Though we've enjoyed a temporary hiatus in the discussion of new federal cosmetic legislation, things are heating up once again on Capitol Hill. The Cosmetics Safety Enhancement Act of 2012 was formally introduced earlier this week. Authored by Rep. Pallone (D-NJ) and co-sponsored by Rep. Dingell (D-MI), it is the latest attempt by the House of Representatives to revise and update existing laws that impact how cosmetics are manufactured, marketed and distributed within the United States. I encourage you to read the complete text of H.R. 4262 by clicking here.
Attempts to revise the structure of cosmetic legislation are not new and we've previously seen several pieces of legislation by way of the FDA Globalization Act of 2008, the Safe Cosmetics Act of 2010, the Safe Cosmetics Act of 2011, etc. In fact, a team of small business representatives from the industry has been in DC on several crusades since 2008, meeting with the FDA and legislatures to help them understand our particular niche in the beauty industry and how to best protect both consumers and small business. If you aren't familiar with the history, I invite you read a collection of my previous blog posts on the subject.
On Tuesday, March 27th, a public hearing was held by members of the House Energy & Commerce Committee to discuss the current state of cosmetics. For more than two hours, witnesses from the FDA, Cosmetic Ingredient Review, small business, industry trade groups and the California Safe Cosmetics Program submitted testimony and answered questions from congressional representatives. If you missed the live event, you're in luck! A recording of the full hearing is below.
Video streaming by Ustream
I've summarized a few key items from H.R. 4262 that I believe have particular relevance:
Mandatory Facility Registration
Any facility involved in manufacturing, packing or holding cosmetic products will be required to register the precise physical location of those activities with the FDA. The FDA will then issue a unique facility identifier to each location. At present, registration is voluntary and encouraged, but not mandatory.
Mandatory Product Registration
All cosmetic products will need to be registered with the FDA, including the brand name, product name, category type and a list of ingredients in descending order of predominance by weight. Additional information would also include: the unique facility identifier and relevant contact information for the the individual submitting the information.
User Fees
President Obama has called for a $19million increase in the new fiscal year, designed to fund and expand the activities of the FDA's cosmetic oversight programs. The current legislation requests a fee of $500 for each facility, beginning in 2013. A formula has been proposed to determine the fee in subsequent years.
Safety Substantiation
The "responsible party" for each facility must establish and maintain a safety file for each product, comprised of "studies, tests, data, or other information known to the responsible person that relates to the cosmetic product’s safety." That file must be surrendered upon request to the Secretary or officials requesting information on the Secretary's behalf.
Adverse Reaction Reporting
A formal system is proposed for mandatory submission of reports detailing any unexpected, adverse reactions to a product. Adverse reactions are defined as those which result in death, a life-threatening experience, inpatient hospitalization, disability, disfigurement, congenital anomalies or birth defects.
Good Manufacturing Practices
The Cosmetics Safety Enhancement Act of 2012 charges the Secretary with promulgating new good manufacturing practices, based on current international standards.
Mandatory Recall Authority
The bill gives the FDA the authorization to recall adulterated products that it believes pose "serious adverse health consequences" to humans. The Secretary will offer the responsible party the opportunity to cease distribution and recall the product; however, the FDA has the right to act if the responsible party fails to voluntarily do so.
At present, the bill has just one co-sponsor and has been referred to committee. It has a long journey to passage, though there has been talk of attaching it to another piece of legislation designed to reauthorize funding for the FDA, enabling it to hire hundreds of staffers to review new drug and medical device applications in a timely manner. That particular legislation is expected to be voted upon this summer.
Sharp eyes will notice that the current bill language does not mention any small business considerations. I am confident that forces are at work on Capitol Hill encouraging legislators to consider the impact of this type of regulation on thousands of thriving small businesses. It's a delicate balance to protect public health in such a manner as to avoid stifling the innovation of scads of companies at the forefront of the natural product movement who seek to offer an alternative to mass marketed formulations.
I encourage those of you who love cosmetics, those of you who manufacture or distribute cosmetics and those of you who have an interest in the public health of women to follow this legislation and its developments closely. I remain optimistic that we can reach a reasonable outcome that satisfies all parties. Fingers crossed!
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