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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.

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FDA Flags 13 More Sanitizers, Issues One Warning for Methanol Content

Methanol content or possible associations therewith account for 12 of the 13 latest additions by the U.S. Food and Drug Administration (FDA) to its "do not use" hand sanitizer list, along with one warning letter.

The goal was to improve the sensitivity and consistency of analyses and inter-laboratory concurrence relevant to reporting asbestos and similar particles in talc that could potentially affect cosmetic product safety.

5 Key Facets of Talc Testing: FDA Paper Outlines Expert Consensus

The goal was to improve the sensitivity and consistency of analyses and inter-laboratory concurrence relevant to reporting asbestos and similar particles in talc that could potentially affect cosmetic product safety.

While the concerns expressed over these materials are not specific to cosmetics, and only two are currently listed as cosmetic ingredients, it is worth noting the potential safety issues of these materials as well as the likelihood of the bans initiated in California to spread nationwide.

California Bans 4 Food Additives, FDA Proposes Same for BVO Emulsifier

On Oct. 7, 2023, the State of California banned four food and beverage additives reportedly linked to health issues: potassium bromate, propyl paraben, Red Dye No. 3 and brominated vegetable oil (BVO). The FDA may follow suit with BVO.

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U.S. FDA Investigates B. cepacian Complex Outbreak Linked to Personal Care

A no-rinse foam cleanser has been linked to at least 10 confirmed cases of Burkholderia cepacia complex; Shadow Holdings dba Bocchi Laboratories has voluntarily recalled the product as the FDA investigates.

Product safety is paramount for fast-moving consumer goods such as cosmetics and personal care products. Recent recalls and class action suits highlight this fact.

Benzene, Methanol and Lead Headline Recent Class Actions and FDA Alerts

Methanol in hand sanitizers and lead in a baby skin care are cited in the latest U.S. Food and Drug Administration recall notices, while benzene content in dry shampoo and spray sunscreens persists among class action suits. Following is a roundup.

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FDA 'Do Not Use' Hand Sanitizer List and Methanol, 1-Propanol Warnings

The U.S. Food and Drug Administration (FDA) has issued a guide for consumers to explain the dangers of methanol and 1-propanol, and to search and find hand sanitizers on its "do not use" list; some 165 entries are on it so far.

FDA Warns Consumers About Side Effects from Topical Acne Actives

The U.S. Food and Drug Administration has issued a warning to consumers that over-the-counter (OTC) acne products containing benzoyl peroxide and salicylic acid can cause severe irritation or severe allergic reactions in rare instances.

FDA Seeks Public Input Ahead of ICCR Cosmetics Regulation Meeting

The U.S. Food and Drug Administration will hold a public meeting on September 10, 2015 to receive input from the public on various topics pertaining to the regulation of cosmetics.

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FDA Warning Expands: More Hand Sanitizer Recalls Due to Methanol

The FDA has issued yet another warning to consumers to not use given hand sanitizer brands due to reports of the presence of the toxic and possibly deadly substance methanol.

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.

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...

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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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.

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