Friday, August 19, 2011

Registration Requirements of the Safe Cosmetics Act


Registration Requirements of the Safe cosmetics Act
Section 612

Registration of cosmetics manufacturers seems reasonable, and I think that anyone who makes cosmetics should be registered with the FDA. By doing so it allows open communication between FDA and cosmetics manufacturers so that information about ingredient toxicity can be openly shared. Its interesting though that this bill exempts small businesses, those that sell less than $2M annually, from registering with the FDA. I am confused about the reason for this. Without registering there is no open communication and no means for small businesses to get up to date information from the FDA. It also brings up the suspicion by consumers and other regulatory organizations that small businesses do not necessarily make safe cosmetics since they are not in contact with FDA. This is anything but leveling the playing field. As a small (micro) business I do not want to feel second rate and am proud to be voluntarily registered with the FDA already.

Cosmetic companies would be required to file a report of all cosmetics they produce and the functions of such cosmetics. The FDA already defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" so its unclear if they are wanting more information on the function of the cosmetic or not. Reporting gross sales from cosmetics is required; forcing small privately owned businesses to reveal personal financial information. Yes, I do feel like this violates my rights. Sole proprietorship's and LLCs should not be required to make public their personal finances. I’m curious how FDA will even be able to keep track of this, especially when small businesses are not even required to register. I fear a lot of companies will be trying to ‘fly under the wire’ or go ‘underground’ so to speak, not have the knowledge they need and make unsafe cosmetics because of that.

The part I mainly object to is that companies must supply the name and address of any company that supplies ingredients. This is especially difficult for a small company as suppliers can change frequently. This prevents any last minute changes in formulas. If I happen to run out of olive oil from my supplier I have listed, I cannot go to the grocery store to buy emergency olive oil as I have been known to do. Any errors or inaccuracies in information submitted can lead to cancellation of registration or even

What's an alternative? I think cosmetics companies should all register with the FDA. This allows a path of communication between the FDA and manufacturers that is important. Not only to receive up to date information from the FDA but also for the FDA to receive information from manufacturers and consumers on adverse reactions. Fees can and should be waived for small companies. Suppliers should not have to be reported to the FDA. If olive oil is safe why does the FDA care who I buy it from? As long as safe ingredients are used it doesn't seem like a good use of FDA time to have to keep track of where I buy them from.

But what's worse is that now legislation is being introduced in a number of states to regulate cosmetics at that level as well. This means there is a good chance that you will have to deal with this type of registration in each and every state as well as at the national level.

If you are a small business how do you feel about this part of the bill?

2 comments:

Nancy Liedel said...

I am registered and would be okay with paying an amount I can afford, but because I'm small (smaller than you), I cannot pay additional fees for the change of suppliers.

I am happy to fill out paperwork and pay some reasonable fees, but I'm good and will get better and as I learn and grow, my company will. I am about to incorporate for the very reason that I have no desire to share all of my financial issues with the FDA. Thank you very much.

"Look in April the Liedel's bought $600.00 worth of food. Those kids must really be eating."

Okay, it's never that personal, but I built a formulary out of my living room, put down proper floors (still need a drain) and went way beyond what a home-based company is expected to.

Why? I didn't have to. I want to make sure my products are safe and healthy for me and anyone who entrusts their face to my company. Not because Big Brother is making me. The people who lie, cheat and sell are going to do it regulated, or unregulated. There will always be people who skirt rules and tell people, "D and C Red 33? Sure, it's fine for your eyes and I can put as much as I want on your lips...um, no. They go ahead." Sheesh. Or my all time favorite, "Heals your ___________." with no testing.

The FDA can't keep up with that now. How will they do it in this economy without more money and a lot more than they will be able to get out of Cosmetic Manufacturers even if they get more money from those firms. This is just a way to hamper and hurt the FDA, and manufacturers. I get that real regulation is needed. This is not real regulation. It's a band aid to make people feel better.

What should we do instead? I don't know. Maybe get more cosmetic scientists involved, with real research behind the rules. I am not a big fan of pseudo science. A study of 25 anything is hardly what I would call worth being alarmed about. The fear mongering among companies pushing an agenda, small and large. I would rather see more products placed through really good studies done and close the book...what am I saying? People think scientists are wool pullers too. I have no answers. I want some, but I'm too busy installing a drain in my former living room and darn happy to do it (we never used it anyway. Except for a tree and we go to Grandma's for holidays).

Cindy said...

Thanks for your comments Nancy. You're right about there being no easy answers here. Too much time has been wasted with this bill already. I'm sure we will see it put to rest very soon.

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