Enjoy Your Life! Build Your Business! Have Your Way!
Today, I bring news that HR 4262: The Cosmetic Safety Enhancement Act of 2012 has been introduced. You can open a link to read and download the PDF version of the bill here.
This is a bill, not a law. It has been introduced and will now undergo committee review. This post summarizes at a very high level the provisions contained in the bill. It will be supplemented if appropriate as I continue to read (and re-read) the provisions. If you make cosmetics, this summary is not a substitute for you reading the bill yourself, so please make sure you do that.
In anticipation of two questions I’m sure you will have, the bill, as currently drafted, contains no exemptions for small or micro-business owners, nor does it contain a clause addressing uniformity of law. That does not mean either of those things will not be added now that the bill is in committee. I just don’t know at this point. Here is a high level overview of the major provisions.
Registration of facilities and products made: The bill proposed that companies be required to register with FDA the following: where product is made, brand name of product, product category, and ingredients contained in the product, no later than March 31 of each year.
Fees: Under the bill as drafted, companies would pay an annual fee of $500 beginning 2013. Fees for 2014 and following are set according to a formula contained in the bill.
Good Manufacturing Practices: The bill requires FDA to promulgate mandatory good manufacturing practices, and to review international GMP standards in so doing. (Current GMP guidelines would presumably remain in effect until FDA does that.)
Serious adverse events reporting: The bill proposes that companies report any “serious adverse event” regarding use of a product within 15 days of learning of the event. “Serous adverse event” means death, anything life threatening or requiring inpatient hospitalization, and other things listed in the bill.
Retailers that sell to consumers products with their name on them have a similar reporting requirement. Records of these reports are to be maintained for no less than 6 years.
Safety substantiation: The bill states that companies would have to maintain for no less than five years, a file on each product it makes containing “studies, tests, data, or other information known that relates to the cosmetic products safety and demonstrate that such cosmetic product is safe.”
Mandatory recall: The bill states that FDA can request that companies voluntarily recall products FDA believes will have “serious adverse health consequences” to humans or animals, and barring voluntary recall, can recall products on its own.
Under the bill as drafted, most provisions take effect 18 months after the enactment date. Other parts don’t take effect until three years after passage.
There may be other cosmetics related hearings in the near future. As I find out about them, I will let you know. As you know from this week’s hearing, the issues of small business exemptions and the need for a uniform rule of law were raised repeatedly and by nearly every lawmaker who posed a question to the witnesses.
I am confident that both issues remain under consideration, and will be keeping an eye out for updates in this regard.
Meanwhile, none of this changes the way the Indie Beauty Network serves its members. We are here to ensure that you are as fully informed as possible, to be a positive and useful influence on the process, and to help you implement any new requirements so that your business can flourish and prosper in the face of any changes that may be on the horizon.
This is REALLY important stuff... thanks for sharing and giving us the digest... I'm gonna take a deep breath in a few days and plow through the deeper reading.
Thank you for the summary of the bill.
I began reading the bill, and will do so again until I understand each and every line of it. Anyone that makes cosmetics, I agree with you dM, needs to dig into the bill.
The scope of the proposed bill goes beyond the manufacturing facility/business. One example of who can/will be affected by the law (if adopted) beyond the manufacturing facility: A private label wholesale customer for which we manufacture cosmetics might be required to register their holding facilities. And this leads me to the question, what is the defininition of "holding" facility? I am not asking anyone to answer these questions here, I am just throwing out thoughts as to why it is important to think through the bill. And, if the product is held in a warehouse, how can that differ from being held in a store? Would the store that sells the cosmetics also be required to register as a holding facility? Again, a few of my initial thoughts about some of the details within the bill.
Basically what we are doing is paying for them to be the soap police. (license please!)
They kept saying "isn't it a fact that large numbers of chemicals are banned in Europe?" (OH NO!) Chemicals are Banned in Europe! Why did not anyone say that there is most likely a list of less than 500 ingredients that are used 99% of the time for cosmetics globally, with 20-1000 (or more) years of precedent? It is almost the same for food. I guess that's why it's the FDA, because they want to overlord all livelihoods available to peoples for health, hygiene, nutrition and well being. (Pay the tax! the government is here to keep you safe.) They want to call vitamin C a drug! a prescription for an orange! (state grown of course!)
Thanks dM for posting this. I will read though the bill a few times as well to make sure I understand what is being stated. I am concerned since I manufacture out of my home and concerned of other things as well. Thanks again!
What I am not understanding is the government will allow all kinds of nasty chemicals in food, like the chemically treated "pink slime" that is some kind of cheap hamburger on the market. I read that they have to treat it with chemicals so that it is edible, yet the government wants to mess with consmetics????? I think they need to clean up the food, first. I mean, how many times do you hear of cosmetics causing people harm versus food that is always making people sick or causing death (ecoli, salmonella, etc) I have decided that if this goes through, I will just revert to selling only soap.
The problem I foresee with turning to just selling soap is the possible rise in cost of the ingredients to make it. Seriously. Undue regulation on food grade ingredients (to our suppliers) is going to drive the cost way up. I can see the cost of the bar of handcrafted soap doubling. Not trying to look at this as doomsday, just with a head's up to what we could be facing, Habie.
Ok, well how about telling Rep. Joseph R. Pitts (Pensylvania) the chairman of The Health Subcommitte who will be voting on this bill on June 12th how you feel.
What happened to the small business exemption in the 2011 bill? We need the small business exemption reinstated into the bill.
RE: H.R. Cosmetics Safety Enhancement Act of 2012
Don't forget to tell your customers. We need to act now!
Thank you so much for your comments and for being here with us.
Of course we can all write our lawmakers at any time about anything. I don't suggest it for HR 4262 at this time.
The July 2011 bill (HR 2359) was introduced by Jan Schakowsky and others, and it is still alive, though not the subject of much discussion at this time from what I can tell.
HR 4362 has one co-sponsor at this time.
Telling customers is important, in a way that represents your brand well and which does not encourage them to panic or become confused.
Those are just my thoughts ...
I agree with dM on this. Panic time is a long long ways off.
Currently, the bill has literally 1 co-sponsor and has not moved. Between the 200+ bills the sponsor and co-sponsor have introduced, they have only had 9 passed (not a great track record).
Now is the time to be focusing on your business and making sure that your customers are happy, your products are formulated well and your labeling falls within current labeling laws.
Excellent points, Anne-Marie.
I also think now is the time to set the best example possible. Steadfast and focused.
Ann-Marie and Donna Maria, I will take your advise on this.
I am sure that you have a better understanding of this bill than all of us do since you have been working direclty with the politicians involved with it.
I am so grateful for all the hard work you have done to represent us on this matter.