Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, January 9, 2012

FDA Freedom of Information Act Request Reports-Overview

Last week I received via email a response to my Freedom of Information Act Request to FDA and the Department of Health and Human Services. Contained in the email are several pages of documents regarding FDAs investigation into GlitterSniffer Cosmetics and the recall.
It has been a bit of  a struggle in determining how to post this information as the sheer volume of it is a bit overwhelming. In an effort to make this a bit easier to parse I will be separating the posts into the three different reports, divided by section. There will then be a final, separate post with scans of the reports in their entirety, save for what FDA has redacted and one minor redaction I myself made in order to ensure that a former associate of GS is protected as per their request.
A quick note about my FOIA Request: I have been informed I may still receive other documents from other government agencies in addition to what I have already received, which currently stands at 13 documents. There is generally a fee involved in receiving an FOIA request, based on a sliding scale starting at $23.00 for the first hour of research, with copies of the reports priced individually per sheet. I requested a fee waiver from FDA and HHS for this FOIA request on the grounds that this information was in the public interest and readily identified myself as the author of this blog. I was not charged for the research time or copies sent to me for this portion of the request. I publish them now just as I informed FDA and HHS I would, in the public interest.
Post One: Establishment Inspection Report dated 1/10/11 and 2/7/11
Post Two: Memorandum from the Department of Health and Human Services dated 2/8/11
Post Three:  Memorandum from the Department of Health and Human Services dated 7/20/11
Post Four: Scanned copies of the records
Fair warning, if you thought the Michigan Attorney General post was long then you’re in for more of the same with these upcoming posts, which I will be working on in the coming days. I appreciate your patience and will have them up as quickly as possible.

Tuesday, December 27, 2011

GlitterSniffer Complaints: One Year Later

As of yesterday it has been one year since I first posted to this blog. In that time I have posted about all thing GlitterSniffer Cosmetics, as well as other issues surrounding safety in indie cosmetics. I thought for a long time about what this post should say. I could go on ad naseum, but instead I give you this:

Today I received a response from my Freedom of Information Act Request from FDA and The Department of Health and Human Services. I will be receiving the documents on the GS investigation soon, though I currently have no ETA.

I want to thank you all for your patience as I know this will be another long post once these documents have been received. Until then, I am working on several other posts.

One year later and the grand total of refunds issued by GlitterSniffer Cosmetics for the recall (mine was not recall related) still stands at $0.00.

Friday, August 5, 2011

You've Got Glittermail!

I posted the other day that the store credit packages from GlitterSniffer Cosmetics had been given Delivery Confirmation numbers. Those packages began arriving yesterday. In all I have almost 150 pictures of packages. It would be overwhelming to post them all so I'll post a select few here.
All of the packages that I have seen arrived well packaged with only one leak. They were bagged together according to product type: Pigment or Soap. Included in each was a sheet which listed ingredients for all products. This sheet also had a manufacturers/distributor statement, but no listing of net weight or uses. There were individual labels on some, but not all, the products. Most pigments came unlabeled individually, with no indication of the names.

It is important to note that since the products were all packaged in plastic bags together by product type that the sheet included appears to meet FDA requirements for labeling, as long as everything that needs to be on a label is present. The missing net weight information and, especially, the uses are troubling as these items are required for labels. Since GS uses ingredients such as Ferric Ferrocyanide and Chromium Oxide Green in some of their pigments it is important that it be noted these shades are not approved for lip use in the US. This was not indicated on the sheet, in the packages, nor is this information available on the site.

The store credit packages were given for those that either asked for the credit in lieu of a refund, were only eligible for store credit, or, in one case, as a gesture of good faith. Those with store credit sent their requests, with color families and preferred products, though as far as can be determined no one was able to make specific requests.

What follows are photos of the packages. They will be separated according to package and, when the information is available to me, how much the store credit was for. In all I have been sent photos of four packages and I am publishing photos from each.

Package 1,  around $50.00 in store credit. There were no issues with this package. None of the colors were named.




Package 2,  $40.00 in store credit. The package came with $.85 postage due, there is what appears to be hair embedded in one of the soaps, an unidentified 'toothpicklike' foreign object packaged in another, unidentified black spots on another. This customer had requested no soap be included in her package.




Something resembling a hair embedded in the soap

'Toothpicklike' object in the packaging

Black spots
Black spots

Postage Due
Package 3, around $30.00 in store credit. There were no names on any of the pigments, something had leaked in the bag containing the perfume items, the massage bar arrived melted, and the solid perfume had no discernible scent except wax.

 



A Leak

A Leak


Melted Massage Bar

Solid Perfume with No Scent



Package 4. This package arrived with $3.28 postage due, a melted massage bar with a brown lump in it, a half full glitter vial, and both a fullsize and sample of the pigment Rings of Saturn. Rings of Saturn was swatched for comparison purposes. After opening and swatching the pigment the customers eyes became irritated and puffy. Previous to this the customer had never had a reaction to any GS pigments.








Melted Massage Bar

Unidentified Brown 'Lump" in the Melted Massage Bar

Unidentified Brown 'Lump" in the Melted Massage Bar


This Collection was originally released in February






Rings of Saturn. Swatched dry on bare skin, 2 swipes each. Left swatch is the sample, right is the fullsize.



I want to thank everyone for sharing.

**8/5/11 ETA** Moved a photo from Package 1 to Package 3 as it uploaded incorrectly.

Saturday, July 23, 2011

GlitterSniffer Cosmetics: Readying Packages and Releasing Customer Information

I apologize that I have been out of pocket. I have much to post and am going to condense it all into one post to streamline, outlining the happenings of the past week or so. I appreciate your understanding.

GlitterSniffer Cosmetics is working double time in order to gear up to open and begin sales.

Posted yesterday was a link to the new website as well as a Shop tab added to the Facebook Page.



On 7/22/11 GlitterSniffer Cosmetics posted a variety of pictures showing packages ready to be shipped out for those that requested store credit in lieu of a refund. There are no discernible ingredients labels in any of the photos. This is not to say they aren't being included elsewhere in the package to meet regulations, however. Once the packages begin going out will we know for certain.

What is troubling is that in at least one of these photos customer information, including name and address, is clearly visible for anyone to see. When conversing via email with Lela regarding FTC regulations on customer privacy during the exchange of refund information (for which I directed her to the FTC themselves) she stated in no uncertain terms she would be calling them to ensure she was meeting their guidelines. Though I don't claim to be an expert regarding FTC regulations it is doubtful that posting customers name and address on the internet meets those guidelines. (Picture has been edited to remove personally identifying information though I have the original intact).


Inadvertent though this may be it still constitutes an major issue for GS, namely that the focus on following all guidelines is not what it needs to be at this point.

Also this week on the GS Fan Page (which is *still* moderating comments) a post went up regarding Scentsy, with a link to purchase to help fund GS reopening. Lela stated she would not be receiving the funds but that supplies would be being purchased for GS, presumably with the profits the Scentsy seller is making from the purchases. Currently there is only one person who publicly announced a purchase, an (as of July 18, 2011) "associate" of GS who has been assisting in getting the company up and running.


It is not clear how being an "associate" of GlitterSniffer Cosmetics works, if it is a paid postion or not, but she was welcomed to the team, though currently there are only two employees publicly listed for GS besides Lela Warren, Brandy Cameron and Katherine Huhl-Herndon.


A new Private GS group was created ostensibly for the fans to post without being "harassed via messages". While there were instances in the past of others contacting fans via PM on Facebook in an effort to educate them on the past issues it should be noted that I have never done so myself. I was, however, contacted on July 18, 2011 on my own private Facebook profile via PM by a GS associate regarding matters related to GS, despite the email address for all things GlitterSniffer Cosmetics related being publicly available on the Complaints Facebook Page. I have yet to respond to the message but encourage the person to contact me via email to discuss the matter. I will again reiterate publicly that any owner, employees, affiliates, associates, or family members of GlitterSniffer Cosmetics or Lela Warren should contact me via that email address only.



 It has been my policy in the past not to post any information I received from the previous GS Private Group. The group as it was was run by fans for fans and although Lela was an Admin and a member it felt very invasive to me to post from that group. As it now stands the new Private Group was created by Lela herself and she is the sole Admin (even encouraging people to add her personal profile to be added to the group and despite her assertion she would not be running it). Therefore I have changed my stance on posting anything as it pertains to the Private Group as this is yet another extension of the GlitterSniffer Cosmetics business. Posting of information from the new GS Private Group is in line  with GS' new policy of openness with any information regarding their business practices.



And what of those business practices that brought GS to this point? As posted previously Lela has had issues separating business from personal, and actually lost her original Facebook account due to advertising (the second and third Facebook accounts are TOS violations). She admitted that keeping up with so many different forms of communication caused issues and repeatedly asked people not to contact her regarding GS on her personal profile (after telling them to add her to do so). Why then is Lela encouraging people to add or message her through her personal Facebook?

 


It also seems premature to be entertaining the idea of offering store credit/discounts as prizes, offering possible discounts to those inquiring about ordering, or sponsoring contests, especially when that cuts into the profit margin that is to be going to refunds, no matter how miniscule that cut may be.



As a quick update to the Refund information posted on July 11, 2011, I have not been contacted regarding the refund amount due nor with any information regarding the charities (TWLOHA, GLAAD, ASPCA) that Lela said she would be contacting to discuss the $3000.00 owed to them. Lela updated here stating she had contacted two of them, but there was no information given as to which they were or what the outcome was. She states that as soon as the third charity responds she will release that information. The note also states she provided FDA with her labels and ingredient information. She also states that FDA has been informed of the intent not to wear gloves while placing sifters in pots (or other tasks where this may "cause more harm than good"). GS is back to manufacturing again but has not, as yet, posted videos of this process as stated they would in this note. The refund form was posted to the GS Fan Page and a deadline of August 15, 2011 was enacted. When questioned Lela stated it will be GS policy not to accept returns or exchanges and she did not want new customers to be confused by the current refund process. It was also announced that refunds would be for $2.00 per jar, far less than the original amount offered. I have also been informed that 15% of the profits (minus shipping costs) will go towards refunds. 

While it is still my sincere hope that everyone affected by GlitterSniffer Cosmetics past business practices gets the refunds due to them the lingering issues do seem pervasive, especially the release of customer information, the amount being offered for refund (when customers provided proof of what they actually paid), and the dependance upon personally befriending Lela Warren for business purposes. This is in addition to the quality control concerns posted last week. One would hope that prior to proceeding these issues would have been recognized and a plan in place to prevent the same issues from recurring but sadly, it seems they have not.

7/3/11 ETA: Removed a piece of PII. I regret the oversight.

You're Not Alone

Subscribe

Bloggers' Rights at EFF

Easy Access

ACE Books Amazon Payments Artfire ASPCA Attorney General Bellasugar Better Business Bureau Big Cartel Business Opportunity Buyer Beware Cellini Red Charity Child Safety Closing Coastal Scents Complaints I Filed Consumer Affairs Consumer Product Safety Commission Consumer Reports Consumerist Contact Copyright Cosmetic Safety Craftzine.com Craigslist Cream Eyeliner Dammit Pigment Detroit Handmade Detroit Urban Craft Fair Disney Double Labels Ebay Email Etsy Etsy Call Out Blog Facebook FDA Federal Trade Commision Flickr Frankening Freedom Of Information Act FTC Get Crafty Gift Cards Gift Certificates Gift Exchange GLAAD Glam Rock Magazine glittermail GlitterSniffer GlitterSniffer Bath GlitterSniffer Cosmetics GlitterSnifferCosmetics.highwire.com Glow in the Dark Google Checkout Handmade HBO I Answer Your Questions Ingredients Internet Crime Complaint Center Kids in Danger Labeling Lawsuit Listia Mail and Telephone Order Merchandise Rule Maker City Faire Mascara Media MedWatch Mermaid Tail Michigan Department of Agriculture Michigan Radio Mineral Makeup Class My Story New Products News Not Approved OFT Old Stock Open Letter Overview Party Paypal Perfect Mint Personally Identifying Information PETA Pigmentchick PIRGIM Pissed Consumer Promises Psycho Bath Co PureLuxe purpose Randoms Recall Refund Rep. John D. Dingell Repackaging RipOffReport.com Sanrio Seuss Soap Statement Store Credit Technorati Terms of Service The Conservatorie The Princess Bride The Spotted Box Tim Burton True Blood TWLOHA USPS Vegan Wayne County Health Department Web Wholesale Women's Health Working Girl Cosmetics Your Story
Powered by Blogger.