Cosmetic Manufacturer or Drug Lord? Which one are you?

Education goes a long way when it concerns safe cosmetic manufacturing and I am not only talking about the "big guys" but also many small businesses as well.  In our quest to make a fabulous product and our passion to share it's wonderful benefits we may in fact be selling drugs. Making health claims on your products is a BIG no no unless you have the data and the license from the FDA to make those claims.  The FDA is very adamant about what you can and cannot say with your cosmetics-

http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm

"Intended use may be established in a number of ways. The following are some examples: 

• 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, increase or decrease the production of melanin (pigment) in the skin, or regenerate 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 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." For example, 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. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug."

Be very careful about making these claims because they do not play when they come knocking on your door. Whether you have stated in your description on your own online website, ETSY or distribute information at your craft shows--seller beware BIG brother is watching you. 

So do not become one of these companies:

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/WarningLetters/ucm081086.htm

More links you want to know about:

http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/CosmeticsQA/default.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm2007006.htm
http://www.fda.gov/Cosmetics/ResourcesForYou/CosmeticsManufacturersPackagersDistributors/ucm142760.htm
http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/ucm126444.htm#clgk

Are you thinking of making a cosmetic and want to stay within the guidelines?  I suggest purchasing this fabulous book--  

Marie Gale makes it very easy to wade through these guidelines by providing examples to help you comply and not sell drugs without a license.  I hope you have found this information helpful.