Cosmetics label information

In addition to these regulations, the state of California requires that warning labels inform users of any chemical in the product known to cause cancer or be a developmental and reproductive toxicant. California also has a cosmetics disclosure law that requires the disclosure of all toxic chemicals contained in cosmetics and personal care products. ... 

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. 

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. 

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... 

FDA (Food and Drug Administration)—agency administered under the U.S. Department of Health and Human Services (formerly Health, Education and Welfare) "to enforce the Federal Food, Drug, and Cosmetic Act and thereby carry out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions drugs and therapeutic devices are safe and effective for their intended uses cosmetics are safe and prepared from appropriate ingredients and that all of these products are honestly and informatively labeled and packaged."... 

Dietary Supplement Health and Education Act (1994) Amended the Federal Food, Drug, and Cosmetic Act of 1938 to establish standards with respect to dietary supplements. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply. 

The harmonization activity should further the FDA s mission to protect the public health by, among other things, ensuring that food is safe and otherwise not adulterated or misbranded that human and veterinary drugs, human biological products, and medical devices are safe and effective as required by law and are not adulterated or misbranded that cosmetics are not adulterated or misbranded that electronic product radiation is properly controlled and that all of these products are labeled truthfully and informatively. 

The FDA is an agency within the PHS, which in turn is a part of the DHHS. The FDA regulates over 1 trillion worth of products, which account for 25 cents of every dollar spent annually by American consumers. The FDA touches the lives of virtually every American, every day, for it is FDA s job to see that the food we eat is safe and wholesome, the cosmetics we use will not harm us, the medicines and medical devices we use are safe and effective, and radiation-emitting products such as microwave ovens will not cause harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. The FDA also ensures that all of these products are labeled truthfully with the information people need to use them properly. 

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