Tag Archives: cGMP

Dietary Supplement Firms, CGMPs and the Park Doctrine

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

2010 Supplement Law and Business Predictions

2009 was an incredible year for the dietary supplement industry.  While the rest of American business floundered amidst the depths of a recession, the dietary supplement business thrived.  Americans concerned about maintaining their good health stocked up on supplements by the shopping cartful. In a year when initial public offerings and acquisitions were almost unheard

Three Significant Supplement 1st Amendment Suits filed versus FDA – Part II

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

FDA enforcement action will be swifter, with less notice

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.

Follow cGMP or the FDA will seek to shut you down

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.

Product quality: the never-ending frontier of GMP

Following up on a post from June 30, the question of consumer confidence in nutritional supplements arises again. The Times-Herald reports that many supplements have quality problems. No one knows just how many of 40,000 products underdeliver on the goods listed their labels and over-deliver on unlisted, harmful ingredients and contaminants. “I believe that the problem is narrow, that the well-established and reputable brands deserve their reputations,” Michael McGuffin, president of the American Herbal Products Association, tells the paper that serves the Hudson Valley of New York.

Who pays for product safety and quality?

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

For Zicam’s maker, troubles do not end with recall

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,

Toxic chemicals in child-care cosmetics products create public stir

Looking to promote the safety of your product? Tout the fact that your children’s bath and shampoo products do not contain formaldehyde. In a recent test, the Campaign for Safe Cosmetics found 23 children’s bath products that that may cause cancer and skin allergies. Another product, 1,4-dioxane, was found in 32 of 48 products. The