Hindsight and 2020
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Are you CBD curious?
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 [...]
Quality Agreements with your Contract Manufacturer
It has been a while since we have sent any updates for our dietary supplement clients. The FDA has remained busy inspecting supplement companies and writing many, many warning letters. The regulations for dietary supplement Good Manufacturing Practices (GMPs) include a section on quality control [...]
FDA Warning Letters to Cosmetic Companies
The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics. Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning [...]
Does your Contract Manufacturer Comply with cGMPS?
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 [...]
Warning Letters: Gelatin and Water as Dietary Ingredients
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 [...]
Recent insights from FDA Warning Letters
Once again I’d like to share information about FDA’s recent warning letters. This time, several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling. The first involves the use [...]
FDA Warning Letters to Food Companies
Hello! Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating. In the past several months [...]