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Type: Article

Section: Regulations

Industry Debate: US FDA vs. Sunscreens

During last month’s NYSCC Suppliers' Day, several attendees expressed frustration regarding the delay of the US Food and Drug Administration’s Final Sunscreen Monograph. Cosmetics & Toiletries asked its LinkedIn members to comment. Here’s what the market had to say.

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Why the FDA's 'Sunscreens in the Bloodstream' Study is Flawed

A recent study published in the Journal of the American Medical Association tested the potential systemic absorption of certain sunscreens. Results identified their presence in subjects' bloodstreams; however, as industry expert David Steinberg explains, the study is misleading and fails to consider crucial variables.

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Croda Ingredients Aligned with FDA New Proposed Regulations for Safer Sunscreens

Croda offers a range of metal oxide dispersions that have been identified as the preferred route to safe and effective UV protection.

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FDA Weighs in on Holographic Cosmetics

Holographic, iridescent and other special effect color additives have been allowed to shine in recent consumer trends. Click through for the U.S. Food and Drug Administration's take on how these additives are regulated.

FDA Prepares for Y2K

Yes, here we are in year 2000. Its well-known acronym "Y2K" has been the subject of increasing conversation over the past year. It has not arrived!

The FDA's 'Wish List': A Unified Agenda

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the publication of a semiannual inventory of the rulemaking under development, and the US Department of Health and Human Services (HHS) publishes this wish list for the FDA. The latest came out on Dec. 7, 2009.

Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.

Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

Frequency of Use of Organic UV Filters as Reported to the FDA

The author reports on frequency of use of 17 organic UV filters in nearly 18,000 formulations voluntarily reported to the United States government as of May 2003.

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

US Regulations Update: FDA Issues Final Monograph for Skin Protectants

On June 4, 2003, the FDA published the Final Monograph (FM) for Skin Protectant Drugs for Human Use.

In response to the FDA's proposed ten cent per pound fee increase, Dobos explains how the price has not been adjusted since 2005 and represents an approximately 30% increase.

Dobos Responds to U.S. FDA's Proposed Color Additive Fee Increase

Considering the U.S. Food and Drug Administration's (FDA's) proposed ten cent per pound fee increase on color additives, Dobos responds here noting that the price has not changed since 2005 but it also represents an approximately 30% increase.

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Is Your Microbiology Lab FDA-compliant? Part I: Personnel, Facilities and Equipment

This two-part article provides an overview of areas relevant to the U.S. Food and Drug Administration’s (FDA’s) inspection of cosmetic microbiology laboratories. Part II will appear in our July 2018 edition.

Regulatory Review—US and Canada Updates: Canadian Cosmetic Harmonization and the FDA's Claim Crackdown

Several major regulatory changes are coming in cosmetics from Canada, while in the United States, the U.S. Food and Drug Administration (FDA) has been active in sending out warning letters to cosmetic companies making unapproved drug claims. This column provides an overview of them.

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Pick and Choose—Balancing Sunscreen Benefits: Sun Protection or Vitamin D?

It’s well-known that over-exposure to UV light is harmful to the body, yet it is vital for production of essential vitamin D. Understanding the balance between the benefits of sun protection and vitamin D synthesis is not yet well understood.

Recent stories from the FDA include 5000 lbs of eye shadow that were seized en route to Washington state, Unilever recalling dry shampoo and the appointment of Norman Birenbaum in the FDA.

FDA Roundup: Cosmetics Seized, Unilever Recall, Cannabis/Public Health Hire and More

Recent stories from the U.S. Food and Drug Administration include: 5,000 lbs of eye shadow seized en route to Washington state, Unilever recalling dry shampoo, the appointment of cannabis expert Norman Birenbaum as public health advisor, and more.

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.

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