Debbie May - Update from Washington DC

I am back from my trip to Washington DC and wanted to provide you with an update.

On this trip I was accompanied by Marla Bosworth and Allison Kontur, both very experienced in the handmade soap and cosmetic industry.  The three of us were very fortunate to have two full days of meetings that spanned four different governmental buildings.  I need to tell you the tone of these meetings was much more down to business and less educational.  We have learned there remains one introduced bill, two draft bills and one draft bill being conceptualized.
Instead of running through each of the bills and draft bills, I would like to highlight the different components of the bills, how they may impact our industry, and what I am supporting and strongly opposing.

Let me first begin by explaining that the overwhelming concern of all authors is consumer safety.  This is the underlying theme for all they are doing.  They clearly understand that our cottage bath and body industry produces handmade products because they feel our products are safer than anything on the market.  If an ingredient or product is proven to not be safe, it is our industry that would be the first to ban its use.

1.     FDA Recall Authority – All documents include language on this topic.  It is my personal opinion that this will not impact our industry.  If you polled most people you would find they believe the FDA already has an FDA recall system.  I personally support this portion because I don’t see any language that will negatively impact our industry and it contributes to public safety.

2.     Mandatory Adverse Event Reporting – All documents include language on this topic. There is one document that does a great job of outlining life and limb threatening events.  Clearly none of the authors are interested in having reports filed for minor topical reactions.  I think if you polled most people you would find they believe the FDA already has a mandatory adverse event reporting system.  I personally support this portion because I don’t see any language that will negatively impact our industry and again, it contributes to overall public safety.

3.     Ingredient Safety – All authors agree that ingredient safety needs to be addressed.  One group believes that that Cosmetic Ingredient Review (founded and funded by an association representing large corporations) should be given full federal authority to be the sole entity that determines safety.  Other groups indicate that the FDA should establish their own panel for determining safety.  One group believes that anyone with reliable scientific data should be able to submit data regarding safety.  Authors are not discussing the need to include trace elements, trace element testing and molecular composition of natural ingredients in any legislation I have seen discussed.  They are not talking about over-regulating essential oils as those would be treated as aromatic compounds.  I personally support the FDA giving us a public list of safe ingredients.  The way an ingredient gets on that list is up to the company inventing the ingredient.  All GRAS (generally recognized as safe) ingredients should be included since they are already approved for ingestion and regulated by the food industry.  As long as we are not required to re-test ingredients, I do not feel our industry will be hurt and consumer safety will again be improved.

4.     Mandatory Facility Registration – Document authors are split on this issue.  One states strongly that there should be NO exemptions for any business.  One states that there should be an exemption for all small businesses and two agree that they could support exemptions for very small businesses but not small businesses as defined by the SBA. 
We discussed the need for an exemption to foster the handmade industry and preserve jobs.  By the time we left DC there seemed to be momentum building for a monetary exemption modeled after the recent food safety bill which has a monetary very small businesses definition of sales under $500,000 a year.  Given how vital this exemption issue is for our industry I would personally support a registration exemption for businesses under $500,000 in annual sales.
5.     User Fees – It is a consensus by all authors that the FDA needs funding through user fees.  There appears to be NO consensus of how fees should be fairly distributed among small and large businesses.  I was asked how I felt about a fee of $500 per year for a business that sells over $500,000 a year.  My response was that I would not be happy about it but felt that most businesses selling $500,000 a year would not go out of business with a $500 user fee.  I also asked for fairness in regards to fee structure as it relates to company revenues.  I would expect a multi-billion dollar company to pay far more than $500.

6.     Incidental Ingredients & Processing Aids – Some document authors are attempting to close these two loopholes often used by manufacturers to hide controversial preservatives and/or ingredients.  I support the closing of these loopholes.  In reality our small batch handmade industry doesn’t use them.  Our industry is very honest and lists all ingredients.  Larger companies are using these loopholes to make their products appear more natural, self-preserving and handmade.  I support removing these loopholes for increased label honesty and consumer safety.

7.     Registering of Formulas & Suppliers – One document author suggests strongly that every batch produced needs to be logged with the FDA and the supplier for each ingredient needs to be documented.  I strongly oppose this requirement.  It would not increase cosmetic or consumer safety and it would needlessly inundate our industry in useless paperwork.  Instead of spending hours working to grow our small businesses, we would be putting in endless late night hours filing useless paperwork.  Consider the entrepreneur who needs to source three local grocery stores to buy 500 lb of sugar for a sugar scrub and then additional stores to source plant oils and so on.  That business owner would need to notify the FDA of every change in supplier. I strongly believe this rule is being proposed by large cosmetic corporations to create an unfair advantage over small bath and body businesses nationwide.

8.     Preemption – There is one document author that supports creating a high threshold for cosmetic labeling regulation.  Essentially, this would affect a state’s rights to create their own cosmetic labeling requirements.  On one hand, having a patchwork of regulations seems ineffective and on the other hand we are a country of individual states and I support each states right to governance.  I am not sure this is an issue we will need to champion.  I am fairly sure that each state, on its own behalf, will be arguing against it.

9.     Good Manufacturing Practices (GMP) – I am told that there is support by all document authors to create GMP for cosmetics.  I am also told the specifics will be determined by the FDA and the FDA is making small business considerations.  For example, it is not realistic to mandate testing of filling lines if there are no filling lines. Also, there will not be a mandate to have a chemist on staff.  Before I take a stand on this issue, I would like to personally review the proposed GMP.  Once the FDA introduces the GMP there will be an opportunity for input and comment.  I will update you when I am alerted when something is published.
Lastly, I am told that there will be a push to have the new legislation adopted into law June 2012.  It will be attached to a bill that must pass by July 2012 to keep the FDA funded with user fees.  
I expect to be traveling to DC every 2-3 weeks.  I look forward to keeping you updated as concerns for our industry are resolved.


Debbie May is a recognized and trusted advocate for small businesses specializing in handmade products.  Debbie has outlined her advocacy and policy positions here.  You can follow Debbie at Debbie May.com (http://www.DebbieMay.com)  and you may email her directly at Debbie@DebbieMay.com