FDA Dispute Resolution-Followup

Two hours after my email to the FDA Office of the Ombudsman regarding the escalation of my complaint about the March 23 FDA Enforcement Report and the information within it I received a reply.

My concerns have been forwarded to the Compliance Division of the FDA Center for Food Safety and Applied Nutrition, the FDA regulatory arm for cosmetics.

I will update as more information becomes available.

FDA Dispute Resolution

I emailed the FDA Office of the Ombudsman  at ombuds@oc.fda.gov to escalate my FDA complaint in regards to the March 23 FDA Enforcement Report and the information it contained.

According to the FDA site the Office of the Ombudsman is for dispute resolution:

The Office of the Ombudsman is a resource for individuals and for companies when they are experiencing problems with the regulatory process or with the application of FDA policies or procedures. The Office of the Ombudsman provides assistance if there are problems or concerns that are not being addressed, or cannot be addressed, at the center or district level, or when there are concerns about raising an issue at that level. If requested, confidentiality will be maintained by the Office of the Ombudsman to the greatest extent possible.

I outlined my concerns about the information provided to the FDA about the recall, including the communication of the recall by the company and the possibility that the reach exceeds the 500 units in commerce that was reported to the FDA. I included a link to the post with supporting information and I identified myself by name.

There is no clear turnaround time for response, but I plan to make a follow up call in a week to (301) 796-8530 if I have not heard back about my concerns with the handling/reporting of the GlitterSniffer Cosmetics recall.

Wash, Rinse, Repeat: GlitterSniffer Cosmetics Commits to Change

On April 10, 2011 GlitterSniffer Cosmetics recommitted to a 3-5 day turnaround time, and a "150%" commitment to turn "this ship around". They cited "a serious rough few months" and depression, but stated they were finally ready to make some "serious changes".

GlitterSniffer Cosmetics has a history of recognizing the need for change and committing to it.

From July 28, 2010:

December 21, 2010:

October 23, 2010:

December 23, 2010:

and from January 13, 2011, the 'official' recall information.

In the ten days since their commitment to give 150% here is the reality of what has been happening:

The email address was supplied by a fan, not GS.

 

All these were taken from the GS Facebook Fan Page and most have since been removed.

From 4/19/11, an announcement that orders were being sent. Of the eight replies from paying customers waiting for orders four were asking about replacement or incorrect orders.

Currently the only thing publicly for sale on the GlitterSniffer Cosmetics Artfire is a 1/2 Pot of Pigment for $1.00.

There are no ingredients in this listing. As they are technically samples the FDA does not require ingredients to be labeled, though it should be noted that GS themselves committed to list all ingredients for all products they sold after the recall.

 

Though it has been reiterated numerous times and the company has recognized the need for change and even commits to it it is demonstrable that they continue to fail to follow through, with the issues arising again in increasingly shorter intervals. People are still waiting on refunds promised since December. Orders are still incorrect, if they are received at all. Emails are still going unanswered. 

When two blogs, a Twitter, and a Facebook page are created to inform people of your business practices, and the page alone has a membership that is 10% of your company's Facebook fan base that should be a clear indicator that something is extremely amiss.

That the company committed to serious changes not ten days ago and then went right back to not answering emails shows that it's going to take a mighty big rudder and a steady hand at the helm to turn the GS ship around. I know I for one will be watching to see how exactly they plan to do it.

Mark Twain once said “If you do what you’ve always done, you’ll get what you always got.” It seems in the case of GlitterSniffer Cosmetics  truer words have never been spoken.

GlitterSniffer Cosmetics Mineral Makeup Class

Recently GlitterSniffer Cosmetics announced it would be holding a Mineral Makeup formulating class.

 

The class was to be held at the Redford, MI YWCA on April 23 with a cost of $35.00.

I was made aware that several people had contacted the YWCA with their concerns regarding the class and the possibility of liability for the YWCA. It should be noted that GS stance is that all of their current products are eye approved and their formulating techniques are sanitary.

The class had ostensibly been canceled, with no clear explanation given, though the event invite was still on Facebook. I contacted the Redfield YWCA to confirm the cancellation on 4/15/11. After several phone calls I was informed that it was indeed canceled, that the event invite was still up in error, and was given an apology for the misinformation. The direct quote from the person I spoke with at the YWCA was "We are not affiliated with her". The event invite for the class has since been removed.

The event has now been rescheduled and GlitterSniffer Cosmetics is encouraging attendees to bring their friends and older children.

GlitterSniffer Cosmetics has been less than forthcoming regarding the details of the rescheduled class. After a bit of research and a phone call I was able to determine that the rescheduled class will now be held on Saturday, May 7 at 3 PM at Redford Karate. The cost has been lowered to $15.00 and attendees will be able to keep whatever they make. It is speculation at this point as to whether Redford Karate knows of the past recall and formulation concerns as well as the business practices of GS, but a person no longer publicly identified as being an employee of GS appears to have had some hand, at least tacitly, in the booking and hopefully would have disclosed this information so that RK could make an informed decision.

4/19/11 ETA: I have received an email stating that the class has been canceled. According to the email Redford Karate was informed of GlitterSniffer Cosmetics past and current business practices by a former customer and opted not to have the class.

Buyer Beware: The Conservatorie

**I would like to make it unequivocally clear that I have no knowledge that GlitterSniffer Cosmetics ever purchased from The Conservatorie. This post is about an ingredient supplier and it's effect on several MMU companies and is being posted for informational purposes as The Conservatorie has not made the information public. If you are a formulator or a person who purchased from The Conservatorie for personal use please take a moment to check your ingredients. Though the company is not publicly releasing this information there is a chance that what you have been sold may not be used for what you intended.**

Over the last few months safety of Indie MMU has been in the spotlight. I am very cognizant of the fact that there are people who are now shying away from Indie makeup due in part to this blog. This is very unfortunate, as most Indie MMU sellers are safe and put out amazing, unique products, and, for the most part, this blog is here to illustrate the business practices of one company. GlitterSniffer Cosmetics is not representative of Indie MMU as a whole. Most Indie MMU companies take safety seriously and the health of their customers is their first concern.

Recently two of these companies were faced with the unfortunate task of recalling products. RockABetty Beauty and Morgana Cryptoria initiated recalls after discovering that their ingredient supplier The Conservatorie (first link on the google search) had changed their ingredient information and what they had previously purchased as either eye or lip safe or vegan was, in actuality, not.

In the case of RABB the company responded to customer concerns about glitter fallout by checking the ingredients on The Conservatorie site, only to find that the listings had changed and none of the glitter they had purchased was eye safe. The company immediately pulled all of their shades containing glitter and posted about the recall. They offered several options to their customers, including reformulated shades, trades for other shades, refund, or store credit. They then followed through on all their commitments.

Morgana Cryptoria discovered the ingredient changes in their own research. As a matter of course they research ingredients even if they have previously purchased them. As soon as the company realized the ingredients had been changed they issued a recall on some of their lipsticks, offering store credit, refund, or exchange. In all nine shades were recalled, some as containing carmine (the lipsticks were sold as vegan) and some not approved for lip use in the US as they contained Chromium Oxide Green or Ferric Ferrocyanide. Morgana Cryptoria has also followed through on their commitments.

A third company, whose line has yet to be launched, has had to reformulate at least 4 shades as they contain carmine, an ingredient change that affects this particular company as they will sell strictly vegan product. Due to issues with the INCI listing on The Conservatorie site they may have to reformulate several more.

There has been no effort on the part of The Conservatorie to notify customers that they changed their ingredients. Had it not been for the diligence of the above mentioned formulators the issue would still be unknown.

There was another change to The Conservatorie site as well. If you click the first link in the google search linked here, scroll to the bottom, and click on the Policies link you can read the suppliers' revised policy. This policy is what prevents me from linking directly to the site. Another change is that it, in effect, releases the company from any liability whatsoever. It states that they do not guarantee that any of their information is correct and that everything on the site is used 'at your own risk'.The company has made an all out effort to protect themselves, but no effort to communicate the ingredients changes to their customers.

At this time there is no official word as to why The Conservatorie has not made public these changes which have already resulted in 2 recalls. All three of the formulators I've written about in this post have been in contact with the company and they are aware that the changes have resulted in recalls and reformulation.

So what changes were made? Some of their products are now listed as containing carmine, Ferric Ferrocyanide, Chromium Green Oxide, and Chromium Hydroxy Green. Some glitters, previously listed as eye safe, are no longer listed as eye safe. You can review their updated ingredients list by accessing any of their micas and clicking on the Info Chart, which opens a PDF. Below I will post screenshots of Google cached versions of some of their affected previous ingredients for comparison.

A note about Chromium Green Oxide and Chromium Hydroxy Green as The Conservatorie now has them listed. It seems that The Conservatorie is referring to Chromium Oxide Green and Chromium Hydroxide Green, neither of which are lip safe. Even with the updated list the ingredients are not correctly listed. These names are not INCI compliant. Anyone going off this list to label would still be labeling incorrectly as the INCI is incorrect. As per the FDA ingredients on cosmetics must be listed in descending order of predominance by INCI. The correct INCI for these are Chromium Oxide Green (CI 77288) and Chromium Hydroxide Green (CI 77289).

Here are the screenshots for the previous ingredients for some of the affected ingredients, as of 3/7/11 per Google cache.

And from The Conservatorie Twitter, dated 2/3, an answer about the safe use of their glitters:

I present this information for a couple of reasons. As consumers we have a right to know that what we are purchasing, be it from a commercial cosmetics company, an Indie company, or a supplier is what it claims to be. The Conservatorie is not being forthcoming and the extent of the reach of these ingredients is unknown. These recalls do not lie at the feet of the Indie MMU companies who purchased these ingredients and people should know that. I also wanted to show that not all recalls have to be handled in the manner that GS' is.

I would like to thank RockABetty Beauty and Morgana Cryptoria not only for their permission to publish, but for the manner in which their recalls were handled. They could have easily pulled their products and reformulated, but they did not. They researched and did what was best for their customers. Both companies were transparent and apologetic. Though unfortunate, the recalls for these companies only serve to illustrate that diligence in research, concern for the customer, and simply doing what is right goes much farther than the fact that a product had to be recalled ever could. That both companies stepped up to the plate, not only in terms of their recalls, but in answering my inquiries and wanting first and foremost for others to be informed by this publication speaks volumes. It is a horrible situation to be in, but both handled it with grace and a business acumen geared toward the customer.

Again, if you purchased from The Conservatorie please check your ingredients. Be Safe. Be informed. Be well.

GlitterSniffer Cosmetics and the FDA Enforcement Report

On March 23, 2011 The Food and Drug Administration released their Enforcement Report. Included in the Enforcement Report was the recall by GlitterSniffer Cosmetics. The report states the facts that were provided to the FDA by GlitterSniffer Cosmetics regarding the recall, including the recall list, number of products, and notification methods.

FDA Enforcement Report, March 23, 2011

In looking at the report it appears that there may be some issues with the information.

The recall list shows everything that has been officially recalled by the company and the stated reason is thus:

The firm is recalling products which contain ingredients that are not approved for use around the eye.

If this is the case then where are the pink and green mascara on the list?

 
By the company's own admission neither of these products is eye approved, yet these products were omitted from the recall and the information provided to the FDA.

The FDA was also informed this in terms of distribution:

VOLUME OF PRODUCT IN COMMERCE
500 units

A rough accounting, gathered from the GS Complaints Facebook page, Twitter, and email is 1269 pots of recalled pigment. That number is a rough estimate of official recalls, posted by people who saw the message in 18 hours, who felt comfortable sharing. When a non specific number was given (such as 20+) it was rounded down.

This could be easily dismissed as speculation, because there is no solid proof that the amount people state they had is indeed what was dispensed to the public by GlitterSniffer Cosmetics.

Here is just one photo of the roughly 600 pots of recalled product sent home with an Ex-GS Admin in late January/early February.

It should be noted that this alone represents more recalled product than was disclosed to the FDA by GlitterSniffer Cosmetics, and there are still many people who either traded, sold, used, or simply disposed of their recalled product. Suffice to say the estimate given to the FDA by GlitterSniffer Cosmetics appears to be incorrect.

Additionally, the FDA was told that letters were sent out as of February 7, 2011 regarding the recall. As of the writing of this post, not a single person who responded has received a communication via letter about the recall from GlitterSniffer Cosmetics.

Here is what has started arriving in late March instead: Free, postage paid samples given to new fans of GlitterSniffer Cosmetics.

It would seem that once again, GlitterSniffer Cosmetics is not following up on its commitments not only to its customers regarding the recall process, but to the FDA as well.

An Apology and a Request

I apologize I have not been posting. I have had to deal with some issues offline that required my attention. It is my sincere hope to be back to regular posting soon. I have much to share regarding the current state of GlitterSniffer Cosmetics business practices and my ongoing followup on my own complaints.

In the meantime I have a question. Has anyone that purchased GlitterSniffer Cosmetics prior to the recall in 12/2010 received a letter via US Postal mail regarding the recall from GS? The letter would have arrived after February 7, 2011. Please feel free to comment or email, whichever you prefer. I appreciate any information anyone is willing to provide.

Thank you again for your understanding and patience. More information soon.

4/11/11 ETA: To clarify, I would like to know if anyone who may have received products prior to the recall directly from GlitterSniffer Cosmetics, whether purchased or given for review, has received a letter via US Postal mail from GS regarding the recall. Additionally, approximately how many products did you have that were on the official recall list? These would include all those listed here and every pink manufactured between 2006-2010. This does not include anything not officially recalled.

I appreciate your time and hope that these questions will make a bit more sense in a post by tomorrow morning. Thank you.