Activities in Washington DC are back on the radar. Last week, I went to Washington DC on a fact-finding mission with Donna Maria Coles Johnson of The Indie Beauty Network and Lela Barker of Bella Lucce (IBN Member and cosmetics manufacturer based in South Carolina). We spoke with key people to try to determine current climate regarding cosmetics legislation at the federal level.
First let me say, the HSMG is opposed to cosmetics legislation both at the federal and state levels that does not provide an exemption for small business.
The HSMG supports any efforts to maintain and improve consumer product safety, but is definitely opposed to unneeded legislation that will burden our small business industry sector.
Over two days, we met and spent hours talking with The Personal Care Products Council, the FDA and staffers for four members of the House Energy and Commerce Committee. The discussions were lengthy and detailed and there was an excellent exchange of information.
What We Found Out
The FDA Globalization Act of 2009 (HR-759) is dead, but the content may be used to create a new 2010 version. We have conflicting information on the timetable, the new bill could come into existence as early as January 2010. It is likely to contain the following provisions that would affect us:
Mandatory Registration with the FDA
There is currently a voluntary registration program (VCRP) for cosmetics manufacturers, which requires submission of name, address and similar information. From what we heard, the feel is that they are pushing for mandatory registration of all cosmetic manufacturers and products.
Since we have to pick our battles, directly opposing mandatory registration of facilities would give the impression that we have something to hide (which, of course, we don’t). However, registration of all products and ingredients (and their subsequent revisions) would be a burden to small manufacturers who make relatively tiny batches. Therefore, we oppose any new legislation that imposes product and ingredient registration, unless such legislation contains an exemption of small businesses.
In the meantime, it is our recommendation that if you are operating a cosmetics business in the United States that you go ahead and voluntarily register soon. We will be posting information on our website to assist you in the process in the near future.
Good Manufacturing Practices
Currently, good manufacturing practice guidelines are in law for drugs, but not for cosmetics.The FDA uses the GMP guidelines to determine if products might be adulterated or contaminated, but it is the adulteration that is in the law, not whether or not the GMP are followed.
The people we met with indicated that they are considering making compliance with FDA GMP Guidelines mandatory for cosmetics manufacturers. We oppose mandatory one-size-fits-all GMP compliance, unless such legislation contains an exemption for small business.
In our meetings, we stated our case that any legislation should be structured so there is some flexibility for small manufacturers. We’ve been asked to review the GMP guidelines and submit a proposal, which will be done in the next few weeks. While the impact of mandatory compliance with full GMP guidelines could be devastating to our small businesses, we are encouraged by the fact that our input has been requested, and hopeful we can impact the final wording of the bill.
Adverse Reaction Reports
Mandatory Adverse Reaction Reports (either all adverse reactions or only “serious” ones) is likely to be included in any new proposed legislation. Luckily for us, our products rarely (if ever) produce adverse reactions.
There has been a new move in legislation in general to require manufacturers to test their products to ensure they are safe. The Consumer Product Safety Improvement Act of 2008 (CPSIA) required toy manufacturers to test all their finished products for safety levels – even if the product from natural ingredients (wood, cloth, etc). Our discussions on the hill indicated there may be a similar move for pre-market testing of cosmetics to make sure they don’t contain anything “bad”.
Our position is that the responsibility for testing of ingredients for harmful components should fall to the ingredient manufacturer; we oppose any legislation that requires premarket testing of cosmetics made from ingredients that are already confirmed as not containing harmful or restricted components.
As some of you are aware, several states have already passed cosmetic legislation that is stricter than the federal law, and more are moving in that direction. We discussed this with the Personal Care Products Council (PCPC), the FDA and the Congressional staffers we met with. It doesn’t look like we’ll get much help in this arena from the FDA or Congress, but the PCPC is aware of the situation and has lobbyists in several states already.
This will be something we will address in the near future. For now, it’s a good idea for you to investigate the laws in the states where you make or ship cosmetics. Please forward any information you find to me so we can take it into account as we make plans for addressing the issue of state legislation.
The situation is fluid and will be changing over the next several months. Legislation is being prepared, but we don’t know when it will be introduced or exactly what it will say. Certainly it won’t be before the health care debate is over; likely it will be shortly thereafter – maybe as soon as next month, or as late as the end of next year.
While we don’t know the exact timing, it’s apparent that a new draft of cosmetics legislation will be circulated at some point fairly soon. We will be working to be ready to address it when it comes.
I will continue working with Donna Maria at IBN to monitor the situation as well as compile and prepare information to present. Be watching for questionnaires and surveys, and please fill them in when they come your way!
An Additional Important Point
Although we will be opposing any legislation that does not provide an exemption for small business, it is very important that we, as an industry, take a look at our practices and become compliant with the regulations that are already in force:
- Labeling Requirements
- GMP Guidelines – at least the ones that you can manage as a small business
- State Regulations (If you don’t know what your state regulations are do some research to find out, they may or may not exist)
- Proper Record Keeping
- Proper Product Liability Insurance
If even one business is operating without regard to these guidelines it puts the entire industry in jeopardy and invites further regulation.
The good news is that our trip to Washington gave us the information we need to understand what is happening. We know what we need to do as an industry if we have any chance of opposing this legislation successfully.
I will keep you updated as additional information becomes available. We will also be posting all this information, as well as links and resources, on our website to assist you in keeping informed and staying compliant with the existing laws.
The Handcrafted Soapmakers Guild is a registered non-profit trade association that is giving a voice to small business in our industry. The more members we have, the louder that voice becomes. Now, more than ever, it is important for us all to support this effort.
You can also read the post by Donna Maria of the Indie Beauty Network.
Leigh O’Donnell, HSMG President