regulation

A Brief Survey of the Food Safety Modernization Act

Editor’s Note: This article is written by contributing writer Shafiel A. Karim Earlier this year, President Obama signed the Food Safety Modernization Act (FMSA), which amends various portions of the United States Code relating to FDA’s powers to detain and regulate domestic and imported food products.  While the law was primarily drafted to grant the [...]

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 [...]

FDA Commissioner Attempts to Curb Regulated Drug Use in Nutritional Supplements

With an ongoing rise in nutritional supplements containing chemicals regulated as drugs, the Commissioner of the Food and Drug Administration recently sent a letter to all manufacturers of dietary supplements reminding them of their concern of this matter and their plans to reduce the problem. The purpose of the letter is stated as to “address [...]

McCain supplement bill more about pro sports than public safety

To understand why Sen. John McCain introduced a bill on dietary supplements, read the press releases. The legislation announced Feb. 3  addresses public safety, but mostly it’s about the reputation and revenue of professional and Olympic sports. The evidence: McCain says in the release that “a little over a year ago the NFL suspended six [...]

NutriSupLaw Publisher Quoted in National Law Journal

Your’s truly is featured in a front page article in today’s National Law Journal by Jenna Greene entitled “Rule Reversal: Obama’s agencies after one year.”  The article provides a look at six key regulatory areas since Obama took office. On the topic of the FDA and regulation of dietary supplements, I am quoted as saying: [...]

No more kicking around the vitamin hustlers

David Frum could have lowered his rhetorical blood pressure in his CNN.com guest commentary on the evils of dietary supplement marketing by reading the FTC regulations that go into effect on Tuesday. His column then would have begun: The party is over Dec. 1.