No postings this week – sorry about that – travel and business, but will shoot for some good ones next week.
This was another week of tropical rain – the kind that comes and dumps steady water as if a large sponge were being wrung out overhead. The garden is having a mixed experience – the lettuce has had it and so has the dill. The basil, rosemary and thyme on the other hand, appear thrilled. I am less so. In a few days, we will have the longest day of the year. In the meantime, it was an interesting week where the agency really made some headlines with some news that was both wide and deep and some interesting developments transpired.
- FDA Moves to Remove Trans Fats – By now, nearly everyone has heard the news that the agency announced this week related to Trans Fats. FDA is giving food manufacturers three years to remove all partially hydrogenated oils (PHOs) – the source of trans fats – from food. This action finalizes a 2013 preliminary determination that PHOs would no longer hold the Generally Regarded as Safe (GRAS) status. You can learn more about GRAS status here. While providing a three year window, FDA is encouraging consumers to check labels to reduce dietary exposure to PHOs. The agency noted in its press release that “currently” food that is labeled as zero transfat may in fact have up to .5 grams per serving. One wonders if the use of the word “currently” signals a change in the future.
- FDA Partners with PatientsLikeMe – PatientsLikeMe announced this week that the company had entered into a collaborative research agreement with FDA to assess how patient-reported data can have a role in risk assessment and risk management. This new effort appears to open up a new avenue for the reporting of adverse event experiences and pave a new way for the inclusion of patient generated data. In the larger context, patient generated data is occupying a bigger role in medical research – particularly with the addition of wearable devices. There was no word in the release from PatientsLikeMe on the details of the effort.
- FDA Takes Action on Illegal Website Sales – This week the agency announced that it was participating in the eighth sweep of action against websites globally that are selling unapproved or counterfeit drugs and devices to consumers. According to the release, action was taken against a total of 1050 websites. Called “Operation Pangea VIII”, FDA said it sent Warning Letters to operators of nearly 400 websites and in collaboration with other federal agencies did screenings and seizures of material through International Mail Facilities in various cities in the U.S. FDA also provides in the release resources to help consumers identify whether or not a source is possibly an illegal pharmacy.
That’s it for me this week folks. Have a good weekend and enjoy the longest day of the year. Happy Summer!
