Tag Archives: 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:

What marketing draws the ire of the FDA?

Marketers of nutritional supplements often complain that they do not know what the FDA wants. Even after the agency sends a warning letter about misleading claims and advertising, its staff does not explain what would fall within the rules. That’s the reality; the FDA will tell you what’s wrong, not what’s right. Through warning letters,

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

H1N1 treatments: Harsh warnings in the U.S. and warm support abroad

The rules are different here in the United States. Hyde Park Holistic Center in Cincinnati recently received a warning letter from the Food & Drug Administration that read like many others having to do with nutritional supplements and the H1N1 virus. In China, though, the same admonishment could not be heard. First, the FDA’s message