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Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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Will An Upcycled Certification Mark on Packaged Foods Resonate With Consumers?

XTalks

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. In terms of the certification marker, the UFA hired branding agency Modern Species to design the marker for food packaging. Even before the term was formally defined, upcycled foods had been gaining momentum.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g.,

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC. Validation Code.

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In the News: October 2021 Regulatory and Development Updates

Camargo

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.

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It’s Groundhog Day for Food Labeling, Again: The Food Labeling Modernization Act is Back

FDA Law Blog

The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. Subpart B – Supplemental Provisions Subpart B – Supplemental Provisions, adds requirements related to control of records (new § 820.35) and device labeling and packaging controls (new § 820.45). Revised § 820.3