Friday, August 8, 2008

Washington DC Report - FDA Act - 2008

I'm fresh back from the Washington DC fact finding and information sharing trip. If you missed the background of this trip or the FDA Globalization Act of 2008, click here to read about it. It was a well planned out, busy day, shared with invigorating company.

A big "Thank You" to Donna Maria Coles Johnson of the Indie Beauty Network for setting up a whirlwind tour from Maryland to DC on behalf of small home based crafters everywhere. To kick things off in the right way, I made a few bars of this fun John Kerry soap to leave behind, along with our briefing packet. At the very least, it'll help with a good laugh.

Our first meeting of the day was with the Director for the FDA's Office of Cosmetics & Colors, Dr. Linda Katz. Dr. Katz and Patricia Hansen, Ph.D., a Deputy Director were gracious enough to explain their position with regards to the FDA Globalization Act of 2008. If the legislation becomes law, it is the FDA that will promulgate the rules and regulations to implement it.

During our meeting, we described our position with regard to the draft law. For example, we explained how the requirement that having to file paperwork listing each product and each ingredient in each product every time a new product was sold would be a lot of extra red tape for a small business. Here's a fun photo of Jamila White of j.blossom and Donna Maria from IBN posing, right before the meeting started.

Dr. Katz and Dr. Hansen gave us some additional information about the reporting systems currently in place and felt strongly that the systems were manageable for a small business, since they were computerized. They also offered to meet with industry representatives in person, at a conference for example, to train small businesses on various reporting structures. They reminded us that fees are not anything the FDA has input on. They are set by Congress.

So, off to Congress we went.

We took the Metro from Maryland (where the FDA offices are) to downtown DC to meet with a staffer for Senator John Kerry. Kerry is the Chairman of the Senate Committee on Small Business and Entrepreneurship and is a strong advocate for women owned businesses everywhere. Senator Kerry's staffer took copious notes and expressed significant interest in following the draft legislation as it becomes a bill (if that happens). She pointed out that Senator Kerry has no official role in the process until draft legislation becomes a bill, and then moves from the house to the Senate. She thoughtfully offered to follow the legislation to ensure Senator Kerry would be well informed if and when the bill comes up for a vote. Here is a photo of Donna Maria and I in front of the famous Swifboat photos in Senator Kerry's office.


After a short lunch in the Metro Station (wow! What a great variety of food they had in there!), we were off to meet with Virgil Miller, the professional staff member in the House Energy & Commerce committee, where this legislation originated and is now pending. Mr. Miller was very kind and listened to our concerns. He explained Congressman Dingell's (co-sponsor of the draft legislation) reasons for introducing the draft legislation and expressed surprised at the very existence of our small handmade industry.

Jamila White of j.blossom and Lela Barker from Bella Lucce took to the floor to speak passionately about the burdensome fee requirements. It was very gratifying to be listened to with an open mind. After we all had a chance to speak about the potential reporting requirements and fees, he gave us an opening to potentially help shape the final draft of this bill. Specifically, he requested that Donna Maria take the lead in proposing alternatives to the fee structure and reporting requirements now contained in the draft. Donna Maria is looking forward to working closely with IBN members on forming an exemption for small businesses or perhaps a sliding fee fee structure based on the size of impacted businesses. It was great to be asked to participate. Here's a photo of Donna Maria with Lela Barker from Belle Lucce, riding the metro.


And, like dessert, it's good to save the best for last. We met with the Deputy Communications Director and another staffer in Congressman Jesse Jackson Jr.'S OFFICE. They were very surprised to hear about the potential unintended consequences of the draft discussion framework and agreed that it seemed like an oversight to impose fees and paperwork requirements that would essentially tax small businesses heavily, perhaps even right out of existence. The staffers had some very interesting ideas for getting press for the small business cause, as well as helpful suggestions for working within the current framework of the House/Senate bill session. The two staffers we met with were funny, witty and charming. It was almost like sitting down for coffee with good friends.

After that last meeting, we were tired but in high spirits to meet with soapers who had driven up to 3 hours to meet us at California Pizza Kitchen (a tip: their White Pizza is delicious!) for debriefing and some great food. Here's a photo of our merry group. That's Jamila White from j.blossom with the closed laptop. She jumped right on the internet to do some research, right at the table. Now that's a perfect example of an entrepreneur - always thinking and willing to do what it takes to get the job done - even if it's during dinner!

The camaraderie was high and it was an honor to put a face to the names I see online. The main clearing center, the woman who is focusing much of her current time on this potential legislation, however is Donna Maria. Her blog is here. You should check it regularly as well for updates on where the draft discussion framework is going. I'll also keep you posted on what is going on with this legislation through this blog as well.