November 8, 2023, FDA announced that the enforcement date for cosmetic facility registration and product listing will be delayed until July 1, 2024. The announcement stated that this was "to provide regulated industry additional time to comply with these requirements." However, the guidance document itself [...]
Major Cosmetic Regulation Update March 27, 2023 - FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program FDA issued an update today stating that they are no longer accepting voluntary cosmetic establishment registration and that information in the VCRP will not be transferred [...]
The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities. The only exception is the cosmetic sector; registration [...]
The year 2020 started out ordinarily enough for the FDA Compliance Simplified team. We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices. On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.
Few events are truly global but the 2020 pandemic has affected every living being on the planet in some way. It is the rare person whose life and/or business has not been turned upside down this year but I am pleased to bring you a [...]
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Successful launch of a product requires more than a good marketing plan. It is also important to know whether your product is subject to special regulations from various government agencies. While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency [...]
All food, pet food and dietary supplement facility registrations must be renewed between October 1st and December 31st of even-numbered years. 2018 is a renewal year and prior to the renewal period FDA published two guidance documents on facility registration (guidance and supplemental guidance). All [...]
Update February 22, 2017: Many foreign manufactures of foods and dietary supplements are finding that their FDA Food Facility Registrations have been invalidated. These are companies that updated their registration between October and December 2016 as required but whose US Agent failed to confirm the [...]
I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar. The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements. Most of the presenters that talked [...]
If you are crunched for time during this end of year holiday season, this may be good news from FDA: In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. [...]