Search Results for: legislation

Etsy Updates Policies on Cosmetics Making Claims

August 26, 2012 Filed Under: Business Musings

Etsy recently updated their policy on a variety of products that many Soap Queen readers and Bramble Berry customers make: products to help with acne (usually containing Tea Tree Essential Oil), anti-wrinkle creams and serums (often containing luscious ingredients like Tamanu Oil or Seabuckthorn Extract), diaper rash creams (often containing zinc oxide) and anything making anti-itch statements (often with additives like calamine or calendula-infused oils). This move has caused some confusion and frustration in the Etsy marketplace. Bottom line: follow the current, existing FDA guidelines for labeling cosmetics and you will be in compliance with Etsy’s new policy.

For the long post details, including actual languaging from FDA Warning Letters, links to the FDA site, statements from Etsy on the issue, continue reading by clicking “more”. [Read more…]

Bramble Berry Testimony for Congressional Hearing

March 28, 2012 Filed Under: Bramble Berry News

Yesterday, the subcommittee on Health (Energy and Commerce Committee) held a hearing entitled “Examining the Current State of Cosmetics.” You can watch the archive here. Debbie May from Wholesale Supplies Plus testified on behalf of small business. She did an amazing job (photo of her in hearings is below). The written testimony she gave is here. Bramble Berry submitted written testimony that was included into the official record.

Here is a copy of our testimony:

Testimony before the Committee on Energy and Commerce Subcommittee on Health
For the Hearing Entitled “Examining the Current State of Cosmetics”
March 27, 2012
On behalf of Bramble Berry Inc, a small business serving 60,000 independent makers of soap and toiletry products across the United States, I submit the following testimony to the House Subcommittee on Health for their consideration as they hear “Examining the Current State of Cosmetics.”

Microbusinesses manufacturing handmade cosmetics produce exceptionally safe products. If legislation is considered in upcoming hearings, I strongly urge the Committee to include a small business exemption from crushing paperwork and fees.

Across America people launch small handcrafted beauty businesses in their home kitchens to help support their families and to create and sell a higher quality, more natural beauty product than you can buy at your drug store. Any member who has purchased a gift bar of soap at a holiday fair or bazaar has probably met one of our customers.

These small batch producers use familiar, typically food grade ingredients: sugar, sweet almond oil, olive oil, beeswax, etc. These are safe. These small producers are not in business to create new chemicals but to make safe, high quality products from tried and true ingredients for their friends, family and to sell usually in low volumes in their own communities. They work at very small (and often negative) margins. Many would have to close if faced with added regulatory and fee burdens. Some aspire to be the next Aveda (annual sales over $100 million) or Burt’s Bees (employing over 350 people) but will never have that opportunity if their enterprises are strangled in infancy by regulatory excess.

Yes, Aveda and Burt’s Bees started in their kitchens before growing. They are exactly the kind of innovative business we want to see in all our communities. They and others carry on a long American tradition of home based, or “cottage industries.”

Cosmetic safety is a core value of my business. As the CEO of Bramble Berry Inc., I devote a significant amount of time to ensuring our customers understand and follow current labeling laws, utilize GMP standards and use fully-tested ingredients in their small batch cosmetics.

Please ensure that the American Dream of bootstrapping a business from home remains alive. You never know where the next Mary Kay or Estee Lauder will come from. Keeping small business exemptions in any potential draft legislation is the vital to ensuring thousands of (mostly) women can continue to operate their small businesses.

Thank you for the opportunity to comment on this matter, so important to many of your constituents.
Respectfully,
Anne-Marie Faiola
CEO, Bramble Berry Inc.

A bill associated with this series of hearings has been released. It is entitled: H.R. 4262, “The Cosmetics Safety Enhancement Act of 2012”. You can read a full version of the bill here.

Report from DC

December 6, 2011 Filed Under: Personal Ramblings

Hi team,

Greetings from Washington DC where it is warm, muggy and surprisingly easy going in climate. I brought my running shoes and am hoping to go on a run through the monuments tomorrow morning.

Congresswoman Diana DeGette

We had an extremely busy day meeting with Congresspeople and staffers who are working on the Safe Cosmetics Act potential legislation. Debbie May from WholesaleSuppliesPlus and I met ahead of time to go over the results of the industry survey. The results were extremely helpful. Some results from the survey 1998 small handcrafted soapmakers took: [Read more…]

Bramble Berry Testimony in MA

September 13, 2011 Filed Under: Personal Ramblings

Though the Safe Cosmetics Act at the Federal Level continues to work its way through its slow process and has no current update, at the individual State level, there continues to be movement as various States introduce and work on passing legislation that affects soaps and cosmetic manufacturing and labeling.

One of the these bills is MA H02361 had a live hearing today. You can read the full version of the bill here. Though Bramble Berry was not able to attend the hearings in person, we submitted testimony on the Bill. A copy of the letter is below.

[Read more…]

The Safe Cosmetics Act of 2011

July 15, 2011 Filed Under: Personal Ramblings

A new version of the Safe Cosmetic Act has been released. You can read the full version of it here. http://www.opencongress.org/bill/112-h2359/text Many of our customers have asked me why I haven’t come out with a position on the bill yet. The reason is two-fold: (1) I had additional questions that needed to be answered and (2) My sweet baby boy is adorable and still not sleeping (see baby monitor below). In the past, I have been able to travel to Washington, DC myself to meet with Legislators, talk about the bill and its verbiage and learn the intention between many of the points in the bill. With a newborn at home who depends on me for food, I have not been as active with this iteration of the bill as I have been previously. Thankfully, others have.

Leigh O’Donnell from the Handcrafted Soapmakers Guild deserves our gratitude; she has been to Washington DC on this issue six times this year alone. She went to Washington, DC this week with a list of prepared questions from a group of vendors and small businesses about the bill. Many of my additional questions have been answered. While the bill is not perfectly crafted and there are gray areas still existing, it is a better version of the bill than previous iterations. For example, small businesses are exempted from fees in this version of the bill.

I am thankful for the work of the Handcrafted Soapmakers Guild and their paid advocates in getting our voices heard. While the bill, as written, is not perfect, small business does have a seat at the table with the Handcrafted Soap Guild. This bill continues to be a work in progress and this process does afford us the opportunities for change. The HSMG was invited to Washington, DC this week (as was I but was unable to attend) to meet with Legislators to talk about the bill and continue an open dialogue on how the bill can be improved and clarified.

This bill does need to be worked on; intentions in several areas are unclear, and, as written, are open to negative interpretations. But, it is better than what we have seen in the past and because of the HSMG’s careful education and the Legislators’ stated desire to work with small business, I am cautiously optimistic moving forward. Though Bramble Berry’s official position is that additional legislation is not needed for our industry, we believe that legislation is coming; if not this year, then the next. Thus, it is important to keep our lines of communication open to legislators and continue to work proactively so small business continues to be represented.

My hope is to go to Washington, DC in the fall to work on this bill on your behalf. In the meantime, Bramble Berry continues to donate to the Legislative Advocacy Fund of the Handcrafted Soapmakers Guild to help support their professional advocacy work in Washington, DC. I will keep you posted as the bill continues to change and the positions in it, clarified.

Soap Guild Conference Recap

May 25, 2011 Filed Under: Personal Ramblings

This year’s Handcrafted Soapmakers Guild Conference in Miami was three full days of amazing!

[Read more…]

A Voice in Washington, DC … Just for Us!

August 16, 2010 Filed Under: Bramble Berry News

Though Congress is in recess right now, there is still a lot of work going on behind the scenes around the Safe Cosmetics Act – both with its advocates and its detractors. It is Bramble Berry’s official position that the act is too overreaching, too broad and is not enforceable as currently written. Click here to read our initial take on it and here to read about our trip to Washington DC to meet with staffers working on the proposed legislation.

Grassroots letter writing, phone calls, emails, tweets and posts have a place in shaping this legislation. I hope that you will continue be vigilant about educating our lawmakers, your customers and friends about the unintended negative consequences should the Safe Cosmetics Act pass, as currently written.

In addition to our grassroots work, Bramble Berry is also supporting the not-for-profit Handcrafted Soapmakers Guild’s newly formed Legislative Advocacy Fund. This fund will be used to hire an advocate, based in Washington, DC, to speak on our behalf regarding this issue, help with strategy and follow things closely in Washington, DC.

Bramble Berry is financially supporting the efforts of the Handcrafted Soapmakers Guild. You can make a donation to the Legislative Advocacy Fund here. You don’t have to be a memberof the HMSG to support this action.

Thank you for writing those letters, calling your congress people while they’re in recess and continuing to do what you do every day: make safe soaps, lotions and toiletries. Together, we can educate and advocate for reasonable FDA legislation and reform.

Did You Already Eat That? (Guest Post)

August 10, 2010 Filed Under: Bramble Berry News

A big thank you to Emily Caswell for letting me share her post on the Safe Cosmetic Act of 2010! The blog is, of course, written with tongue firmly in cheek but for a serious reason. It is written in response to the broad, overreaching tenants of the proposed HR 5786 which would ‘ban’ ingredients that were proven to be ‘carcinogenic when ingested’ for use in skin care. Most everything is carcinogenic in some way, shape or form when ingested and Emily has a droll interesting way of explaining commonly demonized trace elements that may be lurking in your own fridge. Check out her blog GCDSpa Stuff and website GCDSpa.

The Precautionary Principle: A Cautionary Tale

I’ve been inspired by the actions of WATCH (Women Against Toxic Cosmetics Harm) and the Alliance for a Clean and Healthy Maine, who (with the assistance of the Environmental Working Group and Campaign for Safe Cosmetics) sent away 12 common cosmetics products last spring to be tested for chemicals. Since they’ve already found the hidden toxins in my medicine cabinet, I figured maybe I’d take a look at what was going on in my fridge. I’ve been a vegetarian for more than 25 years and eat a diet based largely on whole, organic foods, so I was sure my food “tests” would come out clean. I was appalled by the results.

Carcinogens

• Formaldehyde

As it turns out, the apples, bananas, beets, broccoli, onions, cabbage, carrots, cucumbers, grapes, green onions, kohlrabi, pears, potatoes, spinach, tomatoes, radishes, and watermelon I have been feeding my family naturally contain 2 to 60 mg per kg of formaldehyde. The dried shiitake mushrooms my husband likes contain a whopping 400 mg/kg! As you may know, formaldehyde is classified by the EPA as a probable human carcinogen, and is known to cause cancer in rats.

• N-nitrosopiperadine

Before I learned of its formaldehyde content, I enjoyed my baked potato, and added a generous dash of black pepper. Now I’ve learned that black pepper, too, causes cancer in mice. It contains substances that break down into N-nitrosopiperadine, which is carcinogenic.

• Safrole

With pepper out of the picture, I figured I’d turn to other herbs and spices to make my poison-laced meals more appetizing. But cinnamon and nutmeg are among many that contain safrole, which causes liver cancer in rats. Rats.

• Tannins

Who knew that my morning beverage was killing me from the inside out? Guess it doesn’t matter whether I choose coffee or tea, or head straight for the cocoa, because with all three I’ll be getting tannins, substances which cause tumors in experimental animals. (What a relief that people don’t consume coffee, tea, or cocoa in large quantities!)

Endocrine disruptors

I thought that by eliminating the parabens from my beauty products I’d be “safe” from endocrine disruption, but I was so misled. Lots of plants apparently have naturally-occurring hormone-like activity, in the form of phytoestrogens. There are high levels of these phytoestrogens in my carrots, legumes, broccoli, potatoes, cauliflower, soybeans, oats, rice, onions, apples, and coffee. Thank goodness I don’t drink beer, because they’re in that, too. Sure, these phytoestrogens are considered beneficial by some, but I also read that when sheep consume these natural hormones it can lead to decreased fertility. Their consumption also disrupts the normal cycles of female rats. And if things are bad for rats (particularly when consumed in grotesque amounts), they must be bad for us (even if eaten in moderation). Right?

Goitrogens, enzyme inhibitors, mutagens, antivitamins

The list goes on and on. It’s a horror show. All of my favorite foods have ingredients that, if not downright toxic, are capable of inhibiting enzyme action, vitamin absorption, and thyroid function as well as causing cellular mutations. Potatoes, tomatoes, eggplant, mung beans, Brussels sprouts, broccoli, parsnips, celery, and wheat are only a few. I’m a walking time bomb, eating my way to the next organ failure.

Now that I understand the dangers, I can’t believe that the government has been advising us to eat fresh fruits and vegetables every single day! Even The Harvard School of Public Health says, “Most people should aim for at least nine servings (at least 4½ cups) of vegetables and fruits a day.” They recommend, “Go for a variety of kinds and colors of produce, to give your body the mix of nutrients it needs.” What are they trying to do, KILL us??

I, for one, will not be brainwashed. You can tell me that these foods are “safe” and even “beneficial,” but I’ve done my research. I know the truth. I’m taking my cue from the Environmental Working Group and their Campaign for Safe Cosmetics, and adopting the precautionary principle with regard to my fridge. Anything that’s been linked to cancer in animals, or has estrogenic or toxic effects, will be banned from my diet. Until further notice, then, I won’t be eating apples. Or bananas, beets, onions, cabbage, carrots, cucumbers, grapes, green onions, kohlrabi, pears, potatoes, spinach, tomatoes, radishes, or watermelon.

Oh, and coffee, tea, cocoa, eggplant, mung beans, brussels sprouts, parsnips, celery, broccoli, cauliflower, beans, lentils, peas, peanuts, soybeans, oats, rice, onions, cinnamon, nutmeg, and pepper. Did I forget anything?

But I’m not going to stop there. These foods are in every supermarket, and as The Story of Cosmetics suggests, we need to make sure that for items in our stores, the “choice to be safe and healthy has already been made.” Surely this must apply to our food, too? Take a look at your broccoli label. Where is formaldehyde listed on that package? Where are the goitrogens? The laws governing these labels are a travesty! I will not rest until my Evian label includes not just “water,” but also arsenic, fluoride, chlorine, barium, mercury, atrazine, copper, chromium, and any other measurable contaminants.

The Safe Cosmetics Act of 2010 is nice and all, but The Safe Foods Act of 2010 is a piece of legislation I could really sink my teeth into. Who’s with me?

‘Safe Cosmetics Act’ NOT So Safe For Small Biz

July 24, 2010 Filed Under: Business Musings

The Safe Cosmetics Act of 2010′ (H.R. 5786) was introduced this week by Democrat Representatives Scharkowsky (Illinois), Markey (Massachusetts) and Baldwin (Wisconsin). The full version of the draft bill for you to read is here. This draft has not yet been voted on. There is still time to have changes made.Now is the time to educate yourselves and write your lawmakers.

Bramble Berry opposes this draft legislation as written recommends that you write your Representative with a customized message opposing this legislation as it is currently written (not sure who your Rep is? Click here to find out!). Add your details; make it personal and let them know that if this bill passes as it is currently written, that your business will be affected. Here’s one example of a letter that you could write:

Dear Representative,

I am writing to express my concerns about H.R. 5786, the ‘Safe Cosmetics Act’. I make lip balms, soaps and lotions and sell them at the local Farmer’s Market. My business makes less than $5000 per year. I sell to pay for my daughter’s piano lessons and my son’s soccer camps every year. What I make augments my family’s income and helps our quality of life. I make my soaps and lotions with common ingredients that you can find in your kitchen. For example, I have a great bar of soap that I make out of four ingredients: Olive Oil, Water, Lye and skin safe fragrance. H.R. 5786 has a bunch of extra reporting requirements that would be virtually impossible for me to comply with. I’m just one woman in a kitchen. I don’t have a huge staff to help me. Plus, I often change my formulations based on the season and what my customers are asking for. Being nimble is a huge advantage for me and if I have to submit a new safety and ingredient affidavit for every product, that will take away one of my key advantages. Please don’t support this legislation. It is well-meaning but is written in such a way that I won’t be able to stay in business because I won’t be able to keep up. Estee Lauder started at her kitchen table. Please don’t take that opportunity away from me.

Sincerely,

Suzy Soaper

Suzy’s Soaps

Bramble Berry is opposed to the bill for the following reasons:

1. It is unnecessary. The cosmetic industry is a safe industry with a wide variety of choice on the marketplace for consumers.It is already illegal to manufacture unsafe cosmetics and is already illegal to not fully label ingredients or contact information on products.

2. This bill would, handicap small manufacturing business. In a time of economic uncertainty and distress for millions of Americans, this is untenable. For some families, the income from the Farmer’s Market may be what they are living on now.

3. The reporting requirements are ‘big brother.’ They ask for your annual sales, number of employees and even the names and addresses of your vendors. They even require you to log your proprietary formulas. It’s not clear what information might be kept confidential or not.

4. ‘Detectable’ trace elements must be included on labels. Since almost everything is detectable, labeling will be confusing to end consumers (even more than it is already). So, “Water” on a label would look like “Aqua, Arsenic, Cadmium, Copper, Lead, Nickel, Silver, Zinc” (and if you live in my town, you’d also have to include caffeine, oral contraceptives and antibiotics in your water labeling requirement).

5. Trace Ingredients that are considered carcinogenic when ingested (eaten) will be unable to be used in skin care products. Ingredients that are ‘found to induce birth defect’s when ingested or inhaled will be banned as well. You will be able to eat apples but not put them in skin care products. That’s because apples contain small amounts of cyanide. Lucky for us our body can detoxify cyanide in small trace amounts. But under this law and the ‘trace elements’ portion of the proposed bill, you still wouldn’t be able to put apples into your products even though you can safely eat apples.

6. Safety Statements, ingredient listing and registration information must be listed for each and every cosmetic, soap, lotion and potion must be made up. With a small scale manufacturer who is making a few of this and a few of that, this is a paperwork nightmare. It does not allow for easy changing of recipes when formulating and trying new recipes.

7. There is no full exemption for small businesses. Small businesses often launched because of the notion that cosmetics could be made with a larger proportion of more desirable ingredients than have typically been used by traditional cosmetics manufacturersI fully believe that the backers of the bill are well-meaning and trust that this bill will have more changes before it is voted on. But it’s up to us to explain what changes need to be made to protect small business. Don’t just take my word and interpretation of the bill as gospel, read the bill for yourself here and start the education and change process today.

Updated 8/1: There is a petition against the ‘Safe Cosmetics Act’ here. Read the petition and sign it if you agree with the statements. The official Oppose SCA site is here. Curious about how a bill becomes law? There’s a fantastic post about it here as it pertains to the ‘Safe Cosmetics Act’ in particular.

Colorado Bill – Update

March 2, 2010 Filed Under: Business Musings

I listened to the bulk of the Colorado hearings over House Bill 1248 yesterday (for an overview, check out the blog post here). The bill would have banned a variety of ingredients, including trace amounts of chemicals, in personal care products. On the face of the bill, it sounded great – less chemicals is a good thing right? Chemicals = Bad. Natural = Good. The problem with that sort of simplistic thinking was that in the rush to ban chemicals, some of the science and practical ramifications of the ban were overlooked.

The bill failed to get out of committee – 4 votes to 7 – for a few reasons:

1. We’re not the E.U.

Those testifying for the bill asserted that European Union had safer personal care products and that the United States should follow along in their footsteps. There was spirited discussion about whether the U.S. should follow bills from the E.U. or even model our laws after the E.U. laws. The bill, as it was written, would have allowed the E.U. to add or take away from the list of ‘acceptable’ chemicals that were used in products in Colorado.

2. Trace elements were not allowed.

Many natural products that come from the earth have trace elements in them. These elements occur in levels that are minimal or in such small amounts that they do not have anything near the levels that you would need to be exposed to in order to have a negative effect. Even apples contain trace amounts of Acetaldehyde! So if this bill had passed, we could *eat* the apple but not grind it up and put it in a fresh face mask. From Indie Beauty Blog:

This point was driven home when Dr. Richard Adamson (testifying on behalf of the Personal Care Products Council), said that in order for lip sticks that contain trace elements of lead to be injurious to human health, one would have to eat (yes, literally eat) 3-4 tubes of it a day for 70 years before it could become potentially harmful.

Dr. Adamson also said of 1,4-dioxane (which can be used as a foaming agent in cosmetics), one of the substances that would have triggered the law, that one would have to take 700 baths a day for 70 years in order for the substance to become potentially harmful to a human being.

3. Science did not back up the ban

Many testified that it seemed like a good idea to ban the chemicals, stating that we shouldn’t wait for the science to prove that the chemicals caused cancer, that instinctively, we should just know that they did. Lawmakers proved unwilling to put 1000’s of Avon and Mary Kay representatives out of business based on feeling rather than fact. From Indie Beauty Blog:

This troubled lawmakers greatly, and for good reason. Everyone who testified, both for and against the bill, repeatedly stated that the science is simply not there to say that any substance used in cosmetics causes cancer or reproductive problems, even if that substance has been determined to be toxic somewhere in the world under some testing condition.

4. It was a boon for the lawyers.

This law was not regulated by a governing body, instead leaving it up to individual citizens to find products containing the ‘bad’ ingredients and sue the manufacturer. This would be great for lawyers, not so great for the court system. In California, lawsuits from Proposition 65 have cost over $406 million, most of it going to lawyers.

In closing, I am thankful that this overly broad legislation was not passed. It would have affected far too many business owners in Colorado during a time when the economy needs small business more than ever. People in Colorado can vote with their dollars; they have a choice when purchasing personal care products. There are many, many natural cosmetic and toiletry companies in Colorado selling alternatives so that the entire spectrum of personal care is available.

You Can Die From Salt Too

February 23, 2010 Filed Under: Business Musings

“You can die from eating a few tablespoons of ordinary table salt at one time, but that doesn’t mean that table salt is a poison at the doses that humans normally consume.”

—- George Bailey, Oregon State University Professor emeritus of molecular and environmental toxicology

Recently a bill has been proposed in Colorado, the ‘Colorado Safe Personal Care Products Act’. Here is a link to the full Act. There are hearings coming up in March in Colorado. You can attend to learn more or voice your opinions. To sum up the bill it would prohibit the sale of ‘…any personal care product that contains a chemical identified as causing cancer or reproductive toxicity.’ This in itself sounds good! After all, who could possibly argue with crafting safe products? But this bill is not setting reasonable limits – it would be an outright ban on anything that is even classified as a ‘potential’ carcinogen. It’s a broadly worded bill that would have many unintended consequences.

1. The bill is overly broad and would ban many natural ingredients.

For example, many people may not realize about this is that this Act would ban even naturally occurring substances that can be found in extracts and essential oils. For example, one of the components of Basil, Citronella, Rose Otto and Tarragon Essential Oils is Methyleugenol. This essential oil component is considered a carcinogen. Does that mean we wouldn’t be able to use these safe, natural additives in our formulations? The way the current legislation is written would open the manufacturer up to fines of $10,000. This law, while well-meaning, is too general and will harm small personal care manufacturers who have less choice of ingredients to use and may in fact, prefer to use all natural ingredients, like essential oils.

The proposed bill is very definite with its complete ban instead of safe usage restrictions which would make more sense (and already exist). Testing of chemicals and ingredients to classify them as ‘potential’ carcinogens is done in very concentrated amounts of the product, generally in larger amounts than the ingredients are used in ‘real life’.

2. How to make your voice heard.

For anyone who would like to voice their opinion, the House Judiciary Committee will be having a hearing for those both in support of and in opposition of this bill on March 1st. The meeting will be in the basement of the Capitol Building, in room 0107.

If you do not live in Colorado, here is all the info to contact the house members who are sponsoring this bill to get more information or suggest how the bill may better be crafted to meet the goals set out in the bill:

The bill is sponsored in the house by Dianne Primavera phone # 303-866-4667 click here to email, Dennis Apuan phone # 303-866-3069 click here to email, Karen Middleton phone # 303-866-3911 click here to email, Joe Miklosi Cap phone # 303-866-2910 click here to email.

A group in Colorado that is in support of this bill is The Women’s Lobby of Colorado. They hold open meetings so anyone who would like to speak in opposition to this bill or in support of a bill simply asking for safe usage rates, can contact them at [email protected] for information on their meetings.

It is important that we speak up for safe regulations instead of a complete ban. Using natural and safe ingredients and taking care of our bodies is important. There is already a governing body that covers beauty ingredients and cosmetic products – the FDA. They have comprehensive guidelines on best manufacturing practices, labeling laws and there already are safety guidelines in place for essential oils, preservatives, fragrance oils and other additives.

3. The bill is backed by questionable science.

I have done research on the testing process to determine carcinogenity and generally, ingredients are tested via injection in high doses or in-vitro injection, nothing as simple as small percentage in a product that is used at skin level. According to Oregon State University:

The health impact of carcinogens is not always “linear,” This means experiments that are done using high concentrations of a carcinogen – a common practice made necessary by cost and logistics – may not accurately predict the actual risks of the compound when exposure in the real world is at lower levels over long time periods. (Oregon State University link to full article)

Here are some examples of wording from EWG or Skin Deep – a group that supports this bill shows testing results for the cancer causing substances that they want to completely ban. They list ‘concerns’ for the ingredients in question, one of these reads: ‘One or more animal studies show tumor formation at high doses‘. Another reads, ‘One or more in vitro tests on mammalian cells show positive mutation results.’ and yet another ‘Cancer – limited evidence.’

When I read these I see ‘high doses’, ‘in vitro tests’, and ‘limited evidence.’

Personal care products are not introduced directly into your body in a dose (like a drug); they are not in any way introduced ‘in vitro’. They are leave on and rinse off. If lotions really absorbed in all that well, anti-wrinkle creams would work like the packaging says they do. If the bill passes as written, many natural options would also be effectively no longer available. We need to speak up for safe and knowledgeable regulation that takes into consideration natural occurrence and recognizes the difference between concentrated doses and personal care product use. Remember, salt and water can kill and no one is looking to ban any of those items.

For a business perspective on why this bill doesn’t make sense, head over to Donna Maria’s blog here.

Other blogs on the subject:

Robert Tisserand’s blog “Tunnel Vision” http://roberttisserand.com/2010/02/tunnel-vision/

Donna Marie’s blog “Oppose the Colorado Safe Personal Care Product Act” http://www.indiebusinessblog.com/2010/02/23/oppose-the-colorado-safe-personal-care-products-act/

Ann-Marie’s blog “You Can Die from Salt Too” http://soap-queen.blogspot.com/2010/02/you-can-die-from-salt-too.html

Cindy Jones’ blog, “Colorado Safe Cosmetics Act” http://sagescript.blogspot.com/2010/02/colorado-safe-cosmetics-bill.html

Kelly Bloom’s blog, “Colorado Safe Personal Care Products Act” http://southernsoapers.com/news/causes-concerns/colorado-safe-personal-care-products-act/

Lisa Rodgers’ blog, “Colorado Safe Personal Care Products Act : How Will it Effect You?” http://cactusandivy.blogspot.com/2010/02/colorado-safe-personal-products-act-how.html

Katherine Corkill blog, “Oppose Colorado Safe Personal Care Products Act.” http://sterlingminerals.blogspot.com/2010/02/oppose-colorado-safe-personal-care.html

Happi Magazine mentions the topic in “Preservative Market Update” http://www.happi.com/articles/2007/05/preservative-market-update

Handcrafted Soapmakers Guild “From the President, Colorado Safe Personal Care Product Act” http://www.soapguild.org/blog/2010/02/from-the-president-colorado-safe-personal-care-products-act/

Cosmetic & Toiletries site, “Bill Proposes the Colorado Safe Personal Care Product Act.” http://www.cosmeticsandtoiletries.com/regulatory/region/northamerica/84985577.html

Michelle Gilbert’s blog “Colorado versus the cosmetic industry” http://sarvasoap.com/blog/?p=706

FDA Globalization Act ’09 – Update

January 30, 2009 Filed Under: Bramble Berry News

The FDA Globalization Act of 2009 was officially introduced on Wednesday the 27th. While this Act would have been introduced eventually, the political cover afforded by the Peanut Butter scare made it perfect timing (even though the Peanut Butter Salmonella problem could have been prevented under existing regulations regarding best manufacturing practices and had the 12 positive tests in 2007 and 2008 been properly dealt with. CNN story here).

No matter what the reasoning, the FDA Globalization Act is on the table to help an agency that is woefully underfunded to deal with the realities of an increasingly global society with imports flooding the United States from countries with more lax regulations around safety. The current iteration of this bill imposes fees and more regulations primarily on the food and drug industry. There have been substantial changes made from the original draft that circulated in 2008. Specifically (full copy here), it appears that much of the feedback the micro beauty business gave in 2008 (read about a Coalition of Small Business & Suppliers that went to Washington DC on your behalf here and here) was incorporated. Yay for a team of committed individuals helping to enact positive change!

Salient points for the FDA ’09 Act are:

Registration – Like having a business license with your city, you will need to register your bath and body business with the FDA (page 115 – 116)

Inspections – Besides registering with the FDA, they are not asking for inspection of your facilities.

Fees – Under the current draft legislation, there are no fees to register your business or submit your ingredient decks (aka: list of ingredients used in your products)

Ingredient Listing – When you manufacture a product to sell, you need to submit your ingredients for the overall product. You will not need to submit for each individual fragrance, provided the base does not change. (page 119)

Adverse Events – Right now, reporting “Adverse Events” to the FDA is voluntary. This means that if one of your customers reports that your lotion gave them an allergic reaction that sent them into the hospital (highly unlikely) that the FDA would currently like you to report this but they do not make you. In the future, reporting serious Adverse Events will be mandatory within 15 days of the event. See below for full definition of Adverse Events. (page 122)

There are a group of committed business owners, advocates and vendors working diligently behind the scenes to proactively monitor the situation. Between The Soap Guild, The Indie Beauty Network, Essential Wholesale, WholesaleSuppliesPlus and Bramble Berry, we’ve got your best interests at the forefront of our monitoring and actions. We will keep you up to date as we hear anything.

Press Release regarding release of FDA Globalization Act of 2009 here
CNN story on peanut butter contamination history here
The term ‘serious’, with respect to an adverse event, means ” resulting in death, a life-threatening experience, inpatient hospitalization, a persistent and significant disability or incapacity or a congenital anomaly or birth defect.”
I’m not a lawyer. You should read the bill yourself to make sure you agree with my interpretation of the data

Washington DC Report – FDA Act – 2008

August 8, 2008 Filed Under: Bramble Berry News, Business Musings

I’m fresh back from the Washington DC fact finding and information sharing trip. If you missed the background of this trip or the FDA Globalization Act of 2008, click here to read about it. It was a well planned out, busy day, shared with invigorating company.

A big “Thank You” to Donna Maria Coles Johnson of the Indie Beauty Network for setting up a whirlwind tour from Maryland to DC on behalf of small home based crafters everywhere. To kick things off in the right way, I made a few bars of this fun John Kerry soap to leave behind, along with our briefing packet. At the very least, it’ll help with a good laugh.

Our first meeting of the day was with the Director for the FDA’s Office of Cosmetics & Colors, Dr. Linda Katz. Dr. Katz and Patricia Hansen, Ph.D., a Deputy Director were gracious enough to explain their position with regards to the FDA Globalization Act of 2008. If the legislation becomes law, it is the FDA that will promulgate the rules and regulations to implement it.

During our meeting, we described our position with regard to the draft law. For example, we explained how the requirement that having to file paperwork listing each product and each ingredient in each product every time a new product was sold would be a lot of extra red tape for a small business. Here’s a fun photo of Jamila White of j.blossom and Donna Maria from IBN posing, right before the meeting started.

Dr. Katz and Dr. Hansen gave us some additional information about the reporting systems currently in place and felt strongly that the systems were manageable for a small business, since they were computerized. They also offered to meet with industry representatives in person, at a conference for example, to train small businesses on various reporting structures. They reminded us that fees are not anything the FDA has input on. They are set by Congress.

So, off to Congress we went.

We took the Metro from Maryland (where the FDA offices are) to downtown DC to meet with a staffer for Senator John Kerry. Kerry is the Chairman of the Senate Committee on Small Business and Entrepreneurship and is a strong advocate for women owned businesses everywhere. Senator Kerry’s staffer took copious notes and expressed significant interest in following the draft legislation as it becomes a bill (if that happens). She pointed out that Senator Kerry has no official role in the process until draft legislation becomes a bill, and then moves from the house to the Senate. She thoughtfully offered to follow the legislation to ensure Senator Kerry would be well informed if and when the bill comes up for a vote. Here is a photo of Donna Maria and I in front of the famous Swifboat photos in Senator Kerry’s office.

After a short lunch in the Metro Station (wow! What a great variety of food they had in there!), we were off to meet with Virgil Miller, the professional staff member in the House Energy & Commerce committee, where this legislation originated and is now pending. Mr. Miller was very kind and listened to our concerns. He explained Congressman Dingell’s (co-sponsor of the draft legislation) reasons for introducing the draft legislation and expressed surprised at the very existence of our small handmade industry.

Jamila White of j.blossom and Lela Barker from Bella Lucce took to the floor to speak passionately about the burdensome fee requirements. It was very gratifying to be listened to with an open mind. After we all had a chance to speak about the potential reporting requirements and fees, he gave us an opening to potentially help shape the final draft of this bill. Specifically, he requested that Donna Maria take the lead in proposing alternatives to the fee structure and reporting requirements now contained in the draft. Donna Maria is looking forward to working closely with IBN members on forming an exemption for small businesses or perhaps a sliding fee fee structure based on the size of impacted businesses. It was great to be asked to participate. Here’s a photo of Donna Maria with Lela Barker from Belle Lucce, riding the metro.

And, like dessert, it’s good to save the best for last. We met with the Deputy Communications Director and another staffer in Congressman Jesse Jackson Jr.’S OFFICE. They were very surprised to hear about the potential unintended consequences of the draft discussion framework and agreed that it seemed like an oversight to impose fees and paperwork requirements that would essentially tax small businesses heavily, perhaps even right out of existence. The staffers had some very interesting ideas for getting press for the small business cause, as well as helpful suggestions for working within the current framework of the House/Senate bill session. The two staffers we met with were funny, witty and charming. It was almost like sitting down for coffee with good friends.

After that last meeting, we were tired but in high spirits to meet with soapers who had driven up to 3 hours to meet us at California Pizza Kitchen (a tip: their White Pizza is delicious!) for debriefing and some great food. Here’s a photo of our merry group. That’s Jamila White from j.blossom with the closed laptop. She jumped right on the internet to do some research, right at the table. Now that’s a perfect example of an entrepreneur – always thinking and willing to do what it takes to get the job done – even if it’s during dinner!

The camaraderie was high and it was an honor to put a face to the names I see online. The main clearing center, the woman who is focusing much of her current time on this potential legislation, however is Donna Maria. Her blog is here. You should check it regularly as well for updates on where the draft discussion framework is going. I’ll also keep you posted on what is going on with this legislation through this blog as well.

The Law with Unintended Consequences

August 1, 2008 Filed Under: Business Musings

Recently, the FDA (U.S. Food and Drug Administration) announced that it was considering legislation to strengthen food, drug and cosmetic safety (see the Draft Discussion here). While I sincerely believe that the FDA and all that testified on behalf of the legislation have the consumers’ best interests at heart, I am deeply concerned about the unintended consequences of this action. I am so concerned about the ramifications of this legislation that I will be heading to Washington DC next week to speak on behalf of Bramble Berry’s customer base and add my voice to all of you who have worked hard to turn this hobby into a business. Joining me will be three amazing women: Donna Maria Coles Johnson from the Indie Beauty Network, Lela Barker from Belle Lucce, Jamila White from jBlossom.com and Kayla Fioravanti from Essential Wholesale. We will be meeting with staff of the House Energy & Commerce Committee (under whom this discussion framework is moving forward), Senator Kerry (Senator Kerry chairs the Senate Committee on Small Business & Entrepreneurship) and the Deputy Press Secretary for Congressman Jesse Jackson Jr. Rep. Jackson serves on the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.

In a nutshell, the FDA Globalization Act of 2008, is designed to impose stringent monitoring, manufacturing and reporting requirements on all products under FDA purview. The “Cosmetics” portion of the bill is actually very small (1/64th of the entire bill) in relation to the “Food” portion. None the less, the implications for small, home based crafters and cosmetic manufacturers, is concerning.

This legislation is coming at a time when cosmetics and personal care consumers have never had more choice, nor have the products they have to choose from ever been more safe. Just look at these quotes from experts:

Pamela Bailey, President of the Personal Care Products Councill (formerly CFTA), stated in her April 12th testimony to the Energy & Commerce Committee, “Cosmetics and Personal Care Products are the safest category regulated by the FDA.”

Additionally, Stephen F. Sundolff of the Center for Food Safety and Applied Nutrition stated, “The FDA’s oversight has ensured that the Nation’s cosmetics are among the safest in the world.”

The experts quoted above believe the system is already working and we here at Bramble Berry are pleased to help you make some of the most useful, safe and innovative products in the country.

Consumer safety is important to me. I am a strong advocate of proper ingredients labeling, best manufacturing practices and education. As Bramble Berry’s founder and CEO, I am consistently impressed with your commitment to the safety and purity of your products. This is why I am so concerned about this legislation.

With this potential legislation at our doorstep, it imperative that you review all of your products, formulations and manufacturing practices to ensure that you are within full compliance of all current laws for home crafters and cosmetic manufacturers. This new proposed legislation will do nothing to strengthen the cosmetics industry safety. Rather it will just be a bigger burden which could force some small producers out of the market.

The areas in the current discussion framework which I find particularly disturbing are:

• Requirements that you register all of your formulations with the FDA – Cosmetic manufacturers select from a list of approved ingredients generally regarded as safe by the FDA. This rule would add another unnecessary burdensome reporting requirement onto small businesses. Who exactly of the 18 people currently employed by the FDA to oversee Cosmetics is going to look at the formulations? If there were 100,000 large and small manufacturers, each with 25 formulations … well, that’s a lot of paperwork to go through! Not to mention, as a small business owner, you’re already doing enough, stressed to the max and now you’re going to need to fill out forms rather than work on bettering your business? Yikes. Talk about tying your hands with red tape. Consider also the stifling effect such a reporting requirement will have on new product innovation, or even minor improvements made to old products.

• Requirements that you report all “Potential Adverse Reactions” to the FDA – Again, through self-regulation (GRAS list, The Cosmetic Ingredient Review (CIR) and Cosmetic Ingredient Dictionary) there is a comprehensive list of approved (and not approved) ingredients to use. Who is to say what a “potential adverse reaction” might be? I might have an adverse reaction to the foundation I just made … if I put it directly on my eye. No one can legislate or know what consumers do with our end products. Why would the government want us to even try? According to the Personal Care Council, every year, out of 11 BILLION personal care products sold, there are less than 150 adverse reactions. That’s a safety factor of .00000000136%. There is no evidence that the current laws and regulations are not working. In fact, the excellent safety record of the Cosmetics Industry proves the contrary.

• Fees, fees and more fees will jeopardize businesses all over America. In uncertain economic times, it is imperative that Americans have choices about how they earn their money. At the minimum, this act would require a registration fee of between $2000 up to $12,000 per year, no exceptions. 95% of Bramble Berry’s extensive customer base would not be able to bear this burden. In fact, only 40% of our customer base grosses over $250 in sales per month. Yet, it is from this very customer base that the next Mary Kay or Estee Lauder may arise.

Just think of how these three points might affect YOUR business. The time to act is now. This law has many unintended consequences. Rather than strengthening the cosmetics industry, it will force thousands of small producers out of the market. And, where there is less choice, there is always a higher price in the end.

If you haven’t yet signed the petition, there is still time. Head to Indie Beauty Network’s site here. Be sure to sign your name, business name and city and state.

I’ll be in DC next week – let me know what you think is important for the committee to hear. What would you tell them? I’d love to meet you at the Indie’s In the City meet-up after our busy day of meetings on the Hill. Learn more about that meet-up and RSVP here.

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Resources & Links referenced in the post:

Committee on Energy & Commerce: http://energycommerce.house.gov/FDAGlobalAct-08/index.shtml
Discussion Draft Legislation: http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf
Testimony of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research http://www.fda.gov/ola/2008/fdaglobalact050108.html
Testimony of Stephen Sundolff for Center for Food Safety And Applied Nutrition http://www.fda.gov/ola/2008/devices051408.html
Testimony of Patricia Bailey of the Personal Care Products Council http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.051408.DiscDraftCosmetics.shtml
Testimony of Center for Science in the Public Interest: http://www.cspinet.org/foodsafety/fdaglobalizationact.pdf