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Type: News

Section: Regulations

Xforms is just one digital option available for creating an SPL file with cosmetic product facility registration and product listing information. Two additional electronic options are available.

FDA Debuts Digital SPL Xforms, Paper Forms for Cosmetics Facility, Product Submissions

The FDA has rolled out Structured Product Labeling (SPL) Xforms, a digital tool, and downloadable PDF forms to register cosmetic product facilities and list products, as mandated by MoCRA.

“We are excited to welcome Emily back to lead our legal team and guide our industry’s legal and regulatory strategies,” said Tom Myers, PCPC’s president and CEO. “Her diverse and extensive expertise will be instrumental in navigating our industry’s complex legal and regulatory landscape, enhancing our support to member companies.”

The Personal Care Products Council Names VP Legal and Regulatory Affairs and General Counsel

Manoso previously worked as PCPC’s associate general counsel and staff counsel and has served as a trail attorney for the U.S. Department of Justice.

Fda Computer Screen Adobe Stock 516632560 Editorial Use Only

FDA Opens Cosmetics Direct Registration Portal for MoCRA

Cosmetics Direct is an FDA Structured Product Labeling authoring tool that, according to the FDA, features user-friendly data entry forms.

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days.

FDA Releases Update to Ongoing Activities Related to Serious Adverse Event Reporting for MoCRA

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days.

In January of 2023, the CMA expanded its work on environmental claims to include fast-moving consumer goods (FMCG). These are essential items that include food and drink, cleaning products, toiletries and personal care items.

Unilever Eco Claims Under Scrutiny in Greenwashing Investigation

In January of 2023, the CMA expanded its work on environmental claims to include fast-moving consumer goods (FMCG). These are essential items that include food and drink, cleaning products, toiletries and personal care items.

According to the European Commission's Safety Gate, numerous products, ranging from soaps and fragrances, to body care, shampoo, bath milk and others, have been flagged for the present of the fragrance allergen butylphenyl methylpropional.

Recall Alert: L'Oreal's Mizani, J&J's Clean & Clear, Marcelle's 40+ Cream and Others

Globally, within the past couple of months, numerous cosmetic product recalls have been issued for microbe contamination and fragrance allergens, among other contaminants. Following is a roundup.

Sunscreen materials were at the center of a recent European court case that calls into question the enforceability of animal testing bans.

EU's Cosmetics Animal Testing Bans Challenged in New Court Decision

Cruelty Free Europe's director of science and regulatory affairs, Emma Grange, Ph.D., said: “This decision is a huge backwards step in our fight to stop animals suffering and dying in the name of beauty."

Beginning Dec.1, 2023, domestically produced toothpaste must be notified with the provincial-level drug supervision and administration department in the jurisdiction of the notification applicant before being marketed and sold.

China National Medical Products Administration Updates Toothpaste Regulations

Beginning Dec.1, 2023, domestically produced toothpaste must be notified with the provincial-level drug supervision and administration department in the jurisdiction of the notification applicant before being marketed and sold.

As reported in 2022, the lawsuit follows the release of findings published in the Journal of the National Cancer Institute associating hair straightening product use with incident uterine cancer. The study did highlight the fact that Black women could be disproportionately affected, as 60% of the 33,947 total participants who reported using hair straighteners self-identified as Black women.

Hair Relaxer-Cancer Lawsuits Will Move Forward

Earlier this year, racial justice organization Color of Change urged consumers to sign a petition demanding that Target, ShopRite, Giant, Food Lion and other major retailers remove "toxic" products such as lye relaxers and hair dyes from shelves.

The FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, deadline.

FDA Delays MoCRA Enforcement by 6 Months

The U.S. Food and Drug Administration (FDA) announced it will delay the enforcement of facility registration and product listing requirements under MoCRA for six months after the Dec. 29, 2023, deadline to give the industry "sufficient time" to submit.

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.

October was the deadline but it came and went without a MOCRA portal to show for it.

FDA to Industry: Review SLP Guides, Gather Data Until MOCRA Portal Launches

October was the deadline but it came and went without a MOCRA portal to show for it. As the industry waits, the FDA advised members to continue collecting data and reviewing guidance documents — including the latest one for Structured Product Labeling.

Requirements range from creating an adverse event reporting system, and maintaining current and complete safety substantiation records, to ensuring facilities are registered with the FDA and more.

[poll results] How prepared are you for MOCRA requirements?

The Modernization of Cosmetics Regulation Act (MOCRA) goes in to effect on Dec. 29, 2023, giving the U.S. Food and Drug Administration increased authority over cosmetics. Are you ready for it? We want to know - please take our 1-click poll.

According to the company, the tool can save organizations hours in time typically spent on regulatory and retailer standards review.

Cosmex AI Takes Regulatory Compliance for Cosmetics to the Next Level

Those who were wondering how artificial intelligence (AI) might take cosmetic product development to the next level now have their answer. Cosmex AI can scan 30,000+ ingredients to instantly indicate if a product complies with regulators or retailers.

Loose plastic glitter used as a cosmetic product can continue being sold until Oct. 16, 2029, for leave-on cosmetics.

How the EU Microplastics Ban Affects Glitter

The European Commission's (EC's) ban on microplastics intentionally added to cosmetics went into effect on Oct. 17, 2023. This includes some forms of glitter, individually and in mixtures, which the commission explained in a recent Q&A.

According to the European Environmental Bureau, this indicates the commission 'bows to chemical and farm industry pressure yet again.'

EC Delays REACH Yet Again, 'Abandoning' Chemical Reform

The European Commission's 2024 Work Program was recently rolled out with a glaring omission — REACH provisions, "backtracking on its pledges made under the 2020 Chemicals Strategy for Sustainability," per the EU Observer. This was not the first time.

The ICCS is a global initiative focused on the adoption of animal-free assessments of cosmetics and its ingredients for human health and environmental safety.

Inolex and CTPA Join ICCS, Further Promote Animal-free Testing Methods

The ICCS is a global initiative focused on the adoption of animal-free assessments of cosmetics and its ingredients for human health and environmental safety.

The three-judge appeals panel reportedly wrote that 'the lower court failed to fulfill its 'gatekeeping role' of assessing whether the plaintiffs’ experts based their testimony on sound science.'

$223 M Talc Verdict Against J&J Overturned on 'Junk Science'

According to NJBiz, in an Oct. 3 ruling, a federal appeals court overturned a $223 million jury award and ordered a new trial because the awarding jurors were allowed to hear "improper scientific testimony" linking J&J's talc-based products to cancer.

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