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!

My Story Part 2

After further research into how a recall works it seems that it is a possibility that I cannot request a refund for my pigments for a couple of reasons.

• The pigment that initiated my request, Sammy Jo, is not on the official recall list.
• I requested a refund for all my pigments based on pictures of alleged unsafe formulation and packaging, which is not covered under the recall. 

So, what, exactly, does this mean for GlitterSniffer Complaints?

If you've noticed the focus of the blog has slowly shifted away from recovering my funds and more toward making sure the public is informed. I fully intend on following up on every complaint I've filed, filing more if need be, and in general being the (legal and ethical) bee in GS bonnet.

I won't lie. It's my hope that the FDA requests a recall of all GS products due to the issues surrounding the company. At that time I will be eligible for the refund I feel, recall or not, that I deserve.

In the meantime expect just as much determination from me. I always said that my filing of complaints was not contingent upon a refund, and I meant it. Someone in this mess needs to stand behind their words. That someone is me.

How a recall works

I was asked if I had any information regarding how recalls work. I found some interesting information at the FDA site.

According to the FDA they find out about voluntary recalls when:

A company discovers a problem and contacts FDA.

From the screenshots I have published previously I know that Lela stated she had been reported to the FDA, but at no time has it been publicly disclosed that GS have reported the recall to the FDA.

Also:

What is a cosmetic firm's responsibility in a recall?

Under the guidelines in 21 CFR Part 7, you are expected to do the following:

• You should notify your customers. The content, format, and extent of notification should be commensurate with the hazard presented by the product and the recall strategy developed for the product, as detailed in 21 CFR 7.49.
• When you initiate a recall, you should notify the appropriate FDA district office [21 CFR 7.46(d)].
• You should submit periodic recall status reports to the appropriate FDA district office so that we may assess the progress of the recall [21 CFR 7.53]
• If FDA or your firm determines that a public warning is necessary, you should submit such a statement and plan for its distribution to FDA for review and comment [21 CFR 7.42(b)(2)].
• You should conduct effectiveness checks, as described in 21 CFR 7.42(b)(3).
• You are responsible for the disposition of the recalled product, whether the product is destroyed or brought into compliance [21 CFR 7.55].

In terms of a refund things become less clear.

For other products, such as foods, dietary supplements, and cosmetics, take them back to the place of purchase and ask for a refund.

 Well, I've done that, to no avail. There is some discussion on the GSC Facebook page that GS has purportedly limited the refunds to the last 45 days. The FDA states it will review the provisions of any recall and see if the terms are satisfactory. Since, to my knowledge, GS has not formulated a plan, nor contacted the FDA it stands to reason that should GS be placing a 45 limit on refunds that this may be considered unacceptable by the FDA, and thus, unenforceable.

At this point it really is in the hands of the FDA. I will be amending my complaint to include the information that GS has apparently failed to follow (yet another) FDA guideline by not reporting the recall and safety issues with their products.

1/2/11 ETA: I found further information on this site. I;ve got some good news, and some bad news.

Who pays for the Recall?
The manufacturer/company is responsible for all of the costs involved in this process. Most companies carry product recall insurance to assist with the costs of the recall.
Can I get my money back?
All recalls are voluntary, and the terms are determined by each company when a recall is announced. Each company evaluates the costs of removing products, replacing products or reimbursing customers, and of future “corrective” marketing (restoring the public’s trust in purchasing their products), as well as the amount of recall insurance they have purchased, to determine what they can afford and how to proceed.
In general, a company will refund the suggested retail value of the recalled item(s). The company may choose how to reimburse customers, including:

• cash or check covering the suggested retail price, or
• product exchange (damaged product is replaced with a new product without charge), or
• voucher (coupon for a free product that replaces the damaged product).

Are receipts required for a refund?
Recalls are based on returning a defective product to the manufacturer, and not the actual purchase. Receipts are generally not accepted, unless returns are made directly to the store at which it was purchased.
Manufacturers generally require the actual product to be returned (and tested or destroyed by their facility). Receipts are not generally required, since the manufacturer’s goal is not to prove that you paid for the product, but that you have it.  To prove that you have the product, they often require the entire product be returned, including any unused portion. This also allows the company to test returned product, and confirm which products, lot numbers, production lines, etc., have problems, and that any hazard has been removed and destroyed…and also helps the company protect against fraudulent claims.

So, it seems that GS cannot ask anyone to send back their pigments at their own cost, GS can offer a replacement of commensurate value instead of a refund, and you must return the product to get whatever they are offering as a replacement.

A few things: GS had previously outlined their policy  terms in the recall notice. At no time was there a time limit placed on the recall. As a matter of fact, the recall notice specifically states it is for pigments from the years 2006-2010, and offers a choice of refund or replacement. Additionally, the recall list states that you must show proof of purchase, which I now know is not needed.

Others Experiences

The following was posted to the Facebook page for GlitterSniffer Complaints.

Per Christina:

That is me she called. She claimed I told people "personal" information, which is complete BS. If you read in redacted statement about GS, I commented on there. within minutes lela called me twice. I didnt answer both times. The second time she left this vm. I filed a police report with my PD and her PD the very next morning. I have also taken the necessary steps of protecting myself from further harassment.

You may hear the voicemail here. Please be advised it is highly NSFW.

Thank you to Suzanne for sharing, and to Christina for permission to publish.

Charity

I  contacted the ASPCA, TWLOHA, and GLAAD and informed them that their organizations names were used to raise funds that are now being used for personal use.

I outlined the situation, and included links to the products as well as the recall list, as GLAAD had 3 pigments recalled as either not being FDA approved or not approved for eye use.

I also included a link to this screenshot where Lela admits that the money is not being donated and that she will have to reraise it.

I cannot speak to it specifically but aside from the potential charity fraud it appears this may also fall under the copyright and trademark issues as well.

Child Safety

I contacted PIRGIM, a public interest group based in Michigan that handles issues involving child safety, and Kids in Danger, a nonprofit organization dedicated to protecting children by improving children's product safety.

I outlined the issue and included a link to the Little Girls Kit and the recall list. I also pointed out the following comment on the product, which illustrates that it was indeed intended for children (edited to remove identifying information and Facebook HTML):

• Redacted Would this be appropriate for my 4 year old? :D

  November 27, 2010 at 5:42am ·
• Glittersniffer Cosmetics! Totally!

 I have screenshots of both the product and the comment should either of them be removed from the site.

Copyright and Trademark

I contacted the Disney Company regarding the sale of the Twisted Princesses Collection. Specifically, Aurora from this collection was recalled as being unsafe for use around the eyes.

I sent them an email summarizing the situation, and included links to the product and the recall list.

Thanks to Annony1 for the information.

1/2/11 ETA: I was also pointed in the direction of the Wizard of Oz Collection. Upon further research it appears that WOO is public domain, and as such, is not subject to copyright or trademark