FDA Announces Availability of Decision Tool and SPL Xforms For MoCRA Facility Registration and Product Listings
Client Alert | 1 min read | 01.12.24
On January 8, 2024, the U.S. Food and Drug Administration (FDA) announced that SPL Xforms, a Structured Product Labeling authoring tool, is now available as an additional option for completing facility registration and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As a result, companies may submit their facility registration(s) and product listing(s) in one of four ways:
-
- FDA Direct;
- Electronic Submissions Gateway;
- SPL Xforms; and
- Paper Submissions via FDA Form 5066 (Facility Registration) and FDA Form 5067 (Product Listing).
Completed paper submissions can be emailed to RLC-PaperSubmissions@fda.hhs.gov or mailed to the following address:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Office of Cosmetics and Colors
Registration and Listing of Cosmetic Product Facilities and Products Program
5001 Campus Drive, CPK1, Room 1B-046
College Park, MD 20740-3835.
The FDA indicated that it does not intend to enforce the facility registration and product listing requirements until July 1, 2024. Nevertheless, companies are now able to submit this information and are encouraged to do so in advance of the July 1, 2024 enforcement deadline.
The FDA’s Decision Tool should also be of help to cosmetics companies who are still trying to determine whether to register one or more facility.
Insights
Client Alert | 7 min read | 08.16.24
Over the past several years, federal courts have increasingly questioned the authority of administrative law judges (ALJs) to adjudicate alleged violations of certain labor and employment statutes. In the last several weeks, two U.S. district courts in Texas issued decisions halting unfair labor practice proceedings before the National Labor Relations Board (NLRB) on the grounds that NLRB ALJs lack the constitutional authority to preside over such actions due to unconstitutional protections against their removal.[1] Similarly, the last year has seen several decisions by courts in the Fifth and Eleventh Circuits finding that ALJs, whose decisions are not reviewable by a Presidential appointee, lack constitutional authority under the Appointments Clause to adjudicate claims.[2] The trend illustrated by these decisions, combined with the Supreme Court’s decision in June to abandon the Chevron doctrine of extending deference to federal agency rule-making proceedings, portend significant changes in the way employers interact with federal agencies that enforce labor and employment law.
Client Alert | 2 min read | 08.15.24
Department of Defense Plans Increased Investment in Clean Energy
Client Alert | 7 min read | 08.15.24