AMA Analytical Services, Inc. tested a sampling pool of 50 talc-containing cosmetics products, and results confirmed none showed evidence of asbestos contamination.
In its application to the FDA, Valisure noted its independent testing results revealed ‘that high levels of gaseous benzene could be generated from a BPO containing product and emanate into a consumer environment such as a hot car or bathroom during a...
As cosmetics manufacturers and suppliers have ‘a responsibility to ensure the safety of their products,’ industry members must understand the critical tenants of cosmetic safety substantiation under MoCRA. In this seminar, Dr. Paula Brock of EAS reviewed...
AHPA Director of Regulatory Affairs Robert Marriott discusses serious adverse event reporting (SAER) requirements, FDA’s upcoming proposed rule on labeling of fragrance allergens, and more to note in the months ahead.
SPL XForms are now an additional option for cosmetic companies for submission along with the Cosmetic Direct portal, FDA Electronic Submission Gateway (ESG), as well as paper Form FDA 5066 and Form FDA 5067.
Manufacturers and suppliers to the cosmetics and personal care product industries can now adjust their strategies for MoCRA compliance following the FDA's recent announcement confirming a six-month extension of the facility registration and product...
Newly issued guidance on the intent to delay enforcement of these key regulatory requirements under MoCRA for six months will allow cosmetics and personal care product companies more time to enact compliance measures.
To glean the most important takeaways from the FDA’s latest recommendations outlined in the draft guidance document published earlier this week, CosmeticsDesign interviewed associate Kelly Bonner of Duane Morris LLP and partner Jessica O’Connell of Covington...
In accordance with MoCRA, the FDA’s draft guidance document outlines recommendations to establish a new electronic submission system to replace the Voluntary Cosmetic Registration Program (VCRP) by the end of this year.
As part of MoCRA regulations, the FDA has until December 2024 to propose a cosmetic GMP standard, which will have significant impact on manufacturers and suppliers to the cosmetics and PBC product industries.
In our round up of the most popular articles from the recent business quarter, we’ve focused on news and trend developments in the North and South American beauty and personal care markets, including the FDA’s suspension of VCRP submissions, the launch...
The FDA opened a Listening Session for public commentary of the Good Manufacturing Practices section of MoCRA today with an open docket for commentary through July 3, 2023.
To fulfill new industry requirements for facility registration and product listings, the FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program as the organization develops and implements a new system for cosmetic product...
With MoCRA coming into force at the end of this year, the FDA has proposed that the Office of the Chief Scientist assume primary responsibility for color certification and cosmetic regulation oversight and enforcement.
From the FDA’s new mandatory recall authority to reporting and record-keeping requirements for serious adverse events, we caught up with attorneys from Perkins Coie on the key aspects of the Modernization of Cosmetics Regulation Act.
The Long Read: What Industry Needs to Know about MoCRA
By the end of this year, US manufacturers, packers and distributors of cosmetics will be required to comply with new legal requirements under the Modernization of Cosmetics Regulation Act (MoCRA) and they need to be looking carefully at it now, says a...
The US Food and Drug Administration has banned the use of lead acetate in consumer hair dyes, with one public interest group calling for further reform of the federal regulations for cosmetics.
Late last week the US Food and Drug Administration warned consumers about the serious risks of consuming sanitizer and the packaging and flavors showing up in the marketplace that up the likelihood of ingestion.
This week, as part of its response to contaminated and unsafe hand sanitizers, the agency published a testing methodologies document. The protocols outlined in the new document can be used to determine the quality of finished sanitizer products.
In today’s Coronavirus Update, the US Food and Drug Administration emphasizes efforts to maintain the safety of hand sanitizer and also takes care to state that sanitizer is not a medical treatment.
Late last week, as part of the U.S. Food and Drug Administration’s ongoing efforts to keep pace with this country’s needs during the Coronavirus pandemic, new guidance documents were issued addressing both manufacturers and pharmacists.
It wasn’t until 2020 that Coronavirus disease 2019 (COVID-19) became a factor of import in the cosmetics and personal care industry. But by now, no matter where in the world you are, the virus has changed things. Here Cosmetics Design looks at how our...
In early February, the public health agency will hold a public meeting on testing methods for asbestos in talc and for cosmetic products containing talc.
A letter from the FDA to a member of congress underling that the organization is understaffed and only has the resources to check a small fraction of cosmetics imports in the US is causing alarm.
A new study by Northwestern University highlights how the number of complaints to the FDA relating to cosmetic and personal care products more than doubled between 2015 and 2016.
The Environmental Working Group (EWG) has made a renewed call to update laws governing cosmetics products, claiming the FDA still has little authority to review the safety of chemicals in products, which proposed legislation could change.
In doing so, the agency brings a whole new level of transparency to the beauty and personal care industry, though completeness and accuracy of the reported data is at issue and concerns are being raised about what this means for consumer class actions.
Following the US Food and Drug Administration’s (FDA) decision that antibacterial wash manufacturers must ban 19 ingredients from their products within one year, Japan has announced it has already put this in motion.
The US Food and Drug Administration is circulating a consumer update advising against the use of any beauty product formulated with mercury, which the organization doesn’t (for the most part) allow in cosmetics.
Friday, the Administration announced that a retinoid, previously available by prescription, received FDA approval and can now be included in over-the-counter skin care products. It’s the first such approval since the 1980s.
The FDA has created a webpage outlining its guidelines for smaller and homemade cosmetic players in an effort to regulate this niche but fast growing area.
It’s not uncommon for consumer-facing publications, beauty blogs, or activists to voice disapproval of US personal care regulations, but this Sunday the online new site Business Insider joined in the chorus.
The US Food and Drug Administration has issued a warning against over the counter acne treatments, noting that severe allergic reactions can result from the usage of certain acne products, and these reactions have the potential to be lethal.
On the back of Skin Cancer Awareness month, New Hampshire’s Republican senator, Kelly Ayotte, has announced her support for the Sunscreen Innovation Act, which hopes to streamline the FDA’s approval process.
The Administration is feeling the heat from the (PASS) Coalition, who is urging it to allow Americans to have access to the latest safe and effective sunscreen products available.
A crop of FDA warning letters have been sent to a number of companies in recent weeks warning about unintentional drug claims, which according to one law expert underlines the need to audit product claims.
With various cosmetic companies feeling the wrath of the FDA over misleading marketing claims of late, the Independent Cosmetic Manufacturers & Distributors association is focusing on helping the industry to avoid making the same mistakes in the future.
The US Food and Drug Administration has released draft guidelines on the safety of nanomaterials in cosmetic products, urging manufacturers to meet with it before incorporating the ingredients into formulations, to substantiate the product’s safety.
The US Food and Drug Administration has announced it recently carried out tests on certain cosmetic products containing talc after general concerns about the possible presence of asbestos were raised.
Friends of the Earth along with half a dozen other US non-governmental organizations have filed suit against the FDA for its failure to regulate nanomaterials as requested in a petition to the FDA these groups filed in 2006.
Investing in having formulations and labels reviewed to ensure they only use permissible color additives, as well as ensuring ingredients are named correctly on the label can save cosmetics manufacturers and importers a lot of time, stress and money,...
Last month’s FDA monograph announcement, in which it endorsed nano sunscreens, could open the door for formulators to utilize inorganic filters according to a leading ingredients supplier.
The U.S. Food and Drug Administration's newly released sunscreen rules do not sufficiently consider the risks posed by nanoscale ingredients according to some public interest groups, leading them to label the latest announcement 'disappointing.
Triclosan and its presence in antibacterial handsoaps is being questioned by the National Resource Defence Council (NRDC) which is taking the FDA to court over the alleged lack of regulation of the ingredient.
Canadian life sciences and technology company Botaneco has announced the compliance of its oleosome-based sunscreen formulation with the FDA sunscreen monograph, which can now be marketed in the US with an SPF 30 claim.
Washington D.C. Representative Edward J. Markey has issued a statement calling for a ban on the use of chemical tricoslan in cosmetics and other consumer products.
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