Posts Tagged ‘FDA’


Tuesday, October 3rd, 2017

Drug manufacturer, Allergan, announced the FDA approval of BOTOX Cosmetic (OnabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines.  This is the third approval awarded to the BOTOX brand of neurotoxin, which had previously been approved only for the cosmetic treatment of crow’s feet and glabellar (“elevens”) lines. While the approval comes as no surprise to most Undercover Agents, it is surprising to learn that BOTOX Cosmetic is the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the U.S. (competitors, Dysport and Xeomin, are more limited in their FDA-approved uses).

“Allergan recognizes that forehead lines are a top area of concern for patients,” says David Nicholson, Chief Research and Development Officer at Allergan. “Our goal in pursuing a third indication for BOTOX Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes.”  Approved for use in over 75 countries, BOTOX Cosmetic is the most widely researched and studied treatment of its kind.


Tuesday, September 26th, 2017

A federal judge ordered Flawless Beauty LLC, who has sold injectable skin whitening and other beauty products, to stop selling and recall some of its products.  According to the complaint for permanent injunction, filed on the FDA’s behalf, Flawless Beauty sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products.  Intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks. The company also sold several products that are labeled to contain human placenta, which can result in serious illness.  Some of the products sold by Flawless Beauty also implied FDA approval or endorsement, which the company did not have.

“Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge consumers to beware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”


Tuesday, August 8th, 2017

The Environmental Working Group (EWG) and Women’s Voices for the Earth allege that the Food and Drug Administration has failed to act on dangerous hair straighteners which contain unsafe levels of  formaldehyde, in a motion filed July 28th in federal district court.  This is an addendum to the groups’ lawsuit against the FDA for its failure to act on a six-year-old petition requesting an investigation into popular hair smoothing treatments that are still sold in stores and salons. These straighteners – often known as keratin treatments or by the name of one prominent brand, Brazilian Blowout – contain formaldehyde, a known human carcinogen and potent allergen.

“The FDA has failed to protect stylists and consumers from exposure to formaldehyde,” said Melanie Benesh, a legislative attorney at EWG. “Since at least 2008, the agency has known about the health hazards associated with these hair straightening products and done nothing. Despite the complaints, the FDA has yet to take action to regulate these products.”  High levels of formaldehyde make many keratin hair straightening treatments a serious health threat for both clients and salon workers. These treatments involve liquids applied to hair, which are then heated using blow dryers and straightening irons. The high temperatures of these hair styling tools cause the liquids to release formaldehyde into the air. (more…)