Foreign device manufacturers must designate one U.S. agent through FDA’s Unified Registration and Listing System as part of annual establishment registration under 21 CFR Part 807. This agent serves as FDA’s official point of contact, receiving communications and, when designated, …
Missed FDA registration or U.S. Agent deadlines expose foreign manufacturers to import detention, listing suspension, and removal from FDA’s registered facility database. Food facilities that skip the biennial October 1–December 31 renewal lose registration status entirely, halting shipments to U.S. …
FDA warning letters in 2026 continue targeting compounding pharmacies. Telehealth operators, with a notable wave issued June 18, 2026, alongside sustained enforcement against online GLP-1 marketing—facilities. Products must maintain accurate FDA registration and listing to avoid triggering these actions. Foreign …
On March 27, 2023, the U.S. Food & Drug Administration (FDA) announced that it will no longer be accepting submissions to its Voluntary Cosmetic Registration Program (VCRP). Starting in 1972, VCRP has been the only type of submission that is …
On September 9, 2019, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to JUUL Labs, Inc. (JUUL), in connection with the marketing of its exceedingly popular e-cigarette products. According to the FDA, JUUL is alleged to have …
On August 5, 2014, the U.S. Food and Drug Administration (“FDA”) regulations regarding “gluten free” labeling came into effect. Last year, on August 5, 2013, the FDA issued a final rule that effectively determined what characteristics a food must have …
On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as …
On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the …