FDA Petition 99P 1340
The Environmental Health Network of California
files
Petition with the FDA
The Environmental Health Network of California has filed a petition with the FDA to have the fragrance Eternity by Calvin Klein declared misbranded. The basis of this petition is the lack of a warning label on the product informing consumers that all the materials in the product and the product has not been adequately tested for safety.
Cosmetics which includes personal care products, hair dyes, make-up, lotions, creams, deodorants, toothpaste, perfumes, and colognes are not required to be safety tested before marketing. However, if each individual ingredient in the product and the final product has not been adequately tested for safety the product is to carry a warning label to that effect.
21 CFR 740.10
Subpart B--Warning Statements Sec. 740.10 Labeling of cosmetic products for
which adequate substantiation of safety has not been obtained. (a) Each
ingredient used in a cosmetic product and each finished cosmetic product shall
be adequately substantiated for safety prior to marketing. Any such ingredient
or product whose safety is not adequately substantiated prior to marketing is
Page 201 misbranded unless it contains the following conspicuous statement on
the principal display panel: Warning--The safety of this product has not been
determined.
Independent lab analysis revealed the use of ingredients that the chemical, physical, and toxicological properties have not been throughly investigated. The health and safety data that is available on these materials raises concerns over their use in fragranced products.
The following analysis of a fragrance demonstrates the types of materials
found in modern fragranced products and the health and safety data available. A
typical perfume is made up of approximately 80% ethanol and 20% fragrance
formula.
PETITION TO THE FDA
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