I was sent the below in my e-mail. Interesting reading.
buenos dias,
Lynnette
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For Immediate Release
November 16, 2007
Jan Marini Skin Research, Inc. Responds to
FDA Seizure of Discontinued Eyelash Product
The Food and Drug Administration (FDA) issued a press release today, Nov. 16, announcing the seizure of a discontinued product, Age Intervention Eyelash, which Jan Marini Skin Research, Inc. (JMSR) has not manufactured or marketed for more than one year.
The FDA asserts that it has safety concerns about JMSRs discontinued product, but those concerns are not substantiated by any study or analysis that JMSR is aware of, and are certainly not substantiated by any study or analysis offered by the FDA. We are not aware of any instances where JMSRs eyelash product has damaged any users vision or caused optic nerve damage, blindness, macular edema, or uveitis and the FDA has not informed JMSR of any. The FDA press release purporting to warn consumers about such risks has no factual support we know of.
The FDAs glaring failure to take action against other eyelash products containing the same ingredient undermines its stated safety concerns. The FDA was notified months ago that several other companies have copied JMSRs discontinued product and continue to market their competing products with drug claims for eyelash growth, but the FDA has taken no enforcement action to remove those products from the market.
JMSR has conducted numerous safety tests on both its original and reformulated products, far beyond those ordinarily required for a cosmetic product, and the test results showed that both products are safe. JMSR also conducted additional safety studies at the request of the regulators and the results of those studies also showed the products are safe.
The discontinued product was stored in JMSRs warehouse since September 2006, when it was embargoed by the California Department of Health Services' Food and Drug Branch at the FDAs request. JMSR offered to destroy the product voluntarily, but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure.
JMSR reformulated its eyelash product in late 2006 to eliminate the marketing claims and the ingredient questioned by the FDA. JMSRs new Age Intervention Eyelash Conditioner does not contain bimatoprost or any other prescription drug ingredient. A new ingredient was substituted to confer similar benefits and JMSR released its reformulated product in February 2007. JMSRs current product has not been seized or embargoed.
JMSR has distributed Age Intervention Eyelash Conditioner to tens of thousands of satisfied customers with only a few instances of reported minor irritation and no reports of lasting adverse side effects.
Let's look at the claims made by Jan Marini in this press release.
1. They point out it's a discontinued product - Yes, discontinued because they knew they were going to get into trouble with the FDA if they continued to sell it.
2. Safety concerns are not validated. This isn't how the cosmetic industry works. All products are assumed UNSAFE until they are proven safe to the standards of the FDA.
3. "...no factual support that we know of." A classic logical fallacy called Ad ignorantiam. Since they aren't aware of any studies showing the product is harmful that must mean there are none. Yeah right.
4. "...the FDA has taken no enforcement action..." against other companies. This sounds so childish. "We're breaking the law but so are they. Why aren't you going after them too? If you're not going after everyone then you should let us all go." Ridiculous.
5. The product has been safety tested "...far beyond those ordinarily required for a cosmetic product," Yeah, unfortunately they are making drug claims and the safety testing done is far below those required for drugs! If they had done the testing, they wouldn't have had their product seized.
6. "...JMSR offered to destroy the product voluntarily, but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure." So, the FDA doesn't let JMSR sweep their illegal product under the rug. After announcing the product seizure just look at how many of the other rogue companies that copied the illegal Jan Marini product decided to change there formulas. Sounds like an efficient use of authority to me.
The more I read about this story, the more annoyed I get with it. People depend on we cosmetic manufacturers to put out high quality, safe products. When companies like Jan Marini cross the line and start giving questionably safe prescription drugs to the population, it makes the whole industry look bad.
I heard alot of rumors about this previously, I even heard that someone went blind because of it, but to see that the FDA confirm its harmful puts the final nail in the coffin. I used this product with some success but didn't get the full results I wanted yet and I really don't want to keep using it now. Anyone know of any safer products for eyelash growth?
Hey Left - I'm proud of your persistence on this one. Keep fighting the good fight! And I love the way you explain the logical fallacies. You should write a blog post about those!
This press release bothers me greatly. Sounds like some slick lawyers and PR people figured how to spin things so they could look blameless. Thanks for giving us the real facts, Lefty.
Based on this, I will never buy a single product from Jan Marini.
Hey, just passing along what I got in my e-mail from someone who sells her product. Don't kill the messenger.
Lynnette
After thinking this over-- I am always willing to give someone a second chance. People make mistakes. Are we all going to stop purchasing the toys from the manufacturers who have their products made in China? We are all in an uproar over the lead issue, but we will still buy their product. Or are we going to forgive them and let them make it up to the consumer? JMHO...
Lynnette
After reading all the above comments, it seems that Lynnette is the only reasonable one in the bunch! Left Brain sounds to me like the revolutionary that stands on a pedestal with a torch and fires up the mob to support her agenda! I read all the published reports about Jan Marini and Revitalash (which I use). It sounds to me like another crappy action by an incompetent governmental agency to save some kind of face in the wake of all its failings. Why did they seize the product if it had been sitting in JM's warehouse for 9 months? If women and their eyes were being so horribly endangered by the 'evil queen' of cosmetics, why didn't the White Knight of the FDA swoop in a year earlier when it would saved a damsel or two? In actuality, JM seems to have cooperated fully to address any concerns ,as unsubstantiated as they ARE. The 6 points that Left Brain makes in her reply to Lynnette's sharing message smack of biased hatred of big companies in general, always assuming that they have evil ends to make the almighty dollar. I don't explicitly trust them either but neither am I condemnatory. Both Jan Marini and Revitalash have outstanding records of safety and quality for their products. What the FDA did to JM was unwarranted, unfair and back-stabbing to meet their own ends. I have no agenda here. I don't use Jan Marini products. I just despise injustice and wish others would not be led along by the revolutionaries who claim to be there for the poor commoner who they claim to be protecting. And I thank Lynnette for her thoughtful words.
the FDA couldn't have gone in and seized anything without following their own SOPs, and testing everything (twice, thrice) to confirm that their initial suspicion had the correct results..
IF the FDA had gone in there to seize products based on initial complaints and/or suspicions, and had not done proper testing/auditing to justify seizing and banning of said products, what would your reaction be?
and all those tests do take a while.. plus there's all those paperwork and what not that they go through..
Agreed. The FDA is damned if they do and damned if they don't. If something turns out to be harmful and they don't act quickly then they're criticized. If something may be harmful but it hasn't been proven definitively and they do act quickly then their overreacting. Everyone expects them to be correct every time and also to act quickly every time but it's never that simple or easy.
Lynnette, i am not the same ampaone as you described in your message; i don't have a blog nor am involved with any groups that do, except this one. I'm just a little gal that gets overheated at others' comments sometimes. Maybe my daughter is right and I need to lighten up and watch my blood pressure! Dang , what fun is that!!??
To Karen, YEP, here we go again, ain't it fun?
To taiwanesegurl, if FDA did all that testing and auditing of lash products, why didn't they mention them in their report. In fact, they didn't even have a single case complaint that implicated any lash product. What they did say is that if one used a lash product containing the bimotoprost and was already using a glaucoma medication, that there was a possibility of harm. Newsflash! Anyone already using glaucoma meds WOULD NOT NEED a lash product because their lashes would already be out there!! Sheesh!
Purplerules, you make a good point! And that applies to us all. We all are damned if we do and damned if we don't! And Hell never hangs "No Vacancy"!
I don't think you can assume that someone already using glaucoma meds wouldn't also use a lash product. Some people who desperately want something are willing to try things that they know are dangerous. Some people would say to themselves, "Hey if I use this AND glaucoma meds, my lashes will be really, REALLY out there!" Consider that after Allure magazine published an article discussing how dangerous a new hair straightening procedure was, demand for the procedure spiked. Some people do need to be protected from themselves.
But wouldn't you need a prescription for the glaucoma drops?
I have a client who uses the drops for his glaucoma (he says his "catamaracks"!) and his eyelashes are gorgeous. It is the meds that did this and it was a prescription.
I do not think he is using lash products. I know he isn't.
Not to mention that the lash product is retailing for $160 and prescriptions are most likely covered by a plan.
JMHO,
Lynnette
Lynette, is it possible your client always had nice lashes (even before using the drops for glaucoma)? That's another variable to take into account. Some people are just blessed genetically w/ great lashes. My younger brother has had the most AMAZING lashes his whole life (long, super thick, and so curly- they curl back so far, the tips almost touch his eyelids!) and I know for a fact, he doesn't take any kind of lash products (or has glaucoma).
Sadly, those great lash genes weren't passed to me as well. *sigh*. Bro got all those. Gorgeous lashes. He's single too ladies. Just sayin`. :wink:
Ampaone, so good to have you back! We missed your side of the debate. We didn't miss your propensity for engaging in Ad hominem arguments e.g Left Brain sounds to me like the revolutionary that stands on a pedestal with a torch and fires up the mob to support her agenda!These kind of debate tactics undermine your message and aren't really needed. But to respond to your accusations I leave the following."The 6 points that Left Brain makes...smack of biased hatred of big companies in general, always assuming that they have evil ends to make the almighty dollar."
I wonder if you actually read my comments or the Beauty Brains blog. If anything it would be more appropriate to claim we have a bias against SMALL companies, not BIG companies. Big companies rarely launch products that are deemed so unsafe by the FDA that they are forbidden to sell them to the general public. Big companies know & follow FDA rules. Small companies are typically the ones that break the rules in labeling, cosmetic claims, and product safety testing.
Jan Marini is a small company who demonstrates little compunction about selling illegal products to the general population. I make no assumption that companies big or small are evil. Companies like Jan Marini and Athena Cosmetics (makers or Revitalash) make the entire cosmetic industry look bad. If they wanted to sell their product as a drug that would increase eyelash growth they could've followed the SOPs designed by the FDA to get the drug approved for that. Of course, that would've cost them a lot of money & time so it's reasonable to suspect they decided to gamble that the FDA wouldn't go after them. I'm not unhappy that they lost. Now the next rouge company will think twice before prescribing pharmaceutical grade drugs to an unsuspecting public.
You spend so much time disparaging me or the FDA and no time disputing my points except to dismiss them as "biased hatred". The only thing even close to addressing my points was when you said both Jan Marini and Revitalash (not actually a company) have outstanding records of safety. What information is that based on? Where are these records of safety that you talk about? The only record I know about Jan Marini is that they made a product that the FDA seized because of safety concerns.
You also claim that what the FDA was unwarranted, unfair and back-stabbing. What is this based on?
1. FDA seizure was unwarranted. The Jan Marini company broke the law. How was seizure unwarranted?
2. FDA seizure was unfair. I can understand this notion and agree that it is probably unfair. The FDA should get all the companies that sell similar products. However, the FDA doesn't have enough resources to catch every one. Jan Marini was the first one to sell this product. All the rest, like Revitalash, were just copy cats. The FDA probably figured they could crack down on the originator and the rest of the companies would be frightened into compliance. And according to this report, it worked.
3. FDA seizure was back-stabbing. How is this? What is the FDA's "own ends"? It seems to me that if their ends is to scare cosmetic companies into selling products proven safe then they did the right thing. I don't understand what you mean by "back-stabbing".
I'll leave you with a final thought.
If Jan Marini and Revitalash have indeed switched to an analogue of bimatoprost does it bother you that they had to kill animals to prove the new chemical was safe? All new chemicals put in cosmetics have to be animal tested before they can be used.
I hope they don't claim their products "aren't tested on animals". (Ok, that was a little over the top, but something to think about.)
Sylvie,
No, he did not have the long, lush lashes before he started using the drops. It is amazing what this has done for him. Those lashes are gorgeous and belong on a woman. I WANT THOSE LASHES!! ;-)
buenos dias,
Lynnette
It's like how pharm. companies volunteered recalled all their baby medication. Some people just don't follow directions, and in another case, sometimes no warning labels are attached. I've been on the websites for both Jan Marini and Revitalash, and neither of them warned me of not using their products if I were on glaucoma medication. Being a woman, a very vain one at that, even if my lashes were already long and beautiful from using glaucoma medication, I'd probably be vain enough to think that it could be even MORE lushes and gorgeous with this magical potion!
So like PR says, some people do need protection from themselves.
And let me tell you something about SOPs, since we've just had a bunch of them revised in our company, they are such a pain to write, revise, read, and follow. Almost every single lab technician recently got in trouble because none of us, including the super senior techs, followed 1 little line that was immediately after a big line that was BOLD, UNDERLINED, AND IN CAPS.
At least somebody caught it, and we generated a DR and set appropriate CAPA, so we won't get in trouble with the FDA. I think....
But yea.. I go to work for 8 hours, and seriously, more than 1/2 of those times is spent making sure that SOPs are followed. I made a mistake on Thursday, and had to redo the paperwork. My coworker, who had verified me earlier and signed on the original paperwork, had left already. I busted out of our building, still in my lab coat and gloves, to chase down his car. Luckily we aren't on a busy street, but one girl walking by did give me funny looks.
I just read an interesting article in Parade Magazine.
Here it is:
The Worry Over Lead In Lipsticks
This year, millions of kids toys were recalled after lead was found in them. Now a new study shows that more than half of the 33 red lipsticks tested from drug and department store brands contained detectable levels of lead, a proven neurotoxin in humans. One-third of them exceeded the Food and Drug Administrations level for lead in candy. As it turns out, the FDAwhich regulates the beauty industryhas no pre-market approval authority over cosmetics and can only ask for a product recall, not demand it. And manufacturers dont have to file data on ingredients or report injuries. Nearly 90% of the over 10,000 chemicals used in cosmetics have not been evaluated for safety, says Stacy Malkan of the Campaign for Safe Cosmetics, which conducted the study. Critics of the study assert that any trace amounts of lead ingested from red lipsticks would be harmless.
Here is the link:
http://www.parade.com/articles/editions/2007/edition_12-02-2007/Intelligence_Report
So, does this mean the FDA cannot "seize" product?
I know that they cannot go into salons and take the MMA product out of them.
buenos dias,
Lynnette
Karen, you are right, there is no point or good made by flamng.
I will ,however, say that I think it is being hypocritical to say others are engaging in ad hominem and ad ignorantium when doing the same in points 3 & 4 of the 6 points made by Left Brain. LB calls JM 'ridiculous' and does not offer evidence of the supposed tests and reports that would have warranted the FDA's actions. Or don't they have to do that rather than acting on rumors or hearsay of so-called professionals?
In her last message, she left 3 questions about the FDA actions:
1) Unwarranted? Yes, because JM had already pulled it off the market, out of stores, in full compliance with FDA instructions.
2) Unfair? Not because JM was 'targeted' as JM could understadably feel. Because the only possible results from such seizure was to diminish JM's reputation and 'cosmetically' enhamce the FDA's image.Tactics of a common bully!
3) Back-stabbing? Yes because JM responded to the FDA's concerns by fully cooperating with them without any notion that the FDA would turn around and stab them with what resulted in harmful bad publicity. For something that the FDA has no documented proof of.
Left Brain is right though in that I need to stick to the argument and not stick it to the other party. After all, I'm not a lawyer! Gotta stop acting like one.