GlitterSniffer Cosmetics Recall and the FDA Investigation-NYC

Another day, another visit from the FDA to a GlitterSniffer Cosmetics customer, this time in New York City. The recall letter was also shown during this visit as well.

 She gave me her business card and a copy of a letter that GS allegedly mailed to all there customers. I explained to her my brief experience with GS and what I have heard from others. I told her that my jars were not labeled, I had only placed one order back in 12/10, all randoms. I told the lady all the horror stories I've heard. I showed her the pigments I have. She said not to even bother using them as nail polish. The lady said they were randomly selecting customers from a list of everyone who has ordered GS.

The FDA Enforcement Report about the GS recall classifies it as Class II recall:

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

According to Title 21: Section 7.40 there is a notification process that must be followed in a firm initiated recall situation. 

(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.

As an affected customer I can unequivocally state that I have never received a letter, mailgram, or telegram from the company about the recall. To date, not a single customer of GlitterSniffer Cosmetcis has come forward to verify that they received the notification from GS about the recall., despite the company's assertion to the FDA that the letters were sent on or about February 7, 2011.

The FDA's role in a firm initiated recall is to monitor compliance with the terms of the recall. It is not clear what actions, if any, the FDA will take if GlitterSniffer Cosmetics does not follow the outlined recall protocol, though Subpart C 7.40 does indicate that some further measures can be taken, including seizure, multiple seizure, or other court action when it is determined the recall is ineffective.

There is also Subpart E, a section covering Criminal Violations, but it is blank.

The FDA did update the Regulatory Procedures Manual this year, in particular The Park Doctrine. An explanation of The Park Doctrine, as outlined in the manual:

The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense. A Park Doctrine prosecution...refers to a recommended prosecution of a responsible corporate official for a misdemeanor violation of the Act....Once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is a felony, even without proof that the defendant acted with the intent to defraud or mislead...In some cases, a misdemeanor conviction of an individual may serve as the basis for debarment by FDA.

 It should be noted that the FDA does not routinely recommend such cases for prosecution without consideration of other factors:

1. Whether the violation involves actual or potential harm to the public;
2. Whether the violation is obvious;
3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
4. Whether the violation is widespread;
5. Whether the violation is serious;
6. The quality of the legal and factual support for the proposed prosecution; and
7. Whether the proposed prosecution is a prudent use of agency resources.

This is but one possible outcome of the current FDA investigation. At this point there is no clear indication that GlitterSniffer Cosmetics proprietor Lela Warren should or will be recommended for prosecution. The FDA could conclude that GS needs to simply send out the letters and continue on with no repercussion. Only time will tell what, if any, consequences the company will have to deal with pending the outcome of the FDA investigation.