Year-End Review of Regulatory Issues

Jun 26th, 2009

David C. Steinberg, Steinberg & Associates

I have been accumulating odds and ends of regulatory issues over the year, and this column-the last of 2002-seems like an ideal place to present them.

United States
There are four areas in US regulations that should be briefly reviewed at this time: child-resisitant packaging, new ways to improve OTC drug actives, and issues in California regarding VOCs and Proposition 65.

Puresterol (Pueraria mirifica) based face serums reduce wrinkles in clinical trials

Puresterol (Pueraria mirifica) based face serums reduce wrinkles in clinical trials

Bio-Botanica® announced Puresterol® (Pueraria mirifica) based serums found to reduce wrinkles in clinical trials

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.

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.

'I think the biggest game-changer about [MoCRA's] ... requirement for GMPs is how it changes what it means to be adulterated,' Brandi Reinbold, senior manager of global certification for NSF International, said in this sponsored videocast. Register now to watch and learn more. It's free.

[video] GMP Standards to Meet MOCRA and Retailer Mandates of the Future

While the enforcement of MoCRA has been delayed until July 1, 2024, this is no time to rest on our laurels. As this sponsored video from NSF International explains, there's much to do and it will take time. Register now to watch and learn how to prepare.

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.

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.