FDA Regulation of Fragrances

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FDA "Regulation" of Cosmetics and Fragrances

Whenever the safety of perfumes and fragrances is questioned, the fragrance industry's standard reply is that perfumes are regulated by the FDA. This statement is true, as perfumes do come under the regulation of the FDA. However, let's take a closer look at what this regulation really consists of:

By law, the ingredients of a product must be listed on the label. These are listed in order of predominance. There are a few exceptions to the labeling requirements. Fragrance formulas are considered trade secrets and so the ingredients in fragrances are not required to be revealed. So the word "fragrance" must be put on any product that has ingredients added to give the product an odor. The word "fragrance" on the label may represent many ingredients, sometimes hundreds.

FDA Authority Over Cosmetics

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FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public.

FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read:

WARNING: The safety of this product has not been determined."

Prohibited Ingredients in Cosmetics

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With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA. The Federal Food, Drug, and Cosmetic Act requires that color additives used in cosmetics must be tested for safety and be listed by the FDA for their intended uses.

The use of the following ingredients is either restricted or prohibited in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants, hexachlorophene, and methyl methacrylate monomer in cosmetic nail products.

Decoding the Cosmetic Label

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Federal regulations require ingredients to be listed on product labels in descending order by quantity. Consumers can check the ingredient listing to identify ingredients they wish to avoid. Based on the amount used, an ingredient such as water is usually found at the beginning of the product's ingredient listing while color additives and and fragrances, used in small amounts, are normally seen at the end of the ingredient listing.

Cosmetic ingredient declaration regulations apply only to retail products intended for home use. Products used exclusively by beauticians in beauty salons and labeled "For Professional Use Only," and cosmetic samples, such as those distributed free at hotels and department stores, are not required to include the ingredient declaration. However, these products must state the distributor, list the content's quantity, and include all necessary warning statements.

Fragrance Free and Unscented

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"Fragrance-Free" and "Unscented" – What do these terms REALLY mean?

The terms "fragrance free" and "unscented" are presently used by the cosmetic industry virtually without restriction, since the expressions have no legal definitions. The majority of consumers consider these terms to be equivalent and interchangeable and understand these terms to mean that a cosmetic product so labeled has no perceptible odor.

Many raw materials used in the manufacture of cosmetics have characteristic odors that may be considered offensive to consumers. Because of this undesirable odor, cosmetic manufacturers add ingredients to their products to both cover any offensive odor originating from ingredients and to impart a fragrance for marketing purposes. In the case of products labeled as "fragrance free" or "unscented," manufacturers generally add fragrance ingredients to cover the offensive odor, but less than what is needed to impart a noticeable scent.

Hypoallergenic Cosmetics

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Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergenic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, are told that these products will be gentler to their skin than non-hypoallergenic cosmetics.

There are no Federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of hypoallergenic cosmetics are not required to submit substantiation of their hypoallergenic claims to FDA.