Resources for Selling Natural Products

Cosmetics and the FDA (Federal Drug Administration)
There is a fine line between a cosmetic and a drug.  It has to do with claims being made about the product, the intended use of the product. A cosmetic does not have to be approved by FDA but a drug must be approved before it is available to the public. 

Making claims about your product:
If you make claims that your product heals, repairs, stops, helps you to sleep, etc. then your product is considered a drug.

If you say the difference is 5 times better, significant, etc., it must be proven with data showing the improvement in change.

Advertising claims are reviewed by NAD (National Advertising Division), www.nadreview.org

Definition of 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.”

Definition of a Drug
”The FD&C Act defines drugs, in part, by their intended use, as
articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or intended to affect the structure or function of the body.” FDA Website for regulation of cosmetics
http://www.cfsan.fda.gov/~dms/cos-toc.html

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.”

Sunscreen
Sunscreens are regulated by the FDA and are considered a drug, not a cosmetic.  If making claims about sunscreen, the product must meet the requirements of the FDA.

 “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

Colors
Color additives are also regulated by the FDA.  There are approved colors listed that may be used in cosmetics.  If the color additive is not on this list, the cosmetic is considered adulterated. 

For complete information on color additives
http://www.cfsan.fda.gov/~dms/cos-col.html

Color Additives approved for use in cosmetics
http://www.cfsan.fda.gov/~dms/opa-col2.html

AHA’s Alpha hydroxy acids
There have been some complaints to the FDA of sensitivities to AHA’s on individuals skin. 

The FDA recommended labeling for AHA’s
http://www.cfsan.fda.gov/~dms/ahaguid2.html

Labeling
Package or Product must be labeled with
A summary of what needs to be on the product label:
1. Name of the Product
2. Identity (common name or illustration of the product)
3. Any Safety Warnings
4. Directions for Safe Use
5. Name and Place of Business (If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by)
6. Net Quantity of Ingredients
7. Ingredient Declaration (listing the ingredients with the highest proportion first down to the least)

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

*FDA cosmetic labeling guide http://www.cfsan.fda.gov/~dms/cos-lab3.html

* A good article on Cosmetic Labeling
http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=3800FDA Information on the Cosmetic Industry
http://vm.cfsan.fda.gov/~dms/cos-ind.html   

INCI
A universal system used to name cosmetic ingredients for labeling.  It stands for International Nomenclature of Cosmetic Ingredients.
A helpful ingredient name list: www.oshun.ca/inci.html

Good Manufacturing Practices/GMP
Cosmetics must be manufactured in sanitary conditions to keep from becoming adulterated.  Use stainless steel, wear gloves and use sanitized equipment. 
Maintain a log record that includes:
-the name of the product and batch size
-the listing of the ingredients
-the date when the product was made and who made it
-the date product was packaged, the container used and who packaged it
-a sample of the product labeled with lot, batch number and dated
Guidelines/Inspection Checklist

Product Liability insurance includes networking forums
Indie Beauty Network
www.indiebeauty.com

Handcrafted Soapmakers Guild
www.soapguild.org  

Natural Ingredient Resource Center
Natural Product Labeling Guidelines
www.naturalingredient.org/index.htm

Product Challenge Testing
*Essential Wholesale www.essentialwholesale.com  503 722-7557 Portland, Oregon
*Minnesota Valley Testing, Laboratories www.mvtl.com 800 782-3557 New Ulm, MN
*BioScreen Testing Services, Inc www.bioscreen.com 314 214-0043 Torrance, CA
*Sage Script Institute www.sagescript.com 303-485-6289 Longmont, CO
*Microbac Laboratories, Inc. http://www.southerntesting.com 252-237-4175

Aerobic plate count (APC) Fungal/yeast count (F/YC)
*Sage Script Institute www.sagescript.com  303-485-6289 Longmont, CO
*Check with companies listed under Product Challenge Testing

Selling handmade products without a website
You can create your own product pages with your own website name through Etsy
www.etsy.com

Blog Review of Products
The Organic Beauty Expert www.theorganicbeautyexpert.com

Memberships
Post photos and market your products as an active member of these organizations
Indie Beauty Network www.indiebeauty.com
Handcrafted Soapmakers Guild www.soapguild.org