201010.11
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Obama’s FDA

This weekend, the LA Times ran a story by Andrew Zajac about the “reinvigoration” of the FDA under the Obama Administration (check out the story here).  While the focus of the article was food, drugs, medical devices and over-the-counter items (e.g., mouthwash), there’s no doubt that the increased “regulatory activism” is also being expressed toward…

201009.29
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New Dietary Ingredient (NDI) Enforcement: FDA Takes Curious Action against NDI’s in the Absence of Highly Anticipated Guidance Document

Our firm has been warning industry that FDA was likely to begin turning its attention toward the New Dietary Ingredient (NDI) requirements in the near future. The legislation proposed by Senator McCain and the subsequent compromise with Senator Hatch added support for our prediction, as NDI’s were at the forefront of the negotiation, culminating in…

201008.03
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Too Little Too Late

The Federal Trade Commission’s first probiotic claims case has concluded with Nestle HealthCare Nutrition agreeing to drop claims that its children’s drink, BOOST Kid Essentials, could reduce illness-related absences from school or daycare. In the first of what is shaping up to be several investigations centered on probiotic products, FTC concentrated on whether claims about…

201006.28
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The Class Action Jackpot

When doing a review of your labels and advertising material, you think about Federal regulations and the risk of state Attorney Generals or district attorneys investigating your claims, but what about private attorneys? You may believe that the only worry you could have about claims from a private attorney concern the physical injury resulting from…

201006.25
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Additional FTC Powers NOT Part of Wall Street Reform Bill (S. 3217)

In a House and Senate conference of the Wall Street Reform Bill and Consumer Protection Act, conferees ultimately decided not to include the broad rulemaking authority granted to the Federal Trade Commission (FTC) in the House version of the bill advocated by Congressman Henry Waxman (D-CA). This is a huge win for the nutritional supplement…

201006.25
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“TIMES THEY ARE A-CHANGIN’” Supplement GMPs are in Full Effect

June 25, 2010 –  Today marks the date by which small businesses, meaning dietary supplement manufacturers with less than 20 employees, must be compliant with the current Good Manufacturing Practices (cGMPs) for dietary and nutritional supplements. It has been nearly 16 years since the Dietary Supplement Health and Education Act (DSHEA) was passed. DSHEA contained a…

201006.16
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New Dietary Guidelines for America

This week, Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius released a draft report entitled the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.  In the face of widespread dietary misinformation and an epidemic of obesity, the draft report examines both what Americans are eating…

201005.24
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New Steroid Law Still En Route?

Some law-makers in Washington have been asking, how did “hidden steroids” get into bodybuilding supplements when the amended steroid law of 2004 was supposed to have solved the problem?  Supplement industry critic Senator Arlen Specter [D-PA] chaired a Senate subcommittee hearing last September (http://judiciary.senate.gov/hearings/hearing.cfm?id=4081) to get some answers from DEA and FDA brass. The Senator appeared…