Doing The Right Thing
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March 18, 2013
With extensive media and Congressional attention—and none of it good—focused on energy drinks, some industry experts are speculating that the category is ripe for government intervention.
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January 24, 2013
Since the release of the New Dietary Ingredient (NDI) Draft Guidance in 2011, synthetic botanical constituents have been a hot topic. FDA has held steadfastly to its position that synthetic botanical constituents are not legal dietary ingredients bec…
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November 1, 2012
Election Day approacheth! On November 6th voters will descend on the polls to choose our local, state and federal leaders, from the city council to the White House. In California, voters will also be asked to decide on many ballot initiatives, includ…
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September 15, 2012
It is clearly time for the responsible industry to get its house in order. If the existence of tainted dietary supplements does not end, those responsible for protecting public health are going to be compelled to do something drastic. The recently pa…
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August 15, 2012
I recently attended a seminar where senior FDA officials were lamenting the dietary supplement industry’s poor compliance with Good Manufacturing Practices (cGMPs). I listened carefully as agency officials offered what they described as serious…
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June 18, 2012
The Food Safety Modernization Act (FSMA) had a long and winding road to passage, which is not surprising given the complexities, the politics and the importance. It took many years and plenty of compromise to finally get something that could pass bot…
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May 15, 2012
In April, the Council for Responsible Nutrition (CRN), working in conjunction with the Consumer Healthcare Products Association (CHPA) and the United Natural Products Alliance (UNPA) as the SIDI Work Group, released its new draft voluntary guideline,…
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April 15, 2012
In late February, FDA released a draft guidance titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic,”which has yet to receive much attention. It is a revision of the draf…
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March 15, 2012
Have you ever read a news report discussing Adverse Event Reports (AERs) and dietary supplements? If so, then you may have seen a statistic cited by FDA (and other government agencies) suggesting the agency receives “less than 1% of all adverse…
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February 15, 2012
All too often I find myself reading yet another story about dietary supplements where the author of the article incorrectly asserts that dietary supplements are unregulated. Not only is this incorrect, but it is also potentially damaging to the respo…
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January 16, 2012
Sometimes marriages don’t work. And here’s a classic case. For the dietary supplement industry, 2011 was an interesting year. Two issues in particular were hot topics that didn’t go away when we turned the calendar page to January,…
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