Important Legislative Update – From the President

Activities in Washington DC are back on the radar. Last week, I went to Washington DC on a fact-finding mission with Donna Maria Coles Johnson of The Indie Beauty Network and Lela Barker of Bella Lucce (IBN Member and cosmetics manufacturer based in South Carolina). We spoke with key people to try to determine current climate regarding cosmetics legislation at the federal level.

First let me say, the HSMG is opposed to cosmetics legislation both at the federal and state levels that does not provide an exemption for small business.

The HSMG supports any efforts to maintain and improve consumer product safety, but is definitely opposed to unneeded legislation that will burden our small business industry sector.

Over two days, we met and spent hours talking with The Personal Care Products Council, the FDA and staffers for four members of the House Energy and Commerce Committee. The discussions were lengthy and detailed and there was an excellent exchange of information.

What We Found Out

The FDA Globalization Act of 2009 (HR-759) is dead, but the content may be used to create a new 2010 version. We have conflicting information on the timetable, the new bill could come into existence as early as January 2010. It is likely to contain the following provisions that would affect us:

Mandatory Registration with the FDA

There is currently a voluntary registration program (VCRP) for cosmetics manufacturers, which requires submission of name, address and similar information. From what we heard, the feel is that they are pushing for mandatory registration of all cosmetic manufacturers and products.

Since we have to pick our battles, directly opposing mandatory registration of facilities would give the impression that we have something to hide (which, of course, we don’t). However, registration of all products and ingredients (and their subsequent revisions) would be a burden to small manufacturers who make relatively tiny batches. Therefore, we oppose any new legislation that imposes product and ingredient registration, unless such legislation contains an exemption of small businesses.

In the meantime, it is our recommendation that if you are operating a cosmetics business in the United States that you go ahead and voluntarily register soon. We will be posting information on our website to assist you in the process in the near future.

Good Manufacturing Practices

Currently, good manufacturing practice guidelines are in law for drugs, but not for cosmetics.The FDA uses the GMP guidelines to determine if products might be adulterated or contaminated, but it is the adulteration that is in the law, not whether or not the GMP are followed.

The people we met with indicated that they are considering making compliance with FDA GMP Guidelines mandatory for cosmetics manufacturers. We oppose mandatory one-size-fits-all GMP compliance, unless such legislation contains an exemption for small business.

In our meetings, we stated our case that any legislation should be structured so there is some flexibility for small manufacturers. We’ve been asked to review the GMP guidelines and submit a proposal, which will be done in the next few weeks. While the impact of mandatory compliance with full GMP guidelines could be devastating to our small businesses, we are encouraged by the fact that our input has been requested, and hopeful we can impact the final wording of the bill.

Adverse Reaction Reports

Mandatory Adverse Reaction Reports (either all adverse reactions or only “serious” ones) is likely to be included in any new proposed legislation. Luckily for us, our products rarely (if ever) produce adverse reactions.

Product Safety

There has been a new move in legislation in general to require manufacturers to test their products to ensure they are safe. The Consumer Product Safety Improvement Act of 2008 (CPSIA) required toy manufacturers to test all their finished products for safety levels – even if the product from natural ingredients (wood, cloth, etc). Our discussions on the hill indicated there may be a similar move for pre-market testing of cosmetics to make sure they don’t contain anything “bad”.

Our position is that the responsibility for testing of ingredients for harmful components should fall to the ingredient manufacturer; we oppose any legislation that requires premarket testing of cosmetics made from ingredients that are already confirmed as not containing harmful or restricted components.

State Laws

As some of you are aware, several states have already passed cosmetic legislation that is stricter than the federal law, and more are moving in that direction. We discussed this with the Personal Care Products Council (PCPC), the FDA and the Congressional staffers we met with. It doesn’t look like we’ll get much help in this arena from the FDA or Congress, but the PCPC is aware of the situation and has lobbyists in several states already.

This will be something we will address in the near future. For now, it’s a good idea for you to investigate the laws in the states where you make or ship cosmetics. Please forward any information you find to me so we can take it into account as we make plans for addressing the issue of state legislation.

Summary

The situation is fluid and will be changing over the next several months. Legislation is being prepared, but we don’t know when it will be introduced or exactly what it will say. Certainly it won’t be before the health care debate is over; likely it will be shortly thereafter – maybe as soon as next month, or as late as the end of next year.

While we don’t know the exact timing, it’s apparent that a new draft of cosmetics legislation will be circulated at some point fairly soon. We will be working to be ready to address it when it comes.

I will continue working with Donna Maria at IBN to monitor the situation as well as compile and prepare information to present. Be watching for questionnaires and surveys, and please fill them in when they come your way!

An Additional Important Point

Although we will be opposing any legislation that does not provide an exemption for small business, it is very important that we, as an industry, take a look at our practices and become compliant with the regulations that are already in force:

  1. Labeling Requirements
  2. GMP Guidelines – at least the ones that you can manage as a small business
  3. State Regulations (If you don’t know what your state regulations are do some research to find out, they may or may not exist)
  4. Proper Record Keeping
  5. Proper Product Liability Insurance

If even one business is operating without regard to these guidelines it puts the entire industry in jeopardy and invites further regulation.

In Closing

The good news is that our trip to Washington gave us the information we need to understand what is happening. We know what we need to do as an industry if we have any chance of opposing this legislation successfully.

I will keep you updated as additional information becomes available. We will also be posting all this information, as well as links and resources, on our website to assist you in keeping informed and staying compliant with the existing laws.

The Handcrafted Soapmakers Guild is a registered non-profit trade association that is giving a voice to small business in our industry. The more members we have, the louder that voice becomes. Now, more than ever, it is important for us all to support this effort.

You can also read the post by Donna Maria of the Indie Beauty Network.

Leigh O’Donnell, HSMG President

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16 Comments

  1. Thank you so much for this report and all of your work. I was following you, dM, and BellaLucce tweets and was excited each and every step of the way.
    Is there a way you can guide me as to find out what my state, NY, has in regards to cosmetic legislation. Are there useful websites I should bookmark that I can read weekly?
    Again thanks for all you do.

    Melissa
    Naturally Good Soaps
    From My Hands to Yours

  2. Leigh,

    Thank you for your work on this and your dedication to the HSMG and its membership. It can’t have been easy to take time to go to DC and deal with all this; laws and legislation (not to mention politics) aren’t the easiest areas to get enthusiastic about.

    It looks like the “powers that be” are once again trying to solve a problem that doesn’t exist – at least in the realm of our handcrafted soap/cosmetics industry. Of course, that probably won’t stop them in the long run.

    That you have given us all a heads up on what may be coming is very helpful. I, for one, will be working diligently to make sure my house is in order. I’ll also be registering through the volunteer registration program as you recommended.

    I’m located in Oregon, and will check things here and let you know what I find out.

    Please count on me for any support you need.

    Marie Gale
    Chandler’s Soaps

  3. Leigh: Thanks for collaborating with me on behalf of small business owners. Working together continues to be fun, enlightening and productive. Along with IBN members, I am honored to be joining forces with you on behalf of small and independent business owners nationwide!

  4. Leigh,
    I don’t know how you found the time to squeeze one more thing into your schedule but you did! Thanks for all you did and are continuing to do on behalf of the HSMG.
    Your email to us in enlightening, encouraging as well as challenging. I’ll follow-up on the rules in regards to the requirements here in Missouri and let you know what I learn. Thanks again,
    Sr.Cathleen
    Programs & Services Chair
    (Monastery Scents too!)

  5. I am just making the decision to turn this hobby of mine in to a business so there is no doubt that I am filing for membership with HSMG. Thank for all your hard work with the research you have done. As with Melissa above, I too am in New York and would be interested in resources for us to follow up on in our state.
    Gina
    Mists of Calencir
    Spiritually Enhancing Soaps

  6. Thanks for gathering the information and breaking it down so we can understand what we are potentially facing and what we need to do. I will see what I can find in the State of NJ as to what our cosmetic legislation is. I will keep you posted as to what I uncover.

    La Shonda Tyree
    Nyah Beauty and Handmade Soap Coach

  7. Thank you for going to DC and speaking out for small businesses. Great overview of your trip. We can be heard when we work together. Thanks for leading the charge along with the Indie Beauty Network. I wish I could have been there with you.

    It is unfortunate that there is a perception that cosmetics aren’t safe out there. Cosmetics on the market are safe and the ingredients reviewed by the CIR panel have been proven safe. Yet there are organizations stricking fear in the hearts of consumers and Congress needlessly.

    I agree, “Although we will be opposing any legislation that does not provide an exemption for small business, it is very important that we, as an industry, take a look at our practices and become compliant with the regulations that are already in force.” I have a blog post that links to detailed posts about ideas on ways become compliant with each of the GMP guidelines at any size based on my talk I gave at the 2009 conference. One size doesn’t fit all, but the more we work to comply with as many of the guidelines as possible the stronger our position becomes.

    There needs to be exceptions in the language of the law for small businesses. Otherwise there will never be another Amway, Bella Lucce, L’Oréal (started 1907, 3 employees in 1920), EO, The Body Shoppe or countless other small companies that started out small.

    Entrepreneurship is not only for the rich or companies with lots of investors. It must remain open to every American.

  8. Leigh,
    I would like to thank you for taking time out from your personal life to go to washington to represent the HSMG members. I appreciate all your hard work. Your report has opened my eyes to what the future could hold for us small business owners. It’s good to know that there are those like you who care about the challenges we may have to face down the line. I hope that we can get all soapmakers to join the HSMG so that we may have a stronger voice in this fight for our survival.

  9. Thank you so much for informing us. My family is still fairly new to the natural skin care industry and have worked very hard to get where we are today, and we had no idea of what is going on in the political world in this industry. We very much want to stay informed and get involved in any way we can.

    Thanks again.
    The Pure-N-Simple Soap Family.

  10. So what actually does all this mean in black and white for us? Will yearly fees be involved? I am so stuck right now as what to do and how to progress with my business. Should I push on with what I am doing or just hold off until this thing passes?

    I am really confused and nervous.

  11. To Trying,
    Yes, soap is still considered separate from a cosmetic as long as it is labeled correctly as said in Marie Gale’s book, “Soap and Cosmetic Labeling”. http://www.soapguild.org/store/product.php?productid=16288&cat=276&page=1

    If these three advocates, HSMG President, IBN President and Bella Lucce President had not stepped forward to be our voice, we soapmakers who also handcraft wonderful bath and body products would be blindsided. We would have no voice in these matters as they dramatically affect our lives. These women are to be commended for taking the responsibility of their positions and supporting the membership that count on them.

    For HSMG, our mission is to promote the handcrafted soap industry; to act as a center of communication among soapmakers, and to circulate information beneficial to soapmakers. HSMG members can count on their membership dues to be put to use for their own betterment.

    Maria Gelnett
    Vice President – HMSG
    Social Media Chair
    (also angelicglow.com)

  12. Amy,

    I would hang in there, there is no need for panic, we just need to take notice of what is and what could potentially happen.

    All of our information right now indicates that there won’t be yearly registration fees, or any registration fees. Since the situation is so fluid, keep watch out for further updates.

    What you can do now is make sure your house is in order. Make sure you are following the current regulations and stay on top of the new developments.

    We will keep posting updates as they become available.

    Regards,

    Leigh O’Donnell
    HSMG President

  13. Leigh,

    Thank you for heading to DC on this fact finding mission.

    While the news that some sort of legislation may be revived to give additional oversight to our already-safe industry is not ideal, having the opportunity to have a discussion with those crafting the legislation is valuable. I am thankful that they met with you, Lela and Donna Maria to further understand the position of small, micro businesses in this industry.

    As we all know from anecdotal evidence, our industry is inherently safe without any known complaints that I’ve heard of in the last 13 years. Ultimately, what we eat and put IN our body is more likely to cause damage than what we put ON our body. We all know that most wrinkle creams are ineffective but vitamins, when taken internally, clearly are absorbed by the body and put to good use.

    While the idea behind reviving the act may be well intentioned, it is one that would have damaging consequences for small business. As Kayla said above: “Entrepreneurship is not only for the rich. It must remain open to every American.”

    Now is not the time for burdensome legislation. Small business is needed more than ever. I, too, would oppose any legislation if it did not contain specific exemptions for small business.

  14. I’m so glad that you went to DC, Leigh. It is so very important to have our voice united and have it heard by the policy makers. I look forward to seeing how the HSMG can help shape this legislation.

  15. Leigh,

    I’m someone who makes cosmetics and keeps an eye on regulations for soapers as well as cosmetic manufacturers. Thank you for your efforts and you timely blog post keeping us all updated.

    I’m wondering, you said above that they may be using the content from the Globalization Act of 2009 as a starting point for this newest legislation. Is there any possibility they will also be incorporating the changes and exemptions you all were able to suggest for that Act before it died? Do you know if the same, or some of the same, legislators involved in drafting this and who are already familiar with our issues were also involved with the 2009 Act?

    Thanks again, to all of you.

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