Lets Play GlitterSniffer Cosmetics Connect the Dots

This post is a bit of a Mobius strip so please bear with me as post what amounts to a game of GlitterSniffer Cosmetics Connect the Dots.

Dot One: In December 2010 GlitterSniffer Cosmetics announced a recall of all pink pigments and those that were made using soap dyes. A preliminary list was drawn up which contained the 80's Collection. The 80's Collection was on the first and all subsequent lists, including the list provided to FDA, as per the March 23, 2011 Enforcement Report.

Dot Two: On January 9, 2011 GlitterSniffer Cosmetics posted the recall/refund information to their website, including the information that they had already been in contact with FDA.

Dot Three: According to the FDA Enforcement Report from March 23, 2011 GlitterSniffer Cosmetics stated they sent a letter to all of their customers informing them of the recall on or around February 7, 2011, copies of which were provided during FDA home visits to GS customers this month. Per Title 21 Subpart C Section 7.49 a recall communication must contain several items.

(a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:
(1) That the product in question is subject to a recall.
(2) That further distribution or use of any remaining product should cease immediately.
(3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.
(4) Instructions regarding what to do with the product.
(b) Implementation. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope:“drug[orfood, biologic,etc.]recall[orcorrection]”.The letter and the envelope should be also marked:“urgent”for class I and class II recalls and, when appropriate, for class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner.
(c) Contents. (1) A recall communication should be written in accordance with the following guidelines:
(i) Be brief and to the point;
(ii) Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;
(iii) Explain concisely the reason for the recall and the hazard involved, if any;
(iv) Provide specific instructions on what should be done with respect to the recalled products; and
(v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.
(2) The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, followup communications should be sent to those who fail to respond to the initial recall communication.
(d) Responsibility of recipient. Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with paragraphs (b) and (c) of this section.

Dot Four: GlitterSniffer Cosmetics released the Chocolate Collection on or around February 8, 2011.

Dot Five: This screenshot, undated, shows GlitterSniffer Cosmetics facilitating a sale of product they personally recalled, the 80's Collection. It appears to be near the same date of February 8, 2011 as the exact same announcement regarding the Chocolate Collection is seen posted just below it.

Connect all the Dots and here is the picture that is formed: GlitterSniffer Cosmetics knew that the 80's Collection was recalled in December of 2010, spoke with FDA in January 2011,  provided FDA with a recall letter prior to February 7, 2011 that had to, by law, state that further distribution of the recalled product should cease immediately, and yet on or around February 8, 2011 attempted to facilitate the sale of the recalled 80's Collection knowing that this violated not only the terms of the recall letter but FDA regulations regarding a firm initiated recall.

The company can spew semantics all they wish regarding the business decisions prior to the recall (Quote from the Recall FAQ: "I have had no issues with the pigments, and in turn assumed that other people would not either."). What is not debatable at this point is that the company knew they were violating Title 21 by facilitating the sale of recalled product and yet chose to do so anyway, possibly putting at risk uninformed consumers and those selling the recalled product with the company's assistance. That's not a pretty picture to end up with for the company, their customers or for those they attempted to assist in violation of federal regulation.

I will be following up with FDA to provide them with this information.

5/17/11 ETA: Corrected year in the third to last paragraph from January 2010 to January 2011.