A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
Largesse: (Form thefreedictionary.com):
1. a. Liberality in bestowing gifts, especially in a lofty or condescending manner.
b. Money or gifts bestowed.
2. Generosity of spirit or attitude.
Two days into last week’s Heart Rhythm Society meeting, Propublica, an independent online investigative journalism-in-the-public-interest endeavor published a series of high profile articles as part of their Dollars for Docs series. Their marquee piece, published prominently in the USA Today, chronicled the strong financial ties (the ‘largesse’) that bind medical societies to industry. Reporters Charlie Ornstein and Tracy Weber highlighted the meeting’s ‘mansion’-sized exhibits, intense advertising, and the fact that most of the opinion leaders, officers of medical societies and guideline writers, the experts, have financial ties with medical device companies. More than half of HRS’ revenues came from industry.
I’ll offer four simple thoughts about all this conflict:
1. Nothing about industry influence at medical meetings is new news. I have been attending medical meetings for nearly twenty years, and industry has always been there. And here’s something you don’t read much about: it was far worse then. That’s all I will say about that. I won’t tell you how cool it was seeing the Charlie Daniels Band play at a medical meeting for free.
You can quibble with the extent of these current-day “cozy” relationships, or the glitz of exhibits at our gatherings, but you should also know that there is progress. The show is now out in the open. There is infinitely more disclosure. Smart people are now watching, tweeting, and reporting. Any doctor who’s been around more than a few years will agree that things have grown increasing more transparent. Which I believe is an improvement. Read more »
*This blog post was originally published at Dr John M*