Editor’s Note: This article is written by Contributing Writer Shafiel A. Karim. As FDA continues to inspect dietary supplement manufacturers under the new CGMP framework, it is clear that many manufacturers share similar deficiencies. Recent FDA warning letters show that many manufacturers are still struggling with structure function claims, the required pre- and post-production qualitative [...]
This is Part II of the Post that began here in which we discuss the three important suits filed this summer by supplement lawyer Jonathan Emord challenging FDA administrative action on first amendment grounds. The cGMP Challenge – FDA Overreaching? The FDA supplement cGMP regulations were anticipated from the time that DSHEA was passed in [...]
The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. The agency has shifted to a policy of less talk and more action. The industry response must be to get better or get out.
Three New Jersey companies that manufacture and sell nutritional supplements and protein powder have just learned what happens when you do not follow health directives from the Food and Drug Administration. The FDA wants a shutdown that could last weeks, even months depending on the amount of work needed to trap animals, disinfect equipment and eliminate unlisted ingredients.
Anne Hart has lots of questions about the quality and safety of nutritional supplements, 19 questions to be exact. They revolve around product integrity, contamination, mislabeling (think sibutramine), FDA oversight and so on. A nutrition columnist for Examiner.com, Ms. Hart has several ideas for matching products to their labels, all of which create more questions [...]
Manufacturers beware. Your regulatory problems may not be over when you pull a product from the store shelves. Matrixx Initiatives Inc. recalled its Zicam products on June 16 and three days later the Securities & Exchange Commission sent a letter of inquiry. The company said that it did not know what the regulatory agency wanted, [...]
