It is Halloween Weekend. It is also the weekend to Fall Forward and reset the clocks. We are getting closer and closer to the big FDA Social Media Public Meeting on November 12 and 13. By coincidence, or perhaps not, there is also a meeting of the Risk Communications Advisory Committee during those same two days. Timing is everything.
And now it is time to review a bit of what has been going on lately:
- Sharfstein Gives Talk on Regulation of Vitamins and Supplements – This actually occurred on the 22nd, but I just caught up to it. In remarks given at an annual meeting of the Council for Responsible Nutrition, Dr. Sharfstein stated that while there has been progress in working with industry to reinforce safety, that there are significant remaining challenges. Paramount among them is the identification and control of supplements containing anabolic steroids being sold in online gyms and stores to an ever widening circle of consumers. Under DSHEA, new dietary ingredients (NDIs) in supplements must first be reviewed by FDA. Excluded from this requirement are ingredients that were marketed before DSHEA became law. This, he said, could provide FDA with a tool for gaining some control over the situation. However, he stated that there is no master list of ingredients that were grandfathered in under this provision, making it difficult to identify what exactly qualifies as an NDI. He indicated that the agency will set up a guidance to explain "how to demonstrate that a product is grandfathered in and where supplements do not qualify, the FDA will ask manufacturers to voluntarily pull the product from the market. What he did not say was that if this does not work, look for proposed legislation to give the FDA more teeth in this area – the environment is certainly ripe for that. The day after that, by the way, the FDA posted a vid on supplements and steroids.
Dr. Hamburg Testifies on Food Safety -Going before the Committee on Health Education, Labor, and Pensions in the Senate, Dr. Hamburg offered her thoughts on Keeping America's Families Safe and the Reform of the Food Safety System. She highlighted legislative authorities needed to improve food safety for the FDA, as noted by President Obama's Food Safety Working Group. They are (i) an enhanced ability to require sanitation and preventive controls at food facilities, based on a scientific hazard analysis; (ii) the ability of the FDA to access basic food safety records at facilities; (iii) enhanced ability to use resources flexibly to target food at the highest risk and achieve maximum gain for public health; (iv) enhanced ability to establish performance standards to measure the implementation of proper food safety procedures, and (v) the ability to require mandatory food recalls. She stated that all of these authorities are contained in the Food Safety Enhancement Act of 2009 that recently passed in the House. She also signaled quite plainly that FDA is ready to work closely with CDC and USDA, as recently called for by a GAO report.
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That's it for me this week. The vid of the week goes to CDC for their bit on discouraging free-wheeling use of antibiotics for viral infections: