In your quest to develop a new natural skincare line, the first thing you MUST do is read the FDA labeling regulations. Too often people are not informed about this before selling these products to the public. There is a fine line between a cosmetic and a drug when making claims of curing or preventing a disease. Be aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body may cause the product to be considered a drug. The labeling for cosmetics is pretty easy to follow and does not require that your product pass FDA approval. The cosmetic requirements are mostly related to what is included on the label and the size of the print. However, once a claim is made, for example, repairs wrinkles, you have now entered the area of a drug. The requirements for a drug are much more stringent and must be approved by the FDA first. So be careful in the statements made promoting your products. Even sunscreen can be considered a drug because it claims to prevent skin cancer.
The next area of concern is labeling a product as organic. To label a product as “100% Organic” your product must contain 100% USDA certified organic ingredients (excluding water and salt), have zero non-organic ingredients and all processing aids used to make the product must also be 100% USDA certified organic. Products that meet these requirements may display the USDA Organic Seal and must display the certifying agent’s name and address.
In order to label a product as “Organic” your product must contains at least 95% organic ingredients (excluding water and salt) and the remaining 5% ingredients can be non-organic allowed ingredients. With the “organic” label there is also an ingredient exception that states that any agricultural ingredients in the product must be organic unless not available. “Organic” products can display the USDA Organic Seal and must also display the certifying agent’s name and address.
If you label a body care or cosmetic product as, “Made With Organic Ingredients” it must contain at least 70% organic ingredients (excluding water and salt) and the remaining 30% of ingredients can be non-organic allowed ingredients or non-organic agricultural ingredients. Your product label may list up to three of the organic ingredients on the principal display panel. In this case your product may not display the USDA Organic Seal but must display the certifying agent’s name and address.
If your product contains less than 70% organic ingredients, it may not display the term “organic” anywhere on the principal display panel. A product such as this may however identify specific ingredients that are USDA-certified on the ingredients statement. These products may not display the USDA Organic Seal and may not display a certifying agent’s name and address.
Knowing your labeling requirements will help you develop your own line without the fear of the FDA shutting your business down. On another note, as a wife of an attorney, I would strongly advise anyone producing and selling your own products to obtain liability insurance to protect your business in the case of an adverse reaction to your products and a lawsuit.
Good Luck in your quest to produce the best natural skincare line out there!
Source= About Money, Jennifer Chait Organic labeling requirements viewed Dec 29, 2014.
Source=FDA labeling regulations viewed Dec 29, 2014.