80 REGULATIONS
that the product is destroyed or suitably reconditioned. Manufacturers and distributers are responsible for obtaining all data and information to substantiate the safety of their products. Cosmetic products which are also drugs must either receive premarket approval from the Food and Drug Administration through the new drug application process or conform to a monograph for a specific drug category. The Food and Drug Administration has published monographs for acne medications, treatments for dandruff, seborrheic dermatitis, psoriasis and sunscreens.
Adulterated and misbranded cosmetics
Adulterated cosmetics are covered in section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 361). A cosmetic is deemed to be adulterated if it contains a “poisonous or deleterious substance” which may be harmful to the consumer when used according to the directions on the label or when used in the customary or usual manner.4
Coal-tar hair dyes are
exempted from this requirement if they contain a specific caution warning. A cosmetic product is also deemed to be adulterated if it contains “any filthy, putrid, or decomposed substance”; if it has been manufactured, packed or stored under insanitary conditions which may lead to the product becoming contaminated or injurious to human health; or if it has been packed into a container that contains a “poisonous or deleterious substance” that may make the product harmful to human health.
A cosmetic product is considered to be misbranded5
if it contains false or
misleading information on its label; if it is lacking required information on the label; if information required by the Federal Food, Drug, and Cosmetic Act is not prominent enough on the label; if the packaging is misleading; if it is a colour additive which has been improperly packaged and labelled; or if its packaging or labelling violates the Poison Prevention Packaging Act of 1970. Nanomaterials may be used in a formulation providing they comply with the requirement that the product is not adulterated or misbranded.6
Prohibited and restricted ingredients Unlike the European Regulation (EC) No. 1223/2009 which contains long lists of prohibited and restricted ingredients the Code of Federal Regulations specifically prohibits and restricts the use of very few ingredients. The Code of Federal Regulations prohibits the following ingredients: bithionol (21CFR 700.11); chloroflurocarbon propellants in cosmetic aerosols (21 CFR 700.23), chloroform (21
PERSONAL CARE EUROPE
CFR 700.18); halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) (21 CFR 700.15); methylene chloride (21 CFR 700.19); vinyl chloride (21 CFR 700.14); zirconium containing complexes in aerosols; and some ingredients derived from cattle (21CFR 700.27). It restricts the use of hexachlorophene to a maximum concentration of 0.1% when no other preservative has been shown to be effective providing it is not used on the mucous membranes such as the lips; and mercury compounds to a maximum concentration of 65 ppm of mercury in eye area products when used as a preservative if there is no other safe and effective preservative available. Sunscreens can be used in cosmetic products to protect the products colour providing the label contains a suitable explanation such as “Contains a sunscreen to protect product color” (21CFR 700.35). If the explanation is not present then the product may be considered to be a drug.
Colour additives
Colour additives except for coal-tar hair dyes are subject to approval from the Food and Drug Administration.7
The colours
which have been approved for use and exempt from batch certification are listed in Part 73, Subpart C of Title 21 of the Code of Federal Regulations. The colours which have been approved and are subject to batch certification are listed in Part 74, Subpart C, and Part 82 Subparts B, C, D. For each colour additive the Food and Drug Administration has specified whether the colour can be used in the eye area, generally (which includes lipsticks) or external use. For some colour additives there are maximum concentration usages. Full information on colour additives and their intended uses can be found on the Food and Drug Administration website.
Coal-tar hair dyes Coal-tar dyes are treated differently to colour additives, they do not need approval from the Food and Drug Administration.8 Under US law the Food and Drug Administration can take action if a cosmetic product is harmful to the consumer when used in the customary or expected way. However the Food and Drug Administration is not able to take action against coal-tar hair dye products if the label contains a special caution statement and there are adequate directions for the consumer to carry out a skin test prior to using the product. The special caution statement is as follows: “Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not
be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”9 The Food and Drug Administration can take action if the product does not contain the caution statement on the label or another ingredient other than the coal-tar hair dye itself is harmful. Hair colouring dyes made from plant or mineral sources are regulated in the same way as colour additives and must get Food and Drug Administration approval and be listed in the colour additive regulations. Coal-tar hair dyes are not permitted to be used to dye eyebrows or eyelashes. Colour additives intended to colour the eyebrows and eyelashes require Food and Drug Administration approval.
Good manufacturing practice The Food and Drug Administration has published draft guidance for good manufacturing practice.10
The guidance
covers documentation, records, buildings and facilities, equipment, personnel, raw materials, water, colour additives, prohibited and restricted cosmetic ingredients, production, laboratory controls, internal audit, complaints, adverse effects and recalls. It incorporates elements of ISO 22716:2007.
Sunscreen products Sunscreens are over the counter drugs and are regulated by the Food and Drug Administration (21 CFR 352). The sunscreen actives which can be used in sunscreen products are: Aminobenzoic Acid (PABA), Avobenzone, Cinoxate, Dioxybenzone, Homosalate, Menthyl Anthranilate, Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, Padimate O, Phenylbenzimidazole Sulfonic Acid, Sulisobenzone, Titanium Dioxide, Trolamine Salicylate, and Zinc Oxide. Unlike the European cosmetics regulation (EC) No. 1223/2009 which does not restrict the combinations of sunscreen actives, the Code of Federal Regulations restricts which sunscreens can be used together.11 Sunscreen products can make a water resistant claim if they satisfy the water resistant sunscreen product testing procedure.12 The Sunscreen Innovation Act was enacted on 24 November 2014 to provide an alternative process for the review of safety and effectiveness of sunscreen actives. The safety data required to establish that an over the counter sunscreen active ingredient is generally recognised as safe and effective (GRASE) include human irritation and sensitisation studies, human photosafety studies, human absorption studies/maximal usage trial, paediatric considerations, carcinogenicity studies, development and reproductive toxicity studies and toxicokinetics.13
April 2018
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