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Section: Regulations

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.

Reauthorization fee programs have been considered “must pass” and are often used to advance other priorities related to FDA regulation; in this case, dietary supplements and cosmetics reforms.

Senate Considers FDA Fee Reauthorization Approach to Cosmetic Oversight

Senate members will present a draft legislation to reform the U.S. Food and Drug Administration's (FDA's) oversight of cosmetics, supplements and some lab-based tests based on a fee reauthorization approach, STAT reports.

One guideline is to include quantitative information from control groups; specifically, companies should fully describe the comparator used.

FDA Finalizes Guidance on DTC Drug, Biologicals Promotional Labeling

While cosmetics are not drugs, the industry could take inspiration from the U.S. Food and Drug Administration's (FDA's) guidance from the Office of Prescription Drug Promotion on labeling direct-to-consumer (DTC) drugs and biological products.

While the cosmetics industry is not FDA-regulated, it often follows or adopts labeling and ideas from foods that are familiar to consumers. Could this be the next clean beauty?

The Next 'Clean' Beauty? FDA to Research 'Healthy' Food Claims, Labeling

The U.S. Food and Drug Administration (FDA) announced plans to research and identify rules for claims that foods and beverages contain "healthy" nutrients. Could this be the next "clean" beauty?

The draft guidance is intended to help ensure the safety of cosmetic products that many consumers use day-to-day. The FDA is accepting comments on the draft guidance until Sept. 7.

FDA Issues Draft Guidance for Cosmetics Company Product Registration and Submission

The draft guidance is intended to help ensure the safety of cosmetic products that many consumers use day-to-day. The FDA is accepting comments on the draft guidance until Sept. 7.

PASS Coalition and Congressman Sam Farr Press FDA for UV Filter Approval

The PASS Coalition expresses its gratitude to subcommittee ranking member Sam Farr (D-CA) for pressing the FDA about the approval of pending sunscreen ingredients but notes that some UV filters have been pending with the FDA for over a decade.

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AAD Responds to FDA Labeling Decision on Eczema Medications [Feb. 21, 2006]

The American Academy of Dermatology (AAD) recently issued a statement in response to the U.S. Food and Drug Administration’s (FDA) decision that a black box warning be added to labels...

PASS Coalition and Congressman Sam Farr Press FDA for UV Filter Approval

The PASS Coalition expresses its gratitude to subcommittee ranking member Sam Farr (D-CA) for pressing the FDA about the approval of pending sunscreen ingredients but notes that some UV filters have been pending with the FDA for over a decade.

To date, Adam’s Polishes has not received any reports of injury, illness or other adverse events related to this recall.

FDA Alert: Adam's Polishes Recalls Hand Sanitizers Over Methanol Concerns

The company is voluntarily recalling lot #133475 of Adam’s Polishes Hand Sanitizer after the U.S. Food and Drug Administration found this lot contain undeclared methanol; 19 other lots have been recalled to err on the side of caution.

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18 More in 18 Days: FDA's Sanitizer Hot List Just Got Longer

Since our latest report 18 days ago (at press), the U.S. Food and Drug Administration has added 18 more listings to its Do Not Use "hot list" of hand sanitizers due to known or potential methanol adulteration, as well as possible sub-potent efficacy. Voluntary recalls are also stacking up.

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FDA's Sanitizer Hotlist Cites Nevada Distributor, Calls Out Subpotency and Methanol

Since last quarter, the U.S. FDA has added 20+ listings to its "Do Not Use" hand sanitizer database, which were flagged for subpotency and methanol-related issues. One Nevada-based manufacturer also made the list.

The 'Skin Facts!' Initiative aims to help consumers understand the potential risks and to help identify whether the products they purchase contain these harmful ingredients.

FDA Issues Warnings, Pushes Consumer Education of OTC Skin Lightening Products

The FDA is once again cracking down on companies selling skin lightening products containing hydroquinone or mercury. Its public health campaign, Skin Facts!, urges consumers to get educated on skin care ingredients.

The inner packaging of a serum and product kit containing said serum listed SPF when the product has no SPF.

FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

In recent months, the U.S. Food and Drug Administration (FDA) reported six voluntary recalls for an impermissible color additive, mislabeled SPF and several contaminants. It also urged companies to be "recall ready" and provided final guidance to do so.

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.

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FDA Raises Methanol Alarm with Import Alert; Adverse Events, Deaths Reported

The FDA has heightened measures to prevent toxic methanol-containing hand sanitizers from reaching the U.S. market. These include an import alert, more product warnings, recalls and a growing "do not use" list of products due to contamination and adverse health effects—including death.

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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.

FDA To Report Lead and Arsenic Levels for Batch Approval of Specific Colorants

The U.S. Food and Drug Administration (FDA) has announced that it will report specific values of lead and arsenic for a number of color additives before Certificate of Analysis (CoA) are granted for their batches.

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FDA Updates: VCRP Tally, Color Additives and Lead Acetate in Hair Dyes

The U.S. Food and Drug Administration (FDA) provides the latest tally on voluntarily registered cosmetics, color additives and lead acetate in this collective fall 2021 update.

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