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Section: Regulations

Pf Fda Lead 31319

Ned Sharpless to Serve as Acting FDA Commissioner

The announcement comes following the resignation of Scott Gottlieb, who devoted his tenure to addressing youth e-cigarette use and modernizing food safety.

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FDA Issues Warning on Certain OTC Analgesic Topical Products

The FDA has asked six companies to respond to the warning letters within 15 days of receipt stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law.

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.

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FDA Reports 646 Voluntary Cosmetic Registrations in One Month

The U.S. Food and Drug Administration reported 646 cosmetic products were voluntarily registered in August 2020.

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FDA Calls Preliminary Public Meeting for International Cosmetics Regulation

The U.S. FDA announced it will hold a public meeting in June to prepare for the broader International Cooperation on Cosmetics Regulation meeting of worldwide authorities in July.

The U.S. Food and Drug Administration reported 357 cosmetic products were voluntarily registered in December 2020. This brings the total of filed products to 17,357 since 2018.

FDA Adds 357 Voluntary Cosmetic Registrations in One Month

The U.S. Food and Drug Administration reported 357 cosmetic products were voluntarily registered in December 2020. This brings the total of filed products to 17,357 since 2018.

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.

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FDA's Quarterly Color Additives Report: Red Alert

"Most notable in this certification report is the total absence of Red 6 Lake," Kelly Dobos reports.

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FDA Clarifies Executive Summary on Talc is Solely to Solicit Data

In response to concerns that the FDA's Executive Summary on talc could be interpreted as official recommendations, the agency clarified this summary is solely intended to solicit scientific information.

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.

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FDA Warns 1,500 New Sanitizer Makers: Follow the Rules

Safety and fraudulent claims are new concerns in the hand sanitizer market. Since the U.S. Food and Drug Administration (FDA) eased restrictions, some 1,500 new hand sanitizer manufacturers have registered to help; but many are not following the FDA's policy.

The virtual public meeting will inform manufacturers of agency efforts to develop regulations to establish good manufacturing practices for cosmetics.

[updated] FDA to Outline Efforts Toward Good Manufacturing Practices

The U.S. Food and Drug Administration (FDA) will hold a virtual meeting, "Good Manufacturing Practices for Cosmetic Products Listening Session," on June 1, 2023.

FDA Issues Warning Letter for Eyebrow/Eyelash Growth Product Claims

Cosmetic manufacturer Lifetech Resources LLC has been issued a warning letter by the US Food and Drug Administration (FDA) regarding claims touted on three of its eye care products.

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Dermatology Association Urges FDA to Postpone Program for Isotretinoin Patients

Patient safety while taking isotretinoin depends on the careful oversight of the prescriber, according to the American Academy of Dermatology Association.

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FDA Calls Out Contaminants, Methanol and Packaging in Latest Alerts

Methanol content, yeast contamination and packaging resembling beverage bottles are among the U.S. Food and Drug Administration's latest hand sanitizer and product recall alerts.

The FDA has received reports of serious side effects including skin rashes, facial swelling and discoloration from the use of skin brighteners containing hydroquinone.

FDA Flags 12 Companies for Illicit Hydroquinone-containing Skin Brighteners

The products contain the active drug hydroquinone, rendering them unapproved over-the-counter (OTC) drugs rather than cosmetics.

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FDA to Use Adverse Event Reports to Monitor Cosmetic Safety

AERs that are submitted usually deal with hair products including shampoos, conditioners, hair smoothing products and hair dyes as well as skin products.

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