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 [...]
A respected colleague, Marian Boardley, recently published a blog post that is important for anyone in the dietary supplement industry. I’d like to share some highlights with you. Ms. Boardley frequently evaluates FDA data on inspections and shares her insights. In her recent post she shared a table [...]
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
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 [...]
I hope that your business is doing well enough to allow you to relax a bit as summer starts. Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs [...]
FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up. In a February 9, 2011 letter [...]
The folks at Pharmalot have written an article about the Johnson & Johnson consent decree. The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. The consent decree details the systems that need [...]
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 FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements. The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA [...]
Hello! I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere. Since dietary supplement companies are now required to comply with FDA’s Good [...]
Hello! We have become aware of a new manual from the American Herbal Products Association (AHPA) that provides guidance as well as templates for preparing Standard Operating Procedures (SOPs) for compliance with Dietary Supplement Good Manufacturing Practices (GMPs). Having SOPs is an important part of [...]
Hello! Many of our dietary supplement clients have struggled with complying with the Good Manufacturing Practice Regulations FDA wrote the industry. The following link takes you to an article in The Natural Products Insider that discusses the agency’s view and includes a video of Vasilios [...]
In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly. Why is this? First, last fall the agency hired hundreds of new [...]