There are a few things in here that I am impressed with that are much different than previous bills. One being that rather than calling for outright bans on random ingredients they are asking that the FDA review 5 ingredients for safety each year. That first set of chemicals they are asking to be reviewed are diazolidinyl urea, lead acetate, methylene glycol/formaldehyde, propyl paraben, and quaternium-15.
The bill is being backed by many large companies including L'oreal, Johnson & Johnson, Proctor & Gamble, Revlon, Estee Lauder, and Unilever. It is also backed by the Personal Care Products Council, and of course the Environmental Working Group.
Small businesses are not so quick to endorse the bill, however, as it may have adverse effects to us. My advise to all who may be affected is to first read the bill - its only 98 pages. But only by reading it will you identify the issues that might affect your business. In the past many makers have jumped on the bandwagon thinking that any bill claiming to make cosmetics safer must be a good thing, but unless you read the bill you can't know exactly what someone else's opinion of a safe cosmetic is or what is required of the manufacturer to get one.
The Independent Cosmetics Manufacturers and Distributors (ICMAD) group and the Hand Crafted Soap and Cosmetics Guild has come out against the bill due to the repercussions it would have on small businesses.
Here are some highlights.
Anyone who makes cosmetics will need to register with the FDA (I think this is a good thing).
Ingredients and possibly formulas you use for cosmetics will have to be registered with FDA.
5 ingredients per year would be reviewed by the FDA.
Cosmetics companies will have to supply more information online if they sell online.
All adverse effects would need to be reported to FDA.
The FDA will have the authority to recall cosmetics.
Companies may need to supply safety information on their ingredients and formulas (but its vague).
The FDA will set up Good Manufacturing Practices that must be followed.
I am not supporting the bill because what they are asking of topical products is more than what is asked of food products that are ingested. Other questionable areas to me include Good Manufacturing practices. Currently, FDA has 'guidelines' for GMP. This bill states that the FDA will come up with mandatory GMPs. Again, this sounds good, but there are several things about the current recommended GMPs that make it impossible to be in business alone such as requiring that a second person check each measurement made. I hope that if/when the FDA writes mandatory GMPs it will take into consideration small businesses and those who work by themselves. A second concern is that product manufacturers must make some statement as to the safety of their product. What is actually required here is vague. Previous bills seemed to suggest expensive testing on final cosmetics products.
Getting safety information on specific ingredients also poses some concern. When I buy large quantities of ingredients I am typically supplied with safety information and MSDS from the supplier, but for small manufacturers who may for instance buy a gallon of olive oil at the grocery store, they have no access to safety information or testing done on that bottle of olive oil. Another big concern of mine is always for those of us who use herbs from our gardens/farms. Most of us have not run safety tests on our soil or herbs and it would be very difficult to do so. Being able to make natural, sustainable products is a big concern of mine.
FDA will need money to carry out its part of this bill so collection of fees is a big part. Companies with sales less than $500,000 are exempt from fees and fees from companies selling from $500,000 to $2,500,000 will be just $250. After that fees increase dramatically.
Now if you make soap and no cosmetics this bill does not appear to affect you as it only addresses cosmetics.
Lawyers associated with The Coalition of Handcrafted Entrepreneurs reported on the Indie Business Success phone call (May 1, 2015) that they thought the bill would not go far. There just doesn't seem to be alot of interest at the Senate level and there are plenty of other more taxing matters to deal with. I hope this is true because I am having fun running my business and don't want to have to take time out to fight this bill.
Want to take action and write to your legislator about this bill? See instructions at the Coalition of Handcrafted Entrepreneurs website.
Here are a few additional blogs you can read that review the bill
Lucky Break Consulting
Indie Business Success Call - When the recording becomes available it's well worth the listen.
FDA Law Blog
Manufacturers and Distributors (ICMAD)
Modern Soapmakers Blog
7 comments:
Thanks for this summary, Cindy. I've only skimmed the bill but will be reading more carefully (especially since it's co-sponsored by one of my senators!). The GMPs have always been some of my biggest concerns because I do work by myself most days. Requiring safety statements is even more concerning, though, and I find this ridiculous when many of us are using ingredients that are food-safe and the same tests (and statements) are not required of foods.
Though I'd support the FDA ingredient safety reviews, I, too, find myself hoping that this bill follows the others into oblivion. The amount of time that we all have spent addressing and worrying about this legislation over the years could have been better spent serving customers. Certainly the same is true of our representatives in Washington and their "customers"! You're right that there are more taxing matters for them to deal with.
Thanks for your thoughtful post!
Thanks for your informative and well-thought out post, Cindy. This was a great summary for those of us that have not yet read the entire bill. I share your concerns and I, too, hope this bill will fade into oblivion.
Thanks for summarizing. I hope this bill doesn’t discourage people from trying to start their own handmade businesses.
Thanks for the comments. I'm hoping we don't have anything to worry about, but we'll keep watching.
Section (3) FACILITY
The term ‘facility’ includes
4 any factory, warehouse, or establishment (including
5 a factory, warehouse, or establishment of an im6
porter) that manufactures, processes, packs, or holds
7 cosmetic products or cosmetic formulations, or any
8 other entity whose name and address appear on the
9 label of a cosmetic product. Such term does not include—
‘‘(G) domestic manufacturers with less
5 than $100,000 in gross annual sales of cosmetic
6 products;
------
I interpret this section to exempt small business that gross less than $100,000 a year. Do you read it the same, Cindy?
Anya, sorry I didn't see your post before. But yes, it looks like businesses that gross less than $100,000 per year are exempt from most of the bill. They may have to register, but they are exempt from the fee.
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