Thursday, August 22, 2013

FDA Non Approved Drug Used In Peter Roth Eyelash Products

Ingredient Labels Are Crucial In Identifying A Potential Risk Of Harm

Peter Roth LLC created a brow, mascara and eye lash treatment containing an ingredient that is found in Latisse, known for growing longer and thicker eyelashes.  I guess they felt they could offer an eyelash treatment similar to that of Latisse.

In looking at the ingredient label for this eyelash treatment known as "Lashes to Die For Plantinum", it is clear due to the location of the prostaglandin as the second ingredient, it could be considered high in content therefore becoming an active ingredient.  It is clearly added for some purported benefit due to their claims.

The ingredient label follows below:

Water, 17-Phenyl Trinor Prostaglandin E2 Serinol Amide, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Panthenol, Retinyl Palmitate, Ascorbyl Palmitate, Tocopheryl Acetate, Phospholipids, Cyclodextrin, Triethanolamine, Disodium EDTA, Methylparaben, Imidazolidinyl Urea

The product description follows below:

A nighttime eyelash treatment that helps lashes appear nearly twice as long, in just eight weeks.  It will dramatically increase the appearance of lash length, thickness, and fullness in just four to eight weeks. This formula's key ingredient, Prostaglandin Analogue Complex, is concentrated at clinical strength to deliver dramatic results. Lashes are strengthened and nourished with Vitamins A, C, E, pro vitamin B5, and aloe vera.  This product is ophthalmologist tested, endorsed, and recommended.  

Research Results:  In an eight week clinical trial on 40 female subjects (ages 18-60):- 100 of users reported the appearance of longer lashes.- 100 of users reported the appearance of thicker lashes.- 100 of users reported the appearance of fuller lashes.

As I have written in the past about clinical studies, especially on such a small number of women, the results can be whatever the trial wants to report.  Was this a controlled study, instead of a blind study?  Was this their study or a study duplicated by Latisse?  Is it their product that is endorsed by ophthalmologists or are they following the endorsement provided with Latisse?   Many questions..... and without these questions being factored in for the public, this proves nothing, including not revealing in the study on any side effects, only on the purported benefit. 

The Drug Benefit Now Becomes A Liability

Unfortunately, in my opinion and apparently the opinion of the Tennessee Attorney General's office (I'll get into that later), this is irresponsible on the part of the manufactures of this eyelash product.  They essentially are taking a controlled substance and infusing it into their eyelash formula without any drug monograph or warnings to the user as to any known side effects which accompany this drug, at all points of sale.

Peter Roth LLC has not done FDA approved studies proving the benefit, let alone the lack of care in releasing a drug on the open market in the form of a cosmetic in the first place without the FDA approved clinical trials....essentially placing the consumer in harms way.  Latisse duplicated studies cannot be extrapolated to Peter Roth products.  They must perform their own independent trials.

They also can't have it both ways legally; on one hand make product claims only to not list the proprietary ingredient as "active" and then place a disclaimer on the same package.

The drug component of this product can have similar side effects of other prostaglandin analogues such as bimatoprost.  So the users eyelash area where this drug is applied, similar to Latisse warnings, could turn blue and the color of the eye (the iris) could change to brown along with experiencing irritation, redness, and extreme tearing.   I mean really, why do you think Latisse is available by prescription only?

Where this goes beyond being reprehensible, the product is sold at multiple locations such as Amazon and Sephora, and they offer no medical warnings or drug interactions with the drug 17-Phenyl Trinor Prostaglandin E2 Serinol Amide contained in this eyelash treatment at the point of sale.  So, if you're using medicated eye drops to manage glaucoma, this could have an impact on your eye health.  An Opthalmologist should be consulted on this drug interaction if using any medication for your eyes...since eyes are sacred, and damaging them...well there is no going back and this scares the heck out of me.

However, how would one unsuspecting consumer know since the ingredient is added benignly among other ingredients instead of showing it as "Active"?  Did they do this to avoid FDA compliance with gaining OTC drug approval or following labeling requirements?  So now the unsuspecting user of this product is placed at risk of having any of these reported drug side effects, and once the iris changes color, it becomes permanent.  Is this worth it for our vanity sake?

Tennessee Attorney General Takes Peter Roth LLC To Task

Peter Roth LLC did resolve the lawsuit filed by the Tennessee Attorney General’s office after allegations that their products contained  FDA non approved ingredients in a product being sold as a cosmetic.  The company was alleged to have included a derivative of the drug compound prostaglandin in eye lash products “Lashes to Die For” (now discontinued), “Brows to Die For” and “Lashes to Die For Platinum.” (the replacement for the original due to a higher drug ratio was incorporated into the product)

The state says that using this potent hormone-like chemical without authorization and without informing customers of the health risks violates the Tennessee Consumer Protection Act of 1977.

The lawsuit was resolved by Roth denying any wrongdoing but voluntarily agreed to stop selling the products.  Attorney General Cooper said: “Although there were no complaints from Tennesseans, we are satisfied the company agreed to stop sales and comply with the law before anyone could be harmed.”

I can assure you however, the FDA disclaimer they place on the labels does not remove their responsibility of not following FDA drug regulations, and the State of Tennessee agrees.  If you're going to incorporate a known FDA regulated drug into the formulas, it is now a drug / cosmetic combined, and needed FDA approval as an OTC drug, just like more, no less.

SIDE NOTE For Clarification: In regard to the use of minerals in makeup where they are known as an FDA approved OTC for sunscreens, and not listed as "active" do not fall into the same category since they are also defined by FDA as a colorant and are used to change shades on color products.  It is about the claims of the purported sunscreen benefit which would change a cosmetic to a drug, as Peter Roth did in his claims made on the label along with the fact that the ingredient in question is a DRUG, constituting this as an OTC drug.

The investigation of the eyelash and eyebrow products yielded positive results for protecting consumers.  They were essentially accused of having “illegally manufactured, marketed and sold the eyelash products that contain analogs or derivatives of the drug phostaglandin without FDA approval.” 

They did reach a settlement and it specifies that the company will stop selling their eyelash products in the state until they have been authorized by the FDA or declared outside its jurisdiction.  The company was also ordered to make a token payment of $1500.00 to cover attorney’s fees and costs of the investigation.

I have noticed though, that Sephora and other websites have done the responsible thing by no longer making it available, which is a good thing since this should not be isolated to just Tennessee.  However, you can still find it being sold by Ebay stores and Amazon.  An example of the blind leading the blind...basically "no one told them!"

What The Heck Is All The Hoopla About This Drug?

Prostaglandins are chemical compounds used for medical purposes to lower blood pressure, regulate body temperature and platelet formation, control inflammation and vascular permeability and affect certain hormones.

They are commonly used in cosmetic eyecare products by prescription only, or at the very least getting approval as an OTC drug / cosmetic because of their effect of creating longer, thicker lashes through a drug benefit, which in turn would include a drug monograph warning consumers of drug reaction and interactions.

They have been associated very rarely with health problems in some customers.  Although Prostaglandins are legal in the US, the state claims that if Roth wished to include them in their products, they needed to obtain approval from the FDA and disclose the fact to customers.

No matter the minimal effects from the drug, a side effect is a side effect and should be divulged at the point of sale so the consumer can make an intelligent decision in regard to their health when it comes to spending their hard earned dollar.

Peter Roth Not Alone On This One

The Tennessee state Attorney General also settled in February with cosmetics company Nutraluxe LLC, who agreed to stop selling the so called “Beautylash” products which were found to contain prostaglandin derivatives or analogs as well.

Nutraluxe, who retailed their brand through Amazon, also denied wrongdoing as part of the settlement of the lawsuit.....well of course they did.

My only question at this point is, why a local state had to intercede?

I'm waiting and watching to see, if ever, the FDA will become involved since this is a prime example of a cosmetic which would be determined by the FDA as ILLEGAL and MIS-BRANDED!

In the meantime folks....PLEASE check your ingredient labels where provided, and if there is an ingredient you don't understand or aren't sure of, hit the PAUSE button and put the item back on the shelf after notating the ingredient in question and then Google it...either at home or right there on your cell phone.  It may very well keep you from having an unexpected reaction due to lack of knowing what the heck it is.

And for those that continue to not disclose the ingredients to the public all for the sake of masking certain ingredients, or only list the "key" ones.....then by all means, take your dollars elsewhere.  Because you'd have to wonder what else they are hiding...wouldn't you?

We always comply with truth in labeling and disclose every ingredient used at the point of sale where you add to your shopping bag and is on all of our product labels.  No secret ingredients or mysterious labels, just the facts!

Be Wise and Be Safe!

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