Tag Archives: FDA

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

Facebook widget: Bad medicine for Novartis

Facebook widgets are being blamed for computer viruses, personal data theft and now health dangers. The Food & Drug Administration told Novartis in an August 2010 letter that its widget for the leukemia drug Tasigna violated FDA advertising rules in part because the widget lacked information about potential health dangers. In response, the drug maker

FTC takes snap, crackle out of Kellogg cereal health claims

The three little guys on Rice Krispies boxes are in trouble for claiming that their cereal supports the immune systems of children. The Federal Trade Commission announced on June 3 that Kellogg Co. had  agreed to pull back on health claims for the puffy cereal. In a statement, commission chairman Jon Leibowitz said, “We expect

FDA Finally Getting Tough on False Food Claims

Guest Post from The Customs and International Trade Law Blog The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims displayed on their food and drink products, including those marketed to children.  Some food products brazenly claim to increase a person’s immune system, reduce the chance

Some iPhone apps may require FDA regulation

As more iPhone apps are released for medical purposes such as diagnosis and treatment of symptoms, Electronic Medical Records (EMR), and other health-related purposes, Apple‘s mobile device is garnering more attention from the FDA. Don Witters of the FDA Center for Devices and Radiological Health (CDRH) said the agency’s goal is to achieve safe, secure, and reliable

Some iPhone apps may require FDA regulation

As more iPhone apps are released for medical purposes such as diagnosis and treatment of symptoms, Electronic Medical Records (EMR), and other health-related purposes, Apple‘s mobile device is garnering more attention from the FDA. Don Witters of the FDA Center for Devices and Radiological Health (CDRH) said the agency’s goal is to achieve safe, secure, and reliable

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:

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