Cosmetic Ingredient Label Declarations

Section 5(c)(3) of the FPLA specifically authorizes FDA to promulgate regulations requiring the declaration of all cosmetic ingredients on product package labels of cosmetics considered ''consumer commodities'' (loc. cit., Ref. 24(b)); these regulations are codified at 21 CFR 701.3. Exempt from the ingredient declaration requirement are professional cosmetic products, such as hair and skin preparations or makeup products used by cosmetologists, beauticians, or aestheticians on clients at professional establishments such as salons, spas, and theaters, provided that these products are not also sold to consumers through the professional establishments, workplaces, or other miscellaneous beauty supply retail outlets for their consumption at home; such cosmetics are not legally considered ''consumer commodities.'' Similar exemptions apply to ''free'' (gratis) samples, gifts, cosmetics distributed as free amenities at hotels, and cosmetics and toiletries made available to workers and visitors (but not sold) for on-site use at occupational settings, such as construction sites, hospitals, clinics, etc. However, cosmetic products offered as ''gift with purchase'' are ''consumer commodities'' and subject to the ingredient declaration requirement, because the ''gift'' is only available in conjunction with a retail sale. Professional cosmetic products exempt from the ingredient declaration requirement are frequently labeled ''for professional use only.''

Ingredient declarations must be ''conspicuous'' and ''prominent'' in placement on any appropriate information panel of the outer container, and not less than certain size specifications in relationship to the size and shape of the product package, in order to ensure that the declaration is likely to be read at the time of purchase by the consumer.

FPLA labeling requirements specify that cosmetic ingredients must be declared, in descending order of predominance (see 21 CFR 701.3 [a]), utilizing ingredient names derived in hierarchical order of precedence from the nomenclature sources specified by regulation (see 21 CFR 701.3 [c] and 701.30); alternatively, the ingredients may be grouped and the groups declared according to 21 CFR 701.3 (f). The ''common or usual'' names specified by regulation in the United States are required to be stated in the language understood by American consumers, namely English, except as provided at 21 CFR 701.2 (b) (see Cosmetic Labeling, p. 746, loc. cit.). Cosmetic ingredients present at one percent or less (< 1%) may be declared after ingredients present at higher levels without regard to order of predominance, and fragrance and flavor, if any, being complex compositions of matter in themselves, may be declared for purposes of product package label-

Figure 3 Typical cosmetic label elements. (Note: For illustrative purposes only. See 21 CFR 701 for correct letter heights and proportions.)

ing as "flavor" and "fragrance," respectively. ''Incidental ingredients" (see 21 CFR 701.3 [1]) need not be declared, and those ingredients accepted by the FDA as exempt from public disclosure and granted ''confidentiality'' or ''trade secret'' status may be declared as ''and other ingredients'' (see 21 CFR 720.8).

''Soap'' products meeting the requirements of 21 CFR 701.20(a)(1) and (a)(2) are exempt from the FPLA requirement for mandatory label ingredient declarations applicable to cosmetics.

The manner of declaration of ingredients in OTC drug-cosmetic products is specified at 21 CFR 701.3(d), as recently amended (see 64 FR [email protected], March 17,1999). Drug ''active ingredients'' present in OTC drug-cosmetic product formulations are declared first, as required at 21 CFR 201.66(c)(2) and (d) of this chapter, and following the standard-format ''Drug Facts'' information fields (i.e., ''Use(s),'' ''Warnings,'' ''Directions,'' and ''Other Information''), any ''inactive'' or cosmetic ingredients are declared in descending order of predominance or grouped, in accordance with the provisions of 21 CFR 701.3(a) and (f), respectively. An exception in the manner of declaration of inactive or cosmetic ingredients is provided for, if there is a difference in the labeling provisions in 21 CFR 201.66 and Sections 701.3 or 720.8; under these circumstances, the labeling provisions at 21 CFR 201.66 are controlling (see 21 CFR 201.66(c)(8) and (d) of this chapter).

Recent efforts to achieve ''international harmonization'' with cosmetic ingredient nomenclature standards required by the 1976 European Union (EU) Cosmetic Directive [27] and its more recent amendments [28] have resulted in the FDA agreeing to exercise regulatory discretion toward the interim use of parenthetical ''dual declarations,'' employing systematic Linne (Latin) taxonomic genus/species nomenclature for certain categories of ingredients (i.e., botanicals and/or ''trivial'' ingredients) pending review of a citizen petition submitted by CTFA [29]. Color additives are named using the monograph titles in their respective listing regulations (see 21 CFR 73, 74, 82), although, here, too, the impact of ''international harmonization'' efforts has resulted in the FDA agreeing to exercise regulatory discretion towards the interim use of parenthetical ''color index (CI) numbers'' in a dual declaration [29]. Examples of the new interim ''harmonized'' ingredient declarations are given in Table 4.

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