US FDA Cosmetic Regulation Overhaul
Cosmetic regulation in the US has undergone a significant change that companies need to be aware of. Within the Consolidated Appropriations Act, 2023 that was passed by the US Congress on December 29, 2022, under Subtitle E, it included the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA), which creates new legal requirements for cosmetic companies and new authority for the US FDA. This Act is expected to provide greater FDA oversight and tracking of cosmetics. Key points in brief: (Definitions: "responsible person" = manufacturer, packer, or distributor of a cosmetic product whose name appears on the label; "facility" = site of manufacturing or processing but not including entities involved solely in one or more of: labeling, packaging, holding, distributing). Facility Registration (Sec. 607(b)): each facility that manufacturers or processes cosmetics for sale in the US, including foreign facilities, must register with the Secretary within 1 year of enactment (by [...]
US FDA GRAS Process
Food science is always evolving, and companies continue to innovate new ingredients to make foods better - here is an overview of the US FDA GRAS process for companies looking to market novel food ingredients! Under the US Federal Food, Drug, and Cosmetic Act (FD&C Act), any substance (or chemical, ingredient, material) that becomes part of a food or affecting characteristics of a food is defined as a "food additive" and therefore requires that substance to undergo a pre-market review by the US FDA via a "food additive petition" (or FAP) process, unless it is exempt from this definition. Exemptions include ingredients that have been determined to be Generally Recognized as Safe (GRAS), have been reviewed and permitted under a Food Contact Notification (FCN), or is a prior sanctioned ingredient. Note that "color additives" are not defined under food additives and require a mandatory pre-market review by the FDA under [...]
California Cleaning Product Right to Know Act Now in Effect – Are you Ready?
The California Cleaning Product Right to Know Act is a relatively new piece of legislation that you should be aware of. If your company manufactures any type of cleaning product and sells it into California, then you likely have already heard about the "California Cleaning Product Right to Know Act of 2017" ("the Act"). If not, here is a general summary to bring you up to speed! This Act requires manufacturers of certain types of cleaning products to disclose the presence of certain chemicals on the company's website, as well as on product labels. The website disclosure element of the Act became effective for products sold on or after January 1st, 2020, while the product label disclosure part of the Act became effective on January 1st, 2021. Essentially, companies need to check whether the ingredients in their products are listed on any of the 22 "designated lists" prescribed in the [...]