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question about labeling soaps

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When using crisco in your soap recipe what would be the best way to put that into your ingredients list. Crisco is a brand name and can't be used, so what should it be called.... hydrogenated shortening, vegetable oil or something else????


What other info do you put on your label other than the ingredeints list, name of soap, scent, weight, directions on how to use, and your contact information?

Especailly when complying with FDA rules.......
(just wanna make sure I have it right)
 

Neil

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What is Crisco but...hydrogenated vegetable oil
 

Tabitha

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You've got it faithy. The only thing missing is the disclaimer: The saftey of this product has not been determined. Please discontinue use.. yadda yadda yadda.

I *thought* crisco was soy bean. I can't swear to that though cause I don't use it.

BRB, I am going to google.
 

Buttercupsoaps

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Crisco

Well since Crisco has soy in it. I've listed it as soy, also palm. Some folks like/dislike soy products, so I figure it covers it. Does the FDA get involved with handmade soaps? :shock: I thought they don't unless you claim to "heal or cure" something.
 

Tabitha

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"Crisco now consists of a blend of soybean oil, fully hydrogenated cottonseed oil, and partially hydrogenated soybean and cottonseed oils"

http://216.109.125.130/search/cache...ing+containment&d=dFDEnLXiQG5a&icp=1&.intl=us

"The initial purpose was to create a cheaper substance to make candles than the expensive animal fats in use at the time. Electricity began to diminish the candle market, and since the product looked like lard, they began selling it as a food. This product became known as Crisco, with the name deriving from the initial sounds of the expression "crystallized cottonseed oil".

Who knew?
 

Tabitha

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I think people like soy better when you list it as *Amerian Soybeans*. Somehow that makes them cool 8) .
 

Tabitha

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It is my understanding if you use any sort of claim word like soothing, moisturizing, etc, the product becomes classified as a cosmetic w/ regard to the FDA.
 

Lane

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Changed the image name and now it messed up the post...bargh...
 

Tabitha

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Cool labels you got there & the little lines just add to the whymsy of it all. Looks like an etcha-sketch which is very trendy in the artsy circles :wink: ...
 

Soapmaker Man

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All sounds/looks fine to me. Like Tab mentioned FDA gets testy if you start making any kind of claims. It is just "soap" call it that and that only and all will be fine. Soap in itself cannot be "moisturizing" as soap cleans the skin. The glycerine in it left on the skin acts as a humidistat and draws moisture to your skin. That is why store bought big name soap is so drying....no glycerine left in it and full of chemicals, yuck!

Paul....
 

Tabitha

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You can also conclude from the *loose* FDA guidelines that if a soap is intended for human use only it is a cosmetic as aposed to a dish soap, laundry soap or pet soap.

The FDA is *loose* in their terminology so they can bend it to meet their needs on any given day.

If it was black, it would be black, but they purposely made it grey so they can make a case by case descision on everything & not have to stick to a black white guidline thus making it harder to find that loophope since you know they can still make a *judgement* call at any time.

How was that for a run on sentance?
 
G

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I'm familiar with the FDA rules, and lord knows i've emailed them enough questions and gotten replies. LOL

And if you make 'claim' then it's classed as a drug and that's a whole different ball of yarn.

But i was wondering on the correct term to use for "Crisco"........ mostly and was wondering what ya'll put on your labels. I do write that it's made with goats milk, or heavy cream, or aloe juice, or what butter I happen to put into it.... But I don't make any type of claim about it other than it's soap made with those ingredients.
 

Tabitha

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Some claims are cosmetic in nature while others are drug in nature. Again it is not a black white issue. here is a quote from the FDA website:

"Examples of products that are both cosmetics and drugs are shampoos that treat dandruff, fluoride toothpastes to prevent dental decay, and sunscreens and sunblocking cosmetics, including foundations that contain sunscreens. (See "Dodging the Rays" in the July-August 1993 FDA Consumer.)"

...and more...

"Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)
The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?
The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.


How does the law define a drug?
The FD&C Act defines drugs by their intended use, as "(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease..and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

How can a product be both a cosmetic and a drug?
Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about "cosmeceuticals"?
The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

How is a product's intended use established?
Intended use may be established in a number of ways. Among them are:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.

How are the laws and regulations different for cosmetics and drugs?
The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. You should direct questions regarding laws and regulations for drugs to CDER.

How approval requirements are different
FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives. Drugs, however, are subject to FDA approval. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either -

Be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or
Comply with the appropriate monograph, or rule, for an OTC drug.

What do these terms mean?
An NDA is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the U.S. FDA only approves an NDA after determining, for example, that the data are adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system and their 'switch' to OTC status is approved via the NDA system.

FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use. Among the many non-prescription drug categories covered by OTC monographs are -
acne medications
treatments for dandruff, seborrheic dermatitis, and psoriasis
sunscreens
A note on "new drugs": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, no matter how ancient or "traditional" its use may be, once the agency has made a final determination on the status of an OTC drug product it must have an approved NDA or comply with the appropriate OTC monograph to be marketed legally in interstate commerce. Certain OTC drugs may remain on the market without NDA approval pending final regulations covering the appropriate class of drugs.

Where to learn more about NDAs and OTC monographs: If you have questions about NDAs and OTC monographs, you should address them to CDER. The CDER Handbook provides an introduction to the drug approval and OTC monograph processes. Other resources, also available on CDER's Web site, provide additional information on these subjects.

How good manufacturing practice requirements are different
Good manufacturing practice (GMP) is an important factor in assuring that your cosmetic products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

How registration requirements are different
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].

How labeling requirements are different
A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."

And what if it's "soap"?
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.

How FDA defines "soap"
Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when --

The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
If a cleanser does not meet all of these criteria...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product --

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
it is regulated as a cosmetic.

If a product --

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.

If a product --

is intended solely for cleansing the human body and
has the characteristics consumers generally associate with soap,
does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic."
 

Tabitha

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I realizi you were just askig about how to label crisco, which would be * soybean & cottonseed*, but I got sucked into theFDA website & since I am there I figured I would post some things I found. It might be helpful to soemone in the future.

Here is the complete list on what is required on a cosmetic label. The one main thing not mentioned previously in this post is net qty or weight.

http://www.cfsan.fda.gov/~dms/cos-lab3.html
 

soapgardener

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Wow, thanks Tabitha. "primarily consists of alkali salts of fatty acids". Where does this leave melt and pour soap? What is MP made out of? If it consists of glycerine and chemical cleansers would it not be considered soap?
 

Tabitha

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In my opinion, this is where M&P fits in:

"If a product --

is intended solely for cleansing the human body and
has the characteristics consumers generally associate with soap,
does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic."


It's all so subjective though.
 
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