I am pleased to announce that, on December 3 and 4, I’m leading another delegation to the US Food & Drug Administration (FDA). The purpose of my visits is to share small business perspectives on pending cosmetics legislation, and also on current rules, regulations and current events affecting the cosmetics industry.

This is my second trip, and it comes after months of new developments where legal issues affecting small and independent business owners are concerned. This time, I will be accompanied by longtime IBN member Lela Barker of Bella Lucce (who came on my last trip) and Leigh O’Donnell, president of the Handcrafted Soapmakers Guild.

Why This Trip Is Crucial

More and more people see the wisdom of owning a small business of their own, and technology makes it easier and more practical for small businesses to get underway. As a result, there are thousands more competitors in every industry than there were just a few years ago, and many of the new entrants are very tiny, often home-based, businesses.

As these new participants come into the market, lawmakers and policymakers are not equipped to keep up with changing industry landscapes on their own. Instead, they do what they’ve always done — meet with the same lobbying firms and large business representatives to discuss legal and policy issues. While small businesses compete in the same industries as those large companies, and they are regulated in the same ways, small companies operate very differently from big companies.

Large companies and lobbying firms cannot speak for small companies. In addition to being their direct competitors, they also have no idea how small companies operate. Congress is therefore at a huge disadvantage when it comes to passing new laws. After all, if they don’t have any information about small companies in a particular industry, how can they be expected to pass laws that take their unique interests into account? They can’t.

And yet, the same “one-size-fits-all” laws and regulations do not work for an entire industry the way they used to. As a result, it is urgent that small companies participate in the process. We can’t wait around on the sidelines for a hammer to drop. History has shown that the stakes are too high for that.

History Need Not Repeat Itself

Consider what happened with the Consumer Product Safety Improvement Act of 2008 (CPSIA) (PDF), which requires that the Consumer Product Safety Commission require that all products designed for children ages 12 and under be tested for lead before they can be marketed in the United States. (You can listen to an Indie Business Radio Show episode devoted entirely to CPSIA at this link.)

CPSIA, which originated in Energy & Commerce, was signed into law by President Bush in August 2008 in order to curb the behavior of very large companies that were importing toys made in countries with unacceptable levels of lead content. The safety testing requirement is designed to force companies to produce safer products, which in turn benefits consumers.

While everyone agrees that the law has noble goals, since the same law applies with equal force to all market participants, even the tiny companies that were not contributing to the problem, the law ended up forcing small companies out of business because they could not afford the expensive testing. These little companies did not import toys or toy components. In fact, many of them made children’s products for years in small manufacturing facilities in small towns throughout the nation. Many of them were women-owned companies that made things like baby blankets, children’s hair accessories, and dolls. They did not use lead or lead by-products at all. And they made products in very small quantities.

Even though the law was passed in 2008, most people didn’t know about CPSIA until January 2009 when the CPSC began proceedings to create the rules that would be used to enforce the law. At that time, the small manufacturers rose up in protest, but by then, it was too late. The law had passed and the CPSC had no choice but to do what Congress told it to do.

An after-the-fact rally, threatened class action suit and several Internet petitions could not change what Congress had enacted. This terrible consequence points out how vitally important it is for small businesses to remain active in the legislative process so they can educate lawmakers about their businesses before new laws pass.

And this is what our trips to Energy/Commerce and the FDA are all about. For those just joining in, here’s a short historical summary of the events leading up to our trip.

1. April 2008. Word began circulating that the Energy/Commerce was circulating a draft of the FDA Globalization Act of 2008. I immediately got my hands on a copy and identified several items of concern. This video summarizes my very first impressions.In brief, I was concerned about 5 things: (1) a requirement that the current “Good Manufacturing Practices” (GMP), which are now guidelines, be made to apply as law, across the board, to all cosmetics manufacturers regardless of size or annual gross sales; (2) a requirement that all companies pay an annual fee of up to $12,000; (3) a requirement that all companies report “anticipated adverse events;” (4) the treatment of cosmetics in in similar fashion to the way other FDA-regulated products — food, medical devices and drugs — each of which is regulated very differently from cosmetics; and (5) the timing of a one-size fits all law that did not take into intersection between technology and the current recessionary economy, which are the combining to create new opportunities for people to pursue the American dream.Hearings on the draft bill took place on April 24, 2009.
2. June 2008. On behalf of IBN, I issued a press release criticizing the draft of the FDA Globalization Act of 2008.
3. May-July 2008. IBN Member Mobilization. After analyzing the legal issues involved, on July 24, I sent this letter (PDF) to Energy & Commerce on behalf of my IBN members. By August, we had collected over 4,000 comments and signatures from people who opposed the draft of the new law.
4. August 2008. First Delegation To Energy & Commerce and FDA. On August 5, I led the first delegation to Energy & Commerce and the FDA to share my members views about the current state of cosmetics regulation and how the draft bill, if passed into law, would affect them. I was delighted to be accompanied by a proactive and well-spoken group of small business owners who thoroughly articulated our positions and spoke eloquently on behalf of small business owners nationwide. These women deserve special recognition for traveling thousands of miles at their own expense, taking valuable time away from their businesses to speak for other small business owners.They are: Kayla Fioravanti of Essential Wholesale, Lela Barker of Bella Lucce, Anne-Marie Faiola of Bramble Berry and Jamila White.One of the first things that became clear to us upon arrival was how interested the Congressional staffers and FDA directors and deputies were to hear from us. They took notes, asked questions and began to understand the dynamics of small business ownership in a new way. We remained engaged with them throughout the rest of the year.

   The Soap Guild eventually joined our effort, and in October, IBN and the Soap Guild sent this joint letter (PDF) to Energy/Commerce to further elaborate on our position and policymakers were to hear from us.

   We sent a joint supplemental letter in February of this year.

   Our efforts continued through the end of the year. During this time, IBN members called and emailed their Congressional representatives to share their concerns that, if it became law, the FDA Globalization Act of 2008 would put them out of business for no reason and with no corresponding consumer benefit.

5. January 2009.In January 2009, the FDA Globalization Act of 2009 was introduced as HR-759. The bill was substantially different from the 2008 draft in many ways.First, instead of applying current “Good Manufacturing Practices” as law across the board to all cosmetics manufacturers, it empowered FDA to promulgate new GMP. This gives companies of all sizes an opportunity to urge FDA to change GMP to accommodate different manufacturing styles.Second, the annual fee was done away with completely. Imagine our excitement about that one!

   Third, the “anticipated adverse events”  requirement was changed to be more reasonable. While we’re certain Congress heard from people outside of our community of small manufacturers, we also know that the changes in the 2009 Act are a direct result of our advocacy efforts.

6. June 2009. In June, Energy & Commerce removed food entirely from HR 759 and began to focus efforts there via the Food Safety Enhancement Act of 2009. Drugs, medical devices and cosmetics were put on the “back burner” so that food issues could be sorted out via the food-specific legislation. We are all but certain that Energy/Commerce is poised to circulate a 2010 Act, and we believe it is highly likely that the cosmetics portion will be separated out as the subject of its own piece of legislation. The time is obviously now, to return and see how the wind is blowing as we bring Congressional staffers us to date on how our industry is growing and thriving.Throughout the summer and until now, I am also seeing increased activity from consumer groups that are spreading untruths about how FDA regulates cosmetics in the United States. In particular, the Campaign For Safe Cosmetics, an organization I have reached out to on numerous occasions — to no avail — in an effort to find common ground on behalf of small cosmetics companies.While most of their fear mongering points blame at large companies, the adverse impact is felt by small manufacturers in large part because consumers don’t always know enough about the industry to know how differently small companies operate from larger ones. I feel it is important to alert Congress and FDA to these issues so they can take them into account as they address the coming changes.

In light of these developments, I recommended to my members that a second visit to Energy/Commerce and FDA was in order, and those visits will take place on Thursday and Friday of this week. We will also be meeting with representatives from the Personal Care Products Council, the oldest trade organization serving the interests of the world’s largest cosmetics companies. While our manufacturing practices and philosophies are quite different, it is the same set of lawmakers and the same regulatory agency that we must deal with.

It is important that we do our part to ensure the free flow of information and work together, if possible, to urge passage of laws that benefit consumers while encouraging a level playing field for all industry participants. It is possible we will be able to meet with at least one representative from the Small Business Administration but I’m still sorting that out at the moment.

While the focus of our meetings will be HR 759, you can see that this is not just about cosmetics. It should be clear to everyone reading this that the issues are far bigger than cosmetics.

This is about men and women, mothers and fathers, young people and old people, and anyone who wants to create a better life for themselves and their families.

Technology is opening up new opportunities for small businesses to be successful. The barriers to entry in many industries have fallen drastically, thus paving the way for new companies that would not have been able to even start just a few years ago.

I firmly believe that the promise of technology can only be fully realized if lawmakers, policymakers and regulators understand that

the fact that to companies compete in the same industry does not mean that it is in the public interest to regulate them in the same exact way.

It’s not enough to simply say, as the Regulatory Flexibility Act requires, that the interests of small businesses are taken into account when new laws pass. More than that is required.

What’s required? You and me, that’s who! We cannot blame Congress and regulators for regulating us out of business if we are not at the table when the laws and regulations are passed. We have to show up. We have to introduce ourselves and participate in the process.

Complaining about how awful laws are does nothing to change them. Whining about the impact of bad legislation after the fact may result in lots of conversation and sharing of viewpoints, but it does nothing to change bad legislation. Bad-mouthing regulators for doing a poor job of regulating, and then refusing to communicate with them, perpetuates the problem.

We have to show up. So that’s what we plan to do this week. And we plan to do it over and over again, and we plan to ask for your help. Won’t you join us?

Question: What do you think of these issues? Are there other things you would like us to discuss? What have we missed?

When I was a cosmetics manufacturer years ago, I joined the Personal Care Products Council (formerly known as the Cosmetic, Toiletries & Fragrances Association). At the time, I lived in Washington, DC and I enjoyed going to their offices from time to time to use their library. I also learned a lot from them about how to run a successful cosmetics company under the authority of the Food & Drug Administration, which regulates cosmetics.

Today, the pending FDA Globalization Act of 2009 is poised to amend the cosmetics laws for the first time in decades. The pending legislation got me to thinking about an interesting quirk in the law the makes it difficult for startup and small and independent cosmetics companies to label their products in accordance with FDA law.

One of the documents I used most at the PCPC library was the “INCI Dictionary,” which contains the names required to be used to identify ingredients on cosmetic product labels. Then as now, only members or non-members who purchased the INCI Dictionary had access to it. As I recall, the price was somewhere around $400 and it was not available online. Today, the INCI Dictionary is available online from PCPC. The price is $995.00

What Are INCI Names?

INCI names are the names required by federal regulation to be used to identify the ingredients in a cosmetic, and must be listed in the ingredient declaration. The FDA established the requirement for cosmetic ingredient declarations on product labeling under the authority of Section 5 of the Fair Packaging and Labeling Act (FPLA) (21 CFR 701.3).

The FPLA provides authority to promulgate regulations “necessary to prevent the deception of consumers or to facilitate value comparisons.” To accomplish these goals, the regulation requires that cosmetic product labels be prominent and conspicuous so they are “likely to be read and understood by ordinary individuals under normal conditions of purchase…”
(21 CFR 701.3(b)). Further, Section 5(c)(3)(B) requires the use of “the common or usual name” for identification of each such ingredient included in the preparation.

In other words, the same names — INCI names — must be used on all products to ensure that cosmetic ingredients are consistently identified and consumers can readily compare ingredients when making purchasing decisions.

The specific section of the regulations that says the INCI names must be used is Title 21, Section 701.3 of the Food Drug & Cosmetic Act. You can find the entire section here, but the critical language where INCI is concerned is that, if the FDA does not specifically say which name should be used to identify an ingredient (and it does so only rarely), then name adopted for that ingredient in the PCPC dictionary — the INCI name — is to be used. (Note: PCPC is identified as CTFA, the former name of the PCPC.)

And where is this dictionary available? It’s available from PCPC’s PCPC website. Members can subscribe (PDF) to the online version of the Web Based International Cosmetics Ingredient Dictionary & Handbook for an annual fee of o $495. Non-members must pay $995. The hard copy version of the Dictionary is also available for $495.00 (PCPC members) or $795 (non members)

What’s A Small Business To Do?

This presents an obvious challenge for small businesses. They either have to join PCPC (PDF) at a minimum annual price of $640, and then purchase the INCI information for a minimum of $495, or they have to purchase the information without joining for between $795 and $995.

It would be one thing if using INCI names was optional, but it’s not. Requiring companies to pay a fee to a private non-profit entity in order to access information that is necessary (not optional) in order to comply with the law amounts to a barrier to entry into the cosmetics arena. Small businesses have adapted by getting the INCI information from second-hand sources. That is, people purchase the information from PCPC and then share it with others. This behavior obviously solves the small manufacturer’s labeling problem, but only to the extent they can trust the second hand source. (Of course, the fact that the INCI dictionary bears the PCPC copyright ownership notice is another issue altogether.)

The bottom line? The mandatory nature of the labeling rules forces small businesses to either rely on second hand information to comply with the law, or spend $1,000 a year to comply with federal labeling laws.

What Should Happen?

I am not sure, but I do not believe the current situation was the intent of Congress, the FDA or the PCPC. After all, the current regulatory structure was implemented at a time when only large companies made cosmetics. For them, $1,000 for a labeling manual was and still is a drop in the bucket.

At the leader of a 800+ member trade organization that serves the cosmetics industry, I know that there are thousands of tiny new entrants bringing massive amounts of innovation and energy to the industry. To me, it seems clearly unduly burdensome for these small companies to have to pay $1,000 to gain access to information that is required by law to be included on their product labels.

I think it’s time for Congress and/or the FDA to act, in particular while it is considering new legislation anyway, to create a level playing field that enables all companies, large and small, to have unencumbered access to the information needed to label their cosmetics in compliance with the law.

I will continue to monitor issues of interest as they impact progress on the FDA Globalization Act of 2009 and the Safe Baby Products Act, and report relevant information here.

Question: What do you think? Do you think it’s time for INCI names to be made public so all can see and have unfettered access to them? Post your thoughts and opinions in the comments section below.

I read an interesting post today at the the CPSIA Comments & Observations blog. Maintained by Richard Woldenberg, chairman of Learning Resources, a manufacturer of learning toys and hands-on classroom educational materials, the CPSIA Comments & Observations blog tracks activity with regard to the Consumer Product Safety Commission’s (CPSC) implementation of the Consumer Product Safety Improvement Act of 2008 (PDF).

If you look closely at Woldenberg’s post, you will see a consistent theme that boils down to these three important points.

1. Consumers Matter. At the end of Woldenberg’s post, he mentions how important it is for the customers of small business owners to speak out about new laws that would unnecessarily hurt the companies that make the products they love. My experience with IBN members and small businesses in general is that small companies have their customers’ interests at heart. Many small businesses get their start because the owner starts creating products that are not available at “big box” stores.People like doing business with people they can relate to on a personal level. That’s one reason why social media is so effective for small business owners. It is therefore important that small businesses are joined in this effort by the customers who love their products.

   Consumers matter. If small businesses ask their customers to join the effort to prevent imposition of unnecessary laws, advocacy efforts are much more effective.

2. Numbers Matter. If only a few people are vocal on an issue, the federal government cannot prioritize that issue. With health care, a war and the economy, the government is only going to turn its attention to priorities. They won’t see something as a priority unless we do.Woldenberg’s post states that one of the commissioners on the Consumer Product Safety Commission (which is considering implementation of CPSIA) said that if something was a big deal, the CPSC would have heard about it from more than just one small trade association. If true, such a statement demonstrates that one or two organizations waiving a flag is not enough.

   Numbers matter. While change starts with a small number of people, it takes a village to affect an act of Congress.

3. Timing Matters. While no one can say when Energy & Commerce will act to update or change HR 759, it was made clear to us last week that action is planned. If we wait too long to speak up, or never speak up, Congress will act. Once that happens, the only resource left is to do what Woldenberg is now doing: argue points before the regulator. But remember that the regulator does not make laws, it merely implements rules and regulations pursuant to those laws.Congress makes law, and once a law is passed, that’s it. It’s the law. Agency officials then work with industry to implement it. At that point, the options are necessarily limited by what the law says. An agency cannot do anything Congress does not first give it the power to do.

   While it’s important to continue to meet with agency officials, it’s Congress (Energy & Commerce specifically) that is now addressing the cosmetics laws. FDA is just waiting for Congress to tell it what to do.

   Timing matters. If we wait until it’s in the FDA’s hands alone, Congress will turn its attention elsewhere and our options will be even more limited than they are now. Your business is being discussed now. You want to be involved as that happens!

   Don’t Get Caught Napping!

   Consumers. Numbers. Timing. Ignore any one of them at your own peril. Lets work together to ensure that any new laws advance consumer safety without diverting FDA resources from real safety issues and putting unnecessary burdens on small cosmetic manufacturers.

   Question: Does the situation with CPSIA help to underscore the urgency where new cosmetics laws are concerned? Why or why not?

Last week, I shared plans to return to Washington, DC on a fact-finding mission with regard to the FDA Globalization Act of 2009 (FDAG 2009). If you have not done so, please read that post for background and context. This post provides a high level overview of what I learned on that trip. (If you are a member of IBN, check your email for a more in depth report with Action Items.) Along with Lela Barker of Bella Lucce and Leigh O’Donnell, president of the Handcrafted Soapmakers Guild (pictured with me in front of FDA’s offices in College Park, Maryland), I met with the head of the FDA’s Office of Cosmetics & Colors, and two of her deputies.

We also met with Congressional staffers in the House Energy & Commerce Committee, specifically staffers from the offices of Rep. Frank Pallone Jr. (D-NJ, Rep. Tammy Baldwin (D-NY), Rep. Jan Schakowsky (D-IL) and Rep. Henry Waxman (D-CA). Finally, we met with legislative advocacy personnel at the Personal Care Products Council.

During our meetings, we confirmed that the Energy & Commerce is considering, either through revision of the currently pending FDAG 2009/HR 759 or through an entirely new bill to be introduced in the future, to:

• Require that all cosmetics companies register their facilities, the products they make and the ingredients contained in those products in a federally maintained database;
• Craft, or ask FDA to craft, a specific new set of Good Manufacturing Practices (GMP) which will apply to all cosmetics companies, regardless of size; and
• Include some provisions dealing with ingredient safety.

We also confirmed that, even though FDA regulates cosmetics, neither Congress nor FDA will take any action to address the patchwork quilt of state cosmetics regulations that are being put in place at the local level.

We do not have a specific time table for circulation of a new set of draft legislation, or amendments to the pending bill, but Congressional staffers inferred that Congress will turn its attention to cosmetics laws, at the latest, when health care legislation is dealt with one way or another. Since that situation is fluid and ever-changing, we must be prepared to address these issues immediately either way.

In light of these developments, as the president of the Indie Beauty Network, along with the Handcrafted Soapmakers Guild, I am opposed to new cosmetics legislation at the federal and state levels, unless they contain appropriate exemptions for small businesses.

We are opposed to new cosmetics legislation without exemptions for small companies because it would unnecessarily infringe on the ability of small businesses to participate in the cosmetics industry on a level playing field, all the while doing nothing to protect consumers from unsafe cosmetics. While there are many nuances to this position, and it is constantly being addressed to keep up with changing developments, here are some of the specific reasons why we oppose increased cosmetics legislation, specifically at the federal level, and also at the state level.

Mandatory Facility, Product and Ingredient Registration

Since 2005, registration of cosmetics facilities with the federal government has been voluntary through FDA’s Voluntary Cosmetics Registration Program (VCRP). FDAG 2009 contains a mandatory registration requirement that not only requires registration of company name and facility contact information, but probably through application of the voluntary program which includes registration of products and ingredients, of specific cosmetics products and the ingredients they contain.

If this passes, it means that a tiny company will have to register each new product it introduces to the market, presumably before it begins to market that product. For each product, the ingredients contained in that product will also have to be registered. Finally, to comply, a product registration must be updated each time an ingredient in that product changes.

While we do not oppose registration of facilities (company name and basic contact information), requirements to register, and subsequently update registration, of products and ingredients unnecessarily burdens small businesses without any corresponding consumer benefit.

We therefore oppose product and ingredient registration requirements unless they contain an exemption for small cosmetic businesses, and look forward to working with lawmakers and policy makers to craft an exemption that is carefully tailored to protect consumers without decimating small businesses.

(You can voluntarily register with the FDA at this link. If you are a member of IBN, you can take advantage of an exclusive VCRP training seminar (scroll to 3/19/2009). Led by an FDA official, the training seminar walks you step-by-step through the voluntary cosmetics registration process.

Good Manufacturing Practices (GMP)

Currently, FDA oversees voluntary GMP Guidelines for the manufacture of cosmetics. As their name suggests, the guidelines are guides, as opposed to legal requirements.

FDAG 2009 contains a requirement that FDA promulgate a new mandatory set of cosmetics GMP. In our meetings last week, we urged Congress to structure any new law so that FDA has the flexibility to impose GMP that recognizes the vast differences between the way large cosmetics companies make cosmetics and the way small companies make cosmetics. Our position is that there is no reason to require that a company making 1,000 bottles of lotion a month comply with the same GMP that a company making 1,000 bottles of lotion a minute must comply with.

The Congressional staffers asked us to share an approximation of how many small manufacturers are currently complying with GMP Guidelines. While they did not tell us exactly what new GMP they are contemplating, or what ingredient safety testing may be a part of any new GMP, they did tell us that some kind of GMP requirements would become mandatory.

It is our position that the nation’s smallest companies should not be required to comply with a specific set of GMP. Current cosmetics laws already require companies, regardless of size, to manufacture unadulterated products. Forcing the tiniest companies to comply with an additional set of specific procedures hampers their ability to innovate and get a relatively small number of products to market, all without any real benefit to the customers they serve.

Small companies make a small number of products, and when you balance the benefit to the public of being able to enjoy personal care products made by small and independent business owners with the extremely low risk of injury to the public based on use of a cosmetic made by a tiny company, the need to force thousands of tiny manufacturers to make their products in a particular way is obviated.

We therefore oppose the imposition of specific GMP on cosmetics companies unless there is an exemption for small cosmetic businesses, and look forward to working with lawmakers and policy makers to craft an exemption that is carefully tailored to protect consumers without decimating small businesses

Ingredients

Closely related to the issue of GMP is the issue of ingredients. In my post last week, I told you about how the Consumer Product Safety Improvement Act forced small businesses to close because it contained a pre-market testing requirement designed to curb the behavior of big businesses. Even though the requirement was aimed at large corporations, many of whom manufacture their products overseas (as do many big cosmetics companies), since there was no exemption for small companies, little businesses were forced to close their doors.

A similar undesirable result can be avoided here simply by making sure that any testing requirements be imposed on the manufacturers of ingredients used in cosmetics, and not on the manufacturers of the cosmetics. In this way, small companies can substantiate the safety of ingredient they use without being unfairly burdened with testing requirements that would put them out of business in the same way CPSIA forced companies out of business. This would make the information easily available to the public without unnecessarily burdening small businesses.

A requirement such as this would protect consumers the public the information it While FDAG 2009 does not contain specific ingredient requirements, nor does it require the testing of ingredients in products before they can be sold, it is possible that new cosmetics legislation will address this issue in ways that are similar to the Consumer Product Safety Improvement Act of 2008 (CPSIA). CPSIA has already put many small companies out of business because they cannot afford to test their products to ensure that specific ingredient levels are met.

The ingredients at issue where cosmetics are concerned are ingredients that small companies don’t even use. To force small companies to participate in testing, especially where they don’t even use the ingredients that cause concern, is unnecessary and unfair. Moreover, it is not required to protect the public interest.

Any new cosmetics laws requiring pre-market testing of ingredients, where those ingredients are not used by small companies, should not be imposed on small companies. To require otherwise serves only to burden small business owners with no corresponding public benefit.

Thus, we oppose new cosmetics legislation imposing testing of ingredients where those ingredients are not used by small businesses, and look forward to working with lawmakers and policy makers to craft an exemption that is carefully tailored to protect consumers without decimating small businesses.

State Laws

While an in-depth discussion of state cosmetics laws is beyond the scope of this post, we shared with FDA and Congressional staffers our concern that states are passing different cosmetics laws, thereby creating a sort of “patchwork quilt” of red tape for small businesses. I am hoping that we can form task forces to monitor specific state legislation (and perhaps oppose it), but that is for another day. For now, it is important that you investigate the laws in the states where you make and/or sell cosmetics to make sure you are complying with those laws. If you are a member of IBN, you can take advantage of our Business Resource Center which contains links to state laws, including cosmetics ones where applicable. (Use your member username and password to access that information.)

Helpful Links and Ideas

This is a very fluid situation. Congressional staffers are preparing new legislation, but we don’t know when it will be introduced, nor do we know exactly what it will say. Our only guideline with regard to the timing seems to be based on finalization of the health care debate. That could be as soon as next week, or as late as the end of next year. While we do not know the timing for sure, everyone we spoke with was very engaged and on top of the issues. It therefore seems clear that a new draft of cosmetics legislation will be circulated at some point, and we want to be ready to address it when we see it.

While we await next developments, it is more important than ever for small cosmetics companies to comply as best as possible with current FDA laws and guidelines. Here are helpful links and ideas:

Registration: Become familiar with the current FDA Voluntary Cosmetic Registration Program and register your facility. In addition to the FDA’s website, if you are an IBN member, you can follow the FDA’s presentation of how the program works through our members only website. (Scroll to the 3/19/2009 audio presentation and link.)

Good Manufacturing Practice Guidelines: Become familiar with the guidelines and comply with the ones you can comply with, or implement alternative procedures that make sense for your small operation but which further the goals of the guidelines to produce unadulterated cosmetics.

Labeling: Make sure you know how to properly label your cosmetic products using the FDA’s Cosmetic Labeling Manual. Where you are not sure about an what to call a specific ingredient, consult with your supplier to obtain the proper ingredient name to be used on the product label. Be sure to remove all labeling information that makes drug-like claims on a cosmetics product. If you need additional help, check out “Soap & Cosmetic Labeling Book” by Marie Gale.

State Laws: Check your own state to see if there are any laws applying to cosmetics and do your best to comply with them.

Obtain Products Liability Insurance: In addition to complying with state and federal requirements (laws), and doing your best to comply with guidelines that help give you confidence that your products are being manufactured in a safe and clean environment, if you are selling products to the public, procure products liability insurance so you are covered if any problems do occur. IBN’s products liablity insurance program through Stratus Insurance Services is a good place to start. If you gross less than $5,000 a year in cosmetics sales, check with RLI Corporation, a nationwide insurance company that may be able to provide coverage for you.

I will continue working with the Handcrafted Soapmakers Guild to prepare industry questionnaires so we can get a handle on the current state of the small scale cosmetics industry.

Summary

The information we have at this time is consistent with what is stated here. I will keep you updated on information as it becomes available. In the meantime, remember that our main concern is that our customers continue to be able to enjoy the safe cosmetics that small businesses make on a very small scale. The main concern is with the potentially broad application of laws to tiny businesses where there have been no problems with the cosmetics they make, nor is there a foreseeable risk that there will be. The likelihood that any problem will be caused by tiny businesses is so low that the burdens associated with proposed laws, without exemptions for little companies, outweigh any benefits.

I am excited to continue to work with Congressional lawmakers and policymakers, and also with FDA and state regulators to create laws that further the public interest without unnecessarily decimating the small businesses that make this nation great.

You can read the Handcrafted Soapmakers Guild’s post about our visits at this link.

Question: What do you think? Do you plan to oppose new cosmetics laws unless there are exemptions for small businesses? Why or why not?

[This post was originally published on my Twitwall on March 12, 2009. I think it is important for context to share it with you at this blog as well. You can see the comments on the original post beneath the post itself.]

A 32-page report (PDF) entitled “No More Toxic Tub” has been released by the Campaign For Safe Cosmetics. The report purports to show that a large number of cosmetics designed for children contain harmful ingredients. The report is undated so I’m not sure when it was released, but it seems to be quite recent. One of the things the report suggests is that federal laws should be changed to require that cosmetic ingredients and products designed for children should be proven safe through testing before the products are sold.

The report also says that “provisions should be made to support businesses, particularly small businesses, in meeting federal regulations for safer products.” While I am encouraged by this statement, its appearance at the bottom of page 22 of the 32-page report is not especially indicative of a commitment to make sure that small businesses are not regulated in the same manner as large ones.

Moreover, while the report asks people to write their Congressional representatives and alert the media about the issue, it does not encourage them to let them know that small businesses are not a part of the overall problem.

I know that some large manufacturers with billions of dollars in annual sales and millions of customers worldwide are using questionable ingredients in their products. This is a problem that the newly introduced FDA Globalization Act of 2009: HR-759 should address. However, and this is important, it is not the small, artisan, Indie and handmade companies that are using these unsafe ingredients and therefore, any new law must be carefully tailored to ensure that small companies are not regulated in the same way that larger ones are.

We Made A Difference On Capitol Hill

When I went to Capitol Hill last year with several other members of the IBN (Essential Wholesale, Bramble Berry, Bella Lucce, J.blossom), this is exactly what we urged, and we were successful in removing several troublesome provisions in the draft of the cosmetics law, including annual fees of up to $12,000. We did this in conjunction with the Handcrafted Soap Makers Guild (@soapguild). These victories were fantastic, and they help to make sure that while the public is safe, small business are not decimated.

We Must Continue To Make A Difference

We must continue the progress we began last year as we work with Congress and others to preserve a level playing field for the small businesses that are such a critical part of the American economy. We must continue to inform everyone we can about the crucial differences between the way huge multi-national cosmetics companies do business and the way Indie Beauty businesses do business.

Some people do not want the new law to pass with any kind of waiver or special consideration for Indies. I am not one of those people.

Let’s Not Let History Repeat Itself

We have already seen what happened with the CPSIA, the new consumer law which requires that children’s toys, clothing and other items be tested for lead before they are sold. Small companies are regulated under this new law in the same way that large companies are. This happened because the law law passed without any consideration for small businesses, many of which are no longer in business because they can’t afford to test their products for ingredients they already know those products do not contain.

Let’s make sure the same thing does not happen in the cosmetics arena. Cosmetics should contain safe ingredients. We all want that. But companies that are using safe ingredients should not be required to test for ingredients that they know they are not using in the first place. Requiring such pre-market testing would put thousands of small companies out of business without doing anything to protect consumers.

As manufacturers, IBN members are committed to producting quality cosmetics and to providing consumers with safe alternatives to mass marketed products.

With your help and support, I intend to continue to inform legislators, regulators, my colleagues, IBN members, consumers and all stakeholders on this important issue.

Question: What are your thoughts on the Toxic Tub report? Do you think it goes far enough to distinguish between the larger companies that may be the source of the problems complained of from the small companies that don’t use the ingredients discussed in the report? Do you think it’s fair?