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FDA Drafts Guidance On Safety-Data Musts For GRASE Sunscreen Actives

 
• By Ryan Nelson

Time and extent applicants seeking GRASE status for UV filters should provide FDA with the kind of clinical safety data used to support approval of chronic-use cutaneous drug products, and nonclinical testing should focus on potential long-term adverse effects, according to newly released draft guidance required from the agency under the Sunscreen Innovation Act. FDA is particularly interested in receiving comments about final formulation safety testing it anticipates requiring under specified monograph conditions.

FDA provides insight into its expectations for safety and effectiveness data supporting sunscreen ingredient GRASE determinations in a draft guidance released on deadline and 10 months after the agency's tentative rejection of eight related time and extent applications.

Prepared for publication in the Nov. 23 Federal Register, "Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry" summarizes FDA's "current thinking" on the scientific evidence needed to...

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FTC Consumer Privacy Policy Driven By ‘Straw Man’ Arguments – Commissioner Holyoak

 
• By Eileen Francis

The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.

FTC’s New Commissioner ‘Dismayed’ By Agency Overreach

 
• By Eileen Francis

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

Beauty Brands Not On TikTok Shop ‘Really Missing Out’ – KO-Pack

 
• By Eileen Francis

At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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E.l.f. Plans To Acquire Hailey Bieber Beauty Brand For $1Bn

 
• By Eileen Francis

E.l.f. Beauty, Inc. has agreed to acquire celebrity and model Hailey Bieber’s rhode lifestyle beauty brand for $1bn, the firm reported during a 28 May fiscal fourth quarter earnings call, during which it also announced plans to raise product prices to ‘partially’ mitigate the impact of tariffs.

FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,

Urgo Makes Moves In Poland And Belgium

 
• By Tom Gallen

French consumer health player Urgo has added to its dietary supplements offering with separate deals in Poland and Belgium.