# Product labeling



## studioalamode (May 8, 2009)

It seems I'm asking more questions than contributing answers... but here I go again...

I pulled the FDA guidelines and in the midst of about 31 pages of directions, I think I gleened the following information.

I have to list
*Name of product
*Size (in oz or fl oz), and if multiple soaps (such as novelty) in a package, the size of each piece and a net weight of the package.
*Ingredients
*My name and address

*And if a bath product, directions for use.

Is this what you all are doing?

Also, with ingredients, it says the scientific name as well as the common name must be given.  So, "daffodil"would be listed as "narcissus pseudonarcissus (daffodil)"

It seems that would take up a lot of space on small labels.  So my question is, has anyone had trouble with FDA labeling and are you using scientific names or just common names when labeling your products?  

And does it matter how you are distributing your product... such as selling out of your home or in a retail location or in an artists co-op, which isn't really retail, but not exactly home either.

So many questions, to which I hope to get some answers.  With _my_ luck, I would be the one the FDA comes after if I don't do it right.

Thanks in advance for your help!


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## Tabitha (May 8, 2009)

*Name of product 
*Size (in oz or fl oz- by weight
*Ingredients - largest % to smallest INCI form
*My name and address -full adress is required unless they can find you in the local phone book, then just biz name, city/state/zip
*And if a bath product, directions for use. 

*disclaimer EX) The saftey of this product has not been determined by the FDA. If irritation or redness occurs discontinue useage & consult your Dr.


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## Tabitha (May 8, 2009)

That is my understanding. The FDA is not in black & white, it's all up to interpretation much like the copywrite & other similar offices.


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## donniej (May 8, 2009)

There's a lawyer on the infopop BioDiesel forum that makes soap out of his glycerin byproduct.  He did the research and sells his soap as "saponified glycerin and fatty acids" or something very close...  Since you're just using oil, "saponified triglycerides" should suffice.  As for the plant parts, it's been my observation from looking at other labels that only it's common name is used (not the Latin or scientific name).


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## studioalamode (May 8, 2009)

Thank you Tabitha and Donniej.  Appreciate the information.  I think I am going to list the common names, and the disclaimer is a great idea.  Is the disclaimer required... or just a good idea?

Also, do you carry product liability insurance, in case someone has a reaction?


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## Deda (May 8, 2009)

My opinion on this is that if you are going to sell your soap do it right.  Follow the rules to the letter, don't search for loopholes.  

Include all ingredients, using universally accepted INCI terminology.  Include all required information.

If your just selling soap to your next door neighbor's son's teacher's sister-in-law they may not care if my labels are correct, but you should.

As for tempting fate and hoping to not get caught, would you rob a bank because you might not get caught?  I'm betting you don't because you know it's wrong.

I'm supposing that I may sound a little unsympathetic, but I only want the best for all of us.  Soaping and B&B offer us so many ways to be creative, I think spending my energy trying to get around a regulation is a waste of time.  I would much rather muse over then next batch of soap.
_
(Nothing here is directed at any particular person, it's just my thoughts on the subject.  This subject has come up many times, in several threads and I just wanted to make my feelings known.  You all know how I LOVE to do that.   )_


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## Tabitha (May 8, 2009)

donniej,

We are not talking bio, we talking M&P which is not soap by FDA standards. It is a cosmetic because it is detergent based, so it must be labeled as such.


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## studioalamode (May 8, 2009)

Wow, Deda, I think you misinterprepted my post.  I am not trying to get around anything.  And no, I wouldn't rob a bank.  If I didn't care about what I was doing, I wouldn't have posted my question.

What I am concerned about is small labels and so much information to put on them - I asked what I need on there - sorting through 31 pages of details is very difficult.  I listed in my OP what I thought the requirements said and was looking for those who are already labeling their information to see if I'm on track.  I'm not looking for "loopholes" as you so implied.  My comment about "getting caught" or whatever I said, was just a jab at my own luck... because even when I do things right, there is always some foible of some kind.   But since you don't know me, you also don't know my luck.

The soap packaging I have seen on some of the soaps that are being sold don't seem to contain much more than a line of ingredients.  MP bases already have many, many ingredients that should be listed before any recipe additivies are included.  My question was simply to see how others who are experienced have handled the issue.

I don't want to give anyone the impression (implied or inferred) that I am trying to circumvent the law or ethics.  That is not my style.


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## Tabitha (May 8, 2009)

*post*



> Wow, Deda, I think you misinterprepted my post. I am not trying to get around anything.


I am positive Deda was not pointing that comment directly at you.:wink: .


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## Tabitha (May 8, 2009)

Uh-Oh! She posted a disclaimer-LOL!



> (Nothing here is directed at any particular person, it's just my thoughts on the subject. This subject has come up many times, in several threads and I just wanted to make my feelings known. You all know how I LOVE to do that.  )



Looks like she was not talking to anyone in particular....  you are doing your research & asking valid questions.


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## Deda (May 8, 2009)

No no no!  I wasn't speaking to anyone in particular at all!  

I've seen discussions on the subject of honest labeling with the 'manufactures' ranging from college students making MP in college dorms to the Big Guys, like Burts Bees and Aubrey Organics.  

My opinion on the matter is that we have a responsibility to play by the rules. 

StudioAlaMode, you did exactly the right thing.  Dig into the FDA, lots of good info there.  

DonnieJ, the guy you referred to can label his soap anyway he wants.  Find all the loopholes in the world.  Do his customers care?  Maybe, maybe not.  Possibly he thinks his customers are ignorant to what goes into soap.  

I prefer to view my customers, current and potential, as knowledgeable and informed.  Otherwise they could just buy 6 bars from the dollar store.  KWIM?

Like I said before, I won't waste my time trying disguise my ingredients. They are what they are.  I'm quite proud of what goes into my soap.


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## studioalamode (May 8, 2009)

Thanks, Tabitha.  Being new, I was a little shy even asking questions and then when I saw that response, Ithink I did take it personally.   I do want to do things right from the get-go.  My bad.   I will take it as just general advice for us all.


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## studioalamode (May 8, 2009)

Deda said:
			
		

> My opinion on the matter is that we have a responsibility to play by the rules. ...
> 
> I prefer to view my customers, current and potential, as knowledgeable and informed.  Otherwise they could just buy 6 bars from the dollar store.
> 
> ...


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## studioalamode (May 8, 2009)

Well, I clearly don't know how to do the quote thing... got that totally messed up.   See what I mean about my foibles?  Ha-ha.  Geesh.


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## Tabitha (May 8, 2009)

LOL, we know what you meant!


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## Deda (May 8, 2009)

I really didn't mean you!  Or anyone.   I think your question was great and timely.  I recently got my FDA/VCRP number finalized, I'm almost through submitting all my products and ingredients.  I think it took me at least a million years to list every ingredient in every soap and lotion.


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## carolynp (May 8, 2009)

*What the ???????????*

OK ,so what about this then ?ALL THAT LATHERS IS NOT SOAP

by Harold Hopkins
You've been near it all your life, bassinet to bath to boudoir. It was used behind your ears before perfume was used there. It has removed dirt and grime from your face, fingers, and knees. If you've said naughty words your mother may have threatened to wash out your mouth with it. It has cleansed you, made you smell good, added a glow to your complexion, and helped make you feel fresher. But what do you really know about soap? 

Well, in the first place the product you regard as soap may not be soap at all, but a synthetic detergent "beauty" or "bath" bar. These and similar names have been used by copywriters to spare the consumer the awful knowledge that she is not bathing herself with real soap, but with a synthetic detergent which, ironically, is for some purposes superior to soap. Some "soap" bars may consist of soap and synthetic detergent. 

Soap, as long as we can remember, has enjoyed an enviable respect in polite society and this could be at least a part of the reason why Congress placed soap above the law in enacting the Food, Drug, and Cosmetic Act of 1938. This law exempted soap from regulation as a cosmetic. 

So long as no cosmetic representations are made for soap, other than that it cleanses, and no claims are made that it will affect the structure or functions of the body or treat a disease, it is beyond FDA regulation. When such claims are made the soap must meet all FDA requirements for a cosmetic or a drug or both, whichever is appropriate. If it's represented as a drug the label must list all active ingredients; if represented as both a cosmetic and drug or as only a cosmetic the label must list all ingredients. 

For instance, if a soap is labeled as a deodorant soap, FDA considers this to be a cosmetic claim and the label must, as with other cosmetics, carry a list of ingredients. If the soap makes a medical claim, such as that it will cure dandruff, it is considered a drug and must carry required drug labeling and also meet FDA safety and effectiveness requirements. 

Fortunately, plain soap of the noncosmetic, nondrug variety has earned a good reputation. Apart from the familiar sting from getting soap into your eyes or the peril of slipping on a bar in the bathtub or shower, common bath and hand soap is relatively safe. In fact we often use it to remove other substances from our hands and skin that we think are a lot less safe. 

For purposes of excluding ordinary soap from regulation as a cosmetic, FDA defines it as a product in which most of the nonvolatile matter consists of an alkali salt of fatty acids and whose detergent properties are due to these alkali-fatty acid compounds. Our ancestors often made their own soap for laundering, cleaning, and bathing from animal fats and wood ashes. Today's soap may contain perfumes, colors, and oils, but if it is represented only as soap it's out of FDA's regulatory bailiwick. 

Ordinary soap is regulated by the Consumer Product Safety Commission under authority of the Hazardous Substances Act. CPSC's jurisdiction covers most noncosmetic, nondrug substances used in the home. 

If the bar you use for bathing does not claim to be a soap, it's probably a synthetic detergent product. FDA defines a cosmetic as an article intended to be used on the body for cleansing, beautifying, promoting attractiveness, or altering the appearance; thus, a nonsoap product intended for any of these purposes is automatically classified as a cosmetic. 

Soaps and synthetic detergent cleansing agents function in water in somewhat the same way; that is, they break down the resistance barrier between the water and the dirt, grime, oil, or other material, allowing it to be wetted and washed away. Soap works well in soft water, but in hard water, which contains a relatively high amount of calcium in solution, the calcium and soap react to form a gummy material called soap scum, which includes dirt and other matter. This gummy stuff is what forms the familiar ring in the bathtub. 

The increasing number of synthetic detergent bars on the market is due largely to their more efficient functioning in water, regardless of hardness, and because they don't form gummy deposits as does soap. There are many types of synthetic detergents, ranging from strong to mild; usually the milder types are used for personal cleansing. Some of the harsher detergents are capable of causing eye irritation or injury and manufacturers normally avoid using these in personal bathing bars. There are consumers who may experience irritation or allergic skin reactions from some synthetic detergents. Some consumers also may be allergic to fragrances, colors, or other substances added to either soaps or synthetic detergent bars. 

FDA's file of about 70 reports of adverse reactions during the years 1975 through 1977 from use of bar soaps and synthetic detergent bars that qualify as cosmetics includes consumer complaints about skin rash, redness, inflammation, irritation, itching, and burning among the most common problems. The Consumer Product Safety Commission's file of complaints and injury investigations shows similar effects on the skin and eye irritations. Consumer complaints about adverse reactions to synthetic detergent bars and those soaps classified as cosmetics may be made to any FDA district office or to the Director, Division of Cosmetics Technology, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204. * 

Complaints of adverse reactions from ordinary personal cleansing soap not classified as a cosmetic or drug should be sent to the Consumer Complaints Section, Consumer Product Safety Commission, Washington, DC 20207. Complaints may also be made and information obtained on any current recalls, warnings, or bans concerning soap by dialing the toll-free CPSC Hotline for Consumers: 1-800-638-2772. 

Harold Hopkins is editorial director of FDA Consumer. 

U. S. Food and Drug Administration
FDA CONSUMER, February 1979


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Hypertext updated by dms/cjm 2001-JUL-15  It does not seem as if anyone can give a real answer to this question, social responsbility aside WHAT are we leagally required to put on a label of VEGETABLE BASED GLYCERIN SOAP?


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## Deda (May 8, 2009)

*Re: What the ???????????*



			
				carolynp said:
			
		

> OK ,so what about this then ? It does not seem as if anyone can give a real answer to this question, social responsbility aside WHAT are we leagally required to put on a label of VEGETABLE BASED GLYCERIN SOAP?



http://www.cfsan.fda.gov/~dms/cos-lbl.html

This pretty well sums it up.  If you have questions you can call the FDA and ask questions.  They are most helpful.


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## oldragbagger (Jun 23, 2009)

Thank you so much for posting the editorial from Mr. Hopkins.  It has clarified things for me and I have come to the decision to make no claims other than that my soap is pure natural soap.  If I make mention of anything else it will probably have more to do with what the soap doesn't contain.  I also think the disclaimer is a great idea.  You could even expand that to mention allergies (nut oils come to mind).  I have no desire to tangle with the government.  I just want to make SOAP!!


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## llineb (Jun 23, 2009)

Tabitha said:
			
		

> *Name of product
> *Size (in oz or fl oz- by weight
> *Ingredients - largest % to smallest INCI form
> *My name and address -full adress is required unless they can find you in the local phone book, then just biz name, city/state/zip
> ...



tabitha, can you put a website, city and state instead of the complete address.  the website has the phone# and address on it?
thanks, lara


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## Deda (Jun 23, 2009)

Not Tabitha, but I can answer your question.

If your business telephone can be found under your business name in your local phone book then you don't have to list your physical address, only City, State and Zip.  Otherwise, you full address must be on the label.


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