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New in Regulatory (page 42 of 45)
Dec 23, 2005 | 04:29 PM CST
The Regulatory Interface: When is it a Cosmetic and When a Drug?
By: Jean L. Fourcroy, MD, PhD, MPH, and Howard I. …
Both the cosmetic industry and the Food and Drug Administration (FDA) have had a long and interesting history. FDA’s history began in 1906 with the enactment of the Pure Food and Drug Act. This was the first attempt to regulate the safety of products (or additives). For almost 100 years Congress has set the standards and published them in the United States Code (USC). FDA and other federal agencies promulgate regulations through notice and comment rulemaking. Proposed regulations are published in the Federal Register (FR) and the public is given an opportunity to comment. The agencies then publish in the Federal Register final regulations together with a preamble discussing each comment. Industry and regulatory scientists eagerly follow these changes and access them on the Web. Final regulations are compiled in the Code of Federal Regulations (CFR).
Dec 23, 2005 | 04:23 PM CST
US and EU Regulations Update
By: David C. Steinberg, Steinberg & Associates
United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs: nasal moisturizer drug products, urinary analgesic/antiseptic drug products, urinary acidifiers and alkalinizers, aloe vera and urea, wrinkle remover products, lubricants and vaginal moisturizers.
Dec 23, 2005 | 03:55 PM CST
Canada Updated
By: David C. Steinberg, Steinberg & Associates
At the December 2003 Society of Cosmetic Chemists annual meeting, I presented a one-day session on international cosmetic regulations, and concluded by saying that 2004 would be the year of Canada. So far in 2004, three major changes have occurred.
Dec 23, 2005 | 03:01 PM CST
Updates from Europe and the United States
By: David C. Steinberg, Steinberg & Associates
European Updates The European Union (EU) Commission has not issued any changes to the Annexes of the Cosmetic Directive since September 2003 and lags in publishing many changes that have been approved. Adaptation to Technical Progress (opinions put through the EU and Ad Hoc committee review process) will be further delayed because they must be published in all EU languages. As of May 2004, the EU expanded from 15 to 25 countries, complicating the translation list.
Dec 23, 2005 | 02:34 PM CST
Sunscreen Claims: Demystified?
By: Ken Klein, Cosmetech Laboratories
As you know, sunscreen products are regulated by the U.S. Food and Drug Administration (FDA) as drugs because they are “intended” to prevent disease (skin cancer). As such, they are required to follow the rules and regulations as mandated by the FDA. Thus, they must use Drug Facts labeling; list the drugs (sunscreen actives) using the proper drug nomenclature; list the percentage of drug used; specify the drug function (sunscreen) and label; warnings and directions for use, etc.
Dec 19, 2005 | 01:43 AM CST
California Update
By: David C. Steinberg, Steinberg & Associates
On August 26, 2004, the entire cosmetic industry dodged a bullet--or rather, Armageddon–by a single vote. The California Assembly rejected a bill that would have prohibited California companies from making or selling cosmetic/personal care items that contain phthalates and other ingredients considered under this law as toxic. The vote was 4 in favor, 5 opposed and 10 others either abstained or weren’t present.
Dec 19, 2005 | 01:35 AM CST
Implementing 21 CFR Part 11 in Cosmetics
By: Richard Balano and Lenore Coyle, NOVA Technolo…
21 CFR Part 11 specifies the comprehensive set of administrative, procedural and technical controls that must be implemented when data files, records and signatures are created, maintained or archived in an electronic format as part of a program to comply with FDA rules. In the cosmetics industry, specific applications are in development and testing of OTC drugs and color additives.
Dec 13, 2005 | 11:14 PM CST
Cosmeceutical Regulations–A Global Overview
By: David C. Steinberg, Steinberg & Associates
Cosmeceuticals are not regulated as such in the Europeon Union, United States or Japan. In the EU, most are considered cosmetics; in the United States, most are seen as drugs that probably have not been approved by the U.S. Food and Drug Administration (FDA). In Japan, they are regulated as quasi-drugs. As you can see, we go from the extremes of limited regulated cosmetics in the EU to pre-approvals in Japan, and fi nally a lack of enforcement in the United States.
Dec 13, 2005 | 10:50 PM CST
USP: Setting Ingredient Standards
By: Lawrence Evans III, Ph.D., Stefan Schuber, Ph.…
This article gives an overview of the standards-setting process used in the United States Pharmacopeia and National Formulary (USP–NF), an annual publication that helps to ensure the integrity of ingredients used in cosmetics, toiletries and other personal care products.
Dec 13, 2005 | 10:45 PM CST
Effect of New Regulations on Hair Colouring Products in the EU
By: R.J.W. Hefford, Independent Cosmetic Advice Lt…
The author suggests that current and evolving regulations may lead to a positive list and fewer allowed raw materials for hair colouring products in the European Union.