Don’t know about where you are, but here in Washington, D.C. the rain has been of epic proportions. The gardens are getting a good long drink and I always like to think, whether or not it is true, that a good, wet summer means for a colorful autumn….
Last week because of the short week with the U.S. holiday, there was no Weekly Roundup so this week may contain a few items of note from last.
- FDA Proposes “Action Level” for Arsenic Levels in Apple Juice – The agency announced that it was setting 10 parts per billion (ppb) as the “action level” at which FDA will consider an enforcement action when it finds that there is an amount of arsenic exceeding this level. The press release does not provide any context or background so some may find it alarming that any arsenic at all is acceptable. However that is addressed in a blog posting to FDA Voices by Deputy Commissioner for Foods and Veterinary Medicine, Michael R. Taylor entitled “Why FDA Proposes an Action Level for Arsenic in Apple Juices“. This level, he notes, is the same level that EPA has for drinking water, which is consumed in much larger quantities.
- FDA Acts on Petition Regarding BPA in Infant Formula Packaging – In response to a petition filed by Rep. Edward Markey of Massachusetts (now Senator-elect Markey), FDA announced an intention to amend food additive regulations to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula. The petition contained information collected from a survey of all U.S. registered manufacturers of infant formula to support the claim that all U.S. infant formula manufacturers have abandoned the use of BPA-epoxy resins as coatings in all food contact packaging for infant formula.
- GAO Publishes Report on Challenges of Regulating Rogue Internet Pharmacies – On June 27, FDA announced a very large action to protect consumers against potentially dangerous medications sold by Internet pharmacies involving over 9,600 sites. This week, the GAO issued a report on just how challenging that can be. Among other challenges, the 55 page report points out that rogue sites are difficult to investigate because they may be “composed of thousands of related websites, and operators take steps to disguise their identities.” On top of that, of course, a site can exist anywhere in the world, crossing jurisdictions and other authorities. It was a timely report given the fact that just a few weeks before, FDA apparently made it clear that despite the challenges, it can be done.
- Postscript to the Quarterly NOV and Warning Letter Update – I received a communication via Twitter from a reader that the assessment I made near the end of the last posting on the Quarterly NOV and Warning Letter Update was incomplete. I had stated that the minimization of risk was attributable to the fact that the product had a boxed warning and that while the statements made regarding the indication included bold faced print, the print for the risk information did not. While correct, he stated that more to the point, FDA had stated that by putting the information on the previous page without any of the emphasis used with the efficacy claims (i.e., print, color scheme, borders, layout) that the risk information did not appear connected to the efficacy claims. He was right – and hat tip for the correction. The lesson from that letter was really the totality of the picture between the risk information and the efficacy information. Thanks to the reader for the Tweet!
Wherever you are, may the sun shine on you. May it shine on me too sometime soon. In the meantime, have a good weekend.