This research center, based in Ohio, conducts extensive clinical research on dietary supplements and sports nutrition. The CEO founder is Dr. Tim Ziegenfuss, a recognized expert and researcher in the exercise and nutrition fields. Dr. Hector Lopez, one of the co-founders of Supplement Safety Solutions, is the Chief Medical Officer for this center.
News and Analysis on Supplements, Health and Nutrition – North America
A working knowledge of the FDA regulations is essential, and this main page on the FDA website is a great place to start.
Guidance documents, while not mandatory or required by law, reflect what FDA considers “best practices.” Hence, an understanding of these is essential, and if FDA inspects your facility, they will expect that your practices are consistent with their guidance documents. So stay current with these!
The reporting of serious adverse events is required by DSHEA. This link provides the information you need to do so. If you are working with a medical consulting group like Supplement Safety Solutions, we would provide that service for you. However, it’s important for your company to understand the essential components of a case, and critical questions to ask if a customer calls to report an adverse event.
This blog is sponsored by a law firm specializing in legal issues in the food industry, and it regularly provides excellent summaries of current laws and regulations, and provides timely updates.
This website identifies all alerts that FDA sends out on dietary supplements. It is a barometer for the types of issues that FDA inspectors are identifying and acting upon. It’s a chance to learn from another company’s perceived deficiencies.
FDA has become very focused on the manufacturing processes in the drug, biologics and dietary supplement industries. In order to remain compliant, a considerable amount of effort needs to go into developing the needed Standard Operating Procedures, and to documenting all activities that go on. It is challenging but FDA is demanding compliance in all industries that it oversees. Be familiar with this document! In addition, below is a link to a PowerPoint presentation by an FDA staffer, which was very informative.
Presentation: Implementation of FDA’s Current Good Manufacturing Practices for Dietary Supplements: Author: Angela Pope, MBA, FDA Center for Food Safety and Applied Nutrition; October 24, 2007
All companies want to avoid Warning Letters, but sometimes it happens. Typically, unless FDA finds an immediate threat to consumer safety, it will give a company a reasonable amount of time to fix an observed deficiency. If the deficiency is not fixed, or FDA believes you are ignoring their recommendations, then issuing a Warning is a viable option. This is to be avoided, as you are required to inform your customers and the information becomes public. Like with the Alerts, reading about issues from another company can help you focus on your own efforts.