The FDA Globalization Act of 2009 was officially introduced on Wednesday the 27th. While this Act would have been introduced eventually, the political cover afforded by the Peanut Butter scare made it perfect timing (even though the Peanut Butter Salmonella problem could have been prevented under existing regulations regarding best manufacturing practices and had the 12 positive tests in 2007 and 2008 been properly dealt with. CNN story here).
No matter what the reasoning, the FDA Globalization Act is on the table to help an agency that is woefully underfunded to deal with the realities of an increasingly global society with imports flooding the United States from countries with more lax regulations around safety. The current iteration of this bill imposes fees and more regulations primarily on the food and drug industry. There have been substantial changes made from the original draft that circulated in 2008. Specifically (full copy here), it appears that much of the feedback the micro beauty business gave in 2008 (read about a Coalition of Small Business & Suppliers that went to Washington DC on your behalf here and here) was incorporated. Yay for a team of committed individuals helping to enact positive change!
Salient points for the FDA ’09 Act are:
Registration – Like having a business license with your city, you will need to register your bath and body business with the FDA (page 115 – 116)
Inspections – Besides registering with the FDA, they are not asking for inspection of your facilities.
Fees – Under the current draft legislation, there are no fees to register your business or submit your ingredient decks (aka: list of ingredients used in your products)
Ingredient Listing – When you manufacture a product to sell, you need to submit your ingredients for the overall product. You will not need to submit for each individual fragrance, provided the base does not change. (page 119)
Adverse Events – Right now, reporting “Adverse Events” to the FDA is voluntary. This means that if one of your customers reports that your lotion gave them an allergic reaction that sent them into the hospital (highly unlikely) that the FDA would currently like you to report this but they do not make you. In the future, reporting serious Adverse Events will be mandatory within 15 days of the event. See below for full definition of Adverse Events. (page 122)
There are a group of committed business owners, advocates and vendors working diligently behind the scenes to proactively monitor the situation. Between The Soap Guild, The Indie Beauty Network, Essential Wholesale, WholesaleSuppliesPlus and Bramble Berry, we’ve got your best interests at the forefront of our monitoring and actions. We will keep you up to date as we hear anything.
- Press Release regarding release of FDA Globalization Act of 2009 here
- CNN story on peanut butter contamination history here
- The term ‘serious’, with respect to an adverse event, means ” resulting in death, a life-threatening experience, inpatient hospitalization, a persistent and significant disability or incapacity or a congenital anomaly or birth defect.”
- I’m not a lawyer. You should read the bill yourself to make sure you agree with my interpretation of the data
Joining the chorus of admiration for those who took on the government and were heard! Everyone in our industry should be grateful to you all.
The registration requirements still concern me. As Robyn stated, many of our ingredients are not listed in the database at all. Plus if you are offering a mix of “finished products” and “raw materials” (I think from now on we will have to consider the essential oils, carriers, hydrosols, etc.that we import as raw materials!) our product list changes almost monthly. The time required to keep the registration product listing current seems overwhelming.
Hi Robyn –
In theory, if this law is enacted exactly the way the bill is written, this will be fixed within 18 months.
I did forward your concerns to Marie at the Soap Guild as well as Donna Maria from Indie Beauty Network and they are both aware of this potential glitch. That way, when they are formulating a response on behalf of their members, they can incorporate this type of feedback.
Congrats on registering!
I went ahead and already registered in the event that this does pass (which I think it will in a fairly close form to the current version) to avoid the rush of submissions. It’s really not bad at all, though since we’re not using INCI #’s, and everything isn’t considered a colorant where order doesn’t matter, I still have my original concerns about not knowing the specific order when adding an ingredient to another that already contains the same ingredient (see titanium dioxide way up earlier). More importantly, I’ve already stumbled upon a glitch. You must use the numbers assigned to various ingredients. I’ve discovered that the database isn’t very thorough. What do you do when you’re using an ingredient that isn’t listed in their database? For example, some of my products have a mica coated with carnauba wax. There is no carnauba anything in the database 🙁
I find this to be exciting news. The fact that individuals like ourselves have used our voices as one and have seen such changes is empowering. The same is true of the CPSIA issues. It gives me renewed faith in our democracy. It may not always work in our favor, but when we come together as one good things can happen.
I am so grateful for all the hard work and effort put into fighting the Globalization Act. I am so proud and incredibly humbled to be a part of such an amazing group of people!
Words cannot express how very grateful I am!
Blessings to all of you!
Susan
I can only echo what the rest have already said but do know I too appreicate all the work each of you have done and are doing. Thank you.
Thank you for all of the work you and the others have spent to ensure that the appropriate revisions have been made.
I have never been opposed to being under the watchful eye of the FDA. I know what I put into my products is good. I label my products’ ingredients and am certain of their safety, by the cleanliness and safeguards in my work environment, etc.
I think there does need to be some regulation, but there needed to be some changes regarding fees/inspections, etc. and this seems quite fair. I am pleased.
Thank you!
As someone who took the small business plunge just last summer, I offer my humble thank you for fighting the fight and keeping us informed. There is pride and joy in what we do, and I am grateful that I may continue my dream.
By coming together and leading the charge, you have made it possible for me to continue working towards my dream of a successful business with a conscience.
“Thank you” doesn’t convey the level of gratitude and inspiration I feel as a result of all your efforts on behalf of small businesses, mine being the smallest. Here is my thank you; I promise I will pay this good fortune forward and help other aspiring business owners whenever possible.
Thanks again!
I see positive changes to the Act in our favor, with “our” being the small cosmetic business owners.
These announcements/updates tells me that they are not targeting us as a group. We are still under their watchful eye, but we are not directly under the microscope.
I plan to march forward, putting my best foot forward. Something tells me, with a lot of integrity and honest, quality work, we will put most concerns with this act behind us eventually.
Thank you for the update, and all of your very much noticed efforts. This is a grand Saturday morning!
It has been a very exciting week. I am honestly pleased with the new version of the FDA Globalization Act of 2009.
No fees for the cosmetic industry equals great potential for small businesses.
More than anything it has been an honor to be on this journey with you A-M. You are a powerhouse in and of yourself and a woman of great integrity, work ethic, and drive. I learned alot sweating along side the woman who marched on Washington together.
See you in Palm Springs!
Thank you Anne-Marie for all the work you have done on this. As a business owner, I owe you a debt of gratitude.
Anne-Marie- I can’t tell you how much I appreciate all the work you and the others are doing in order to help all of us. Being new to this business, it can be frightening to hear all of the changes. Knowing I have the “Powerhouse” in my corner is very refreshing!! I plan on helping in any way I can. I am known to be Loud…lol.
Thanks again,
Rachel
http://www.twitter.com/RachelFerrucci
January 30, 2009 6:33 PM
As you have clearly shown, you don’t have to be a lawyer to be able to interpret legislation.
Well done.
Anne-Marie- I can’t tell you how much I appreciate all the work you and the others are doing in order to help all of us. Being new to this business, it can be frightening to hear all of the changes. Knowing I have the “Powerhouse” in my corner is very refreshing!! I plan on helping in any way I can. I am known to be Loud…lol.
Thanks again,
Rachel
http://www.twitter.com/RachelFerrucci
This has been a worry in the back of my mind. I am so happy to have the update and especially one with such positive news. I am extremely thankful for all that have gone to battle on this issue and represented all of us. I so love what I do and I am thankful that it looks as though I will be able to continue on this path.
Thank you Anne-Marie. Congressman Pallone is my Congressperson, I sent him an e-mail to let him know I was in his district and I had serious questions about this. I am not currently proficient enough to sell the soap I make, but I would like to in the future. I hope that this act isn’t going to push my dreams aside!
I am proud of the business I have built for myself.
I am proud of all the wonderful fellow business people I have met through various blogs, forums, etc.
I am proud to be a meber of such an amazing group of people.
Most of all, I am proud that we stuck together as one united front and fought for what we knew was right.
We didn’t worry about the fact that our businesses may compete with each other.
We didn’t worry about the fact that we were taking on the government of the United States.
We didn’t worry about the people who said nothing could be done.
We just plowed ahead- led by some of the most fearless and knowledgable people- to try and reach our goal.
At the end of the day- we did just that!
Together we accomplished what I don’t think anyone has ever done before- we banded together, stood strong and changed a bill that would have served as our order of execution.
Never in my life have I been so proud to be associated with such an inspiring and caring group of people.
Thank you for leading us in a fight – that if fought alone – would have been lost…only through the leadership displayed by a hand full of brave folks, we united and made something happen.
So while I am proud of many things I have done in my life, I am most proud and honored to have been a part of something so important and amazing.
You have shown me that we CAN make change- that we CAN win!
With many thanks and all my gratitude!
Right on, dM! I love your spirit and you’re right, a group of concerned citizens was able to get the CPSIA to at least put a hold and examine the issue for another year. That’s amazing and all without more than a group of grassroot supporters. Whooo HOO!!!! We can totally do this, working together. Look how much more sensible and less harmful this draft law is compared to the last one.
Robyn, in theory, if we did submit all the ingredients, colorants come at the end and just be the normal INCI listing that they’ve always been on cosmetics. If that does happen, and we are not able to get an exemption for small business (this is a marathon, not a sprint – it’s just a draft), then the same rules for full ingredients listing on bottles would just be submitted to the FDA using a consumer-friendly website.
Since most businesses are keeping track of what they put in their products for batch continuity sake, it would be one more step in the formulation process prior to putting a product out to market.
But, I wouldn’t spend a second thinking about the “Hows”. Right now, the thing to focus on is a request for an exemption for small business. That’s what we all want to be positively and proactively working towards. If this passes as is (which is unlikely), then we can work on those little teensy details.
In the meantime, keep formulating great products and focus on making your company the strongest it can be with awesome branding, energetic marketing and continuous learning.
I’m thankful as well for everyone’s hard work. I’m truly hopeful that DM is right and Indies are the exception to the rule.
Question of the hour: assuming we DO end up having to submit our ingredients (in descending order), how the heck do we do that? Many ingredients come to us combined (many micas already have titanium dioxide in/on them, for example), after which we add more of the same ingredients (let’s use more titanium dioxide to keep things simple). Since we don’t know the exact % by weight of original mica’s TiO2, how do we know where it ranks in relation to other ingredients after we’ve added all our ingredients to create the finished product? It used to be that most of these ingredients were considered “colorants” and could go in no particular order at the end. Are they all still going to be considered colorants?
wow. i sure am grateful to you veterans in the upper ranks of
industry.
while we are still fighting ground wars and html codes and identity creises, we sure are thankful to
you for your proactiv oversight.
thank you to all: Anne_Marie, Donna Maria, Kayla, and the list goes on and on.
when i was involved with herbal medicine, we had the same struggles and issues and even battles with the FDA.
it is hard to not be fearful/antagonistic towards an entity when you realize the big money pushing the agendas that help their own causes……
but
don’t get me started now
or
i’ll
NEVER stop!
Thanks for a great post, A-M! A wonderful summary, and no registration fee! All because you and others worked so hard starting in April last year to fight this. We have more fighting to do. Even absent a fee, we still have some significant arguments in favor of an exemption for small companies. I think we have a shot at getting it. Look at what small businesses affected by CPSIA did!! Stopped a new law IN ITS VERY TRACKS, and all with no lobbyists, no lawyers and no high priced consultants. Just thousands upon thousands of men and women just like us, working hard to provide for their families and create a better tomorrow for all of us. Might doesn’t mean right. Right means right and I am prepared to continue the battle with you and others.
dM
Elizabeth, I’ve read through the whole thing … twice. As far as I can see, as it is written now, there is no cost to register. So, free! $0 =)
Any ideas on how much the registration is going to cost each year?
Thank you for all your hard work Anne-Marie!!! It is amazing what is possible when people work together towards a common goal.