As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include, and how and when to make the submissions. It also provides information on exemptions, such as those for certain small businesses.
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into each aspect of MoCRA, covers the process for substantiating safety of cosmetic products.
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. We will focus on MoCRA’s mandate requiring the Federal Drug Administration (FDA) to establish Good Manufacturing Practices (“GMP”) that the cosmetic industry will have to follow going forward.
As deadlines approach for cosmetic manufactures to comply with all requirements of MoCRA, there might be some worry on where to start. Husch Blackwell’s chapter by chapter breakdown of MoCRA provides guidance on where to begin. This chapter discusses the requirements of facility registration and product listing with compliance due date of December 29, 2023.
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. To begin, we will discuss whether MoCRA applies to your product and, if so, which entity should serve as the responsible person for ongoing compliance.
The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the most significant change to the regulation of cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. MoCRA is a seismic shift in the world of cosmetic regulation, bringing new authorities to the FDA that are similar to those that currently exist for food, drugs and medical devices, among other regulated products. MoCRA has sweeping implications for domestic and international cosmetics manufacturers that market products in the U.S.
Heavy metals, such as arsenic, lead, cadmium, and mercury, are present in baby foods produced by U.S. baby food manufacturers according to a report released in February by the U.S. House of Representatives Subcommittee on Economic and Consumer Policy. Heavy metals are considered dangerous to human health and are especially concerning for children and babies, who are more susceptible to the neurological effects associated with exposure to heavy metals.
Continue Reading Heavy Metals in Baby Food – Congressional Report Unleashes a Flood of Litigation
The influence of the Internet of Things (IoT) will undoubtedly be transformational with a total potential economic impact estimated to be $3.9 trillion to $11.1 trillion a year by 2025. In the race into the IoT marketplace, there are both known and unknown legal hurdles that will affect those who offer of goods and services during the proliferation of the Internet of Things.
Some of the current and potential legal hurdles related to the IoT are well known, some are not, and some are the result of the intersection between the physical and virtual worlds, and the collision between two intersecting major drivers of innovation in IoT. On one hand, there are the established manufacturers of products and consumer goods whose expertise in developing, testing and manufacturing products puts them in an advantageous position. On the other hand, there are the technology companies who are used to developing software and whose expertise lies in software development, data collection, and data processing.
Continue Reading Hurdles the Internet of Things Must Clear for Manufacturers and Providers
|December 4, 2017|
|Missouri Adopts Daubert: What It Means in Product Liability Cases
By Theresa Mullineaux
In March 2017, Missouri Governor Eric Greitens signed House Bill 153, which amended Mo. Rev. Stat. § 490.065, and effectively adopted Daubert standards for Missouri cases, effective in August 2017. As a result, Missouri now follows