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

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