Guest guest Posted March 18, 2004 Report Share Posted March 18, 2004 Well, it is kind of hard understanding all the info on this page: http://www.cfsan.fda.gov/~dms/cos-lab3.html#clgg I have a few questions that would be great if they could be answered in plain English:-) instead of FDAese: 1: What is the definition that causes a product to be either a cosmetic or a drug? Particularly, if someone wants to sell a massage oil for 'invigoration' or 'stress relief', or a salve for wound healing or pain relief, what criteria does the FDA use to determine the classification? 2: On the label info given on the fda site, what is meant by " placement of information " on labels? It sounds like there are actual areas (upper right corner, lower left corner) that you need to place your blocks of information in. I usually see the manufacturer's name and address on the bottom of either the left or right side of the label, but that isn't always the same. 3: Where is the information that I've heard often that if you have less than 1% of an ingredient, you don't have to list it. 4: I understand that there are now standardized botanical names that you have to list, along with the common names. Can't find that info, either. 5: What protects and defines " trade secret " ? I'm asking this on behalf of a lady here in Miami who opened a shop using the labels of the con artist who sold her the franchise. She is endeavoring to get everything legit, and I'm hoping this group can help her. She's lurking here, since she doesn't have much experience with , and is also having a lot of trouble logging into her hotmail account, so she can at least read the answers on the website, if not answer them. Thanks for all your help in advance. Her shop is only about six weeks old, and she now realizes that she needs to fix up the labels on the products. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2004 Report Share Posted March 18, 2004 Hi Anya, I'll try to answers these for ya. > I have a few questions that would be great if they could be answered in > plain English:-) instead of FDAese: > > 1: What is the definition that causes a product to be either a cosmetic or > a drug? Particularly, if someone wants to sell a massage oil for > 'invigoration' or 'stress relief', or a salve for wound healing or pain > relief, what criteria does the FDA use to determine the classification? > If the product does something to the skin, namely beautify it, it is a cosmetic. If you make a claim for it to do something, like heal, have an spf of 20 or the like it then becomes a drug. You can call your massage oil " invigoration " and not make any drug claims and it would be considered a cosmetic. Your salve could not state that it " will heal " or it will become FDA territory and you will have to substantiate it with testing and proof. It would be a drug. What you can say about it, is that (lets use calendula) that it contains calendula which has been used for centuries to help heal burns, minor skin irritation etc.. But you are not actually saying " My product will heal your owies " . > 2: On the label info given on the fda site, what is meant by " placement of > information " on labels? It sounds like there are actual areas (upper right > corner, lower left corner) that you need to place your blocks of > information in. I usually see the manufacturer's name and address on the > bottom of either the left or right side of the label, but that isn't always > the same. Thats a good one. Just make sure your business name is on it, your address, ingredients in order of predominance and of course product name. Oh ya, and the weight of the product. > > 3: Where is the information that I've heard often that if you have less > than 1% of an ingredient, you don't have to list it. Not true this one. List it all in order of predominance. > > 4: I understand that there are now standardized botanical names that you > have to list, along with the common names. Can't find that info, either. There are some and it is not required that you use them. You can list Calendula extract as just that. > 5: What protects and defines " trade secret " ? Not sure bout that one, except that perfumers use it to protect their scent blend. Really, like anyone could make the same blend just knowing that there were 10 different eo's in it. Waste of time and money. Or perhaps its a legal way to " hide stuff " from us. Hmmmm.... Hope all goes okay for the gal with the shop. A really good group for straight forward info on all the legalities of cosmetics and their manufacture including labeling is Cosmeticinfo They have archives of all of this information and much more. Hth a little, Margaret www.naturalindulgences.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2004 Report Share Posted March 18, 2004 At 06:26 AM 3/18/2004 -0000, you wrote: >Hi Anya, Hi margaret -- I had to search for your name at the end, otherwise I thought you were plumberboy! LOL you wrote: >If the product does something to the skin, namely beautify it, it is >a cosmetic. If you make a claim for it to do something, like heal, >have an spf of 20 or the like it then becomes a drug. You can call >your massage oil " invigoration " and not make any drug claims and it >would be considered a cosmetic. Your salve could not state that >it " will heal " or it will become FDA territory and you will have to >substantiate it with testing and proof. It would be a drug. What you >can say about it, is that (lets use calendula) that it contains >calendula which has been used for centuries to help heal burns, minor >skin irritation etc.. But you are not actually saying " My product >will heal your owies " . Thanks for the 'cosmetic v. drug' definition. I think you might be wrong with the caution on claims. That all changed last July when there was a successful lawsuit against the FDA. It'sa First Amendment issue about free speech. If you put a disclaimer on the product such as " The claims make about thisproduct have not be evaluated or tested by the FDA " you can make claims. I have a long reprint from Herbalgram, with all the legal citations. If you buy any vitamins or supplements, or 'whatever' from the health food store, look for the new disclaimers. >> 3: Where is the information that I've heard often that if you have >less >> than 1% of an ingredient, you don't have to list it. >Not true this one. List it all in order of predominance. Not true?? Wow, I have to search for my reference. This is a mystery. I know that many low-carb foods can actually hide carbs because the manufactuers do't have to list the carbs/serving if it's under one, but some people complain if they eat a lot of the food and get an accumulation of carbs :-) I guess 10 diet sodas can throw you out of ketosis, LOL. >> 4: I understand that there are now standardized botanical names >that you >> have to list, along with the common names. Can't find that info, >either. >There are some and it is not required that you use them. You can >list Calendula extract as just that. OK, that is good. I've been seeing so many botanic names cropping up, in addition to my faulty memory again thinking I had seen some legislation on that matter, I got confused. >Hope all goes okay for the gal with the shop. A really good group >for straight forward info on all the legalities of cosmetics and >their manufacture including labeling is >Cosmeticinfo They have archives of all of this >information and much more. I'm going to check into them myself. Now we need a group Druginfo@ for those who want to market their kava kava or mullein extracts! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2004 Report Share Posted March 18, 2004 Hi Anya, >Hi margaret -- I had to search for your name at the end, otherwise I >thought you were plumberboy! LOL Funny! I wasn't getting my mail from and so had to reply via online at the groups site. Actually my hubby is the plumberboy, and we, myself and kids are the family part. lol >Thanks for the 'cosmetic v. drug' definition. I think you might be wrong >with the caution on claims. That all changed last July when there was a >successful lawsuit against the FDA. It'sa First Amendment issue about free >speech. If you put a disclaimer on the product such as " The claims make >about thisproduct have not be evaluated or tested by the FDA " you can make >claims. I have a long reprint from Herbalgram, with all the legal >citations. If you buy any vitamins or supplements, or 'whatever' from the >health food store, look for the new disclaimers. Looks like I might have to find some time to look into this one myself. I do know that there are different rules for food stuffs and cosmetics. I'll see what I can find out. >Not true?? Wow, I have to search for my reference. This is a mystery. I >know that many low-carb foods can actually hide carbs because the >manufactuers do't have to list the carbs/serving if it's under one, but >some people complain if they eat a lot of the food and get an accumulation >of carbs :-) I guess 10 diet sodas can throw you out of ketosis, LOL. Once again, food labeling requirements may be quite different than cosmetic requirements. I put citric acid in my lotions at about one quarter of a percent and it definately has to be listed as does the preservative, which once again is much less than 1%. I'll peruse my cosmetic labeling handbook next chance I get, which could be a while, but will post again if I find out any concrete facts to report. Have a great day all, Margaret _______________ Get reliable access on MSN 9 Dial-up. 3 months for the price of 1! (Limited-time offer) http://click.atdmt.com/AVE/go/onm00200361ave/direct/01/ Quote Link to comment Share on other sites More sharing options...
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