Each day, the average American uses nine personal care products — from cleansers and moisturizers to shampoos and deodorants. This equates to a significant number of unique ingredients to which our skin is exposed every day. However, the FDA currently plays a very limited role in the regulation and monitoring of cosmeceutical products and ingredients.
In 2015, a bipartisan bill was proposed that would make substantial changes to the 1938 Federal Food, Drug, and Cosmetic Act. Although this bill, named the Personal Care Products Safety Act, did not get voted into law back in 2015, it was reintroduced to the Senate in 2017 and has since gained more support.
If it were to be passed as a law, the Personal Care Products Safety Act would enforce four major changes to the ways in which cosmeceuticals are manufactured and regulated.
1. Facility Registration and Inspection
The first major change that this Act proposes is to require all cosmeceutical manufacturers to register their manufacturing facilities with the FDA. All registered facilities would be subject to inspections for manufacturing practices that conform to FDA standards, as well as potential safety concerns. The FDA would be granted the authority to stop the production of a particular product and issue a mandatory recall.
2. Mandatory Cosmetic Ingredient Statements
All cosmeceutical companies would also be required to submit a cosmetic ingredient statement to the FDA, which would also be available to the public. These statements would be required to include possible amounts of each ingredient as well.
3. Track and Report Adverse Events
Currently, cosmeceutical companies are not required to report adverse events to the FDA. The Personal Care Products Safety Act would change this and make it mandatory that companies track and report all serious adverse events to the FDA, excluding minor skin rashes.
4. Mandatory FDA Assessment of Five Ingredients Per Year
Finally, the FDA would be required to assess the safety of a minimum of five ingredients each year. Based on its findings, the FDA would have the authority to ban certain ingredients from personal care products sold in the U.S. The first five ingredients to be assessed by the FDA would be:
Diazolidinyl urea
Lead acetate
Methylene glycol/formaldehyde
Propylparaben
Quaternium-15
In Summary
If voted into law, the Personal Care Product Safety Act would affect not only cosmeceutical manufacturers, but also consumers and physicians who treat various skin conditions and recommend skincare products. Provisions would be written into the law to safeguard small businesses against increased operating and testing costs, and alternatives to animal testing would be promoted.
You can find more information and check on the status of the bill here. To stay up-to-date on the latest updates and news in skincare, connect with me (Leslie Baumann) on LinkedIn, where I share more articles.
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