The FDA Globalization Act of 2009 was officially introduced on Wednesday the 27th. While this Act would have been introduced eventually, the political cover afforded by the Peanut Butter scare made it perfect timing (even though the Peanut Butter Salmonella problem could have been prevented under existing regulations regarding best manufacturing practices and had the 12 positive tests in 2007 and 2008 been properly dealt with. CNN story here).
No matter what the reasoning, the FDA Globalization Act is on the table to help an agency that is woefully underfunded to deal with the realities of an increasingly global society with imports flooding the United States from countries with more lax regulations around safety. The current iteration of this bill imposes fees and more regulations primarily on the food and drug industry. There have been substantial changes made from the original draft that circulated in 2008. Specifically (full copy here), it appears that much of the feedback the micro beauty business gave in 2008 (read about a Coalition of Small Business & Suppliers that went to Washington DC on your behalf here and here) was incorporated. Yay for a team of committed individuals helping to enact positive change!
Salient points for the FDA ’09 Act are:
Registration – Like having a business license with your city, you will need to register your bath and body business with the FDA (page 115 – 116)
Inspections – Besides registering with the FDA, they are not asking for inspection of your facilities.
Fees – Under the current draft legislation, there are no fees to register your business or submit your ingredient decks (aka: list of ingredients used in your products)
Ingredient Listing – When you manufacture a product to sell, you need to submit your ingredients for the overall product. You will not need to submit for each individual fragrance, provided the base does not change. (page 119)
Adverse Events – Right now, reporting “Adverse Events” to the FDA is voluntary. This means that if one of your customers reports that your lotion gave them an allergic reaction that sent them into the hospital (highly unlikely) that the FDA would currently like you to report this but they do not make you. In the future, reporting serious Adverse Events will be mandatory within 15 days of the event. See below for full definition of Adverse Events. (page 122)
There are a group of committed business owners, advocates and vendors working diligently behind the scenes to proactively monitor the situation. Between The Soap Guild, The Indie Beauty Network, Essential Wholesale, WholesaleSuppliesPlus and Bramble Berry, we’ve got your best interests at the forefront of our monitoring and actions. We will keep you up to date as we hear anything.
- Press Release regarding release of FDA Globalization Act of 2009 here
- CNN story on peanut butter contamination history here
- The term ‘serious’, with respect to an adverse event, means ” resulting in death, a life-threatening experience, inpatient hospitalization, a persistent and significant disability or incapacity or a congenital anomaly or birth defect.”
- I’m not a lawyer. You should read the bill yourself to make sure you agree with my interpretation of the data