Recent in Claims/Labeling (page 6 of 7)

Study Reports VapoRub to Cause Breathing Issues in Infants

Vicks VapoRub, a popular topical congestion remedy, was reported to cause airway inflammation, resulting in restricted breathing in infants and toddlers, according to a study by Wake Forest University.

Comparatively Speaking: Trademarks, Principal Register vs. Supplement Register

The Principal Register grants benefits to registered trademarks; the Supplemental Register is primarily designed for marks to distinguish the applicant's goods or services

Manufacturers Trying to be Green on Product Labels

Manufacturers are trying to prove to consumers that their products are eco-friendly, according to a study.

FDA Issues Warning Over Hand Sanitizer Claims

The US Food and Drug Administration (FDA) has issued a warning letter to Procter & Gamble Co. over hand sanitizer claims.

CTFA Establishes Code for Cosmetic Companies

The Cosmetic, Toiletry and Fragrance Association has announced that the Consumer Commitment Code is now in effect.

Misleading Product Claims

Consumers rely on product labels nearly every day. For many, labels provide answers to questions a consumer may have about results, but what if those labels aren't entirely accurate.

The Labeling of Fragrance Allergens in the European Union

The 7th Amendment to the Cosmetic Directive of the European Union (EU) has added 26 new contact allergens that the EU states must be listed on the ingredient declaration if they exceed certain minimum levels.

FDA Proposes Labeling Rule for Color Additives
[Feb. 2, 2006]

The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register requiring the declaration of carmine and cochineal extract...

Substantiating Claims for a Tanning Magnifier

Tanning magnifiers, known in the United States as tanning accelerators, enhance the substrate or the production of melanin. One example is an innovative N-acyl derivative from L-tyrosine. This article describes a way to evaluate its pigmentation efficacy after UV irradiation. Also discussed is the regulatory status of tanning magnifiers.

The Regulatory Interface: When is it a Cosmetic and When a Drug?

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).

Sunscreen Claims: Demystified?

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.

Cosmeceutical Regulations–A Global Overview

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.

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