The main “intent” of the bill is to ban all ingredients known to be carcinogens or reproductive toxins in the state of Colorado and allow consumers to sue manufacturers that violate this with $5,000 – $10,000 fees.

The main problem with this bill, as written, is that it is very vague and confusing.  I have been consulting with leaders in our industry all week as well as many small soap and cosmetics manufacturers.  Even with all these minds put together we are having trouble decifering the nuances of this bill.  It raises too many questions, for example:

• How will this “list” of banned ingredients be created, maintained and updated and by whom?
• The bill mentions “authoritative bodies” or “formally organized groups” as the source for these banned ingredients.  What criterion will be used to deem whether or not a “group” is an acceptable source?  Here is the specific language from the bill:

(1) “AUTHORITATIVE BODY” MEANS THE FOLLOWING AGENCIES OR
3 FORMALLY ORGANIZED PROGRAMS OR GROUPS RECOGNIZED AS
4 AUTHORITATIVE FOR PURPOSES OF IDENTIFYING CHEMICALS THAT CAUSE
5 CANCER OR REPRODUCTIVE TOXICITY:
6 (a) THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
7 OR ITS SUCCESSOR AGENCY;
8 (b) THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR ITS
9 SUCCESSOR ENTITY;
10 (c) THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND
11 HEALTH, OR ITS SUCCESSOR ENTITY;
12 (d) THE NATIONAL TOXICOLOGY PROGRAM, OR ITS SUCCESSOR
13 PROGRAM; AND
14 (e) THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, OR
15 ITS SUCCESSOR AGENCY.

• The bill opens the door for fraud and abuse of the court system, allowing the consumer to sue manufacturers for $5,000 – $10,000 fees.
• The bill isn’t clear on whether it will only regulate manufacturers of cosmetics in the state of Colorado or will it also regulate manufacturers outside the state that sell in Colorado.  The specific language in the bill is here:

11 (3) (a) “MANUFACTURER” MEANS ANY PERSON WHOSE NAME
12 APPEARS ON THE LABEL OF A PERSONAL CARE PRODUCT PURSUANT TO THE
13 REQUIREMENTS OF 21 CFR 701.12.
14 (b) “MANUFACTURER” DOES NOT INCLUDE A RETAILER THAT SELLS
15 PERSONAL CARE PRODUCTS AT RETAIL TO CONSUMERS UNLESS THE
16 RETAILER IS ALSO THE MANUFACTURER OF THE PERSONAL CARE PRODUCT.

HB10-1248 is being sponsored by The Women’s Lobby of Colorado in conjunction with The Campaign for Safe Cosmetics.  The Women’s Lobby holds meetings at the Colorado Education Association at the corners of Colfax & Grant (1500 Grant Street) from 12:00 – 1:15 with lunch included.  Here are the upcoming dates:

• March 3rd
• March 17th
• March 31st
• April 14th
• April 28th

There will be a hearing specifically for HB10-1248 on Monday, March 1st, held by the House Judiciary in rm 0107 in the basement of the Capitol Building.

We will post a letter later today that you can personalize and send to the representatives in Colorado opposing this bill for both residents and non-residents of Colorado.

If you have any questions please do not hesitate to email me: President@Soapguild.org

Leigh O’Donnell

HSMG President

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

Let’s thank them by giving our support!

Hopefully, either through the interpretation and implementation of the CPSIA by the Comsumer Product Safety Commission or through the passage of Sen DeMint’s bill, testing of toys done by the manufacturer will be sufficient, so your final product won’t have to ALSO be tested.

Keep an eye on the CPSC and their statements on the implementation of the bill.  Meantime, contact your supplier and see what records and documentation they have on the safety of the toys your purchased and/or what they are doing to ensure the toys comply with the regulations.  Remember, your supplier is probably also under the gun and likely working frantically to meet the requirements.

Also keep in mind there are special rules for toys intended for children under the age of three.  If your soaps with embeds are intended for the very little ones, you’ll need to ensure they meet those requirements as well.

Marie Gale, President, HSMG

While the CPSIA doesn’t cover soap or cosmetics for children, some HSMG members do make or sell other products for children. That, and the fact that the CPSIA has brought to light the difficulties of very small businesses in complying with legislation designed for “big business”, makes it of interest to us.

The Consumer Product Safety Commission recently published a Guide to the Consumer Product Safety Improvement Act (CPSIA) for Small Businesses, Resellers, Crafters and Charities. It’s a downloadable .pdf booklet that has questions and answers about how to comply with the regulation and what deadlines are in place.  If you make product for children (other than soap or cosmetics) the booklet may provide guidance in how (and when) you need to comply with the CPSIA.

Also of interest, if you are following the CPSIA, is the introduction of a bill by Senator DeMint (SC) to reform the CPSIA.  His press release details the reasoning and provisions of his bill and the impact it would have on

Marie Gale, President, HSMG

Our contact at the House Commerce and Energy Committee requested our input and was quite interested to know if we could “come out in support of the bill”.  Looks like our voices really were heard!!

As a result, Donna Maria and I have co-authored a letter stating our position and concerns.  At this point we are in agreement with a majority of the cosmetics portions of the bill. However, we do not yet fully support the bill. 

There are two sections of HR 759 about which we still have concerns:  submission of cosmetic ingredient statements for EVERY product produced and the possibility of one-size-fits-all good manufacturing practices for cosmetics being made into law.

Our suggestion to the Committee (via our staff contact) is that the sections cosmetic ingredient statements and the GMP be amended to include provisions that allow the Secretary (that would be the FDA) to adjust the requirements as needed for very small businesses.  It doesn’t mandate that the Secretary do it, but does allow the Secretary to do so, which would give us an avenue to present information and documentation during the rule-making process.

To quote one paragraph from the letter:

Empowering the Secretary, using federal rulemaking procedures, to define small cosmetic businesses and treat them appropriately when it comes to submitting ingredient statements and determining good manufacturing practices allows for consideration of industry nuances that are best addressed at the agency level, with the input of industry participants through public rulemaking.

Congress is looking at the big picture (as they should), but needs to allow the FDA the flexibility to address the concerns of very small businesses like most of ours.

If our suggested amendment is accepted by the Committee and then the entire House of Representatives, it will be a step in the right direction.  We will still have a long process of getting our very small businesses understood by the folks at the FDA who have concentrated on large cosmetics firms in the past.  I expect that the concept of a stick blender is very far from their current reality!

However, given the level of activity, the dedication and the passion of HSMG and IBN members, we will have no problem rallying the troops and getting the information to the FDA that they need to understand our issues and concerns.

I’ll keep you posted on any further developments.

Marie Gale, President

The good news is that our voice was heard and the section on Cosmetics has been considerably toned down from the 2008 version.  Huge fees and other impossible requirements are gone!

The bill does require registration of cosmetic manufacturing facilities and some other administrative and labeling requirements.  (And if someone dies or is hospitalized as a result of your cosmetic, you have to report that.)

What happens next?

The bill is in committee for review.  They will go over the bill, propose any changes they see fit and then send it back to the full house approved or not.  Given that it was introduced by key players in the committee, I doubt there will be much change.  They have scheduled a hearing about the salmonella outbreak to be held on February 11th.

Once it’s out of the Energy and Commerce Committe, it goes back to the House.  They’ll either vote on it, or send it to another committee (and the process repeats).  After the house finally votes on it, if it passes it goes to the Senate.  If the Senate passes it, then it goes to the President and is signed into law.

My opinion is that there is not much we can do to change the provisions of the bill at this point.  Congress is in an uproar about the salmonella poisonings and is likely to push this through based on that. Added to that is the fact that it allocates $10 million for implementation, so it will likely be part of the overall budget/money parts of the new Congress’s actions.

What does it mean to us?

The provisions of the bill as currently written say that the changes will take place 18 months after the date the bill is approved and enacted.

Over the next few days I will review the bill in its entirety and post exactly what it appears to say will be required of us in the future.  We will need to understand the regulations that are coming and prepare for them.

Once the bill is enacted, the FDA will create the administrative procedures and rules that implement the regulations.  That is a public process and will will have the opportunity to submit review their proposals and submit input.  Luckily, the bill includes $10 million funding for this, so the likelihood of large fees is minimized.

Next Steps

At this point, I will be monitoring the status of the bill and any changes.  I will post information here and also send data to our membership.

Since I feel fairly certain that given the current climate in Washington the bill will be pushed through, we will be concentrating on keeping track of it and getting informed and up-to-speed on how to deal with the FDA procedures when it comes to actual implementation.

The Good News

The really good news in all this is that we did make a difference.  That means that when it comes to the actual implementation of the bill, we can make our voice heard again!

Marie Gale, President

There is good news on the cosmetic legislation front! As recently posted by Debbie May of Wholesale Supplies Plus and confirmed by Donna Maria in her recent blog post, it looks like the FDA Globalization Act of 2008 has been withdrawn from consideration, at least for the time being.

Turns out that Rep. John Dingle, who was pushing the legislation, is being replaced as the Chairman of the House Energy and Commerce Committee by Rep. Waxman (D-CA). Our contact was on Rep. Dingle’s staff; with Rep. Waxman taking the chairmanship a new staffer from his office will be assigned to handle cosmetics-related issues. At this time it is not known if Rep. Waxman will push for further action on the issues of interest to us.

As a note, the House Energy and Commerce Committee has changed their site and some of the links about the FDAGA are broken.  It is still appearing as part of their “Selected Legislation”, but there is no new information posted at the moment.

More Battles Ahead

However, the issue of cosmetic safety has reared it’s head and it not going to go away. In fact, there seems to be some backroom political dealing already going on in the office of Rep. Jan Schakowski (D-IL). In an article entitled “Fight Looms on Federal Regulation of Cosmetics” (Corporate Crime Reporter, September 5, 2008), Stacy Malkan, spokesperson for the Campaign For Safe Cosmetics reportedly said, “legislation will be introduced soon by Congresswoman Jan Schakowsky (D-Illinois) that will, for the first time, impose federal regulation.”  I just checked, and I couldn’t find anything  on Rep. Schakowski’s website about forwarding legislation to regulate cosmetics,

What’s going on here?

Donna Maria spoke with a staffer in Rep. Schakowski’s office who said there would be a draft “within the next 14 days” but wouldn’t commit to what will happen by year’s end.  She suggested that DonnaMaria call every few days to see if there have been any changes.  (DonnaMaria will keep me posted – and I’ll keep you posted here as I know.)

So it seems that the Campaign for Safe Cosmetics has had Rep. Schakowski’s ear for some time now.  While it’s not clear on their website exactly what they want, there’s no doubt that they are pushing for more stringent legislation for cosmetics.

Luckily, we are in a position to make OUR position known, so our small cosmetic and soap businesses will have a voice in the process.  I, along with others in our industry, will be working to ensure that the “powers that be” understand that our small businesses are DIFFERENT from cosmetic manufacturers in corporate America, and that any legislation will need to take our position into account.

I will keep you posted.

Marie Gale, President HSMG

The article, starts out by saying:

Micro-cosmetics businesses are the latest group to log complaints against House Energy and Commerce Democrats’ draft legislation aimed at shoring up FDA’s competency to police products. Asked recently to formally weigh in by committee staffers who are turning to the cosmetics portion of the bill, leaders of the Indie Beauty Network and the Handcrafted Soap Makers Guild said fee and compliance requirements in the measure will shut down thousands of their micro-business owners.

It goes on to include our specific request of an exemption for micro cosmetic businesses that use GRAS ingredients and have less than $2M cosmetic revenue. She even included a quote from our letter about the fact that implementation of FDA-issued manufacturing standards would be “tantamount to committing business suicide”. All in all, Ms. Edney did a great job covering the issue. (I’m working on getting permission to reprint the entire article and will post it when I can.)

Getting that message in front of members of Congress is a big step forward for us. The more we can get them to see the impact of this possible bill, the more likely we are to see changes in it before the wording is final and the bill is passed.

Thanks to HSMG member, Kathy Gambrell of Chesapeake Bay Bath and Body, for mention of our activities and position on the issue. It just goes to show that we soapmakers permeate all levels of business and industry in our “regular lives”. If you have any connections to anyone who might be influential in getting our message out, please email me (President@soapguild.org)!

Marie Gale
President, HSMG

In summary, we requested be draft be amended to include an exemption from all the regulations proposed in the FDA Globalization Act of 2008 for any “micro cosmetic business” that:

• Has less than $2 Million in annual cosmetic sales AND
• Uses ingredients that are
• generally recognized as safe,
• flavor,
• fragrance or
• approved color additives.

You can read the entire letter to familiarize yourself with the position taken and the arguments in support of it.

There are several people who directly assisted in the development of the position we’ve taken, supplied data and persuasive arguments, proofreading and moral support. I’d particularly like to thank Donna Maria Coles Johnson of the Indie Beauty Network for her hard work, dedication and willingness to join forces to give more weight to our joint words. Our corporate members, Debbie May of Wholesale Supplies Plus and Dennis and Kayla Fioravanti of Essential Wholesale made invaluable contributions, as did HSMG Member Anne-Marie Faiola of Brambleberry. IBN members Jamila White, Lela Barker, Erdele Greene, and Pennie Mills also deserve special mention.

Of special note are the contributions of the HSMG Vice President, Leigh O’Donnell, who provided valuable insight, excellent proofreading and suggestions that improved the overall flow of the document … and this while negotiating the contract for our 2010 conference site, managing the last few days of early-bird conference registrations AND taking her kids trick-or-treating!

We are hopeful that our letter will bring our legislators a greater understanding of the micro cosmetic industry and positively affect the final wording of the bill that will ultimately presented to Congress in 2009. As I have any further information about the draft legislation, I will let you know.

Marie Gale, President HSMG