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FDA Rejects and Detains Imports from Clarins for Failure to Submit New Drug Applications

 

Las Vegas, NV -- (ReleaseWire) -- 05/23/2012 -- In 2008, the National Toxic Encephalopathy Foundation (NTEF), an environmental watchdog organization, submitted a report to the FDA on drug versus cosmetic claims made by Clarins. Citing numerous examples of drug effects rather than cosmetic claims.

Like a recalcitrant child, Clarins kept making drug versus cosmetic claims on their products. Which the FDA is now seizing and detaining from importation.

“We are glad that the FDA is finally addressing fraudulent cosmetic claims, which in fact are drug claims, said Jack D. Thrasher, Ph.D., Toxicologist/Immuno-toxicologist/Fetal-toxicologist and Technical Director of the NTEF. Industry for too long has had free reign to market their products with complete disregard for federal labeling and importation regulations.”

On March 15, 2012, Clarins was entered on the FDA’s List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List), “Unapproved drugs present serious safety and effectiveness concerns. When evidence exists for the marketing or promotion of unapproved drugs to individuals residing in the United States…”. For their
Wrinkle Smoothing (Skin Care Preparations), Mult-Active [sic] Day Early Wrinkle Correction Cream. [1]

This was not the first time that Clarins has had a product returned or detained for drug claims along with false claims for the product. They have been on the FDA’s watch and detain lists for an extended period of time.

“FDA's Newark district office investigator Jacques Maravic looked on last October [1998] while 7,500 1/2-ounce bottles of Clarin's Double-Serum Multi-Regenerant Anti-Aging Total Skin Supplement and 94,000 accompanying pieces of literature in English and Spanish were loaded into a 40-foot-long container. The goods, valued at nearly 100,000, were on their way to being shipped back to the French manufacturer from whence they had come. In any language, it spelled fraud.”

Inspecting the finn's Oakland, N.J., warehouse in October 1988, Newark district investigators found that Double-Serum labels continued to include drug claims. In addition, the brochures were found at department store counters in Washington, D.C., and New York City in December 1988 and March 1989. During a follow-up inspection in May, investigators found 1,560 units of Double-Serum at the Oakland warehouse with 87,000 pieces of literature making false claims for the product. On July 20, at FDA's request, the materials were seized, and in September, Clarins entered into a consent decree, agreeing to export the materials back to the supplier, Clarins, S.A., in Paris, France. [2]

In April 23, 1988, Clarins stated: “Carol Schuler, vice president of advertising and creative services for Clarins U.S.A., said: ''There will be more copy talking about the appearance of beautiful skin, not how products help to promote it. We are not going to be able to explain things in quite as much detail.”” [3]

“Apparently, they were attempting current damage control, that never resulted in a change in the company’s advertising policy,” said Thrasher.

In August of 2008, the FDA determined that Clarins Expertise 3P was in fact a drug not a cosmetic and requested that they submit a New Drug Application. Which upon information and believe they pulled the product rather than submit said application.

Since 1994, Clarins has been on the FDA’s INTENSIFIED COVERAGE Alert, for drug claims. [4]

On June 17th, November 15th and 22nd of 2011, other Clarins products were added to the FDA’s Import Refusal Lists. [5, 6]

The products in question were:

June 17, 2011
SUN WRINCKLE [sic] CONTROL CREAM SPF 30, SUN WRINCKLE [sic] CONTROL CREAM SPF 15, SUN CREAM HP SKIN SPF 30 (SUNSCREN) [sic], SUN SOOTH CREAM PROGRESIVE TANNING SPF 20 (SUNSCREEN), SUN SPRAY OIL FREE LOTION SPF 15 (SUNSCREEN), SOS SUNBURN SOOTHER, SUN SMOOTH GEL FAST TANNING SPF 10, AFTER SUN GEL UTRA SOOTHING

November 15, 2011
FIRMING BODY OIL-TONIC, MEN ABS FIRM, STRECH MARKS CREAMS

November 22, 2011
CLARINS MULT ACTIVE DAY EARLY WRINKLE CORRECTION CREAM

All of the above referenced products were refused for the following reason:
UNAPPROVED 505(a), 801(a)(3); UNAPPROVED NEW DRUG The article appears to be a new drug without an approved new drug application. "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]" OASIS charge code: UNAPPROVED.

January 12, 2012, they again appeared on the FDA list regarding: "Skin Care Products Labeled As Anti-Aging Creams". List of firms and their products subject to intensified surveillance…but the nature of violations may warrant further field examinations…(a.k.a. Yellow List). “There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs.” NOT LISTED 502(o), 801(a)(3); MISBRANDING It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k). [7,8]

April 16, 2012, FACIAL LOTION, NOT LISTED 502(o), 801(a)(3); MISBRANDING It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k). [9]

“The FDA is currently reviewing two petitions regarding Angel Perfume/Cologne for women and men, regarding toxicity, mislabeling and allegations of incorporating ingredients that have systemic adverse health effects,” said Thrasher. “Along with neurological developmental concerns affecting the developing fetus. We expect the FDA to grant the petition and remove these fragrances from commerce.”

“Consumers may want to return these products, since they were purchased predicated on certain advertising claims, that seem to be negated or questionable,” said Thrasher.

[1] http://www.accessdata.fda.gov/cms_ia/importalert_190.html?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Import%20Alert%20#%2066-41&utm_content=1

[2] http://www.national-toxic-encephalopathy-foundation.org/FDASEIZED.pdf

[3] http://www.nytimes.com/1988/04/23/style/consumer-s-world-softer-sell-in-ads-for-beauty-products.html

[4] http://www.accessdata.fda.gov/cms_ia/importalert_188.html

[5] http://www.accessdata.fda.gov/scripts/importrefusals/ir_selection.cfm?DYear=2011&DMonth=6&IndustryCode=53

[6] http://www.accessdata.fda.gov/scripts/importrefusals/ir_selection.cfm?DYear=2011&DMonth=11&CountryCode=

[7] http://www.accessdata.fda.gov/cms_ia/importalert_188.html?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=june%2017,%202011%20import%20refusal%20list&utm_content=2

[8] http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=AEK-8578468-0&DocId=6&LineId=1&SfxId=D&utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=clarins%20refusal%20list&utm_content=2

[9] http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=J49-0320358-7&DocId=2&LineId=9&SfxId=&utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=clarins%20refusal%20list&utm_content=1