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Late 2017 brought a lot of attention to BOTOX®. In St. Louis, where the team of plastic surgeons at Washington University uses the injectable to smooth out crows' feet and more, the news of a new approval from the Food and Drug Administration (FDA) was celebrated as it was around the rest of the country. The approval was for a cosmetic use – reducing the appearance of horizontal forehead lines associated with activity in the frontalis muscle.
While such approvals are routine for the national administration, they can also raise questions among the general public. What does an FDA approval mean? How is it earned? And what if a healthcare provider or other medical professional suggests something that isn't approved by the FDA?
The U.S. FDA regulates food (aside from aspects of eggs and meat handled by the U.S. Department of Agriculture), vaccines, medications for humans and animals, tobacco products, dietary supplements, radiation-emitting electronics, cosmetics and medical devices for humans. Those last two cover the bulk of what is available at a typical plastic surgery office and include lasers, liposuction and other fat reduction devices, injectables (not just BOTOX®, but other botulinum toxin-based treatments, as well as dermal fillers and Kybella® for double chins), breast implants (considered to be devices) and more.
Almost half (48%) of the approvals made by the FDA are for medical devices. One third (33%) are given to foods intended for human consumption. The next largest slice of the pie is cosmetics (8%), followed by housewares and food-related items at five percent, and drugs and "biologics" at 3%.
The administration's goal is to protect the people and animals of the United States from harm by ensuring that the relevant foods and drugs are marketed in ways consistent with what they have been proven to safely accomplish. For example, a yogurt manufacturer can't claim that its food is a miracle cure for male pattern baldness (unless, of course, sufficient trials and studies show that it is).
Basically, these regulations prevent product and device-makers from making wild or otherwise unsubstantiated claims to boost sales or otherwise encourage people to buy what they're selling in the hopes of getting a specific result.
This also means that medical professionals are free to use these products in other ways. Although BOTOX® is U.S. FDA-approved only for three cosmetic uses—frown lines, crow's feet and now horizontal forehead lines—the injectable is routinely employed at West County Surgeons of Washington University and elsewhere to do everything from smooth out bunny lines on the nose to enhance the appearance of the lips to allow downward-dragged eyebrows to sit in a more naturally relaxed and uplifted position.
These uses, while not officially recognized by the FDA, nevertheless have a history of successful and safe use, built by providers around the country. Sometimes, such widespread applications—called "off-label uses"—can lead to an FDA approval after years of clinical trials and carefully performed studies. The body of knowledge built by medical professionals as a collective whole can benefit patients in the interim, as well as serve as a launching point for new lines of research and inquiry.
While FDA approvals happen in a variety of ways, depending on what's up for approval, the route that drugs and medical devices take is a rigorous one. Companies must prove their offerings to be both safe and effective before they can be put on the market. This involves clinical testing, often overseen by medical professionals familiar with the product or device in question or similar products and devices.
The time it takes for an approval to be awarded varies. The FDA itself reports that reviews of innovative new drugs take six months on average, though this timeline can be sped up if the medication is deemed sufficiently important for waiting patients. When it comes to cosmetic-based treatments, products and devices, the trials can take years.