FDA laws and regulations about cosmetics and drugs

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To comply with the FDA laws and regulations in selling a handmade cosmetic, here is some information that both sellers and consumers need to know. 

There are many who simply do not know the laws or they think the laws do not apply to them.

When making a handmade product sellers must comply with the FDA laws and regulations that the big companies follow.  This includes ebay!   As I search through the pages of ebay's items for sale I find so many sellers not complying with those rules and regulation.   Because of this the consumer must be aware of these rules and decide for themselves if they want to buy from that seller or not.

The FDA does not accept natural preservatives in products.   This is a misconception that they do, however there isn't enough research done on the subject for the FDA to approve these natural products that people are using as a preservative.   Many of them are actually antioxidants and will help stop the oils from going rancid or bad, but they will do nothing to stop the growth of bacteria and mold in the product.  While some essential oils may work, but they would have to be in unsafe high levels to be able to be used.   So once again they are not a good option. 

Some of the products that people are using as a so called preservative are the following.    Grapefruit Seed Extract and rosemary oil extract and Vitamin E.

Potassium sorbate is another all natural preservative that is used by some.  While it can be effective in preserving against mold and yeast it is not useful for preventing bacteria from growing in the product.   

So if the seller claims they are using a natural preservative or no preservative, please protect yourself and search for another seller who makes a safe product that your looking for.

Soaps fall into a completely different category and do not require a preservative.


Also the FDA requires the label to contain certain information.   The following is copied and pasted directly from the FDA web site.

It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action. Some of the ways a cosmetic can become misbranded are:

its labeling is false or misleading,
its label fails to provide required information,
its required label information is not properly displayed.

What labeling information is required?
The following information must appear on the principal display panel:

An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration.
An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.


The following information must appear on an information panel:

Name and place of business. This may be the manufacturer, packer, or distributor.

Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..."
 
Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly.
 
Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings. An example of such hazardous products is flammable cosmetics.

Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance.  Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.


I see (and know) that many sellers purchase refined or ultra refined shea butter, and have it only labeled as shea butter.   Leading the buyer to think that it contains the benefits of unrefined shea butter.   So if the product that your considering doesn't say specifically what type of product is being used be sure to ask.   Especially with products made with shea butter because there are two kinds, and they are very different from each other.

 


Another thing to consider is coloring.  The FDA requires FDA approved coloring for cosmetics, and food coloring is not one of them.   So if the seller is using a coloring and doesn't specify what type of coloring is used please do take the time to ask.   And know that food coloring is not allowed by the FDA as a cosmetic coloring.  This includes bath salts.

 


I see many sellers making medical claims, such as treats psoriasis, eczema, dry skin, chapped lips, etc.  Since we are not doctors and our products have not passed FDA inspection we can't make these claims about our handmade products.

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".

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), 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


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."

 

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