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Section: Regulations

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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ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production

Citing public safety concerns, the American Cleaning Institute (ACI) and Consumer Healthcare Products Association (CHPA) are urging the U.S. Food and Drug Administration (FDA) to withdraw its temporary guidance allowing non-traditional manufacturers to produce hand sanitizers.

The U.S. Hemp Roundtable said the FDA’s comments signal 'the new year may offer some promise for the long-awaited regulation of hemp-derived extracts such as CBD.'

FDA to Explore CBD, Hemp Regulations for Food and Supplements

The U.S. Food and Drug Administration (FDA) is exploring whether legal cannabis is safe in food or supplements and expects to make recommendations in the coming months for regulating such products. Could this translate to cosmetics?

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FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls

Sanitizer warning letters and "hotlist" additions, plus microbe-related recalls are among the latest cosmetic-relevant updates from the U.S. Food and Drug Administration.

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U.S. FDA Red Flags Careful Cents, LLC for COVID-19 Claims

Careful Cents, LLC, is marketing essential oils that, according to the U.S. FDA, are misbranded drugs based on their claims. The agency issued a warning letter highlighting examples including immunity-boosting and antiviral effects, and positioned to address COVID-19.

L'Oréal Receives A Warning Letter From the FDA for Drug Claims

The US Food and Drug Administration (FDA) has issued a warning letter to L'Oréal for gene, stem cell and skin regeneration claims associated with Lancôme products.

ACI and PCPC Form Coalition to Promote Antibacterial Use to the FDA

The Personal Care Products Council (PCPC) and the American Cleaning Institute (ACI), which have formed the Topical Antimicrobial Coalition, have submitted their comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule, which they find could elliminate access to antibacterial soaps and increase foodborne illness.

FDA Commissions Study of its Drug, Biologics Application Processes

The U.S. Food and Drug Administration (FDA) released a new report that examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA.

Sindoor Powder Under FDA Fire for High Lead Content

The US Food and Drug Administration is warning consumers to avoid the use of sindoor powder marketed under the Swad brand due to its high lead content.

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.

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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.

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