The current Good Manufacturing Practice (cGMP) regulations for dietary supplements were issued by the FDA in June 2007, and implemented from 2008 to 2010—depending on the size of the company with small companies having three years to comply. For rigorous FDA manufacturing facility inspections from analytical testing, through all procedures, training, paperwork, batch records, and […]

I often hear the statement “supported by clinical trials.” Yet, I always thought that was vague. I wanted more detail. Let’s begin with a basic definition: A clinical trial is a research study involving human volunteers. Clinical trials assess the safety and effectiveness of new ways to diagnose, prevent, or treat a certain health condition. […]

There are thousands of trade associations in the United States. There are trade associations and organizations for every industry imaginable. Trade associations are made up of members of an industry who are working toward a common goal of promoting and improving a particular industry. They advocate for the people who work in the industry as […]

Adverse Event Reports (AERs) need to be a major consideration for dietary supplement formulators, labelers, and marketers. Adverse events can happen at any time and are even associated with the best of companies. They can truly be alarming for any natural products company. Nonetheless, if these reports are processed appropriately, formulators and consumers will have […]