The FDA's Stand on Handmade Cosmetic Products

In light of recent events and accusations against my friends and family of the Handmade Community, I have taken it upon myself to make some calls and get some questions answered myself.

After calling my local State Health Dept. and the Department of Agriculture, I was led to the FDA(Food and Drug Administration). I was told by both of the aforementioned agencies that handmade soaps, lotions, and any other form/s of cosmetics are strictly an FDA issue.

Local agencies have no stand on these products and the only stand that the FDA takes is that they neither approve nor DISAPPROVE of any cosmetic product before it goes on the market. The only stand they do take is outlined below. I was also advised that one is solely responsible if something happens to someone resulting from the use of your products.

Don't let a certain BLOGGER scare you away from making and selling what you love. I already knew all of this before I called, as I am sure most of you did. SOMEONE(You know who you are) is simply trying to scare my friends into doing what HER tainted reputation will not allow her to do.

Unfortunately for HER, I do NOT SCARE EASILY! I never have and I never will let some smoke blowing psychopathic LIAR scare me away from what I love to do. Come after me if it suits you. I will embarrass you with facts and you will feel as stupid as you are acting. Clean up your name and come back when you can act like a decent human being.

To my friends and family of the Handmade Community;
Check your info, make sure your ducks are in a nice, neat, pretty little row, and continue to do what you all love to do! CREATE, SELL, and HAVE FUN DOING IT!

From the FDA website:

FDA Authority Over Cosmetics

March 3, 2005

What does the law say about cosmetic safety and labeling?

The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if--

• "it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" [with an exception made for hair dyes];
• "it consists in whole or in part of any filthy putrid, or decomposed substance";
• "it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health";
• "its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or
• except for hair dyes, "it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)" of the FD&C Act. (FD&C Act, sec. 601)

Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if--

• "its labeling is false or misleading in any particular";
• its label does not include all required information;
• the required information is not adequately prominent and conspicuous;
• "its container is so made, formed, or filled as to be misleading";
• it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
• "its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970." (FD&C Act, sec. 602)

In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act.

It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA's statutory authority over cosmetics would require Congress to change the law.

Does FDA approve cosmetics before they go on the market?

FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.

Who is responsible for substantiating the safety of cosmetics?

Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label:

"Warning--The safety of this product has not been determined." (21 CFR 740.10)