It’s happened again. A new cosmetics Safety Bill has been introduced; the Personal Care Products Safety Act of 2015 was introduced on April 20 by Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine).
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