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 [...]
FDA Compliance Simplified is privileged to help companies of all sizes and from all over the globe achieve compliance with FDA regulations. Many are referred to us by existing customers, some find us online, and other come to us through quality service providers that help [...]
As noted in a previous post, there are a number of new regulations that cosmetic companies must comply with by December 29, 2023 as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The regulations that are effective at the end of 2023 [...]
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 [...]
Helping companies comply with FDA regulations is our specialty. But FDA is not the only regulatory body our clients need to be aware of. As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success [...]
Natural claims continue to be prominent on a variety of food and cosmetic product labels. As discussed in a previous post, FDA has not defined natural but requested public input on what the term should mean when used on food labels. The comment period closed [...]
On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]
The trade magazine, Products Insider Successful Products in Six Steps”. the presentation focuses on the development of dietary supplement products, similar considerations are helpful for cosmetic and food products as well. The steps were written for brand owners using contract manufacturers but also apply to [...]
Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance. I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]
In January we told you about some of FDA’s plans for 2011. The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review. Back in June FDA completed one agenda item, review of proposed [...]
The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]
The most amusing title I have ever seen on an FDA guidance document is “Is it a Cosmetic, a Drug or Both? (Or is it soap?)” http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. This guidance addresses common misconceptions about how certain products are regulated. Hand sanitizers and antibacterial soaps are examples [...]
We thought that you would be interested in learning that the Safe Cosmetics Act of 2010 was introduced in the US House of Representatives this week. If passed and enacted this legislation would increase the regulation of cosmetic product in the US and would affect [...]