Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 Chris, so the contract manufacturers are worth it? Jennifer. I was wondering about that myself... haud desiderium sieze dies Orbis terrarum est meus oyster vos mos non subsisto mihi EGO sum a comic indoles Jennifer Janek-Markey Soapywench _____ On Behalf Of Christine Ziegler Wednesday, July 25, 2007 7:59 PM Important for all toiletry makers! Here are the gov't regs you need to know about .. or else you might find yourself in deep doo doo one day! http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> gov/ora/inspect_ref/igs/cosmet.html Below is what you have to comply with and what inspectors would look at if your manufacturing facilities were ever to be inspected (whether it be your kitchen, your art studio, a little manufacturing area you put together, a lab ..etc ...) My company is shifting to using contract manufacturers at this point, cause I don't need my butt in hot water as I grow! They are happy to use my recipes, my ingredients and I can even go watch my batches being made if I want. To say " I'm so small, they'll never inspect me " might be true, or it might be wishful thinking, like saying " I'll never get audited so I'll throw my tax records away " . Why take a chance messing around with the gov't - who can really mess with you back and ruin your world ): *Smile* Chris (list mom) http://www.alittleo <http://www.alittleolfactory.com> lfactory.com http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> gov/ora/inspect_ref/igs/cosmet.html *III. INSPECTION* _*BUILDINGS AND FACILITIES*_ Determine if the buildings are of suitable size, design and construction and maintained in a clean and orderly manner. Buildings should provide: 1. Adequate space to minimize mixups between different products, raw materials, labeling and cross-contamination. 2. Floors, walls and ceilings constructed of smooth, easily cleanable surfaces. 3. Adequate lighting and ventilation and if necessary for control purposes, screening, filtering, dust, humidity, temperature, and bacteriological controls. 4. Adequate washing, cleaning, plumbing, toilet, and locker facilities, to allow sanitary operation and cleaning of facilities, equipment, and utensils, and to facilitate personal cleanliness. 5. Fixtures, ducts, and pipes installed to prevent condensate or drip contamination in cosmetic materials, utensils, and cosmetic contact surfaces. _*EQUIPMENT*_ Determine if equipment and utensils used in processing, holding, transferring and packaging are of appropriate design, size, material and workmanship to prevent corrosion, accumulation of static material and/or adulteration with lubricants, coolants, dirt, sanitizing agents. The equipment (utensils, transfer piping, cosmetic contact surfaces, etc.) should be: 1. maintained in a clean and orderly manner and sanitized at appropriate times. 2. cleaned and sanitized equipment - stored in a manner that protects it from splash, dust, and other contaminants. 3. constructed to facilitate adjustment, cleaning, and maintenance. 4. of suitable size and accuracy for measuring, mixing, and weighing operations. _*PERSONNEL*_ Determine whether personnel supervising or performing the manufacturing or control of cosmetics have the education, training, and/or expertise to perform their assigned functions. Observe whether personnel coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces wear appropriate outer garments, i.e., uniforms, gloves, hair restraints, etc., maintain adequate personnel cleanliness, are free from abnormal sources of microbiological contamination, i.e., sores, infected wounds, etc. Determine whether eating food, drinking beverages, or using tobacco is restricted to appropriate designated areas. *_RAW MATERIALS_* Determine whether raw materials are identified, stored, examined, tested, inventoried, handled, and controlled to assure they conform to appropriate standards. Raw materials should be: 1. stored and handled to prevent mixups, contamination with microorganisms or other chemicals, and degradation from exposure to excessive heat, cold, sunlight, moisture, etc. 2. held in closed containers stored off the floor. 3. maintained in containers that are labeled with the identity, lot number, and control status (release or quarantine). 4. sampled and tested for conformance with specifications and to assure the absence of filth, micro-organisms, and other adulterants. Review animal and vegetable origin materials and those produced by cold processing methods for filth and/or microorganism contamination. 5. properly identified and controlled to prevent the use of materials that fail to meet acceptance specifications. Determine whether color additives are approved for use in cosmetics (21 CFR 73, 74, & 82) and are certified (21 CFR 74 & 82). Determine if any cosmetic ingredients are prohibited (21 CFR 700). _*PRODUCTION*_ Determine whether written manufacturing and control procedures have been established, i.e., formulations, processing instructions, in-process control methods, packaging instructions. Evaluate procedures and determine if: 1. the selection, weighing, and measuring of raw materials and the determination of finished yield are reviewed by a second individual. 2. major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification, stage of processing and control status. 3. there are appropriate procedures to prevent contamination with microorganisms or chemicals. 4. there are in-process controls to ensure product uniformity, integrity, i.e., in-process batch weights, fill of mixing containers, adequacy of mixing. 5. the theoretical yield is compared with the actual yield. _*LABORATORY CONTROLS*_ Evaluate laboratory controls including sample collection technique, specifications, test methods, laboratory equipment, and technician qualifications. Determine whether: 1. raw materials, in-process and finished product samples are tested or examined for identity and compliance with applicable specifications, i.e., physical and chemical properties, microbial contamination, and hazards or other chemical contamination. 2. samples are representative of the lot. 3. water used as a cosmetic ingredient is tested regularly for conformance with chemical and micro-biological specifications. See IOM Exhibit 653.1-B for guidance for covering deionized water systems. 4. current finished product production as well as reserve samples are tested for adequacy of preservation against microbial contamination under reasonable conditions of storage and use. 5. reserve samples of approved lots of raw materials and finished products are retained for an adequate time period, i.e., expected shelf-life of the product, one year beyond any expiration date, two years after distribution has been completed, etc., whichever is longer. 6. reserve samples are stored under conditions which protect their integrity, i.e., contamination, deterioration, and are retested at appropriate intervals to assure continued compliance with established specifications. 7. returned cosmetics are examined for deterioration, contamination, and compliance with acceptance specifications. Determine what toxicological and/or other testing the firm has conducted to substantiate the safety of products. See 21 CFR 740.10. _*PACKAGING AND LABELING*_ Review the immediate and outer container labels and determine if they bear: 1. on the principal display panel: (a) name of product, statement of identity and net contents. See 21 CFR 701.11 & 13. (b) if safety of the product has not been substantiated, the statement " Warning - The safety of this product has not been determined " . See 21 CFR 740.10. 2. on an appropriate information panel: (a) name and address of the manufacturer, packer, or distributor. See 21 CFR 701.12. (b) ingredients listed in descending order of predominance. See 21 CFR 701.3. © warning statements required for self-pressurized containers (21 CFR 740.11), feminine deodorant sprays (21 CFR 740.12), bubble bath products (21 CFR 740.17), and coal tar hair dyes (21 CFR 740.18 and 601(a) of the Act). (d) any other warning statement necessary or appropriate to prevent a health hazard. See 21 CFR 740.1(a). Identify the health hazard and the basis for the warning statement. (e) directions for safe use of the product. Evaluate tamper-resistant packaging and labeling for liquid oral hygiene products and all vaginal products as required by 21 CFR 700.25. Evaluate primary packaging materials storage and handling procedures for preventing mixups and microbiological or chemical contamination. Determine whether finished product packages bear meaningful, permanent lot or control numbers. Obtain the key to the coding system. _*RECORDS*_ Review records of origin, receipt, examination, testing, disposition, and use of raw materials to determine adequacy of raw material control. Determine whether disposition of rejected materials is documented, including any reworking operations. Evaluate batch production control records and ascertain if they include: 1. documentation of all ingredients (name, code, lot number, quantity, etc.) added to the batch. 2. documentation of all production steps, i.e., processing, handling, transferring, holding, filling. 3. in-process sampling, controlling, and adjusting steps. 4. batch and finished product lot or control numbers. 5. the finished products control status -accepted or rejected. Evaluate laboratory control records for raw materials, in-process materials, and finished products and include sampling documentation, test results, and interpretation of the test results (accept or reject). Determine if initial distribution records are retained which identifies the consignee, product, lot or control number. Determine if records are adequate to conduct an effective recall. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 Here are the gov't regs you need to know about .. or else you might find yourself in deep doo doo one day! http://www.fda.gov/ora/inspect_ref/igs/cosmet.html Below is what you have to comply with and what inspectors would look at if your manufacturing facilities were ever to be inspected (whether it be your kitchen, your art studio, a little manufacturing area you put together, a lab ..etc ...) My company is shifting to using contract manufacturers at this point, cause I don't need my butt in hot water as I grow! They are happy to use my recipes, my ingredients and I can even go watch my batches being made if I want. To say " I'm so small, they'll never inspect me " might be true, or it might be wishful thinking, like saying " I'll never get audited so I'll throw my tax records away " . Why take a chance messing around with the gov't - who can really mess with you back and ruin your world ): *Smile* Chris (list mom) http://www.alittleolfactory.com http://www.fda.gov/ora/inspect_ref/igs/cosmet.html *III. INSPECTION* _*BUILDINGS AND FACILITIES*_ Determine if the buildings are of suitable size, design and construction and maintained in a clean and orderly manner. Buildings should provide: 1. Adequate space to minimize mixups between different products, raw materials, labeling and cross-contamination. 2. Floors, walls and ceilings constructed of smooth, easily cleanable surfaces. 3. Adequate lighting and ventilation and if necessary for control purposes, screening, filtering, dust, humidity, temperature, and bacteriological controls. 4. Adequate washing, cleaning, plumbing, toilet, and locker facilities, to allow sanitary operation and cleaning of facilities, equipment, and utensils, and to facilitate personal cleanliness. 5. Fixtures, ducts, and pipes installed to prevent condensate or drip contamination in cosmetic materials, utensils, and cosmetic contact surfaces. _*EQUIPMENT*_ Determine if equipment and utensils used in processing, holding, transferring and packaging are of appropriate design, size, material and workmanship to prevent corrosion, accumulation of static material and/or adulteration with lubricants, coolants, dirt, sanitizing agents. The equipment (utensils, transfer piping, cosmetic contact surfaces, etc.) should be: 1. maintained in a clean and orderly manner and sanitized at appropriate times. 2. cleaned and sanitized equipment - stored in a manner that protects it from splash, dust, and other contaminants. 3. constructed to facilitate adjustment, cleaning, and maintenance. 4. of suitable size and accuracy for measuring, mixing, and weighing operations. _*PERSONNEL*_ Determine whether personnel supervising or performing the manufacturing or control of cosmetics have the education, training, and/or expertise to perform their assigned functions. Observe whether personnel coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces wear appropriate outer garments, i.e., uniforms, gloves, hair restraints, etc., maintain adequate personnel cleanliness, are free from abnormal sources of microbiological contamination, i.e., sores, infected wounds, etc. Determine whether eating food, drinking beverages, or using tobacco is restricted to appropriate designated areas. *_RAW MATERIALS_* Determine whether raw materials are identified, stored, examined, tested, inventoried, handled, and controlled to assure they conform to appropriate standards. Raw materials should be: 1. stored and handled to prevent mixups, contamination with microorganisms or other chemicals, and degradation from exposure to excessive heat, cold, sunlight, moisture, etc. 2. held in closed containers stored off the floor. 3. maintained in containers that are labeled with the identity, lot number, and control status (release or quarantine). 4. sampled and tested for conformance with specifications and to assure the absence of filth, micro-organisms, and other adulterants. Review animal and vegetable origin materials and those produced by cold processing methods for filth and/or microorganism contamination. 5. properly identified and controlled to prevent the use of materials that fail to meet acceptance specifications. Determine whether color additives are approved for use in cosmetics (21 CFR 73, 74, & 82) and are certified (21 CFR 74 & 82). Determine if any cosmetic ingredients are prohibited (21 CFR 700). _*PRODUCTION*_ Determine whether written manufacturing and control procedures have been established, i.e., formulations, processing instructions, in-process control methods, packaging instructions. Evaluate procedures and determine if: 1. the selection, weighing, and measuring of raw materials and the determination of finished yield are reviewed by a second individual. 2. major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification, stage of processing and control status. 3. there are appropriate procedures to prevent contamination with microorganisms or chemicals. 4. there are in-process controls to ensure product uniformity, integrity, i.e., in-process batch weights, fill of mixing containers, adequacy of mixing. 5. the theoretical yield is compared with the actual yield. _*LABORATORY CONTROLS*_ Evaluate laboratory controls including sample collection technique, specifications, test methods, laboratory equipment, and technician qualifications. Determine whether: 1. raw materials, in-process and finished product samples are tested or examined for identity and compliance with applicable specifications, i.e., physical and chemical properties, microbial contamination, and hazards or other chemical contamination. 2. samples are representative of the lot. 3. water used as a cosmetic ingredient is tested regularly for conformance with chemical and micro-biological specifications. See IOM Exhibit 653.1-B for guidance for covering deionized water systems. 4. current finished product production as well as reserve samples are tested for adequacy of preservation against microbial contamination under reasonable conditions of storage and use. 5. reserve samples of approved lots of raw materials and finished products are retained for an adequate time period, i.e., expected shelf-life of the product, one year beyond any expiration date, two years after distribution has been completed, etc., whichever is longer. 6. reserve samples are stored under conditions which protect their integrity, i.e., contamination, deterioration, and are retested at appropriate intervals to assure continued compliance with established specifications. 7. returned cosmetics are examined for deterioration, contamination, and compliance with acceptance specifications. Determine what toxicological and/or other testing the firm has conducted to substantiate the safety of products. See 21 CFR 740.10. _*PACKAGING AND LABELING*_ Review the immediate and outer container labels and determine if they bear: 1. on the principal display panel: (a) name of product, statement of identity and net contents. See 21 CFR 701.11 & 13. (b) if safety of the product has not been substantiated, the statement " Warning - The safety of this product has not been determined " . See 21 CFR 740.10. 2. on an appropriate information panel: (a) name and address of the manufacturer, packer, or distributor. See 21 CFR 701.12. (b) ingredients listed in descending order of predominance. See 21 CFR 701.3. © warning statements required for self-pressurized containers (21 CFR 740.11), feminine deodorant sprays (21 CFR 740.12), bubble bath products (21 CFR 740.17), and coal tar hair dyes (21 CFR 740.18 and 601(a) of the Act). (d) any other warning statement necessary or appropriate to prevent a health hazard. See 21 CFR 740.1(a). Identify the health hazard and the basis for the warning statement. (e) directions for safe use of the product. Evaluate tamper-resistant packaging and labeling for liquid oral hygiene products and all vaginal products as required by 21 CFR 700.25. Evaluate primary packaging materials storage and handling procedures for preventing mixups and microbiological or chemical contamination. Determine whether finished product packages bear meaningful, permanent lot or control numbers. Obtain the key to the coding system. _*RECORDS*_ Review records of origin, receipt, examination, testing, disposition, and use of raw materials to determine adequacy of raw material control. Determine whether disposition of rejected materials is documented, including any reworking operations. Evaluate batch production control records and ascertain if they include: 1. documentation of all ingredients (name, code, lot number, quantity, etc.) added to the batch. 2. documentation of all production steps, i.e., processing, handling, transferring, holding, filling. 3. in-process sampling, controlling, and adjusting steps. 4. batch and finished product lot or control numbers. 5. the finished products control status -accepted or rejected. Evaluate laboratory control records for raw materials, in-process materials, and finished products and include sampling documentation, test results, and interpretation of the test results (accept or reject). Determine if initial distribution records are retained which identifies the consignee, product, lot or control number. Determine if records are adequate to conduct an effective recall. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 I don't have a business so I don't know much about this but I'm curious-does this apply only to those who have set up an actual business or does it also apply to home crafters who create products and sell them locally but have never set up a " business " for themselves? Susan , Christine Ziegler <chrisziggy wrote: > > Here are the gov't regs you need to know about .. or else you might find > yourself in deep doo doo one day! > > http://www.fda.gov/ora/inspect_ref/igs/cosmet.html > > Below is what you have to comply with and what inspectors would look at > if your manufacturing facilities were ever to be inspected (whether it > be your kitchen, your art studio, a little manufacturing area you put > together, a lab ..etc ...) > > My company is shifting to using contract manufacturers at this point, > cause I don't need my butt in hot water as I grow! They are happy to use > my recipes, my ingredients and I can even go watch my batches being made > if I want. > > To say " I'm so small, they'll never inspect me " might be true, or it > might be wishful thinking, like saying " I'll never get audited so I'll > throw my tax records away " . Why take a chance messing around with the > gov't - who can really mess with you back and ruin your world ): > > *Smile* > Chris (list mom) > http://www.alittleolfactory.com > > http://www.fda.gov/ora/inspect_ref/igs/cosmet.html > > *III. INSPECTION* > > _*BUILDINGS AND FACILITIES*_ > > Determine if the buildings are of suitable size, design and construction > and maintained in a clean and orderly manner. Buildings should provide: > > 1. Adequate space to minimize mixups between different products, raw > materials, labeling and cross-contamination. > > 2. Floors, walls and ceilings constructed of smooth, easily cleanable > surfaces. > > 3. Adequate lighting and ventilation and if necessary for control > purposes, screening, filtering, dust, humidity, temperature, and > bacteriological controls. > > 4. Adequate washing, cleaning, plumbing, toilet, and locker facilities, > to allow sanitary operation and cleaning of facilities, equipment, and > utensils, and to facilitate personal cleanliness. > > 5. Fixtures, ducts, and pipes installed to prevent condensate or drip > contamination in cosmetic materials, utensils, and cosmetic contact > surfaces. > > _*EQUIPMENT*_ > > Determine if equipment and utensils used in processing, holding, > transferring and packaging are of appropriate design, size, material and > workmanship to prevent corrosion, accumulation of static material and/or > adulteration with lubricants, coolants, dirt, sanitizing agents. The > equipment (utensils, transfer piping, cosmetic contact surfaces, etc.) > should be: > > 1. maintained in a clean and orderly manner and sanitized at appropriate > times. > > 2. cleaned and sanitized equipment - stored in a manner that protects it > from splash, dust, and other contaminants. > > 3. constructed to facilitate adjustment, cleaning, and maintenance. > > 4. of suitable size and accuracy for measuring, mixing, and weighing > operations. > > _*PERSONNEL*_ > > Determine whether personnel supervising or performing the manufacturing > or control of cosmetics have the education, training, and/or expertise > to perform their assigned functions. > > Observe whether personnel coming in direct contact with cosmetic raw > materials, in-process materials, finished products, or contact surfaces > wear appropriate outer garments, i.e., uniforms, gloves, hair > restraints, etc., maintain adequate personnel cleanliness, are free from > abnormal sources of microbiological contamination, i.e., sores, infected > wounds, etc. > > Determine whether eating food, drinking beverages, or using tobacco is > restricted to appropriate designated areas. > > *_RAW MATERIALS_* > > Determine whether raw materials are identified, stored, examined, > tested, inventoried, handled, and controlled to assure they conform to > appropriate standards. Raw materials should be: > > 1. stored and handled to prevent mixups, contamination with > microorganisms or other chemicals, and degradation from exposure to > excessive heat, cold, sunlight, moisture, etc. > > 2. held in closed containers stored off the floor. > > 3. maintained in containers that are labeled with the identity, lot > number, and control status (release or quarantine). > > 4. sampled and tested for conformance with specifications and to assure > the absence of filth, micro-organisms, and other adulterants. Review > animal and vegetable origin materials and those produced by cold > processing methods for filth and/or microorganism contamination. > > 5. properly identified and controlled to prevent the use of materials > that fail to meet acceptance specifications. > > Determine whether color additives are approved for use in cosmetics (21 > CFR 73, 74, & 82) and are certified (21 CFR 74 & 82). > > Determine if any cosmetic ingredients are prohibited (21 CFR 700). > > _*PRODUCTION*_ > > Determine whether written manufacturing and control procedures have been > established, i.e., formulations, processing instructions, in-process > control methods, packaging instructions. Evaluate procedures and > determine if: > > 1. the selection, weighing, and measuring of raw materials and the > determination of finished yield are reviewed by a second individual. > > 2. major equipment, transfer lines, containers and tanks used for > processing, holding, or filling are identified to indicate contents, > batch identification, stage of processing and control status. > > 3. there are appropriate procedures to prevent contamination with > microorganisms or chemicals. > > 4. there are in-process controls to ensure product uniformity, > integrity, i.e., in-process batch weights, fill of mixing containers, > adequacy of mixing. > > 5. the theoretical yield is compared with the actual yield. > > _*LABORATORY CONTROLS*_ > > Evaluate laboratory controls including sample collection technique, > specifications, test methods, laboratory equipment, and technician > qualifications. Determine whether: > > 1. raw materials, in-process and finished product samples are tested or > examined for identity and compliance with applicable specifications, > i.e., physical and chemical properties, microbial contamination, and > hazards or other chemical contamination. > > 2. samples are representative of the lot. > > 3. water used as a cosmetic ingredient is tested regularly for > conformance with chemical and micro-biological specifications. See IOM > Exhibit 653.1-B for guidance for covering deionized water systems. > > 4. current finished product production as well as reserve samples are > tested for adequacy of preservation against microbial contamination > under reasonable conditions of storage and use. > > 5. reserve samples of approved lots of raw materials and finished > products are retained for an adequate time period, i.e., expected > shelf-life of the product, one year beyond any expiration date, two > years after distribution has been completed, etc., whichever is longer. > > 6. reserve samples are stored under conditions which protect their > integrity, i.e., contamination, deterioration, and are retested at > appropriate intervals to assure continued compliance with established > specifications. > > 7. returned cosmetics are examined for deterioration, contamination, and > compliance with acceptance specifications. > > Determine what toxicological and/or other testing the firm has conducted > to substantiate the safety of products. See 21 CFR 740.10. > > _*PACKAGING AND LABELING*_ > > Review the immediate and outer container labels and determine if they bear: > > 1. on the principal display panel: > > (a) name of product, statement of identity and net contents. See 21 CFR > 701.11 & 13. > > (b) if safety of the product has not been substantiated, the statement > " Warning - The safety of this product has not been determined " . See 21 > CFR 740.10. > > 2. on an appropriate information panel: > > (a) name and address of the manufacturer, packer, or distributor. See 21 > CFR 701.12. > > (b) ingredients listed in descending order of predominance. See 21 CFR > 701.3. > > © warning statements required for self-pressurized containers (21 CFR > 740.11), feminine deodorant sprays (21 CFR 740.12), bubble bath products > (21 CFR 740.17), and coal tar hair dyes (21 CFR 740.18 and 601(a) of the > Act). > > (d) any other warning statement necessary or appropriate to prevent a > health hazard. See 21 CFR 740.1(a). Identify the health hazard and the > basis for the warning statement. > > (e) directions for safe use of the product. > > Evaluate tamper-resistant packaging and labeling for liquid oral hygiene > products and all vaginal products as required by 21 CFR 700.25. > > Evaluate primary packaging materials storage and handling procedures for > preventing mixups and microbiological or chemical contamination. > > Determine whether finished product packages bear meaningful, permanent > lot or control numbers. Obtain the key to the coding system. > > _*RECORDS*_ > > Review records of origin, receipt, examination, testing, disposition, > and use of raw materials to determine adequacy of raw material control. > > Determine whether disposition of rejected materials is documented, > including any reworking operations. > > Evaluate batch production control records and ascertain if they include: > > 1. documentation of all ingredients (name, code, lot number, quantity, > etc.) added to the batch. > > 2. documentation of all production steps, i.e., processing, handling, > transferring, holding, filling. > > 3. in-process sampling, controlling, and adjusting steps. > > 4. batch and finished product lot or control numbers. > > 5. the finished products control status -accepted or rejected. > > Evaluate laboratory control records for raw materials, in-process > materials, and finished products and include sampling documentation, > test results, and interpretation of the test results (accept or reject). > > Determine if initial distribution records are retained which identifies > the consignee, product, lot or control number. > > Determine if records are adequate to conduct an effective recall. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 And you need to check with your state also. Here in Louisiana, we have to register, we are under DHH. Have you been Pampered Today? Phaedra Stockstill @ The Boutique http://attheboutique.com/osCommerce <http://www.attheboutique.com/osCommerce> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 Hi Jennifer, While I can't speak for anyone else's business, for myself I feel it is absolutely worth it. Currently I have some lofty goals for my company, which, at this point, is totally not just an expensive hobby and is getting too big for its britches. For me it is the only way to grow In addition to the actual manufacturing of the items themselves, I like that the contract manufacturers do all the microbiological testing, etc ... on the items too, so all my necessary paperwork is in place with each item as well. If I were going to enjoy my company as more of a hobby, or keep my focus on selling in small quantities to small entities (individuals and/or maybe a tiny little indie shop or two) and/or was relying on seasonal/sporadic craft show events for most of my business, I might not want to, or need to, make the investment in the minimums that contract manufacturers have (for example, 20 gallons of one item). I suppose it all depends on where your business is at, where it is going and how much you want to (or feel you need to) comply with what the FDA (and other countries' versions of the FDA) considers good manufacturing practices *Smile* Chris (list mom) http://www.alittleolfactory.com Jennifer Janek-Markey wrote: > Chris, > > so the contract manufacturers are worth it? > > Jennifer. I was wondering about that myself... > > haud desiderium > sieze dies > Orbis terrarum est meus oyster > vos mos non subsisto mihi > EGO sum a comic indoles > > Jennifer Janek-Markey > Soapywench > > > > _____ > > > On Behalf Of Christine Ziegler > Wednesday, July 25, 2007 7:59 PM > > Important for all toiletry makers! > > > > Here are the gov't regs you need to know about .. or else you might find > yourself in deep doo doo one day! > > http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> > gov/ora/inspect_ref/igs/cosmet.html > > Below is what you have to comply with and what inspectors would look at > if your manufacturing facilities were ever to be inspected (whether it > be your kitchen, your art studio, a little manufacturing area you put > together, a lab ..etc ...) > > My company is shifting to using contract manufacturers at this point, > cause I don't need my butt in hot water as I grow! They are happy to use > my recipes, my ingredients and I can even go watch my batches being made > if I want. > > To say " I'm so small, they'll never inspect me " might be true, or it > might be wishful thinking, like saying " I'll never get audited so I'll > throw my tax records away " . Why take a chance messing around with the > gov't - who can really mess with you back and ruin your world ): > > *Smile* > Chris (list mom) > http://www.alittleo <http://www.alittleolfactory.com> lfactory.com > > http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> > gov/ora/inspect_ref/igs/cosmet.html > > *III. INSPECTION* > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 26, 2007 Report Share Posted July 26, 2007 Christine, do the rules apply to someone selling their products as you've stated below? Does it matter if they are registered as a business or if they are simply an individual selling their creations? I understand if these are questions that need to be asked of the agency but I thought I'd find out if you knew the info. Also, I have read your recipes and they do sound delicious-I wanted to try some but with all the info about not ingesting eo's I was a bit hesitant. Thanks, Susan , Christine Ziegler <chrisziggy wrote: > > > If I were going to enjoy my company as more of a hobby, or keep my focus > on selling in small quantities to small entities (individuals and/or > maybe a tiny little indie shop or two) and/or was relying on > seasonal/sporadic craft show events for most of my business, Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 27, 2007 Report Share Posted July 27, 2007 Hi Susan, As I understand it, the rules apply to everyone. Have we all been working in commercial kitchens and using contract manufacturers over the years to make our stuff? Maybe not, but does that mean we should continue to do things that may put us in jeopardy either? Mmmm, the wise sage within me says " oh heck no! " The FDA's focus is to be sure that customers are not buying a product that is contaminated with " filth " (which includes bacteria) and that the product is preserved properly (if it is an item that requires preservation) so that it doesn't begin to grow bacteria. The less clean the raw material storage and manufacturing facilities are, the greater the chance for a " product adulterated with filth " . One potential alternative for someone who doesn't want to go to a contract manufacturer, and obviously doesn't have their own manufacturing factory are to contact local " commercial kitchens " and make items there, so you have no worry of potential problems that could arise from making stuff in your own kitchen or makeshift work space. Sometimes local churches, schools and community centers let folks rent their commercial kitchen space inexpensively for such things For example ... when it comes to food prep and commercial kitchens .. in both Colorado and Texas (both states which I've run my biz), it is illegal to sell even one little jar of jelly made in anything but an approved commercial kitchen. I knew a gal who sold jelly at local festivals who made it in her church's school's kitchen at night on Wednesdays. At that point you're still responsible for making sure your ingredients are stored properly, keeping the lot numbers for records, testing for bacteria, etc ... but at least you can confidently show the manufacturing facility you work in to anyone and everyone who asks. This is a litigious society! If one person says " your lotion gave me a rash and I'm suing you for a million dollars " , even if you have product liability insurance, if its found you're storing/making your stuff in a work area that wouldn't pass an inspection, your insurance company probably isn't going to take the responsibility and cover you, and then what happens? Even if you won the case you may go into serious debt thanks to lawyer bills! IMHO, its too scary to mess with and its well worth it to take the extra steps to set up shop right. *Smile* Chris http://www.alittleolfactory.com susan wrote: > Christine, do the rules apply to someone selling their products as > you've stated below? Does it matter if they are registered as a > business or if they are simply an individual selling their creations? > I understand if these are questions that need to be asked of the > agency but I thought I'd find out if you knew the info. <snipped> > Thanks, Susan > > > , Christine Ziegler > <chrisziggy wrote: > If I were going to enjoy my company as more of a hobby, or keep my focus on selling in small quantities to small entities (individuals and/or > maybe a tiny little indie shop or two) and/or was relying on > seasonal/sporadic craft show events for most of my business, > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 27, 2007 Report Share Posted July 27, 2007 Wow, so even a hobbyist who makes and sells or gives products to friends could be in a heap of trouble if a problem arises from their product. Does this apply to soap as well do you know? Susan -- In , Christine Ziegler <chrisziggy wrote: > > Hi Susan, > > As I understand it, the rules apply to everyone. Have we all been > working in commercial kitchens and using contract manufacturers over the > years to make our stuff? Maybe not, but does that mean we should > continue to do things that may put us in jeopardy either? Mmmm, the wise > sage within me says " oh heck no! " > > The FDA's focus is to be sure that customers are not buying a product > that is contaminated with " filth " (which includes bacteria) and that the > product is preserved properly (if it is an item that requires > preservation) so that it doesn't begin to grow bacteria. The less clean > the raw material storage and manufacturing facilities are, the greater > the chance for a " product adulterated with filth " . > > One potential alternative for someone who doesn't want to go to a > contract manufacturer, and obviously doesn't have their own > manufacturing factory are to contact local " commercial kitchens " and > make items there, so you have no worry of potential problems that could > arise from making stuff in your own kitchen or makeshift work space. > Sometimes local churches, schools and community centers let folks rent > their commercial kitchen space inexpensively for such things > > For example ... when it comes to food prep and commercial kitchens ... in > both Colorado and Texas (both states which I've run my biz), it is > illegal to sell even one little jar of jelly made in anything but an > approved commercial kitchen. I knew a gal who sold jelly at local > festivals who made it in her church's school's kitchen at night on > Wednesdays. > > At that point you're still responsible for making sure your ingredients > are stored properly, keeping the lot numbers for records, testing for > bacteria, etc ... but at least you can confidently show the > manufacturing facility you work in to anyone and everyone who asks. > > This is a litigious society! If one person says " your lotion gave me a > rash and I'm suing you for a million dollars " , even if you have product > liability insurance, if its found you're storing/making your stuff in a > work area that wouldn't pass an inspection, your insurance company > probably isn't going to take the responsibility and cover you, and then > what happens? Even if you won the case you may go into serious debt > thanks to lawyer bills! > > IMHO, its too scary to mess with and its well worth it to take the extra > steps to set up shop right. > > *Smile* > Chris > http://www.alittleolfactory.com > > > > susan wrote: > > Christine, do the rules apply to someone selling their products as > > you've stated below? Does it matter if they are registered as a > > business or if they are simply an individual selling their creations? > > I understand if these are questions that need to be asked of the > > agency but I thought I'd find out if you knew the info. <snipped> > > Thanks, Susan > > > > > > , Christine Ziegler > > <chrisziggy@> wrote: > > If I were going to enjoy my company as more of a hobby, or keep my focus on selling in small quantities to small entities (individuals and/or > > maybe a tiny little indie shop or two) and/or was relying on > > seasonal/sporadic craft show events for most of my business, > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 27, 2007 Report Share Posted July 27, 2007 Chris, I think it's neat that you're contracting out the production part of the business. It sounds like it would take a lot of the " headache " part away, but still let you do the most fun things, like experimenting, coming up with new recipes, marketing, researching, etc... What a cool solution! Also interesting to think about it from the contractor's point of view. What if you were really super into standards, and creating an environment that met those gov. regulations? Why stop with just making your own stuff? Now you've got a space, and equipment, that you can basically rent out to people who aren't into that, and still enable their products to get made! Sorry, this setup may be old news to a lot of you, but I've been out of the loop so long that it's new to me, and just struck me as a really elegant way to get stuff done! Susan Farr Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 27, 2007 Report Share Posted July 27, 2007 , " susan " <ripple95 wrote: > > Wow, so even a hobbyist who makes and sells or gives products to > friends could be in a heap of trouble if a problem arises from their > product. Does this apply to soap as well do you know? Susan > > Susan, I think it will apply to everyone. I believe the soapers in Canada and the EU have very stringent regulations in place already. It's not " in place " here in the States yet, but why take chances? Somebody on my group said is it necessary for the perfumer who only creates one bottle at a time? I say yes, not just for the liability issue, but anybody who creates products that involve a recipe or formula should have good records, if only for themselves so they can recreate the product. Having the records on hand will go a long way to proving professionalism and compliance if a product is every called into question. Sincerely, Anya of Natural Perfume Natural Perfumers Guild http://NaturalPerfumersGuild.com Natural Perfumers 1200+ members Group http://tinyurl.com/78kmv PS I'm the one who turned chris onto contract manufacturing. It's absolutely necessary in taking your business to the next level. I contracted out my private line toiletries years ago, and it really frees the artist up in many ways. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 28, 2007 Report Share Posted July 28, 2007 , " susan " <ripple95 wrote: > > Wow, so even a hobbyist who makes and sells or gives products to > friends could be in a heap of trouble if a problem arises from their > product. Does this apply to soap as well do you know? Susan --------------- If you sell or give away anything that injures another person you are liable for damages. This is not surprising. With the growth of the hand made toiletries market it was bound to reach a point where it would come under scrutiny by the FDA. I've seen so many lotions, creams, etc. made with little or no preservative system. A lot of the people wanting to make " all natural " products have been skating along without any lab testing of their formulas. And over the years I've seen dozens of people hop on a list, ask for an " all natural " cream recipe and start selling their products. I've been through the preservative and safety debate more than once with someone who believed that all chemicals were bad. When I started teaching lotion classes, one of my first students was an attorney that handled a case of a home toiletry maker that made a lotion that became contaminated and caused someone to develop a very bad infection. No liability insurance. The only thing they could do as a defense was to claim that she was not actually making a profit or in business, she was just selling to family and friends. The problem is not so much our litigous society as it is people who are manufacturing irresponsibly. Anyone that has ever gone through the legal process can tell you that it is not that easy to get any sort of settlement. However, the bigger concern should be that no one wants to injure someone with their products. These things are regulated for a reason, because there is potential to harm someone through ignorance. JOanne Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 28, 2007 Report Share Posted July 28, 2007 Eventhough I just tinker with making things for myself I can understand the reasoning behind this. I have oftened wondered about many of those who sell online and make lots of claims about their products that seem contradictory to much of the information I think I can rely on by many on this list. I like the idea of the commercial kitchen Christine referred to. It's seems like a great place to work in quiet and private but have access to all the facilities and equipment one needs. Thanks to all, Susan , " shupy3 " <jwittenbrook wrote: > > , " susan " <ripple95@> wrote: > > > > Wow, so even a hobbyist who makes and sells or gives products to > > friends could be in a heap of trouble if a problem arises from > their > > product. Does this apply to soap as well do you know? Susan > --------------- > If you sell or give away anything that injures another person you > are liable for damages. This is not surprising. With the growth of > the hand made toiletries market it was bound to reach a point where > it would come under scrutiny by the FDA. I've seen so many lotions, > creams, etc. made with little or no preservative system. A lot of > the people wanting to make " all natural " products have been skating > along without any lab testing of their formulas. And over the years > I've seen dozens of people hop on a list, ask for an " all natural " > cream recipe and start selling their products. I've been through the > preservative and safety debate more than once with someone who > believed that all chemicals were bad. > > When I started teaching lotion classes, one of my first students was > an attorney that handled a case of a home toiletry maker that made a > lotion that became contaminated and caused someone to develop a very > bad infection. No liability insurance. The only thing they could do > as a defense was to claim that she was not actually making a profit > or in business, she was just selling to family and friends. > > The problem is not so much our litigous society as it is people who > are manufacturing irresponsibly. Anyone that has ever gone through > the legal process can tell you that it is not that easy to get any > sort of settlement. However, the bigger concern should be that no > one wants to injure someone with their products. These things are > regulated for a reason, because there is potential to harm someone > through ignorance. > > JOanne > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 28, 2007 Report Share Posted July 28, 2007 , Christine Ziegler <chrisziggy wrote: > > Here are the gov't regs you need to know about .. or else you might find > yourself in deep doo doo one day! > > http://www.fda.gov/ora/inspect_ref/igs/cosmet.html In Ireland things are slightly different, the health board controls all this stuff and we need to register with them. Also they come and inspect the premises. Also staff members must have HACCP certification (I can't for the life of me remember what those letters stand for even though I have mine.) It requires attending college for two weeks and learning all about bacteria and where the grow and what they do when they get on your skin, stomach etc and how to kill or control them, then sitting an intensive examination (full day). Thats a new(ish) system here. I did my examination around 7 years ago (was it that long) I found what the letters stand for " Hazard Analysis and Critical Control Points " . You can read a little more here. http://en.wikipedia.org/wiki/Hazard_Analysis_and_Critical_Control_Points The HACCP certificate also covers pharmaceutical safety. I must put my certificate in a frame one of these days,lol. Ruth http://www.whitewitch.ie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 28, 2007 Report Share Posted July 28, 2007 Yes, very stringent regulations have been in place in the UK for some years. These regulations are based around the EEC cosmetics regs, but each country tweaks them to suit how their idiot Civil Servants wish to interpret them. Enforcement is strong or weak depending on where you live. One of my customers who lives 2 miles away, had to spend thousands turning a barn into a sterile manufacturing unit with lined walls, filtered air, stainless steel equipment, insect proof, etc. Even after that she still gets a yearly visit from Trading Standards who even check on the type size of labels!! In other parts of the UK people are still producing in their kitchen sinks with few problems. I have been advising therapists for some years not to dip their toe into making cosmetic products for resale as it is a nightmare of regulations. Therapists can still make stuff for individual clients but even that is under scrutiny now. Anya can confirm that for many years I have been warning that tough regulations will become law in the USA. Unfortunately many home producers there have buried their heads in the sand and made no attempt to bring their products into line with 21st Century manufacturing processes. This is made worse by the numerous web sites selling substances that are known to be hazardous with no or few warnings, as well as with suspect preservative systems in their cosmetics. The trade as a whole has failed to ensure customer safety as top priority, or ensure small producers get any training, and now the results of that are coming home to roost via legislation. The newsgroups are packed with people trying to learn how to make products for resale, but without spending their cash on proper information resources. I have recently noticed the owner of a prestigious looking web site (who even claims to have not completed training), yet they are developing formulas based on ideas gleaned from group members. We have had others on this group promoting natural extracts on which there is evidence of safety problems, but fooling people with that overused " traditional use " term. I get really tired of telling people that traditional use by native populations rarely equals safe use in manufactured products for the majority. Yet how many here buy such products from flashy web sites plugging bs marketing " that they are helping native groups " I wonder? I wish you could see the emails I get back after challenging such claims, but it would offend the sweetness and light brigade. The biggest excuse is to hide behind " that's commerce " and " our customers have the freedom to choose what they buy and how they use it " HOGWASH! Martin Watt http://www.aromamedical.com , " anyaperfumer " <anya wrote: > > , " susan " <ripple95@> wrote: > > > > Wow, so even a hobbyist who makes and sells or gives products to > > friends could be in a heap of trouble if a problem arises from their > > product. Does this apply to soap as well do you know? Susan > > Susan, I think it will apply to everyone. I believe the soapers in > Canada and the EU have very stringent regulations in place already. > It's not " in place " here in the States yet, but why take chances? > > Somebody on my group said is it necessary for the perfumer who only > creates one bottle at a time? I say yes, not just for the liability > issue, but anybody who creates products that involve a recipe or > formula should have good records, if only for themselves so they can > recreate the product. Having the records on hand will go a long way to > proving professionalism and compliance if a product is every called > into question. > > Sincerely, Anya Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 28, 2007 Report Share Posted July 28, 2007 Chris, I can certainly understand the guidelines because I make a variety of products and I want to make sure they're safe. However, I do my little company right now out of pure enjoyment, and I like the fact that I handmake my own items. Where can we get our products tested or the supplies that we acquire from other people? Michele Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 29, 2007 Report Share Posted July 29, 2007 Hi Michele, Testing labs aren't hard to find, local even in many cases! Here's a place to get you started looking: http://www.scconline.org/referrals/testing_labs.shtml *Smile* Chris (list mom) http://www.alittleolfactory.com Chaeya wrote: > Chris, > > I can certainly understand the guidelines because I make a variety of > products and I want to make sure they're safe. However, I do my little > company right now out of pure enjoyment, and I like the fact that I > handmake my own items. Where can we get our products tested or the > supplies that we acquire from other people? > > Michele > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 30, 2007 Report Share Posted July 30, 2007 I was telling a marketing friend of mine about this situation and raised the possibility of doing blends in a church kitchen.? He said essential oils are not regulated by the FDA and this would not apply to aromatherapy blending oils, bath salts etc.? Is this true? Jennifer Janek-Markey <pixieladie Wed, 25 Jul 2007 8:57 pm RE: Important for all toiletry makers! Chris, so the contract manufacturers are worth it? Jennifer. I was wondering about that myself... haud desiderium sieze dies Orbis terrarum est meus oyster vos mos non subsisto mihi EGO sum a comic indoles Jennifer Janek-Markey Soapywench _____ On Behalf Of Christine Ziegler Wednesday, July 25, 2007 7:59 PM Important for all toiletry makers! Here are the gov't regs you need to know about .. or else you might find yourself in deep doo doo one day! http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> gov/ora/inspect_ref/igs/cosmet.html Below is what you have to comply with and what inspectors would look at if your manufacturing facilities were ever to be inspected (whether it be your kitchen, your art studio, a little manufacturing area you put together, a lab ..etc ...) My company is shifting to using contract manufacturers at this point, cause I don't need my butt in hot water as I grow! They are happy to use my recipes, my ingredients and I can even go watch my batches being made if I want. To say " I'm so small, they'll never inspect me " might be true, or it might be wishful thinking, like saying " I'll never get audited so I'll throw my tax records away " . Why take a chance messing around with the gov't - who can really mess with you back and ruin your world ): *Smile* Chris (list mom) http://www.alittleo <http://www.alittleolfactory.com> lfactory.com http://www.fda. <http://www.fda.gov/ora/inspect_ref/igs/cosmet.html> gov/ora/inspect_ref/igs/cosmet.html *III. INSPECTION* _*BUILDINGS AND FACILITIES*_ Determine if the buildings are of suitable size, design and construction and maintained in a clean and orderly manner. Buildings should provide: 1. Adequate space to minimize mixups between different products, raw materials, labeling and cross-contamination. 2. Floors, walls and ceilings constructed of smooth, easily cleanable surfaces. 3. Adequate lighting and ventilation and if necessary for control purposes, screening, filtering, dust, humidity, temperature, and bacteriological controls. 4. Adequate washing, cleaning, plumbing, toilet, and locker facilities, to allow sanitary operation and cleaning of facilities, equipment, and utensils, and to facilitate personal cleanliness. 5. Fixtures, ducts, and pipes installed to prevent condensate or drip contamination in cosmetic materials, utensils, and cosmetic contact surfaces. _*EQUIPMENT*_ Determine if equipment and utensils used in processing, holding, transferring and packaging are of appropriate design, size, material and workmanship to prevent corrosion, accumulation of static material and/or adulteration with lubricants, coolants, dirt, sanitizing agents. The equipment (utensils, transfer piping, cosmetic contact surfaces, etc.) should be: 1. maintained in a clean and orderly manner and sanitized at appropriate times. 2. cleaned and sanitized equipment - stored in a manner that protects it from splash, dust, and other contaminants. 3. constructed to facilitate adjustment, cleaning, and maintenance. 4. of suitable size and accuracy for measuring, mixing, and weighing operations. _*PERSONNEL*_ Determine whether personnel supervising or performing the manufacturing or control of cosmetics have the education, training, and/or expertise to perform their assigned functions. Observe whether personnel coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces wear appropriate outer garments, i.e., uniforms, gloves, hair restraints, etc., maintain adequate personnel cleanliness, are free from abnormal sources of microbiological contamination, i.e., sores, infected wounds, etc. Determine whether eating food, drinking beverages, or using tobacco is restricted to appropriate designated areas. *_RAW MATERIALS_* Determine whether raw materials are identified, stored, examined, tested, inventoried, handled, and controlled to assure they conform to appropriate standards. Raw materials should be: 1. stored and handled to prevent mixups, contamination with microorganisms or other chemicals, and degradation from exposure to excessive heat, cold, sunlight, moisture, etc. 2. held in closed containers stored off the floor. 3. maintained in containers that are labeled with the identity, lot number, and control status (release or quarantine). 4. sampled and tested for conformance with specifications and to assure the absence of filth, micro-organisms, and other adulterants. Review animal and vegetable origin materials and those produced by cold processing methods for filth and/or microorganism contamination. 5. properly identified and controlled to prevent the use of materials that fail to meet acceptance specifications. Determine whether color additives are approved for use in cosmetics (21 CFR 73, 74, & 82) and are certified (21 CFR 74 & 82). Determine if any cosmetic ingredients are prohibited (21 CFR 700). _*PRODUCTION*_ Determine whether written manufacturing and control procedures have been established, i.e., formulations, processing instructions, in-process control methods, packaging instructions. Evaluate procedures and determine if: 1. the selection, weighing, and measuring of raw materials and the determination of finished yield are reviewed by a second individual. 2. major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification, stage of processing and control status. 3. there are appropriate procedures to prevent contamination with microorganisms or chemicals. 4. there are in-process controls to ensure product uniformity, integrity, i.e., in-process batch weights, fill of mixing containers, adequacy of mixing. 5. the theoretical yield is compared with the actual yield. _*LABORATORY CONTROLS*_ Evaluate laboratory controls including sample collection technique, specifications, test methods, laboratory equipment, and technician qualifications. Determine whether: 1. raw materials, in-process and finished product samples are tested or examined for identity and compliance with applicable specifications, i.e., physical and chemical properties, microbial contamination, and hazards or other chemical contamination. 2. samples are representative of the lot. 3. water used as a cosmetic ingredient is tested regularly for conformance with chemical and micro-biological specifications. See IOM Exhibit 653.1-B for guidance for covering deionized water systems. 4. current finished product production as well as reserve samples are tested for adequacy of preservation against microbial contamination under reasonable conditions of storage and use. 5. reserve samples of approved lots of raw materials and finished products are retained for an adequate time period, i.e., expected shelf-life of the product, one year beyond any expiration date, two years after distribution has been completed, etc., whichever is longer. 6. reserve samples are stored under conditions which protect their integrity, i.e., contamination, deterioration, and are retested at appropriate intervals to assure continued compliance with established specifications. 7. returned cosmetics are examined for deterioration, contamination, and compliance with acceptance specifications. Determine what toxicological and/or other testing the firm has conducted to substantiate the safety of products. See 21 CFR 740.10. _*PACKAGING AND LABELING*_ Review the immediate and outer container labels and determine if they bear: 1. on the principal display panel: (a) name of product, statement of identity and net contents. See 21 CFR 701.11 & 13. (b) if safety of the product has not been substantiated, the statement " Warning - The safety of this product has not been determined " . See 21 CFR 740.10. 2. on an appropriate information panel: (a) name and address of the manufacturer, packer, or distributor. See 21 CFR 701.12. (b) ingredients listed in descending order of predominance. See 21 CFR 701.3. © warning statements required for self-pressurized containers (21 CFR 740.11), feminine deodorant sprays (21 CFR 740.12), bubble bath products (21 CFR 740.17), and coal tar hair dyes (21 CFR 740.18 and 601(a) of the Act). (d) any other warning statement necessary or appropriate to prevent a health hazard. See 21 CFR 740.1(a). Identify the health hazard and the basis for the warning statement. (e) directions for safe use of the product. Evaluate tamper-resistant packaging and labeling for liquid oral hygiene products and all vaginal products as required by 21 CFR 700.25. Evaluate primary packaging materials storage and handling procedures for preventing mixups and microbiological or chemical contamination. Determine whether finished product packages bear meaningful, permanent lot or control numbers. Obtain the key to the coding system. _*RECORDS*_ Review records of origin, receipt, examination, testing, disposition, and use of raw materials to determine adequacy of raw material control. Determine whether disposition of rejected materials is documented, including any reworking operations. Evaluate batch production control records and ascertain if they include: 1. documentation of all ingredients (name, code, lot number, quantity, etc.) added to the batch. 2. documentation of all production steps, i.e., processing, handling, transferring, holding, filling. 3. in-process sampling, controlling, and adjusting steps. 4. batch and finished product lot or control numbers. 5. the finished products control status -accepted or rejected. Evaluate laboratory control records for raw materials, in-process materials, and finished products and include sampling documentation, test results, and interpretation of the test results (accept or reject). Determine if initial distribution records are retained which identifies the consignee, product, lot or control number. Determine if records are adequate to conduct an effective recall. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 31, 2007 Report Share Posted July 31, 2007 Hi (insert name here please), If you're selling those " bath salts " with the intention that your customers are going to take a bath in those " bath salts " , then you bet your bippy you do! Also, FYI, if you want to make a claim about those bath salts doing anything, here in the US you're getting into the realm of the FTC and you must be very very careful with your wording. *Smile* Chris (list mom) http://www.alittleolfactory.com badgeer wrote: > I was telling a marketing friend of mine about this situation and raised the possibility of doing blends in a church kitchen.? He said essential oils are not regulated by the FDA and this would not apply to aromatherapy blending oils, bath salts etc.? Is this true? > Quote Link to comment Share on other sites More sharing options...
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