From The President – Safe Cosmetics Act of 2010

On July 20th, a new bill was introduced, H.R. 5786, The Safe Cosmetics Act of 2010 by representatives Schakowsky (D-IL), Markey (D-MA) and Baldwin (D-WI).

Read the entire bill here.  (47 pages)

This bill is intended to amend the Federal Food, Drug and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.

IF the bill passed in this format, this is what if would mean for your business:

Who does this bill affect?

Any establishment located in any state that manufactures, packages or distributes cosmetics.

Any foreign establishment that exports cosmetics to the United States without further processing or packaging outside the United States.

How will it affect your business?

Mandatory Registration

Any establishment as defined above will have to register with the Secretary (the FDA) by providing the following information:

  • Name
  • Address
  • Trade Names
  • Description of Activities
  • Number of Workers Employed
  • Gross receipt of Sales
  • Names and Addresses of any suppliers of ingredients

Any changes to the registration will be made within 60 days.

Once the registration is completed the establishment will be assigned a registration number.

The FDA will maintain a list of establishments that are registered and this list will become public information.

Any establishment that fails to provide complete information of fails to register will be removed or suspended.

(Currently the FDA has a Voluntary Cosmetic Registration Program (VCRP) this bill would make registration mandatory and require further information).

Registration Fees

A fee schedule will be determined by the FDA.  All companies with annual gross receipts of less than $1M will not be assessed a fee.

(Although the fees will not directly affect you, it may affect your suppliers or their suppliers and will have a trickle down affect to the end user).

Product Labeling

All products will be labeled with the name of each ingredient in descending order of predominance.  A contaminant or trace element is not required to be listed if the contaminant is present at levels below technically feasible detection limits.

All products sold in e-Commerce will now be required to have an ingredient list on the website as well as the product label.  This includes the establishment’s website as well as the websites of their distributors.

List of Ingredients

The FDA will keep a list of ingredients that are prohibited or restricted for use in cosmetics and continually update that list.  The list will be ingredients that are known to be carcinogenic, mutagenic, or have reproductive and developmental toxicity, based on information from the following:

  • The Environmental Protection Agency
  • The International Agency for Research on Cancer
  • The National Toxicity Program through the National Institutes of Health
  • The California Environmental Protection Agency
  • Other authoritative international, Federal, and State entities (as determined by the Secretary)

(It will be the responsibility of the manufacturer to keep up with what is on the list and what is added to the list, at this time it is not clear how this list will be maintained and in what format).

Safety Statements

Eighteen months after the date of enactment of the Act, each manufacturer shall submit a statement signed by the CEO, based on available information after a good faith inquiry, that –

  • The cosmetic and its ingredients meet the safety standard; or
  • There is insufficient data to determine whether the cosmetic and its ingredients meet the safety standard.

(This will be done for each product that you sell, it is not clear what is done in the case of a product that has insufficient data).

Registration of Products

Each manufacturer shall submit electronically each cosmetic manufactured in the establishment that is intended to be marketed in the United States a statement containing:

  • The registration number of the manufacturing establishment.
  • The registration number of the establishment responsible for distributing the cosmetic.
  • The brand name and the product name for the cosmetic.
  • The applicable use for the cosmetic.
  • The ingredient list as it appears on the cosmetic label of insert, including the particle size of any nanoscale cosmetic ingredients.
  • Any warnings and directions for use from the cosmetic label or insert; and
  • The title and full contact information for the individual responsible for submitting and maintaining such statements.

Any changes will be made in a timely manner and notification will be made to the Secretary.

Each statement will be assigned a cosmetic statement number by the Secretary upon submission.

(This means EVERY product that you manufacture and market to the public which will limit your ability to change and try new products on short notice).

Reporting of Adverse Health Effects

All reports of adverse health effects shall be made within 15 business days of the event.

The content of the report shall include:

  • An identifiable patient.
  • An identifiable report.
  • A suspect cosmetic.
  • A serious and unexpected adverse event.

Confidential Information

All information submitted to the Secretary shall be deemed public information and nonconfidential with the exception of the concentration of cosmetic ingredients used in a finished cosmetic.

At the 2010 Annual Meeting in Denver, Colorado, the membership passed a legislative advocacy statement:

“The position of The Handcrafted Soapmakers Guild is to act as an advocate in all areas that affect the manufacture, sale and distribution of handcrafted soap as defined by HSMG Policy 2005-04-28 Position Statement.  Handcrafted soap under these definitions can be either a soap or a cosmetic depending upon how it’s formulated and labeled.”

The FDA’s website has a page with a very good definition of whether your soap is a soap or a cosmetic.  To re-educate yourself click here.

It is the position of the HSMG that H.R. 5786, The Safe Cosmetics Act of 2010

  • Is poorly written and confusing.
  • Places too much of a financial burden on small business.
  • Over regulates an already safe industry.
  • Destroys the creativity and flexibility of small handcrafted soap manufacturers.
  • Creates further job loss and loss of local revenue in already tough economic times.

Therefore, the HSMG is against H.R. 5786 The Safe Cosmetics Act of 2010 as written.

Leigh O’Donnell

HSMG President

President@SoapGuild.org

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36 Comments

  1. Pingback: Tweets that mention From The President – Safe Cosmetics Act of 2010 « Handcrafted Soap Makers Guild -- Topsy.com

  2. The full force of the Guild should be fighting this bill as it will fundamentally change forever the ability for small craft cosmetic companies to even exist. And soap will be considered a cosmetic for most soaper especially those that use ingredients that will fall under cosmetic restrictions and testing like essential oils, butters, clays and more. I think the guild needs to work with other trade organizations and business to establish a massive opposition front to this bill in the public as quickly as possible. The press needs to be bombarded with press releases, video, interviews and phone calls all opposing this bill yesterday.

    I am planning on establishing or helping to establish a lobbying fund that all those impacted can donate to so that we too can have D.C. representation. I know that collectively we represent hundreds of thousands of small businesses and while most are completely clueless, those that are not and that are planning to grow their operation need to be informed and part of the solution, not just sideline quarterbacks.

    Contact your congressman today announcing your opposition to H.R. 5786 due to the fact, if no other, that it would put you and thousands of other small businesses out of business.

    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h5786ih.txt.pdf

    To Your Success!

    Dennis Fioravanti
    Essential Wholesale

  3. I agree great summation Leigh. I wonder though Does the FDA and the bills supporters even have a clue on the millions of soapmakers this will affect? We should rally a signature campaign OF OUR MEMBERS as support tool of our position? Can we get the small soap groups on line to gather there members signatures? There’s strength in numbers and it will allow small soapmakers to be heard. My first 2 cents

  4. Big government is the death for small business. How can a small business survive while being strangled slowly to death by all these regulations???? Small business are in existence because customers are disgusted with the soaps, lotions, etc on the shelves of the big-box stores. And while most small businesses go to extremes to source good quality ingredients it is those very same small businesses that are being choked to death with these senseless regulations. In the meantime the large companies can get away with syndet bars, parabens, phenols & petroleum based products, etc all the while enjoying the protection of the FDA. It is senseless bureaucracy at its finest and I won’t stand for it.

  5. My concern is the registration of EACH product. If I have say body sprays in 80 different fragrances – would I be required to submit for each individual fragrance if the label ingradients are the same for each body spray?

  6. What can we do as a group to combat this legislation? I’m a member of the NRDC, and they will e-blast their members with pre-written letters, covering all salient points countering poorly crafter legislation so that their members can add to or delete certain points and forward them to their state legislators…
    Do we have any staff at the HSMG who could create this for all of us? I think we need to take cohesive action in this regard. The language of this proposal is clearly onerous and damaging to our craft.

  7. Thanks so much for the information and summary.

    I do not even understand why they would consider soaps cosmetics? It amazes me that the FDA will do so little to regualte herbal supplements, vitimins, cell phones (yes, this falls to them) and yet are going to go after something like this. iT is really sad.

  8. I just read the entire bill. Is there anyone who is serving as a resource for specific questions? I want to make sure I’m clear about the details before I start sending emails and making telephone calls to protest this “legislation.”

  9. It seems to me that if I make soap that is an alkali salt of fatty acids, and during that process glycerin is produced (which is known to be a good moisturizer, but I don’t promote my soap that way), and I add things that make the soap smell good and look good but don’t “promote attractiveness” to the individual, I really haven’t fallen outside the definition of soap that was exempted from regulation by the FDA.

    In reading the details of the FDA article cited in your summary, Leigh, Big Brother seems to be encroaching on the moisturizing properties of glycerin, but only if we promote it that way.

    From what I understand about invoking the soap exemption, it is a matter of how we promote our product. If you don’t say that it will make you beautiful or kill germs, it stays within the definition of soap, which was exempted by Congress in 1935 by a bill introduced by Senator Copeland.

    Of course, I am only talking about soap here, and not creams or lotions or other products that are more clearly within the definition of a cosmetic.

    I would love to hear Donna Maria’s thoughts on this message.

    Richard M. Hamner, PhD
    Green Mountain Soap Co., Inc.

  10. Okay!

    So I just started my business and I would hate to be shut down before I even have a chance to get my foot in the door good! What can we do about this and stop this non-sense bill?

  11. Thanks for the summary Leigh. It is indeed a lengthy and complicated bill. They don’t make it clear either what exactly is considered toxic. I’m guessing its similar to what they wanted to prohibit in the Colorado Bill. If this is true it pretty much means natural products would be prohibited because testing of them would be nearly impossible.

  12. Pingback: Cosmetics Industry Under Fire: Safe Cosmetics Act of 2010 Part 1 « Barcelona Bath & Body Blog

  13. I understand the concern that unsafe cosmetics in the marketplace could be a problem. Personally, I have eczema and psoriasis and returned to the art of soapmaking in midlife to help create soothing products for myself and others.

    However, the bill as it is currently written is the worst possible piece of legislation given the economic environment we are currently in. As an individual laid-off for the last 15 months stifling small business like this is awful. Washington is once again supporter of big business while proclaiming to help support and protect the individual. Very, very sad!

  14. Greetings To All,
    I came over here from reading about this from GeekyClean on Twitter. Here is what I don’t understand, not even being a soap maker but being a consumer. What exactly are they trying to do here? I mean I am sure the suppliers are monitored and such, so why drop the hammer down on the small businesses?

    Please forgive me if I don’t try to decipher 47 pages of government text. I would like, ya know a straight answer. Like the awesome summary here.

  15. Thanks, Leigh. That was some great stuff. It seems from the comments that some of the posters are unclear about the origins of the bill. This bill is not sponsored by the FDA. It was put forth by several congressmen and women at the urgings of private groups – interestingly enough not the big business that it seems would mostly benefit. The FDA would be directed by this bill not the other way around. It is currently in committee and if we get enough people to voice our opposition will hopefully die there.

  16. Pingback: Proposed bill could choke small business’s to death « Gaia Essential’s Weblog

  17. >>DQuartermane

    The Safe Cosmetics Act is not designed to “bring the hammer down on small business.” It is designed to hold corporations accountable for the many ingredients they put into our personal care products, and make the phase out products we know to be toxic (like lead). At the moment corporations monitor themselves. That worked out really well for the banking and realty industries, but was detrimental for the average consumer.

    As for the HSMG, I sincerely hope you consider working with law makers to refine the bill so it will not be onerous to small business people. I for one, think you should view this as a marketing opportunity. Who can the consumer trust, the scary corporation that puts formaldehyde-releasing preservatives in their soap products? Or the Mom and Pop soap crafter that cares about their customer and uses non-toxic ingredients?

  18. Great write up Leigh! Glad to see the position of the HSMG and I agree. So many of us small manufacturers take extra care in creating safe cosmetics. There is a great deal of pride in what we do and a strong connection between us and the customers we serve.

    The Bill, as writen, is not only unfair to the small business owner, it is not needed. Seems to me there are lots of real problems out there to solve rather than making some up and using scar tactics to promote.

    I am with you in opposing this unneeded and poorly writen bill.

  19. Pingback: 5 Ways The “Safe Cosmetics Act” Will Harm Consumers | The Alabu Skin Care Blog

  20. This administration has been systematically attacking small business and cottage industries under the guise of “safety”.

    If you start looking around at the source suppliers such as goat milk, you’re going to find that they’re being attacked also. Industries which have no previous problems with safety are being attacked and the small cottage industries are being threatened.

    Organic farmers, raw milk dairies, farm markets all of which provide “healthy” sources are all being attacked including those how have helped them. On other websites I belong to I’ve read where a family was held at gun point by the FBI, who took off with their computers, because they allowed a farmer to park his truck in their driveway.

    Seems the FBI doesn’t have enough manpower to protect our borders or keep terrorist out of our country but they have plenty of man power to go after independent farmers who are under tighter regulations than commercial farmers.

    My point is that it’s not just our industry that is being attacked by this administration under the guise of “safety” other cottage industries are also being attacked by our government. This administration is definitely anti-business.

    They go after the cottage industries and small business owners because they are the least likely position to protect themselves and don’t have lobby groups. If they can put them out of business then they can slow down the economy even more which makes all more dependent upon the government. It’s a downhill spiral.

  21. Great summary. I am so happy we are working toward educating people about this legislation and why we are opposing it. I have put this on my Facebook, my Twitter, my blog and next my newsletter!

    Thank you so much1!

  22. I for one did the VCRP for my company, and it was not an enjoyable task considering the volume I do as a small business owner. I did do this voluntarily but absolutely do not think this should be mandatory. however have not finished submitting all of my products. I dont not wish this on anyone and was very surprised that that they would even try to make anything like this a must do.

  23. Pingback: The Handcrafted Soapmakers Guild heads to Washington, DC – Safe Cosmetics Act of 2010 « Handcrafted Soap Makers Guild

  24. I saddens me to think that 3 democratic elected officials wrote this short sighted bill H.R. 5786, The Safe Cosmetics Act of 2010.

    I think this suggested bill is an ill conceived attempt at product safety in the cosmetics industry. Please there are currently serious food safety issues (Mad cow, e-coli) that need to be addressed. Clean water is a must for life. These two public safety areas are heavily regulated, THERE ARE LAWS(LIKE the OIL Drilling Industry) but THESE LAWS to protect the safety of our population ARE NOT BEING ENFORCED. Self reporting isn’t working, the honors system, and self regulating, or buying your auditor (Arthur Anderson Accounting and Enron) regulation is not enforced when it comes to corporate America.

    So my suggestion is before we put further laws and regulations on the books we start supporting the ones that are already on the books. Until then I don’t think H.R. 5786 or any further regulation should be written or passed by ANY PARTY.

    Like a vanity book legislation for legislation’s sake to get ones name in the lights is not going to help the situation.

  25. Pingback: 5 Ways The “Safe Cosmetics Act” Will Harm Consumers | Personal Care Truth or Scare

  26. I really appreciate you sending out this information. It would end many small businesses. I make lip balms and body balms too. My clients love the fact that I am a local, small business. I also sell at Farmers’ markets and it’s such a wonderful atmosphere for the community to come together….The government would be reducing us to relying on big business to cover our needs. It’s really unacceptable. Any further information as to how I can help would be appreciated. Thanks again!

  27. “Self reporting isn’t working, the honors system, and self regulating, or buying your auditor (Arthur Anderson Accounting and Enron) regulation is not enforced when it comes to corporate America.” – Pamela on 8.2.2010

    Exactly!

    This is why we should support this bill.

    Soap makers also have an ethical responsibility to disclose all ingredients so that consumers can make informed choices.

    Just like labeling of food products that contain peanuts, soap products _can_ contain substances that can be very harmful/fatal to some people.

    Transparency is the way. The bill’s sponsors will most likely find a way to rectify the labeling issues so that common ingredients can be listed as such.

    Paperwork, labeling and accounting are just part of being a business, I know a designer if you need one.

    Good work all, open discussion/government can solve problems that confront us.

    – John Jay Miller

  28. Pingback: Recent News : H.R. 5786, Safe Cosmetics Act of 2010 |www.ThereseMartin.net

  29. All of us do label our products and are very conscious of a savvy intelligent public who
    read labels and are informed about their health issues.

    The issue for all of us soapers, is that we do not use
    chemicals or their variants in our soaps. The mere process of saponification renders most volatile chemicals useless. Does not anyone stop to think–if that were not the case, all the big companies with millions in research labs and chemists, would have flooded the industry with product.

    For me, the big issue seems to be the fragrance industry. They should continue to independently regulate themselves through IFRA (International Fragrance Association) and with complete compliance to a govt. regulatory agency which at present, I believe they do. If we purchase our fragrances from reputable suppliers who purchase their inventory from companies
    in compliance with IFRA standards then, the burden of safety lies with the govt agencies.

    IFRA org. has full disclosure of ingredients for the interested or concerned consumer on their web site. They also, released their own reply to H.R. 5786 which can be read in its entirety on their homepage.

    Yes, I firmly believe safety issues must always be part of an intelligent society but,
    if we are going to have a govermental agency test thousands upon thousands of soap bars because of a common denominator (fragrance), shouldn’t they start with the common denominator first and stop dividing their neurons to split hairs!

  30. Pingback: Personal Care

  31. The question here is why this bill is being introduced now? Where is the rash of “soap poisonings” taking place? Who has died from allergic reactions to shampoo or lipstick? If an ingredient is known to the government to be unsafe and they don’t want it to be available to the public, then let them ban that ingredient. What sense does it make to permit “dangerous” ingredients to be marketed and sold as long as they are clearly identified? And how does reporting our gross revenues and the names of all our workers make the consumer safe? If anyone can’t see that this proposal has less to do with safety and more to do with protecting the big businesses who are now threatened by our cottage industry, they can’t read the signs of the times. Perhaps if American manufacturers had not shifted all of the jobs overseas they wouldn’t be in this dilemna. But we are where we are and the American people have responded by becoming industrious and inventive small business owners once again. Let us also be intelligent, insistent, and united in urging our lawmakers to vote no! We have the right to engage in free enterprise. Why don’t we write a letter to the President?

  32. I agree with Leonard, it’s not just the cosmetic industry that’s being attacked. This is happening across the board in other industries as well. The United States has moved away from being a capitalist democracy to a socialist technocracy. Because the Environmental Working Group and Campaign for Safe Cosmetics have established their position as that of being the “expert” on this subject, this is influencing public opinion and legislation. Once again, artisans are being eliminated from industry, just as they were during the Industrial Revolution. Remember the Luddites? Except this time the government is behind it, not machinery. Our industry needs professional representation at this time, just as trade unions were established then.

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