Cosmetics labeling

Polymer resins tosylamide/formaldehyde resin, alkyd resins, acrylics, vinyls, polyesters, aryl-alkylsulfonyl urethanes, glyceryl tribenzoate, and tosylamide epoxy resin. These improve adhesion and gloss. Tosylamide/formaldehyde resin is the official name for toluene sulfonamide formaldehyde resin (TSFR), used in labelling cosmetics. In California, toluene is a restricted substance listed in that state s Proposition 65, and this may have prompted the official name change (Schlossman and Wimmer 1992). 

Hair products are normally cosmetics and are thus subject to aU. laws and regulations that control the labeling and claims of aU. cosmetic products. There are, however, several significant variations to this premise, ie, hair colorants, professional use only products, and products that make dmg claims. 

Although these professional-use-only products do not require ingredient labeling, the cosmetics industry has developed a program to voluntarily Hst the components of professional products. However, under this voluntary program, the ingredients are Hsted in alphabetical order rather than descending order. This has been done to make it easier for the professional hairdresser to locate a specific compound that may be of interest. 

Dmg and Cosmetics Act and the Fair Packaging and Labeling Act. Each of these Acts imposes slightly different conditions and labeling requirements for the products under their jurisdiction. 

The Fair Packaging and Labeling Act, which uses the same definitions for dmgs and cosmetics as the Food, Dmg and Cosmetic Act, only has jurisdiction over retail products sold to the consumer for use at home. This condition exempts free samples and professional use products not sold to a consumer for personal use. 

Labeling Regulations. The Food, Dmg and Cosmetics Act requires that the cosmetic product be safe under conditions of use and that labeling is not false or misleading. Under this Act, the labeling of a cosmetic product must contain the name and address of the manufacturer, packer, or distributor the net contents and any appropriate warnings. This information must appear on the label of the product, both inner and outer containers. 

FDA has pubHshed two final rules for hair products as of this writing (69). Any over-the-counter (OTC) dmg product labeled or promoted for external use as a hair grower or for hair loss prevention is regarded as a new dmg and must be the subject of an approved new dmg appHcation (NDA). Products making these claims without an NDA are considered to be ia violation of the Federal Food, Dmg and Cosmetic Act and are also mislabeled. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Economic summaries of the cosmetic industry, commonly documented by sales volume, are sometimes based on unit sales, sometimes on manufacturers sales in monetary units, and sometimes on consumer spending. Figures normally include contributions by private labeling operations but do not necessarily reflect the value of the industry service sector, which includes suppHers of raw materials, beauticians, testing laboratories, and other speciaHsts. Moreover, product categories caimot be rigidly defined. For example, the differentiation between a deodorant (a cosmetic) and an antiperspirant (an OTC dmg) is often obscured by its trade name. 

Hair colorants, the fourth class of color additives, may be used only to color scalp hair and may not be used in the area of the eye. Use of these colorants is exempt, that is, coal-tar hair dyes may be sold with cautionary labeling, directions for preliminary (patch) testing, and restrictions against use in or near the eye. The EDA diligently enforces the rules governing color additives and limits the use of, or even dehsts colorants deemed unsafe. The Hst of substances specifically prohibited for use in cosmetics is short. 

EEC proposals also assert that cosmetic products must not damage human health when appHed under normal or reasonably foreseeable conditions of use. Pinally, the EEC directive states that the label of a cosmetic should include a Hst of ingredients in descending order of weight at the time of manufacture. 

CTFA adopted names are used this notation is used for cosmetic labeling. 

The strongly re search-oriented dentifrice market is dominated by a few primary companies. The industry funds efforts to develop products with superior cosmetic and therapeutic performance. The four principal manufacturers of toothpaste worldwide are Procter Gamble, Unilever, Colgate-Palmohve, and Beecham. Numerous smaller companies and private-label houses also exist. 

If the rejection was for cosmetic reasons, there is no problem but if the rejection was an out-of-tolerance condition the product should either be reworked, repaired, or regraded because the original decision may not be acceptable to all customers. If you do not do these things, the internal concessions should be carried through to the final inspection label, so that if a customer requires products to a particular specification you can check whether the out-of-tolerance condition will be acceptable. 

The term FD C color, often seen on ingredients labels, refers to food, drug, and cosmetic colors. These are organic compounds (as opposed to inorganic pigments, such as titanium dioxide) that are so intense in color that it takes only very tiny amounts to color something, and thus they can be used in concentrations so minute that they are safe for consumption. 

Subchapter D - Information and Education Subchapter E - Environmental Impact Review Subchapter F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics Subchapter G - Safety Reports... 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

A survey of product labels in the cosmetics section of a supermarket will quickly reveal that, quite rarely would a preservative appear in isolation. Preservative combinations are used very widely in most personal care products and there are some very tangible reasons for this ... 

Fig. 8 Example of the advertised indication (cures) from the labeling of a widely used patent remedy, before Enactment of the Food, Drug and Cosmetic Act of 1906. (From Ref. 10.)...

In the home, you or your children may be exposed to lead if you take some types of home remedy medicines that contain lead compounds. Lead compounds are in some non-Westem cosmetics, such as surma and kohl. Some types of hair colorants and dyes contain lead acetate. Read the labels on hair coloring products, use them with caution, and keep them away from children. 

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