News and Notes
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Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals.
The Federal Food, Drug, and Cosmetic Act defines a "new drug", which requires prior approval, as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
It is important to emphasize that "safe and effective" is always conditional on following the directions. For example, aspirin can be lethal when taken in large amounts but is approved to be GRAS/E by FDA for over-the-counter use as directed.
FDA has acknowledged the possible existence of drugs that could be considered GRAS/E that they have not found to be GRAS/E yet. As FDA stated in its 2006 Guidance on Marketed Unapproved drugs: "A product would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time… As mentioned above, the Agency believes it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug. However, the Agency recognizes that it is at least theoretically possible."
For now the signs are down, but we seem to find ourselves living in a construction zone. The owners of Concord Plaza are re-imagining and re-invigorating the office park. The extent of the work has come as a less than welcome surprise. Let us assure you that we are not going anywhere and we are open and ready to see you. despite all appearances to the contrary. Please accept our apologies for the inconvenience and anticipate that our building will be blocked off once again whenever construction begins on the new building planned for the pad adjacent to ours. When that happens, please follow the signage taking you past the traffic circle and around the corner to the right. Then, you can take the 2nd or 3rd right turn, (taking you to either the front or back of our building) and go past the Weldin Building to Webster. Once again, we apologize.
As everyone knows, you get what you pay for:
Every now and again, I receive a solicitation to buy products like Botox® and Restylane® from an outside vendor (not the manufacturer). I find it shocking because, clearly, somebody must be doing business with these people or they wouldn't exist. Lord knows where these products come from, or what these products reallyare. Rest assured, it will never be us. We obtain all of our aesthetic products directly from the manufacturer ... always. Feel free to ask to see the identifiers on the packaging when you're receiving treatment in our office. Outlet or discount sources for these products are suspect of being, expired, pirated, fake, or otherwise, fraudulent. It's your face and your health. Don't be fooled. Here's an actual solicitation that landed on my desk.
I think it is always interesting to read what "Consumer Reports" has to say. To be honest, I have a sunscreen "wardrobe". I choose daily from among six or seven products. Different locales and activities call for varying types of protection. My personal concerns about chemical sunscreens are limited to environmental ones. We now know they are toxic to coral reefs. Fortunately, I am a person and not a coral -- and, anyway, coral isn't so much an issue here in the mid-Atlantic region. So, I do use chemical sunscreens from time-to-time. Just the same, when swimming in the ocean I reach for UPF rash guards and leggings. My advice: just use sun protection consistently and choose whatever you find to be effective and, with which, you are psychologically comfortable. When in doubt, follow my lead and opt for sun protective clothing (UPF 50 or higher). These are widely available online. Also, don't forget the hat and sunglasses. You'll be fine and so will the coral.
Last Friday, Jason Saul, PA-C and I spent the day talking to staff at Longwood Gardens about how best to care for skin that is exposed to the elements all day every day. Of course, not everyone who works at Longwood works out of doors, but even they had questions and concerns we were happy to be able to address.
Overall, we were pleased to note how much many staffers already knew. It has generally been our experience that people who work out of doors are under the impression that they have built up some immunity to sun radiation and no longer need to worry about it. Of course, nothing could be further from the truth and, fortunately, the Longwood folks were already cued into that and were just wanting to know how to go the extra mile to protect themselves. Wind and water exposure also pose problems and we talked about that, too.
Thank you to Madelyn Underwood, Director of Human Resources at Longwood, for inviting and taking such good care of this while we were there. It was so successful, we may make this an annual event.
I must apologize for not taking any pictures. (At Longwood that's almost a sin.) I got so involved in a conversation with folks that I didn't have the chance. But since a visit is worth a thousand pictures, I suggest you visit https://longwoodgardens.org and plan a time to go and see for yourself. Don't forget to bring a hat, lip balm and, naturally, sunscreen.