FDA Act 2009 – Letter to Congress

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I have been working with Donna Maria (Indie Beauty Network), along with terrific input from Anne-Marie Faiola (Brambleberry) and Kayla Fioravanti (Essential Wholesale) to review the FDA Globalization Act of 2009 (HR 759).

Our contact at the House Commerce and Energy Committee requested our input and was quite interested to know if we could “come out in support of the bill”.  Looks like our voices really were heard!!

As a result, Donna Maria and I have co-authored a letter stating our position and concerns.  At this point we are in agreement with a majority of the cosmetics portions of the bill. However, we do not yet fully support the bill. 

There are two sections of HR 759 about which we still have concerns:  submission of cosmetic ingredient statements for EVERY product produced and the possibility of one-size-fits-all good manufacturing practices for cosmetics being made into law.

Our suggestion to the Committee (via our staff contact) is that the sections cosmetic ingredient statements and the GMP be amended to include provisions that allow the Secretary (that would be the FDA) to adjust the requirements as needed for very small businesses.  It doesn’t mandate that the Secretary do it, but does allow the Secretary to do so, which would give us an avenue to present information and documentation during the rule-making process.

To quote one paragraph from the letter:

Empowering the Secretary, using federal rulemaking procedures, to define small cosmetic businesses and treat them appropriately when it comes to submitting ingredient statements and determining good manufacturing practices allows for consideration of industry nuances that are best addressed at the agency level, with the input of industry participants through public rulemaking.

Congress is looking at the big picture (as they should), but needs to allow the FDA the flexibility to address the concerns of very small businesses like most of ours.

If our suggested amendment is accepted by the Committee and then the entire House of Representatives, it will be a step in the right direction.  We will still have a long process of getting our very small businesses understood by the folks at the FDA who have concentrated on large cosmetics firms in the past.  I expect that the concept of a stick blender is very far from their current reality!

However, given the level of activity, the dedication and the passion of HSMG and IBN members, we will have no problem rallying the troops and getting the information to the FDA that they need to understand our issues and concerns.

I’ll keep you posted on any further developments.

Marie Gale, President

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