FDA

FDA Proposes New Sunscreen Regulations

Woman Applying Sunscreen

On February 21, 2019, the U.S. Food and Drug Administration released a proposed rule that would update regulatory requirements for most sunscreen products in the United States. The new rule includes several changes aimed at increasing safety and efficacy of nonprescription, over-the-counter (OTC) sunscreens. The proposal addresses sunscreen active ingredient safety and dosage, sun protection factor (SPF) and broad-spectrum requirements.

FDA Announces First Steps in Medical Device Approval Overhaul

FDA statement on medical device post-market surveillance

On November 20, 2018, the U.S. Food and Drug Administration (FDA) released a statement outlining the steps it is taking to overhaul its existing medical device approval process. The agency’s first goal is to enhance post-market safety by investing in new tools and developing new policies to identify and act upon safety signals related to existing medical devices.

Addressing the FDA Warning on Vaginal Rejuvenation Devices

Addressing patient concerns about energy-based vaginal treatments

On July 30, U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, released a statement concerning devices marketed for “vaginal rejuvenation.” He noted that, although the FDA has cleared or approved laser and energy-based devices for indications including the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts), none of these devices have been evaluated or confirmed by the FDA for “vaginal rejuvenation.”

FDA Issues Warning on Injectable Silicone for Body Contouring

The U.S. Food and Drug Administration has issued an alert reminding dermatologists, plastic surgeons and consumers that injectable silicone is not approved to enhance or augment the body. In a statement released on November 14, 2017, the agency warns that such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism, stroke and death.

FDA Takes Action on Injectable Skin Lighteners

Syringes

Practices that are importing injectable skin lighteners or developing their own compounded injectable products for sale to patients should be aware that a federal judge has entered a consent decree of permanent injunction on behalf of the United States Food and Drug Administration against Flawless Beauty, a New Jersey company. The injunction orders the company to stop selling injectable skin whitening products as well as beauty products containing human placenta and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.

FDA Schedules Public Meeting on Cosmetics Regulation

The U.S. Food and Drug Administration (FDA) will hold a public meeting in order to prepare for the upcoming International Cooperation on Cosmetics Regulation-9 (ICCR-9) Meeting.

The public FDA meeting will take place on September 10, 2015, and will be an opportunity for members of the public to offer input on the regulation of cosmetics. The closing date to request to make oral comments and/or advanced registration is August 27, and special accommodations for guests with disabilities must be requested by September 3.

ALPHAEON Initiates Phase 3 EVOSYAL Study

The U.S. Food and Drug Administration (FDA) has agreed to ALPHAEON’s protocol for a Phase 3 clinical study of EVOSYAL, a botulinum toxin type A neuromodulator, for the treatment glabellar lines.

In the last 12 months, ALPHAEON, a subsidiary of Strathspey Crown Holdings, submitted its investigational new drug application for EVOSYAL as well as completed enrollment in its Phase 2 study. Enrollment of the Phase 3 trial began on January 14, 2015.