The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling. The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”. Under [...]
Update February 17, 2022: Please use this link to view the UNPA webinar "In the BEginning"... Dietary Supplements Supply Chain Starts with Ag mentioned in the original post. The webinar opens with a general introduction and the presentations begin as indicated below. Good Agricultural and [...]
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.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
We are based in Colorado, a state that has legalized both medicinal and recreational marijuana use. Colorado's industrial hemp farming program was initiated through legislation adopted in 2013. On the national scene, passage of the 2018 Agriculture Improvement Act removed hemp from the controlled substance [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications. The guidance contains numerous requirements that will significantly affect the dietary supplement industry and establishes a 60 day comment period if manufacturers wish to affect the final rule. The [...]
The agency has avoided the issue for years but on November 12, 2015 the FDA published a “Request for Information and Comments” on the use of the term “Natural” in the labeling of human food products Note that the general term "food" includes dietary supplements. [...]
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 [...]
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 [...]