Navigation Links
FDA to Take Up Major Enforcement Action Against Cosmetics Manufacturers With Illegal “Anti-Aging” Labeling Claims, According to FDAImports.com, LLC
Date:5/24/2010

U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) will soon initiate a major enforcement initiative against cosmetics product labels bearing illegal drug claims, including “SPF,” “anti-aging,” or “anti-wrinkle,” according to Benjamin L. England, former 17-year FDA veteran and FDAImports.com, LLC Founder.

(Vocus) May 24, 2010 -- U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) will soon initiate a major enforcement initiative against cosmetics product labels bearing illegal drug claims, including “SPF,” “anti-aging,” or “anti-wrinkle,” according to Benjamin L. England, former 17-year FDA veteran and FDAImports.com, LLC Founder.

FDA issued Import Alert #66-38, “Skin Care Products Labeled As Anti-Aging Creams” (IA 66-38) in 1988, subjecting cosmetic manufacturers—including several large, non-U.S. cosmetics importers Estee Lauder, L’Oreal, Avon, Almay and Fleur de Sante—to “intensive surveillance” for importing cosmetics with drug claims on cosmetic product labeling. FDA appears to be cracking down on importers whose cosmetic product labels bear illegal drug claims. As recently as April 2010, FDA added 93 cosmetics products and four firms to the IA 66-38 “Yellow List,” which subjects those companies’ imported cosmetics to “intensive FDA surveillance” including increased import field examinations. “These additions to the alert show that FDA is getting serious,” said England. With a major enforcement initiative coming soon, Mr. England noted, “cosmetics manufacturers and importers of all sizes will likely see increased enforcement on labeling compliance generally, and drug claims, in particular.”

However, some have questioned whether the import alert is enough to curb importation of cosmetics products containing these and other illegal drug claims (e.g., “SPF,” “anti-aging,” or “anti-wrinkle”). Recently, FDA has been increasing its reviews of imported cosmetics. As a result, it has also been detaining more shipments of cosmetic products bearing impermissible drug claims and cosmetics with more technical labeling violations. “The more FDA looks, the more FDA finds,” noted England. All of this is about to increase in intensity and focus, apparently. According to some FDA officials, the agency is preparing a notification to the industry reminding companies about the importance of complying with all labeling requirements for topical cosmetics and over the counter drugs. This probably will come in the form of a group of FDA Warning Letters to a number of cosmetics manufacturers and distributors alleging that because of the claims on the labels, the articles they are selling are actually misbranded or unapproved new drugs. This new initiative seems reminiscent to the recent “Front of Package” food labeling enforcement initiative (announced in March 2010 by FDA Commissioner Margaret Hamburg).

The new FDA cosmetics labeling initiative “will likely bring a measure of parity to FDA’s enforcement practices, since it appears FDA has mainly targeted small cosmetics importers in the past,” said England. “It’s as if, compared to smaller importers, FDA has given multinational companies a ‘get out of jail free’ card on importing cosmetics bearing these kinds of claims.”

Some large firms have received Warning Letters from FDA concerning illegal claims on their product labels. “Then what?” asks Mr. England, “It’s apparent FDA believes the labeling claims are illegal, so it issued Warning Letters. And yet, these products, with these same labeling claims, continue to make it to the U.S. market. In the meantime, FDA detains products from smaller manufacturers imported by smaller importers.” It is expected that FDA’s upcoming enforcement action plans will decrease the inequality of current enforcement at the border and ‘little importers’ will no longer be singled out.

Cosmetics are used for promoting attractiveness or altering the appearance of the consumer. So, all labeling claims must be “cosmetic” claims. Claims that a product can be used to counteract, retard or control the aging process or its effects are drug claims and are illegal on cosmetic labeling. “Anti-wrinkle claims are a big ‘no-no’ to FDA,” says England, “yet look around you the next time you walk through the beauty section of a major department store in the US. Apparently FDA believes it is time to do more than ‘just say no.’”

If you are a cosmetics manufacturer or importer potentially subject to IA 66-38, or are concerned about your product labeling compliance, let FDAImports.com, LLC show you ‘the way through.” FDAImports.com, LLC is a consulting firm that helps importers avoid the financial hardship of FDA enforcement by solving problems before they arise, and by quickly resolving existing enforcement matters. Don’t let a Warning Letter or other FDA enforcement action subject your firm to being placed on the Yellow List of Import Alert #66-38. Contact FDAImports.com today to help your firm succeed in the U.S. cosmetics marketplace without FDA enforcement.

###

Read the full story at http://www.prweb.com/releases/fda-imports/cosmetic-labeling/prweb4037144.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Fertility Fact vs. Fiction: Women Recognizing Age as a Major Obstacle
2. Untreated, Mild May Become Major Depression
3. Doctors miss major cause of infertility and obesity
4. Major New Study Finds Soyfoods Safe and Beneficial for Women With Breast Cancer
5. New approach to emissions makes climate and air quality models more accurate, major study finds
6. Parabit Systems Successfully Installs Infant Protection Systems at Major Long Island Hospitals
7. Fastrack Announces Major Expansion
8. Major Imaging Initiative to Shed Light on Little Known Brain Disease
9. The Concord Grape Commands Attention at Major Scientific Conference
10. The International Multiple Sclerosis Management Practice Announces Major Expansion Plans to NYC Headquarters
11. A Finnish-Swiss team cracks the atomic structure of a major cancer drug target
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA to Take Up Major Enforcement Action Against Cosmetics Manufacturers With Illegal “Anti-Aging” Labeling Claims, According to FDAImports.com, LLC
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/25/2016)... ... 2016 , ... Experts from the American Institutes for Research ... June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR experts ... planning, healthcare costs and patient and family engagement. , AIR researchers will be ...
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
(Date:6/23/2016)... MOUNTAIN VIEW, Calif. , June 23, 2016 ... 9:00 a.m. CST on Thursday, July 7, 2016 , , ... kayla.belcher@frost.com ) , , , , EXPERT PANELISTS:  ... Sciences, Nitin Naik; Senior Industry Analyst, Christi Bird; Senior Industry Analyst, ... The global pharmaceutical industry is witnessing ...
(Date:6/23/2016)... , June 23, 2016 The vast ... an outpatient dialysis facility.  Treatments are usually 3 times ... hours per visit, including travel time, equipment preparation and ... patient, but especially grueling for patients who are elderly ... a skilled nursing and rehabilitation centers for some duration ...
Breaking Medicine Technology: