FDA Globalization Act – 2009

With the new administration and the recent salmonella outbreaks, Rep. Dingell has submitted a new version of the FDA Globalization Act.  It is HR-759, was introduced on January 28th and has been referred to the House Energy and Commerce Committee.

The good news is that our voice was heard and the section on Cosmetics has been considerably toned down from the 2008 version.  Huge fees and other impossible requirements are gone!

The bill does require registration of cosmetic manufacturing facilities and some other administrative and labeling requirements.  (And if someone dies or is hospitalized as a result of your cosmetic, you have to report that.)

What happens next?

The bill is in committee for review.  They will go over the bill, propose any changes they see fit and then send it back to the full house approved or not.  Given that it was introduced by key players in the committee, I doubt there will be much change.  They have scheduled a hearing about the salmonella outbreak to be held on February 11th.

Once it’s out of the Energy and Commerce Committe, it goes back to the House.  They’ll either vote on it, or send it to another committee (and the process repeats).  After the house finally votes on it, if it passes it goes to the Senate.  If the Senate passes it, then it goes to the President and is signed into law.

My opinion is that there is not much we can do to change the provisions of the bill at this point.  Congress is in an uproar about the salmonella poisonings and is likely to push this through based on that. Added to that is the fact that it allocates $10 million for implementation, so it will likely be part of the overall budget/money parts of the new Congress’s actions.

What does it mean to us?

The provisions of the bill as currently written say that the changes will take place 18 months after the date the bill is approved and enacted.

Over the next few days I will review the bill in its entirety and post exactly what it appears to say will be required of us in the future.  We will need to understand the regulations that are coming and prepare for them.

Once the bill is enacted, the FDA will create the administrative procedures and rules that implement the regulations.  That is a public process and will will have the opportunity to submit review their proposals and submit input.  Luckily, the bill includes $10 million funding for this, so the likelihood of large fees is minimized.

Next Steps

At this point, I will be monitoring the status of the bill and any changes.  I will post information here and also send data to our membership.

Since I feel fairly certain that given the current climate in Washington the bill will be pushed through, we will be concentrating on keeping track of it and getting informed and up-to-speed on how to deal with the FDA procedures when it comes to actual implementation.

The Good News

The really good news in all this is that we did make a difference.  That means that when it comes to the actual implementation of the bill, we can make our voice heard again!

Marie Gale, President