Cosmetics Back on the Chopping Block? FDA Wants User Fees, Cosmetic Registration in Light of Safety Fears

Apr 5, 2012 | Cosmetics, Imports, Law & Regulatory

Cosmetics on the Chopping Block

Last week the U. S. House of Representatives, Energy and Commerce Subcommittee on Health, held a hearing entitled, “Examining the Current State of Cosmetics,” the first of its kind in decades, featuring panel testimonies and inquiry related to the overall safety of cosmetics in the USA.  A few assumptions emerged as the hearing got underway:

Cosmetics are under-regulated compared to other products

The FDA has shockingly little resources assigned to cosmetics

The FDA has little authority to regulate, recall, etc…

There is increased worry over dangerous ingredients in imported cosmetics

The FDA doesn’t know much about cosmetics in general: statistics, ingredients, etc…

Sound familiar? It should. This is the same group of concerns that led to the passage of the poorly vetted Food Safety Modernization Act (FSMA – enacted Jan. 4, 2011) and which is being echoed by FDA in dealing with imported drug safety risks.

Clueless in Cosmetics?

Michael Landa, Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), was the lead witness raising these concerns regarding the current state of cosmetics.  It was clear in the opening moments that FDA is feeling the pressure to shore up their oversight and the Government can only envision doing this by increasing user-fees and increasing FDA’s authorities (aka budget).  FDA has already asked Congress in its 2013 budget proposal to begin charging cosmetic companies for various “services.”  There was certainly difference of opinion from the Committee however, in terms of how to address the lack of transparency within the cosmetic industry.  As we learned since passage of FSMA, FDA is grabbing for increased power, budget, resources and authority across the board and cosmetics are not exempted.  From their 2013 budget requests to the hearing on cosmetics we see that FDA’s expectations and demands for more power and money are only going to grow. Much of the financial burden of this growth will be passed on to consumers, taxpayers and businesses.  Landa stated that new cosmetic regulation is needed to accomplish the following:

Set safety standards for microbiological safety

Enable FDA to focus on ingredient safety

Establish GMPs for cosmetics

Enable FDA to have more investigators in the field

Training, education and outreach

Strengthen the voluntary reporting system

What would this mean for the cosmetic industry?  First, expect FDA would demand more information about facilities and ingredients. Second, FDA would increase its inspections and new facility registration requirements, which will lead in turn to new good manufacturing practice mandates.  Third, FDA would want increased authority over ingredients and their sources.  Finally, expect the cost of manufacturing, distribution, and sales process of cosmetics to go up – at all nodes in the supply chain. Start saving up.

Hungry for more?  Read our blog of the best (and worst) quotes from the hearing

Source:

http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9394

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