Maggots Are a Medical Device…and Other Scary Beauty-Related FDA Facts You Had No Idea About
Maggots are considered a medical device.
This stomach-churning tidbit may sound shocking, but the FDA considers maggots a prescription-only medical treatment that helps with wound healing (there’s a whole lot of disinfection and sterilization involved, but that’s it in a nutshell). Likewise, leeches are also considered a medical device, used as tools in skin grafts and reattachment surgery, and in some plastic surgery and reconstructive cases as well.
If you think those two indications seem far-out, doctors say there’s so much more to the story that people are often surprised to find out—in particular, as it relates to beauty. Brace yourself.
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There is no FDA-approval
process for cosmetics, but there is for the color additives used in them.
Omaha, NE, dermatologist Joel Schlessinger, MD, says this one will probably surprise most consumers. “This applies to most skin care and beauty products, with the exception of soap, skin care devices and products with ingredients that are classified as an over-the-counter drug (such as hydrocortisone or salicylic acid). Each individual manufacturer is responsible for making sure its products are safe for consumers when used as directed before marketing them to the public. This is why things like clinical studies are so important for a skin care product, especially one that promises anti-aging results.”
is little FDA oversight for vitamins and supplements.
This one has been in the news of late, and Dr. Schlessinger says it’s particularly scary because it means some claims aren't backed up by any science. “Over-the-counter dietary supplements, such as oral arnica, are not controlled or regulated by the FDA,” explains Norwalk, CT, dermatologist Deanne Mraz Robinson, MD. “Manufacturers are responsible for the safety of the supplements. If a new ingredient will be used, the manufacturer must notify the FDA able the ingredient. However, the FDA will only review safety of the ingredient, and makes no claim on its effectiveness. This is very different from prescription medications, which must be proven safe and efficacious by the FDA.” Dr. Schlessinger adds that, on occasions, vitamins have turned out to be harmful in certain doses, occasionally resulting in severe risks. “We constantly find patients who are using protein mixtures and end up with severe acne, most likely due to substances that act as hormonal boosters. While they may build bigger bodies, they lead to major acne breakouts and the FDA is pretty much unable to control these companies’ shenanigans.”
Many popular “cutting-edge” beauty treatments have zero regulation.
Newton Centre, MA, plastic surgeon Joseph Russo, MD, says there are MANY things he thinks people would be surprised to learn are not regulated by the FDA. One of the biggest, in his opinion: The use of the popular PRP (platelet-rich plasma), fat transfers, stem cells and growth factors. “The last two are often found in topical products, but the FDA only regulates labeling of topicals,” he adds. “As always, it's important for a patient to do his/her due diligence when getting any procedure to ensure they are in expert hands.”