Sunday, January 2, 2011

FDA Information

I received an email from Brittany with further information in regards to FDA requirements and what is, and is not, considered a misbranded product (emphasis on the relevant portions as it may apply to GlitterSniffer is mine):
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.
So, is GS liable if it is proven that they sold a misbranded product?

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.
GS have stated at various times that they either did not know that the pigments were not eye safe, that they knew but warned people in their listings, and that they knew and used them anyway because they personally never had any issues. Does any explanation have any bearing on the FDA labeling requirement or the possible misbranding of their products? NO. :

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)
In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.
In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
From this we can infer that GS was responsible for the ingredients of their products (so the "I didn't know" argument doesn't hold), that the product must include a warning label on the product itself (so the "but I said such and such in the listing" argument doesn't hold), and the finished cosmetic must be safe (they possibly used unsafe ingredients knowingly so the "OK, you caught me, I knew it was unsafe but you kept bugging me for it so I had to sell it" argument does not hold.)

From my understanding of this document it would appear that GS is potentially selling a misbranded product, and thus could possibly be held liable for the recall of all of it's misbranded products.

I can tell you that my pigments are sitting over there, looking all sadly unlabled in their clamshells. They are full sized products, so they are required by law to be labeled correctly. I may just get my refund yet.

Thanks to Brittany for the info!

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