Did Clarins Make 100 Label Violations Regarding Their Fragrances and Cosmetics?

June 17, 2008 - PRLog -- Yes, according to The National Toxic Encephalopathy Foundation (NTEF), who has submitted two formal complaints to the Food and Drug Administration (FDA) regarding the cosmetic and fragrance company, Clarins US.

Clarins has been under investigation by the NTEF since October 2006, when we first reported their incorporation of peanut ingredients in their cosmetics line.  

Since that time two formal petitions regarding their fragrances Angel and Angel Men were submitted to the FDA.  These primarily had Coumarin, a precursor for an anticoagulant drug and the sunscreen chemical Benzophenone 2, an endocrine disruptor in them. Additionally, a formal complaint regarding their Expertise 3P Poly Pollution Protection (3P) product’s claims of: “represents the most advance protection against every type of pollution known today; first time in cosmetology it also protects against the effects of artificial electromagnetic waves;  first time in cosmetics it also protects against the effects of artificial electromagnetic waves; invisible shield of reinforced protection against all types of pollution we encounter today; Biological protection against artificial electromagnetic waves; Biological protection against all urban atmospheric pollution; claims of an unprecedented scientific discovery.”  Which the United Kingdom’s Advertising Standards Authority took them to task on and required that they stop using claims unless they could be backed up scientifically.

These new complaints reference over 30 additional products which the NTEF feels incorporate over 100 labeling violations under the current FDA rules and regulations.

Clarins use of Coumarin was found in four other products. Clarins is again using peanuts and other allergenistic nuts in their cosmetics without the proper label notification as required by The Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282) which went into effect in January 2006. Whether the French accept the fact that peanuts are a health issue is not the point.  Clarins markets their products to the American consumer and therefore are required to follow the mandates of the United States Government.

Clarins has made numerous claims for their products that the NTEF feels are medical claims rather than cosmetic claims. One of the more repetitive was the incorporation of their 3P product and active ingredients which was referenced in over 10 products. Clarins product packaging claims established the intended use of this product as a drug as defined by section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. subsection 321 (g)(1).  Furthermore, the product is a new drug under section 201(p) of the FDCA, 21 U.S.C. subsection 321 (p), because it is not generally recognized by qualified scientific experts as “effective” for its intended use.  Nor may this drug be marketed in the United States without prior approval of the FDA.

The NTEF has requested that the FDA initiate a full investigation into the consistent and concerted efforts by Clarins to usurp governmental requirements in selling their products to the American consumer.  Along with the FDA’s refusal to allow these products to be allowed through customs and introduced into the American retail marketplace.

# # #

National Toxic Encephalopathy Foundation is a 501 (c)(3) and 509(a)(1) non-profit public charity organization, whose core purposes are to provide research, education and services to the growing segment of the population who are adversely affected by everyday chemicals and toxins in our environment.

Established in 1998.