It was only a matter of time before the original FDA Globalization Draft was fast-tracked into a bill. If you are not aware of this proposed legislation, you can learn more here. It appears that the recent Peanut Butter/Salmonella outbreak has provided an incentive to push the bill through the House of Representatives and as of January 27th, this has become a reality. You can click here to read the FDA Globalization Act of 2009. The bill is 136 pages long. Pages 115-124 specifically relate to cosmetics. A copy of the press release regarding the FDA Globalization Act of 2009 can be accessed here.
At first glance, it seems that the originally proposed requirements of this legislation have been significantly altered in favor of small businesses. Gone is the proposed $2000 yearly fee. In its place will be a requirement to register your business with the Food & Drug Administration, free of charge (pages 115-116). Currently, registration is optional. Besides the requirement of registration, the FDA is NOT requesting inspection of your facilities.
Additionally, when manufacturing a product to sell, you will need to submit your ingredients for the overall product. You will not need to submit for each individual fragrance, provided the ingredients for your base does not change (page 119). Under the proposed draft, this required filing will also be free of charge.
The last major change involves adverse reactions to a product. Right now, reporting "Adverse Events" to the FDA is voluntary. This means that if one of your customers reports that your product gave them an allergic reaction and/or sent them to the hospital (which is highly unlikely), the FDA would currently like you to report this but they do not make you report it. In the future, reporting serious Adverse Events will be mandatory within 15 days of the event. See the copy of the bill for a full definition of Adverse Events (page 122).
Indie Beauty Network founder Donna-Maria Coles-Johnson brought up an excellent point that there should be some sort of allowance for an exemption for some businesses based on sales, although this has not been addressed in the current draft.
Note: While a great deal of research has been done amongst myself and others in the industry, I am not a lawyer and the above information is provided simply as my own analysis of the facts available. It is highly recommended that you read over the proposed legislation to form your own opinion.
Allison B. Kontur
www.BathBodySupply.com






















