Personal Care Products Safety Act – Expanding FDA Authority over Cosmetics

On April 20th of this year two senators from Maine and California introduced the Personal Care Products Safety Act . If passed, this bill would expand FDA’s authority over cosmetic products sold in the United States. The changes are similar to that of requirements for nonprescription drugs including cosmetic GMP’s and ingredient review, establishment and product registration, mandatory recall authority, 15 day serious adverse event reporting, and annual reporting of non-serious adverse events. To be compliant, cosmetic manufacturers must also include a domestic phone number or electronic contact information on their product.

In addition to these requirements, FDA will investigate at least five different cosmetic ingredients for safety each year.

It is estimated these changes will cost $20.6 million per year. FDA will cover these expenses with the registration fee. The registration fee, as outlined in the bill, will be linked to the gross annual sales from cosmetics of the registered companies with fees ranging from $250 ($500,000 – $2.5 MM is sales) to $1.1 MM (>$5 billion in sales).

? Email us at info@mdiconsultants.com if you have further questions or need to know more about FDA compliance for Cosmetics. Ref: Personal Care Product Safety Act