Update on The Safe Cosmetics Act

In 2008 the small businesses in the cosmetic industry joined together to fight the FDA Globalization Act of 2008.  We remained together to fight the FDA Globalization Act of 2009, then the Colorado Safe Personal Care Products Act in 2010 and most recently the Safe Cosmetics Act of 2010.  It has been a long hard battle that has been supported by Donna Maria of Indie Beauty Network, Leigh O’Donnell, Marie Gale, Feleciai Favroth from The Handcrafted Soapmakers Guild, myself from Essential Wholesale, along with small business owners Anne-Marie Faiola, Lela Barker, and thousands of business owners that helped spread the word, educate, sign petitions and so much more.

Even though you haven’t heard much about what is happening with legislation over the past few months there has been a lot of work going on behind the scenes.  Most recently Leigh O’Donnell made another trip to Washington D.C. to meet with Congressional staff from Representative Schakowsky, Markey and Baldwin’s offices on June 10th, to continue discussions on the newest version of the drafted Safe Cosmetics Act which may be introduced as early as next month.

With your help we all made a lot of noise – enough to have earned open lines of communication that have allowed your voices to be heard behind the scenes.  Leigh attended the June 10th meeting with the Soap Guild’s D.C. advocate Marry Anne Walsh of Roetzel and Andress.

After the June 10th meeting we were told that the new draft of The Safe Cosmetics Act may include these provisions:

REGISTRATION

For registration of your facility or company and your products:

Any cosmetic company with under $2 million in gross aggregate sales per year will be exempt from FDA registration.

A company that makes between $2 million and $10 million in gross aggregate sales per year will register their company (facility) and their products annually.  There will be no registration fees and no change forms if you introduce a new product within that year.

A cosmetic manufacturer that has over $10 million in gross aggregate sales per year will register their company (facility) and their products and will be responsible for a registration fee to the FDA.  This fee will be determined by the FDA and will be based on gross sales.

Note:  We are anxious to learn what the proposed fees will be because it will cause a trickle down effect on prices of cosmetic chemicals and ingredients necessary for the manufacturing of products by small businesses.

LABELING

All botanicals will be listed as what they are on the label and will not need to be broken down into their organic compounds.  For example, Coconut Oil will still be listed with the INCI name Cocos Nucifera (Coconut Oil).

Also, the legislation will NOT require additional testing of already tested, approved and labeled ingredients. But cosmetic chemicals will be required to list trace elements — and fragrances will be required to list all ingredients.

INGREDIENTS

The FDA will be charged with coming up with three categories of cosmetic ingredients:  Safe without limits, Restricted, and Prohibited.

All food-grade ingredients will be on the “Safe without limits list”.

Ingredients on the “Restricted list” may be used in cosmetics but will have restrictions on usage or quantity.

Ingredients on the “Prohibited list” cannot be used in cosmetics and will have a 2 year phase out period.

To facilitate compliance, the FDA will maintain an online site for companies to access information on the three categories of ingredients and will update regularly, including the addition of new ingredients after testing and determinations are made.

Note: We are anxious to hear what governing or expert body that the FDA will rely on for this information that will be based on science and not agenda driven propaganda.

SOAP

The soap exemption will remain the same as it is in the Food Drug and Cosmetic Act.

How You Can Help
If you have been following proposed legislation since 2008 you will see that there have been major changes.  There are still many subjects to discuss, questions to be asked and many aspects of the bill that have not been addressed yet.  It is encouraging to see that over the years, with your help, the needs of small businesses appear to have made an impact. This isn’t over yet.

Stay tuned.  We will keep you informed when the draft bill is made publicly available, share resources to support or fight depending on the language of the draft and recruit you to spread the word when we know more.

Tell us what you think about the proposed components of the bill listed above by leaving a comment on this blog.

Spread the word by sharing this blog post on Facebook, Twitter, LinkedIN or any other outlet that you are involved with.

If you aren’t familiar with the history of the small business battle against unnecessary regulation you can catch up on Essential U or Indie Business Blog all the way back to 2008.  Both blogs link to other bloggers and small businesses that have been instrumental in getting the word out over the years.  If you need information on the truth about the safety of cosmetics and cosmetic ingredients go to Personal Care Truth for accurate information.

The most important thing to remember as we move forward is that cosmetics are already safe.  For all companies big and small the safety of consumers and the ability for businesses to thrive in an already unstable economy must not be overlooked.  This week at the National Association of Manufacturers’ 2011 Manufacturing Summit White House Chief of Staff Bill Daley was confronted regarding over-burdensome regulation and he said, “…typical sort of bureaucratic stuff that’s hard to defend. Sometimes you can’t defend the indefensible.”

We must stay vigilant in order to insure that the new language of the Safe Cosmetics act does not fall into the category of indefensible bureaucratic stuff.

  • http://personalcaretruth.com Lisa M. Rodgers

    Great post Kayla! I do not support the “big vs small” mentality. The bigger picture, I feel it will be the small manufacturer/crafter who will get the short end of the stick. The PCT platform is about the cosmetic industry as a whole, and while the FDA could use some help in many areas, and cosmetics could use more transparency, I don’t believe new legislation is the answer.

  • Anonymous

    Thank you for this update.

    “All food grade ingredients will be on the ‘Safe without limits list.’” Questions: What are these ingredients? What are the benefits/drawbacks? What is the rate of decay? How are they safely preserved? Are there shelf life or shipping concerns (hot summer months)?

    There still thus far doesn’t seem to be any talk of the regulation companies already in place (IFRA). The US does not appear to be wholly separated from the EU, Canada, Japan, etc. that also have safety regulations in place that would affect the products sold here. In my opnion only, with no proof to back it up (just seems like common sense), unless the restricted ingredients contradict each other there would be no reason to make large batches of the same product but with different ingredients. This also doesn’t address the problem that DayDreams brought up: indie companies that don’t know of the other agencies or don’t appear to be batch testing or preserving properly.

    Trace elements, unless they are allergens or cause skin reactions, are irrelevant. How many trace elements are eaten each day in vegetables and fruits (5-9 servings) in a healthy diet compared to topical applications (number of times irrelevant) of a cosmetic product. One is ingested, the other barely absorbed. This would only muck up the label.

    Tina S

    • http://personalcaretruth.com Lisa M. Rodgers

      Hey Tina -

      That’s the thing. It’s hard to say when we haven’t seen the draft. In my opinion, this information was put out to gauge consumers reaction. I’m not against revising existing cosmetic legislation. Whatever is done, it needs to be done for the good of the industry, both big and small.

      As always, thanks for your comments!

      Lisa

    • Perry Romanowski

      They do realize that parabens and propylene glycol are food grade materials right?

      • http://personalcaretruth.com Lisa M. Rodgers

        I’m quite sure they will find a way to make an exception and put them on the restricted list. They don’t have the science to put them on the prohibited list.

      • Anonymous

        I almost choked on my raspberries….

  • Rich Summers

    I think that this is probably a step closer to getting something that everyone would agree on, however, I do feel that there are a couple of niggly points that I would personally be quite unhappy with.

    First is similar to Lisa thought, that the differentiation between small and big is perhaps not the way to look at it. In my experience it is the smaller companies that either don’t know the legislation or just ignore it ( I will of course add that this is not all small companies, it is a small minority ), and that as they are smaller they manage to stay off the regulatory bodies radar. If a big multinational broke the law it would be all over the front page of major newspapers within the hour.

    The second is essentially the exclusion of all food grade materials from being restricted. Vinegar is a food grade material, I ( and I don’t think any other sane person ) would think that a product containing an unrestricted amount of it would be safe to apply onto skin. This is just an extension of the slightly nonsensical “if you can eat it, it must be safe” mentalism that certain lobby groups insist on, and I don’t agree with it. Why should food stuffs be exempt from safety information ? If they want safe cosmetics they should include all ingredients, not just ones that the lobbyists want. I also think that the restricted list should be compiled by a reasonable panel of independent experts, not a group of people who have no idea what they are talking about and don’t understand risk and hazard………… :-)

    I think that what you are doing is very admirable, and I really don’t envy your position of trying to get sense over emotion. Keep up the good work though and hopefully you guys in the States will get there soon.
     

    • Anonymous

      Rich, I agree. It might be to everyone’s advantage for everyone who makes/sells cosmetics to at least register. That way adverse effects and product issues (contamination) can be tracked. There are people making and selling cosmetics that do not know what they are doing and do not test their products. They learn about the importance of preservation only when a problem arises.

  • http://personalcaretruth.com Lisa M. Rodgers

    Thanks Richard. This is just my opinion, but I believe the food grade exemptions come from the fact that the CFSC and EWG are pushing Green Chemistry http://safecosmetics.org/article.php?id=51. There’s nothing wrong with Green Chemistry, however, if they are trying to craft legislation that only serves their agenda, then I have a huge problem with that.

    • Anonymous

      Thank you for the link. I’m feeling my oats today. One of the links, a few clicks over, takes you to Wikipedia/Green Chemistry. Under principles: “the design of processes to maximize the amount of raw material that ends up in the product” = contaminants? lead? Principle #2 of 12: “Synthetic methods should be designed to maximize the incorporation of all materials used in the process into the final product.” = manmade? contaminants again? Principle #6 of 12: “Energy requirements should be recognized for their environmental and economic impacts and should be minimized. Synthetic methods should be conducted at ambient temperature and pressure.” = removing contaminants takes extra energy so leave them in? Does ambient temperature kill bacteria and germs? The irony: Dow Chemical won an award.

      I’ll leave you alone now. :)

    • Rich Summers

      I have no issue with the idea of green chemistry, it is the current set of applications and the way that they are going about it that irritates me. To me green chemistry should be chemistry that is sustainable, reducing pollutants and the sheer amount of chemicals used to get to an end point and not be a major strain on the environment. The way that these guys seem to be pushing it is that every material made by a green process is safe, which can’t be true.

  • http://personalcaretruth.com Lisa M. Rodgers

    Thanks Richard. This is just my opinion, but I believe the food grade exemptions come from the fact that the CFSC and EWG are pushing Green Chemistry http://safecosmetics.org/article.php?id=51. There’s nothing wrong with Green Chemistry, however, if they are trying to craft legislation that only serves their agenda, then I have a huge problem with that.

  • http://pulse.yahoo.com/_VQ6QXKIJCLIG53PYF6LLPXAJ44 Julie

    While this is a big improvement over the initial proposed bill, there are still some big problems with it. A couple of you have already mentioned the “food-grade is ok without limits” thing, which is not based on science, but on the “it’s ok if you can eat it” principle that Rich mentioned. But almost everything will end up on the “Restricted” list, and then the EWG or whoever will STILL run around yelling about how the cosmetic industry is using all these unsafe chemicals to kill babies. I get questions all the time from people saying, “But this says xx preservative is not allowed!” No, it says “restricted” which is not the same as “prohibited.”

    Anyway, my biggest concern (for my company) is that the annual registration will literally be a full-time job for me at my company, which is a contract manufacturer. We make literally hundreds of different formulas a year (and thousands in R&D). And I’d have to register every single one of them every year? I quit. No, but this might actually change the way contract manufacturers are able to work altogether. It will really hurt our business, I think. And no one ever thinks about that. The legislation only ever thinks about big manufacturers who have the resources to deal with this, and small manufacturers who may make 10 or 20 different formulas a year (or less).

    • http://personalcaretruth.com Lisa M. Rodgers

      Great points Julie! If the EWG and CFSC get everything they want, they will have to stop all the “donate $5 or $10 here” emails because there will be nothing left to fight for in the cosmetic arena.

      As for the registration, when I was still a manufacturer, I voluntarily registered all my products with the VCRP { http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm } and it was actually very easy to do. There needs to be more clarification on the FDA registration, and in my opinion, if nothing has changed in your business, you should be able to click a link to register annually that states everything is the same. If you add a product or 10, or 20, you should be allowed to just add those products when you annually register.

      Finally, the EWG and CFSC are not a reliable source for scientific information. In the end, it’s the consumer who has the final say in what they put on their skin. They have the choice to stay away from certain ingredients, if they believe what the activists are telling them. I don’t need them making decisions for me, or scaring me into believing I’m slowly killing myself.

      The driving force behind this legislation is the CFSC and EWG, not big business. The exemptions are considered because of the small business community voicing their concern when the SCA of 2010 was introduced last year.

      • Anonymous

        LOL, really Lisa, stop the $5.00 donation buttons??? I think not, they are in it for the money no matter what.

        • http://personalcaretruth.com Lisa M. Rodgers

          LOL, well….as far as cosmetics go the donation button can go away. I guess there’s still sunscreen for them to peddle, and create fear.

          • http://www.facebook.com/people/Nathan-Rivas/100001195250784 Nathan Rivas

            Oh, then it the message from the EWG will evolve (devolve?) to: “Please donate so that we can CONTINUE to defend you from the TOXINS of the world!  Think of the children and click that donate now button!”  

  • Anonymous

    The thing that bothers me here is the ‘safe without limits’ classification. There is no such thing as safe without limits, even water is toxic in some dose, route and concentration.  It gives people (customers and small manufacturers/crafters) the misguided conception that some ingredients have no toxicity and will increase this movement of food grade products that have no preservative system.  And yes, like Julie said, it will make it very difficult for contract manufacturers. But I think it is a step in the right direction at least.

  • http://colinsbeautypages.co.uk Colin

    And this is the sensible version?

    • http://personalcaretruth.com Lisa M. Rodgers

      Technically, Colin, this isn’t a version. This is only what has been told “may” be in the revised legislation. As I said earlier, my gut feeling is the release of this information was a fishing expedition to gauge the reaction of the cosmetic community and consumers.

      • Anonymous

        It’s seems an awfully quiet fishing expedition. I expected banners and bugles…or at least lots of lead up to it articles. Interesting.

  • Perry Romanowski

    Shouldn’t people be able to demonstrate there is a problem with the current system before creating new regulations?  If someone has shown a problem, what is it? 

    I don’t see it but perhaps I’m blind to it.

    What problems are new regulations intended to solve? 

    • http://personalcaretruth.com Lisa M. Rodgers

      Perry, here are the first 3 paragraphs of what the CFSC released on Tuesday:

      “It’s up to Congress to close gaping holes in the outdated federal law that allows cancer-causing chemicals in baby shampoo, hormone disruptors in fragrance and lead in lipstick.That’s what you get when you have a $50 billion industry that’s practically self-regulated.

      The Safe Cosmetics Act of 2010 (H.R.5786), introduced by Reps. Jan
      Schakowsky, D-Ill., Ed Markey, D-Mass., and Tammy Baldwin, D-Wisc., was
      designed to give the U.S. Food and Drug Administration authority to
      ensure that personal care products are free of harmful ingredients and
      that ingredients are fully disclosed. Now that the 111th Congress has
      come to a close, the bill will need to be reintroduced in the new 112th
      Congress.

      Existing law – the Food, Drug and Cosmetics Act of 1938 – cedes
      decisions about ingredient safety to the cosmetics industry. Under the
      current law, the FDA can’t require cosmetics companies to conduct safety
      assessments, and can’t even require product recalls. In a recent example, the FDA could not issue a mandatory recall of Brazilian Blowout hair straightening products even after they were found to contain formaldehyde.”

      To read the entire post, http://safecosmetics.org/section.php?id=7

  • http://personalcaretruth.com Lisa M. Rodgers

    Here’s Janet Nudelman, Policy Director, Breast Cancer Fund (call facilitator) of their July 21 press teleconference about the Safe Cosmetics Act. Speakers on the call included:

    Rep. Jan Schakowsky, D-Ill.Rep. Edward Markey, D-Mass.Fran Drescher, actress, cancer survivor, advocate, founder of Cancer SchmancerMaryann Donovan, Ph.D., MPH, expert on chemicals in fragrances
    and cosmetics, Center for Environmental Oncology, University of
    PittsburghJane Houlihan, Vice President for Research, Environmental Working GroupJanet Nudelman, Policy Director, Breast Cancer Fund (call facilitator)

    Link to audio: http://safecosmetics.org.s3.amazonaws.com/COSMETICS_Press-Call_072110.mp3

  • http://personalcaretruth.com Lisa M. Rodgers

    Here’s another link for what the CFSC says it means for Cosmetics Companies:

    http://safecosmetics.org/article.php?id=695

  • http://personalcaretruth.com Lisa M. Rodgers

    Ok, is it a coincidence that the talk of the revised legislation is happening along the same time frame as the original SCA of 2010 was released last year? The links I provided below are from when the original bill was released on July 21, 2010.

    This legislation is making me crazy, lol! I guess it is interesting to hear the audio from last year. I had no idea it existed.

    Apologies for posting links to last years legislation, although, it will be interesting to see how much actually changes.

  • http://twitter.com/essentialU Essential U

    Wait! Someone said that they almost choked on their raspberries!  Be careful that could mean that eating raspberries while reading PCT will be banned.  I’m not kidding (ok I am) but yesterday King county in Washington state voted to require everyone who swims, wades or goes tubing, rafting, using a surfboard, canoe or kayak 5 feet from shore in more than 4 feet deep waters is required to wear a life vest.  If you are caught without a life vest you face an $84 fine. 

    I know I’m off subject…but am I? 

    • Anonymous

      You’re not far off subject. How did we humans ever survive in the water without vests?

      Warning: Do not eat and read PCT comments at the same time. Possible choking hazard due to uncontrollable laughter. (Perry asked a really funny, snarky question.)