Thursday, December 11, 2008

Is SkinMedix an Authorized Retailer? 

Good question! We know that our customers are sometimes confused about the terms “authorized” and “unauthorized” retailers, so we’d like to set the record straight.

 At SkinMedix.com we provide only the highest quality products from America’s leading manufacturers. But the fact is that big corporations like to have as much oversight over their marketing as possible, because more control means bigger profits. They like to operate vertically—that is, with direct control over everything from research to manufacturing to retail sales. This makes it easier to keep retail prices high and profits as big as possible.

 We love their products, and so do our many satisfied customers. But that doesn’t mean that SkinMedix.com needs to be part of the big corporations’ distribution systems. 

 Big companies want you to buy from their “authorized” dealers because they make a bigger profit. At SkinMedix.com, we operate outside the corporate system. We are not authorized to sell many fine products at such low prices by the manufacturer, but we are certainly authorized to do so by the laws of the United States.

Wasn’t There a Legal Case About This?

 Yes, there was! In one recent case, the Supreme Court held unanimously that an American company cannot block the domestic sale of genuine products that had been obtained through legal channels. The Court ruled that once a product had been distributed in an authorized manner (the “first sale,” according to Federal copyright law), the copyright owner had no further control over the product's fate.

 The Supreme Court's decision overturned a lower court case establishing copyright law as a defense against unauthorized retailers. In 1996 the United States Court of Appeals for the Ninth Circuit, in San Francisco, had ruled that a distributor of genuine beauty products had infringed the copyright on a brand of hair products manufactured in the United States for sale at a discount. In the U.S. market, the products were intended for exclusive sale in salons.

 The Supreme Court ruling supports free trade that benefits American consumers. The products in question are authentic American-made goods, not counterfeit or pirated. Trademark law was not at issue in this case because the challenged products were legitimate products authorized by the manufacturer for sale. So big corporations sought to use copyright law as a source of protection.

 How do I benefit?

 Simple—lower prices! Because SkinMedix.com is free to sell genuine cosmeceuticals at a price determined in a free market—not by the manufacturers—we can offer bigger savings than other retailers.

 We are proud of our products and stand behind each and every one. All products on the website are guaranteed to be authentic. At SkinMedix.com, we are dedicated to your total satisfaction and well-being. We don’t just sell cosmeceuticals—we provide happiness!  

Wednesday, February 27, 2008

Jan Marini Eyelash - The Whole Story

We've been offering the ultra popular Age Intervention Eyelash Conditioner by Jan Marini Skin Research for several years here at SkinMedix.com and we're amazed at the amount of misinformation, rumor and confusion that surrounds this product. When a customer inquired yesterday "Didn't several people go completely blind from using that?" we knew it was time to post some clarification. And no, absolutely no one has gone blind from using the eyelash conditioner. In fact, the FDA confirmed to the Wall Street Journal in November 2007 that they had received not a single report of patient injuries or adverse effects related to use of the eyelash product.

Much of the confusion resulted from an FDA press release back in November 2007, but the story starts long before that. For the last decade, eye drops containing ingredients known as prostaglandins with fancy names like latanoprost and travoprost have been used to treat glaucoma. These prostaglandins work by decreasing the amount of pressure in the eye, but have some strange side effects. Increased lash length, thickness, and pigmentation are well-documented side effects of prostaglandin analog glaucoma drops. It was only a matter of time before a skincare company such as Jan Marini Skin Research developed a product to make this side effect an intended effect.

In 2005, JMSR unveiled its product entitled Age Intervention Eyelash (not to be confused with Age Intervention Eyelash Conditioner) which contained the prostaglandin analog bimatoprost. Unfortunately for the company, JMSR made some serious errors bringing this product to market. First, bimatoprost was already in use as the patented prescription drug Lumigan, made by the pharmaceutical giant Allergan. Second, JMSR did not divulge the complete ingredient list on the packaging - instead labeling the active ingredient "Eyelash Growth Factor". The third problem with this initial product was the way it was promoted. In the USA, a company cannot make claims like "grows eyelashes" without first presenting evidence that such claims are true to the Food and Drug Administration.

On a positive note, the initial Age Intervention Eyelash did live up to its claims, and it seemed to work for nearly everyone. SkinMedix.com has never received such overwhelmingly positive feedback on a single product and sales increased rapidly as positive publicity of this product spread. Suddenly, in September of 2006 the product became unavailable. We know now that all 12,682 tubes in JMSR's inventory were embargoed by the FDA while they investigated this product.

Undeterred, JMSR set out to tweak the formula to remove the patented prostaglandin and replace it with a similar unpatented analogue, change the packaging to include all ingredients and remove all claims. The resulting reformulated product "Age Intervention Eyelash Conditioner" emerged in February of 2007. The reformulated version was initially greeted warily by consumers, as it was unclear what exactly had changed or if the new reformulated version would work as well as the original. It wasn't long before it was evident that the reformulated version worked as well as the original product.

JMSR enjoyed 10 months of growing sales of the new "conditioner", and the product was touted by innumerable stories on local news stations and a positive spot on Good Morning America. The company also released a complementary mascara that contained the new prostaglandin formulation. Then in November 2007 the FDA "seized" the original embargoed product creating mass confusion due to the similarity of the names Age Intervention Eyelash and Age Intervention Eyelash Conditioner. Although the product the FDA seized had not been on the market for over an entire year, the press release recommended "that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommended that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use." To date both Jan Marini and the FDA claim there have been no reports of such adverse events.

Thus began the confusion of new and reformulated Jan Marini eyelash products and a host of misinformation and panic. Bloggers picked up the story and erroneously used terms like 'recall' and 'pulled from the market' to further add to the confusion over an FDA action on a product that hadn't been on the market for 14 months. A knee-jerk reaction from eBay prohibited the sale of both products almost immediately. Jan Marini herself helped to clarify the issue with messages to resellers and to visitors to janmarini.com, stressing that the FDA seizure had nothing to do with the current product (see email below).

If this incident wasn't enough to drive Jan Marini to throw in the towel, a patent infringement lawsuit was filed by Allergan against JMSR on November 7th 2007. Jan Marini Skin Research announced in January 2008 they would no longer distribute the Eyelash Conditioner or the Masses of Lashes Performance Mascara.

So that's the story of how this popular product was discontinued by the manufacturer without a single report of an adverse effect, unless you count Jan Marini's headache.

SkinMedix

From: Info < info2@janmarini.com>
Date: Nov 18, 2007 4:17 PM
Subject: A Personal Message from Jan Marini
To:

A Personal Message from Jan Marini

You are among our extremely valued customers and we wanted to notify you regarding the recent government announcement.

The FDA has issued a press release announcing the seizure of our DISCONTINUED "Age Intervention Eyelash" product. As you know, this product was embargoed because of labeling issues in September 2006 and has not been manufactured or distributed since then. (14 months) We released our reformulated product, "Age Intervention Eyelash Conditioner" in February 2007.

We were surprised and disheartened by the FDA's action for three reasons. First, we offered to voluntarily dispose of the product at JMSR's expense. Second, the FDA's safety concerns have never been substantiated and we believe are without merit. The FDA has not identified a single user whose eyes have been damaged by our product, and among tens of thousands of users, Jan Marini Skin Research is not aware of any. JMSR has numerous and excellent safety studies that clearly demonstrate the safety of both the discontinued and new product...

Attached is our media response to the FDA announcement.

This is a trying event to say the least and we truly appreciate your loyalty and support. Please be assured that we are here to assist you.

Warmest regards,

Jan Marini

Jan Marini Skin Research, Inc.

---

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 JMSR's 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 JMSR's eyelash product has damaged any user's 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 FDA's 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 JMSR's 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 JMSR's warehouse since September 2006, when it was embargoed by the California Department of Health Services' Food and Drug Branch at the FDA's 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. JMSR's 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. JMSR's 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.