Isopropyl Cloprostenate FDA

Attention all skin care professionals! Do you carry Revitalash, RapidLash or Neulash? FDA warns sellers to stop sales. Read more…

April 24, 2011 Beauty, Other 2 Comments

Big lashes have made such a splash in the fashion world and they may be turning into a woman’s best friend. Products that claim to boost growth and thickness of lashes are becoming a must have for all fashionistas.

Unfortunately, these must-have products seem to be turning into a big nightmare for both manufacturers and sellers of certain lash conditioners that contain a compound called compound Isopropyl Cloprostenate.

This compound has been shown to have adverse side effects like irritation, inflammation, discoloration. Pregnant women are also being advised to avoid this ingredient. The FDA is urging sellers to discontinue selling any product

that contains isopropyl cloprostenate of “Misbranding” and it’s harmful sideffects.

Two of the most popular brands are RevitalashRapidLash and NeuLash.

If you’re carrying these products, please check the document below for more details.

If you’re either a seller or consumer looking for a more natural line of lash growers and conditioners, check out MD LASH FACTOR, a patented formulation guaranteed to show results within months of use without the adverse side effects. Personally, I am both a user and a believer. Mention Smallworld Beauty Blog, and receive a special discount.

I hope that all manufacturers of the affected brands will come to a better solution and relaunch with a better and safer formulation, but until then, alternative lines that contain FDA regulated ingredients be the the best option overall.

Good luck to all skin care professionals who are dealing with this inconvenience.

ATTENTION:   COSMETIC RETAIL DISTRIBUTORS

SUBJECT: FDA U.S. Food and Drug Administration Warns Eyelash/Eyebrow Conditioner Distributors

DATE: April 22, 2011

Dear  Cosmetic Store Owner/Manager,
This is to inform you that on April 18, 2011, FDA U.S. Food and Drug Administration have officially filed Warning Letter for Eyelash/Eyebrow Conditioner brand holders for “Inspection, Compliance, Enforcement, and Criminal Investigation”.
This letter is in reference to these firms’ involvement in the manufacturing, distribution, and promotion of  Eyelash/Eyebrow Conditioner:
“under section 601(a) of the Act (21 U.S.C. § 361(a)), a cosmetic is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.  “RapidLash” and “NeuLash” are adulterated cosmetics under section 601(a) because they bear or contain a deleterious substance that may render them injurious to users under the conditions of use prescribed in their labeling.  Specifically, “RapidLash” and “NeuLash” contain isopropyl cloprostenate which, under the conditions of use prescribed in the labeling, may cause the following injuries: ocular irritation, hyperemia, iris color change, macular edema, ocular inflammation, and interference with intraocular pressure reduction therapy.  In addition, as mentioned above, prostaglandin analogs for ophthalmic use are currently classified as Pregnancy Class C; women of childbearing age are considered at risk for injury.  ”
It is a violation of section 301(a) of the Act (21 U.S.C. § 331(a)) to introduce or deliver for introduction into interstate commerce any cosmetic that is adulterated or misbranded.
As presently formulated, labeled and promoted these products violate provisions of the Federal Food, Drug, and Cosmetic Act.  The listed brands of products are reported to be UNAPPROVED NEW DRUG AND MISBRANDED DRUG.

Please note,  there are other brands of lash conditioner that contains  the compound Isopropyl Cloprostenate .   If you currently distribute or use lash or brow conditioner,  we urge you to  carefully review your brand’s ingredient list to avoid possible regulatory and consumer issues.

For more information, please visit this public report at:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251951.htm?sms_ss=email&at_xt=4db10c8089a4ed56%2C0

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