Why is soap exempt from FDA regulation? I think that comes down to politics. When the Food, Drug and Cosmetic Act of 1938 was adopted, there was a large soap lobby, and these lobbyists were able to have soap exempted from these laws. This is also true of the Fair Packaging and Labeling Act of 1939. The FDA enforces these acts and has established regulations with regard to following those acts. 

So, now that you have mastered the art of soap-making, you want to broaden you horizons--make some bath salts, lotions and lip balms. This is where things get tricky. You will no longer be an ordinary soapmaker, you will be a cosmetic manufacturer. Once you take this plunge, with adequate labeling, testing, records and storage, you can also report to your customers that your soap is, for example, moisturizing. 

What follows is a overview and my interpretation of FDA cosmetic regulations. By no means can this article replace your own research and study of the actual FDA regulations. This article can help you to decide whether you want to move forward into the realm of cosmetic manufacturing or, simply to stick to making soap. 

Before we begin to look at cosmetic regulations, let's review what a drug is according to the FDA. A drug is intended to treat or prevent disease, or in some way to affect the function of the human body. Products that stop itching, eliminate dandruff, or cure acne are all drugs. Your product must not be "represented" in any way as a drug or cosmetic unless you intend to follow the rules that accompany that claim. 

The FDA considers your product a cosmetic if it is intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or to alter the appearance without affecting the function of the body. It seems that with both cosmetics and with drugs, you may state generally that your product is beneficial to the consumers health, without falling under either set of regulations. However, when you get specific, that’s when you must follow the rules. Almost any ingredient can be used in cosmetics (please note there is a list of unacceptable ingredients that need to be reviewed by the manufacturer), with the exception of colorants. Colorants must meet FDA approval. Some of the prohibited or restricted ingredients are: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene. I suppose this means that you can use sterilized zebra dung in your cosmetics and not be breaking any rules. At least your customers can pronounce this ingredient, in contrast to the list of prohibited/restricted ingredients listed above.

In my opinion, the FDA regulations consist of the following sections:

Labeling, Storage, Equipment, Testing, Record keeping, Production, and Colorants. There are special regulations for some products, such as foaming/bubbling bath products, hair care products, suntan lotions, any product to be taken internally (including mouth wash), or products that are used around the eye area. Your cosmetics do not need FDA approval to be sold to the public.

First, let's look at Labeling. This is a large part of the regulation process. Labels include written, printed, or graphic matter on OR accompanying a product, and must be in English. If the label is accompanying the product, it must be firmly attached to the product. If your product is boxed, the information must be on the box and on the product. The font (letters) must not be less than 1/16 of an inch in height. If the total package area is less than 12 square inches the letters must not be less than 1/32 of an inch in height.

The first label section that stands out is the Warning label. Since it is nearly impossible for the home soapier to adequately test for safety of our products every label must read," Warning- The safety of this product has not been determined". Secondly, all bubbling or foaming bath products should only be marketed to adults unless the label states: "Caution- Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occur. Consult your physician if irritation persists. Keep out of the reach of children". The label of all bubble and foam products should read," For adult use only", or "Keep out of the reach of children", regardless of whether it is sold to children or adults. 

Any product that may be harmful to a consumer if misused must bear appropriate label warnings and directions for safe use. I think this includes bath oils, salts, bombs, and bubbles.

The principal display panel (the part of the container the customer will most likely look at and that usually has the name of the product on it) must tell the name and use of the product and state the net quantity of contents in weight, measure, numerical count, or a combination of thereof. This weight/count must be distinct and placed in the bottom area of the panel parallel to the base or bottom of the product container. This statement must be in pounds and ounces, and if the weight exceeds one pound it must be stated in ounces and then in parenthesis in pounds.

The name and place of business of your company must be on the label. The address is not required if your business is listed in the phone book. 

Ingredients must be declared on the package, listing the most abundant to the least. This information needs to be placed on the package where it is likely to be read by the consumer at the time of purchase. This declaration MUST be on the product and not on an attached label. Ingredients that make up less than 1% of the product may be listed without regard for predominance. Flavors and fragrances may be listed as "And Other Ingredients". Vitamin E must be listed by its chemical name (tocopherol) otherwise it is considered a drug by "leading" the customer to believe that the product may have some type of medicinal properties.

Cosmetics that are also drugs must have "Active Ingredients" listed.

Other Labels required would be: labels on your supplies, and labeled samples.

According to the FDA, the equipment used to produce cosmetics must be clean, of proper construction for the job intended, and in an area that will not allow it to be contaminated.

Now on to Storage. The FDA states that all ingredients and finished products must be stored off the floor, and away from food, tobacco, and filth. Though the regulations do not specifically state so... I would assume away from pets too. The products and supplies must be in closed boxes, bags or containers. The container must be labeled with contents, lot identification, and control status. The supplies and finished products must have samples taken and labeled for testing and for use as a control. They must be kept for a specified period of time, but I have yet to determine what period of time that would be.

There is testing of cosmetics required by the FDA. Materials must be sampled and tested to assure there is no contamination of filth, microorganisms, or other substances (like dead rats). These tested samples must be retained. Products need to be tested for microbial contamination which could occur under normal use and storage by a customer. There is notation of paying particular attention to materials of animal or vegetable origin and those materials used in manufacturing Cold Processed cosmetics to assure they have not been contaminated by microorganisms or filth.

Water must also be tested if it is used in your cosmetics. Water must conform to chemical-analytical and microbiological specifications (I bet you can get this done at the health department or County extension office).

Record keeping is essential. Records must be maintained for the following: 

a- raw materials and packaging, 

b-kinds, lots and materials used, 

c-processes, 

d- sampling , controls, and adjustments on final product 

e- code marks of batches and finished products, 

f- distribution records. 

I would also recommend records on ingredients and packaging suppliers.

Production of cosmetics requires adequate lighting and ventilation. It also requires a second person to check the weights and measurements. Hair nets and gloves must be worn. The person making the cosmetic must be clean. Written instructions, formulations, processes, and transfer and filling instructions must be maintained.

Colorants are the only regulated ingredient in cosmetics besides the restricted/prohibited ingredients. Dyes and colorants like "Rit"tm dye, crayons, "Kool-Aid’tm and candle colorants, are not to be used. There is a long list of color additives that are subject to certification and another long list of ones that are not subject to certification. May I suggest personally looking up the particular colorant you plan to use before actually putting it into your cosmetic. I would also strongly suggest ordering your colorants from the "pigmentlady" (http://members.aol.com/pigmntlady/ and PigmntLady@aol.com). She is very helpful and can assist you in your coloring decisions.

You may read the cosmetic regulations yourself by going to http://www.FDA.com. You may also call 1-888-463-6332 or write to them at: Superintendent of Documents, Government Printing Office, Washington, DC 20402 (202)-(783-3238). You may pay by Visa or MasterCard from the address listed to obtain a printed copy. Look for Title 21, Code of Federal Regulations. This is updated every April. Parts 1-99 and Parts 600-799 are of most interest to the cosmetic manufacturer, but please examine the entire document.

Please be aware that the FDA does have the right to conduct examinations and investigations of products and inspect the manufacturing facility. I would assume they do this after receiving a complaint.

Some other facts to note. 

There are no FDA regulations regarding animal care products.

There is a voluntary FDA Cosmetic Registration program.

You do not have to report customer complaints to the FDA.

The FDA has the right to inspect your manufacturing facility, take samples, remove products that do not follow the regulations and they may take legal action against you. This legal action would be through the Department Of Justice and could include restraining orders to prevent you from manufacturing cosmetics They can pursue and charge you with Criminal Action if they feel you are not conforming to the regulations. 

The FDA considers Lanolin an alcohol...so anything with lanolin in it may not state that it is alcohol free.

You can state that your products are cruelty free (no animal testing) if you have not done so, but be aware that the ingredients very well may have been tested on animals.

Flavors and fragrances do not need to be identified and may be listed on the label as "and other ingredients" if they constitute less than 1% of the ingredients.

Be aware of the special regulations for any internal cosmetic, hair care products (especially egg shampoo), hair dye, any product put into a bath that produces bubbles or foam (like bath bombs), sun tan lotions, and nail products.

The FDA does not like adulterated or misbranded cosmetics. A cosmetic is adulterated if it contains, or is in a container that may make the product harmful to consumers, or if it contains filth, or it is decomposed. A cosmetic is considered misbranded if the labeling is false or misleading, or does not contain the proper warning. It is also considered misbranded if the container is made, or filled, in a deceptive manner.

I hope this article has helped you decide if you are able to abide by the regulations required to manufacture cosmetics in the United States. I know it sounds like a lot to handle.....and it is, but I think it can be done. In my opinion, a separate room of your home would be required to manufacture cosmetics. A room with adequate shelving, tables, containers for storage, lighting and equipment. The walls of that room should be smooth for easy cleaning. Hair nets and gloves would need to be worn and a second person would need to be involved for double checking those weights and measurements. Since food is not allowed in the manufacturing area, our kitchens would be out, and if you or anyone in your home smokes, you would surely need a separate room that would be sealed off and away from the smoke. A computer program to produce those labels would be a must. Any publisher program would do. Finally, a very good record keeping system would be necessary. This system would need to be set up before you begin making cosmetics.

Other considerations before you begin your bath biz may be: sales tax license, trade license, registering your business name, registering with the property tax division (State), insurance, registering with the FDA voluntary program for cosmetic manufacturers, and you may want to check the regulations from the Consumer Product Safety Commission.

Good luck to all of you, and happy soaping!