July 2011

On July 14, 2011, FDA posted an update on how it regulates cosmetic products.  The full update is below for your perusal. In my practice, I have seen warning letters from the FDA, refusals and the insertion of companies on FDA’s Import Alert List (goods are automatically detained when entering the U.S., and it is up to the importer to prove to the FDA that the products are in compliance for EACH importation).  It will be interesting to see if the FDA ramps up enforcement for violative cosmetics.  Interesting to note is FDA’s newer Import Alert (IA) for cosmetic products – IA  66-38, “Skin Care Products Labeled As Anti-Aging Creams,” dated April 8, 2011.  Getting off the Import Alert list is a rather rigorous process, which will be the subject of another post.  Interested to note if you see ramped up enforcement of cosmetics with the new administration?

How FDA Evaluates Regulated Products

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for consumers to use.

Here’s a look at how FDA’s Office of Cosmetics and Colors evaluates the safety of cosmetics.

The Regulation of Cosmetics:

Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do […]

Dear Colleagues,

I am writing today to let you know about some changes that I will be making to the agency’s management structure. As you probably recall, back in January, I told you that I was initiating a review of the Office of the Commissioner. As I explained at that time, this review was driven by the expanding and rapidly changing nature of the Agency’s responsibilities, and the need for a management structure that reflects these changes and best supports your efforts.

I consulted with former Commissioners, as well as with HHS Secretary Sebelius, and considered many options before arriving at the structure that I am announcing today.

The most important thing driving my consideration of this is the changing nature of both the Agency and the job of Commissioner.

Today, the Agency faces several key challenges:

First, we are a very large agency, with an incredibly broad span of responsibility. We regulate products that account for between 20 and 25 percent of every consumer dollar spent in the U.S. and that total more than a trillion dollars annually. For the most part, these are products that people rely on in fundamental ways every day.

Second, as technology and science continue to evolve, we are faced with the challenge of making sure that new ideas translate into the products and opportunities that people need and count on to protect their health. Innovative products that are truly transformative create unique scientific and regulatory challenges, and […]