2) As we have seen a growing number of dosage forms entering the supplement sector (gummies, stick-packs, strips,etc.) the Agency has continued to remind industry of the distinction between dietary supplements and conventional foods and the need to respect the definitional differences.
3) Speaking now as a father and grandfather, I have great concerns about this specific product range, because:
It literally is PEZ in name and shape and colors, which is a candy.
It is a pre-sport workout product that contains a number of dietary ingredients inappropriate for children.
I believe this case rises to the example of where UNPA should consider establishing a position with respect to this specific product as crossing the line into conventional foods and in a manner which presents an unacceptable risk of attracting children’s interest and consumption.
I also believe we are now at the point where industry needs to assert a stronger self-policing posture, particularly as we are in active debate with FDA over its proposed harm reduction policy and reorganization of the Human Foods Program, both of which we see as very negative developments for the DS industry.
What do you think? Please take a moment and answer this very simpleGoogle survey that you either agree or disagree with the views expressed above and add any additional comments you may have. I will report the results and, based on those results, will either move toward a written statement or let the matter rest for the time being.
Thank you for your help, and I’m looking forward to your response and comments.
Loren Israelsen visits with Mike Kauffman, President of Facilities Consulting NW, and discusses the importance of facility design in achieving GMP compliance. Mike
The U.S. Food and Drug Administration (FDA) published a draft guidance on the submission of new dietary ingredient notification (NDIN) master files. The
