Topic
Sunscreen Regulation
9 published works
Focus on Regulation
FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketing
By David Horowitz, Heidi Gertner
On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC…
Focus on Regulation
With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule
By Heidi Gertner, David Horowitz
On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as…
Napoli Shkolnik Blog
We Can’t Trust the SPF Labels on Sunscreen Products?
Every child needs sun protection. The lighter someone’s natural skin color, the less melanin it has to absorb UV rays and protect itself. The darker a person’s natural skin color,…
Health Law
Sunscreen Innovation Act Paves Way for New OTC Sunscreen Ingredients U.S. Market Approval
By Monica Welt
In late 2014, Congress passed the Sunscreen Innovation Act (SIA) to speed the approval of innovative new sunscreen ingredients and formulations, many of which have long been available in Europe,…
Nano and Other Emerging Chemical Technologies Blog
Canada Begins Public Consultation on Revised Draft Guidance Document Sunscreen Monograph
On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document -- Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph…
AdLaw By Request®
The Heat Is On – Just Don’t Get Burned!
Summer is definitely here and most likely you have already made at least one trip to the store to purchase sunscreen. On your trip you may have found yourself a little…
Food, Drug & Agriculture
Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations
By Seth A. Mailhot and Allie Frumin On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens and sunscreen-containing products currently sold over-the-counter. These changes are covered…
TortsProf Blog
New Sunscreen Rules Coming
Over a year ago, I posted (here and here) about a putative class action fraud and consumer protection claim brought against sunscreen manufacturers for the alleged failure to deal with…
Nano and Other Emerging Chemical Technologies Blog
FDA Releases Proposed Rule Regarding Sunscreens
Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug…