Linn pacáiste a lán de na táirgí bia isteach pacáistí bata agus púitsí agus iarrtar go minic ag fiontraithe d'acmhainní maidir le conas a thosú gnó bia. Táimid tagairt de ghnáth iad chuig an Bia agus Drugaí Riarachán. Seo achoimre de na treoirlínte an FDA do tosú le do ghnó bia féin. Bí cinnte chun cuairt a thabhairt ar a láithreán gréasáin chun faisnéis shonrach. Tá nasc ag bun an leathanaigh seo. Conas a Tosaigh Gnó Bia Réamhrá Chun gnó bia a oscailt go bhfuil roinnt riachtanais, beidh ort chun freastal ar. San áireamh sna ceanglais sin a bhaineann le gach gnólachtaí bia agus iad siúd a bhaineann le táirge ar leith bia (le haghaidh bia mara mar shampla nó sú). Chun a fhios do cinnte cad iad na riachtanais ba chóir duit a chomhlíonadh do do áis, d'fhéadfaí tú a phlé leis an Oifig Cheantair FDA agus gníomhaireachtaí stáit agus áitiúla rialála a bhfuil dlínse ag. Gnólachtaí Bia Faoi réir Rialachán FDA FDA rialaíonn ach bianna agus comhábhair bia a thabhairt isteach nó a thairiscint le díol i interstate thráchtáil. Ach bianna ar nós feoil, éanlaith chlóis, agus táirgí uibhe próiseáilte áirithe á rialú ag USDA. Riachtanais a rialaíonn cad rialaíonn FDA: - Bia Chónaidhme, Drugaí, agus an tAcht Cosmaideacha (FFD&An tAcht C) - Teideal 21 an Cód Rialacháin Chónaidhme (21 CÉ) - An tAcht um Sheirbhís Sláinte Poiblí (a chur ar fáil roinnt forálacha de ghníomh seo FDA leis an údarás reachtúil tábhachtach, mar shampla an t-údarás chun rialacháin a dhéanamh chun rialú a dhéanamh ar ghalair theagmhálacha a eisiúint) - Dlíthe i bhfeidhm ag FDA Clárú Áis Bia Sna Stáit Aontaithe, áiseanna a mhonarú, próiseas, pacáiste nó a shealbhú bia a bheartaítear an duine nó ainmhithe a clárú leis an FDA roimh thosú ar na gníomhaíochtaí. Riachtanais a rialaíonn clárú saoráid bia: - Slándála sláinte poiblí agus an tAcht Freagra bhithsceimhlitheoireacht Ullmhacht agus 2002 (An tAcht bhithsceimhlitheoireacht) - Acht um Nuachóiriú Sábháilteachta Bia (FSMA) Acmhainní - Clárú saoráid Bia - Clárú Áis Faoin Acht um Nuachóiriú Shábháilteacht Bia (FSMA) - Treoir Defense Bia Doiciméid & Faisnéis Rialála Recordkeeping Ní mór do gach duine nó gnó a bhfuil baint acu leis an déantúsaíocht agus dáileadh bia a chur ar fáil arna iarraidh sin, taifid a cheanglaítear leis an FDA. Is féidir leat dul i gcomhairle Teideal 21 an Cód Rialacháin Chónaidhme chun a chinneadh cad taifid de dhíth ort chun do áis. Riachtanais a rialaíonn recordkeeping: - Sláinte Slándála Poiblí agus an tAcht Freagra bhithsceimhlitheoireacht Ullmhacht agus 2002 (Bhithsceimhlitheoireacht 2002) - 21 CÉ Cuid 1, Fochuid J - Acht um Nuachóiriú Sábháilteachta Bia Acmhainní - Bunú agus Cothabháil ar thaifid - Taifid agus Taifid Rochtana faoin Acht um Nuachóiriú Shábháilteacht Bia (FSMA) Riachtanais Dea-Chleachtais Déantúsaíochta A cheangal ar na rialacháin cGMP le déanaí go bhfuil bia a thairiscint lena ndíol nó a tugadh isteach i interstate thráchtáil a tháirgeadh faoi choinníollacha sábháilte agus sláintíochta. Riachtanais a rialaíonn cGMP: - 21 CÉ Cuid 110 - Acmhainní - Dea-Chleachtais Déantúsaíochta (GMPs) don 21ú hAois próiseála-bia - Tráchtearraí Faisnéis sonracha Lipéadú Ní mór do na monaróirí bia lipéid a chomhlíonann na ceanglais dhlíthiúla maidir le lipéadú bia a fhorbairt. Ceanglais maidir le lipéadú bianna: - Bia Chónaidhme, Drugaí, agus an tAcht Cosmaideacha (FFD&An tAcht C) - An tAcht um Pacáistiú agus Lipéadú Cóir - Cothú agus an tAcht Lipéadú agus Oideachas - Rialacháin FDA maidir le lipéadú bia- 21 CÉ 101 Acmhainní - Lipéadú Bia agus Cothú Forbhreathnú - Eolas Ailléirginí Bia Lipéid a fhorbairt - Déantúisí a roghnú saotharlann tráchtála a thástáil an t-ábhar cothaitheach bia. - United States Department of Agriculture’s Food Nutrient Database can be used to develop nutrient information for products. - Is féidir le monaróirí i gcomhairle Lámhleabhar Cothú Lipéadú FDA. Tuairisciú Ba cheart áiseanna Cláraithe tuairisc a nuair nach bhfuil dóchúlacht gur féidir earra bhídh ina chúis le hiarmhairtí díobhálacha sláinte nó d'fháil bháis. Intuairiscithe Chlárlann Bia FDA Tá eolas maidir le conas tuairisc ar na cásanna. Rialuithe Coisctheach Mura díolmhaithe go sonrach ag FSMA, an t-úinéir, oibreoir, nó gníomhaire i gceannas ar tsaoráid sin ní mór measúnú a dhéanamh ar na guaiseacha a d'fhéadfadh difear bia mhonaraítear. Ba chóir rialuithe coisctheacha a chur i bhfeidhm ansin chun cosc a chur le guaiseacha den sórt sin. Chomh maith leis sin, Ba chóir taifid na monatóireachta seo a chothabháil go rialta. Cigireachtaí Imscrúdaitheoirí le hOifig an FDA Gnóthaí Rialála (ANOIS) áiseanna rialaithe FDA iniúchadh. FDA iniúchadh áiseanna bia ag brath ar an leibhéal riosca an táirge. Eolas Breise I FFD&Rialacháin tAcht C agus FDA mór d'aon duine nó gnó a Láimhseálann táirgí bia atá sábháilte a chur ar fáil, sláintíochta agus lipéadaithe de réir cheanglais cónaidhme. Le haghaidh tuilleadh eolais, cuairt a thabhairt ar: U.S. Bia agus Drugaí Riarachán.