About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: Vitamins and Supplements
FDA to Examine Inhaled Caffeine
The Associated Press reported this weekend that FDA officials have expressed intent to investigate the marketing of an inhaled caffeine product. The product, called AeroShot, is described as a fine powder that is in a lip-stick type of tube … Continue reading
Posted in FDA Policy, Vitamins and Supplements
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GAO Urges More FDA Control Over Dietary Supplements
There are a few very specific places to look if you want to read the tea leaves of potential reforms by Congress. One is the Oversight committee correspondence with the agency that regulates your area of interest as well as … Continue reading
Posted in Vitamins and Supplements
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Adverse Events Reporting on OTCs and Supplements
As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes … Continue reading
Posted in OTC Switches, Vitamins and Supplements
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Senate Passes Dietary Supplement Adverse Event Bill
As the lame duck Senate gets ready to waddle off to their place in history, they have moved to pass S. 3546 – a bill that would require the makers of dietary supplements to report serious adverse events. Interestingly, this … Continue reading
Posted in Current Affairs, Vitamins and Supplements
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Risk Benefit and DSHEA
The FDA has issued a statement regarding the decision by the Tenth Circuit Court of Appeals reversing a lower court decision on the FDA actions to ban ephedra from sale in the United States. You will recall that after a … Continue reading
Posted in Vitamins and Supplements
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