What SCA “Really” Means For Small Cosmetics Companies, Part II

by Donna Maria on August 13, 2010 · View Comments

In Part I of the “What SCA Really Means For Small Cosmetics Companies, Part I,” I shared a response to the Campaign For Safe Cosmetics’s assertions about “What Companies Will Have To Do.” In this post, I respond to their second point: “How Will The Safety Assessment System Work?” Again, quite a few very important requirements are missing, which are clearly spelled out in H.R. 5786 — things that all cosmetics companies need to know. Rather than put them all in one mega-post, I’m dividing up into digestible pieces. Let’s look at what they say in Point No. 2:

CFSC says (italics are mine), “How will the safety assessment system work?

Over time, the FDA will set up a database containing information about cosmetics ingredients and relevant safety assessments and data, and will provide guidance to industry about the safe use of ingredients. There will be no immediate changes to the ingredients allowed in cosmetics under the Safe Cosmetics Act.

The Act requires companies to share existing safety data with the FDA. It also requires suppliers of cosmetic ingredients to make available to manufacturers information regarding the toxicological properties and the safety – including any safety tests they’ve conducted – of those ingredients, including the chemicals in the fragrance and preservatives. This “producer right-to-know” provision will make it easier for cosmetic companies to make the safe products that consumers are asking for and deserve. Under the current system, suppliers do not have to disclose ingredients to manufacturers and they often won’t provide that information.

The new system will aggregate all of this safety data, and make it publicly available to all companies so they can make more informed decisions about formulation and product safety.

As you can see, I have italicized these issues:

1. The FDA will set up a database
2. Companies are required to share existing safety data
3. The system will aggregate all safety data and make it publicly available

Let’s look at each one quickly.

  1. The FDA Will Set Up A Database. The bill requires that, a year after passage of the new law, all manufacturers and distributors of cosmetics and ingredients are to submit to the Secretary all “reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to the Secretary regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels.”

    This is information would require storage space the size of the Library of Congress! Companies have books, white papers, e-books, CDs, email messages, blog posts, MP3 downloads, iPhone apps, notes taken at industry events and so much more that fits this description. Forcing small companies to scour the history of their lives for such data simply makes no sense. Then, requiring them to disclose every 60 days — six times a year — adds to the craziness and actually distracts people from making safe cosmetics.

    So not only will you have to scour your life for everything you possibly have about safe or unsafe ingredients, but you would have to copy it and produce it to the FDA. Do you have the time to do that? Can you find everything? If you did find it, could you afford to ship it all to the FDA?

  2. Companies Are Required To Share Existing Safety Data. The FDA is to, within 12 months after passage of the bill into law, publish a publicly accessible database of all of the information it collects. After that, FDA is to create a database of ingredients and mark them as prohibited, presumed toxic, restricted or safe without limits, and is to update the database on an ongoing basis. The bill also requires that all companies, upon request, give requesting companies all of the data they have on any ingredient used in cosmetics.

    This section puts the onus squarely on small companies to ask big companies for data and information needed to comply with the law. This is patently unfair because there’s no way for small companies to even know that they might need the data to be compliant. And even if a large company complied with the request for information, the law does not require it to be submitted in a form that small companies can interpret and put to good use. The law does not prohibit companies from charging a fee for the information.

    And is it realistic to expect that a company you are competing with will make it easy for you and thousands of other small companies to request and receive the data they have paid their employees to develop for them?

    Even if you know what to ask for, where do you send the request? What do you do if the company ignores you? What do you do if they respond that they have approximately 1,000 studies that fit you request, and that they’ll send you a PayPal invoice to cover the cost to copy and ship it to you — at $100 per page.

    I realize that the statute itself is not going to answer each of these questions. Congress will leave it to the FDA to sort it out. But the bill does not give the FDA the discretion to do anything if a company does not respond to your request. It doesn’t say that the FDA should set reasonable fees, or no fees, for a company disclosing the information under this section. There is nothing in the bill to prevent small companies from being taken advantage of when it comes to obtaining the information they would need under this bill, as written, to do what this bill says is necessary to produce safe cosmetics.

  3. The System Will Aggregate All Safety Data And Make It Publicly Available.This is an interesting quote, if for no other reason than it makes it seem like this “system” runs on its own. Of course that’s not the case. People run the system, so people will be required to aggregate this data under this bill. That is no small task, and it makes me wonder just exactly how much those annual fees designed to pay for it will be.

    My guess is that even companies making more than $1,000,000 a year would be hard pressed to keep up with fees that would support this kind of regulatory oversight. In fact, the fees is an incentive for companies to stay very small. Why would I grow my business to the million dollar level if I knew that I would have to raise my prices significantly or perhaps even lay people off or reduce innovation or marketing so I could pay an annual fee to the FDA? I digress.

    This portion of the bill says that the FDA is to designate ingredients into certain categories. It contains no restrictions on the use of the data provided by various different companies to create the designations. For example, an ingredient is labeled as “restricted,” but not “prohibited,” in and of itself would be highly misleading to lay persons who may not understand that a restricted ingredient is perfectly safe in certain quantities in certain products. To allow the FDA to label an ingredient in such general terms, and then to cross reference that information in a public database would only tell a part of the story of a company’s use of that ingredient, and the federal government should not be in the business of “rating” companies in that way.

    Section 614 contains no provision protecting manufacturers from false claims in the database. So if the FDA marks an ingredient as somehow problematic, but you have access to studies showing that’s not the case, there is no way you can input the data you have which would contradict the database. This is tantamount to a credit reporting agency being able to say negative things about your credit without you having an opportunity to provide the other side of the story.

    While these things are problematic, the bigger issue is that this is an incredibly inefficient use of corporate and regulatory resources. The vast majority of ingredients used by small companies in cosmetics have been evaluated and are already known to be safe for use in cosmetics. Forcing industry and FDA to duplicate decades of scientific research efforts simply makes no sense.

    It is hard to believe that any company, large or small, could comply with these requirements — in any industry — either as the large company required to provide the data or as a small company being required to ask for it. It is also hard to believe that any regulatory agency could comply, even if the industry it is regulating subsidizes the activities with an annual fee. These provisions are nothing short of a fishing expedition in an ocean that has no end.

    I’ll share my commentary on the rest of CFSC’s statement as I am able in the coming days, especially the part specifically about how this bill would affect small businesses.

    Questions: Would you know what to ask a “big company” for when it comes to test data? Can you pay them for it if they require you to do that so they can cover their costs? Can you imagine a database of data that is publicly cross-referenced with your company, but you have no say in what it says, how it is organized, or even how to respond if the data for your company is cross-referenced incorrectly or unfairly? I’d love to know your thoughts.

{ 2 comments… read them below or add one }

1 Stephanie Greenwood August 14, 2010 at 4:36 am

You bring up some great points here. Thanks for your time and efforts!

Reply

2 Donna Maria Coles Johnson August 14, 2010 at 4:54 pm

You’re welcome. I just want people to be informed, so they can take informed positions on the issues. Thank you for taking the time to read the article. If you have any questions, feel free to post them.

Reply

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