New provisions for small business
The 2015 bill contained only a $100,000 exemption level for small business. This new version contains the following provisions and exemptions
to assist small businesses:
- Handcrafted Soap & Cosmetic businesses that average less than $500,000 in gross sales over a three year period AND home-based
businesses that average less than $1M in gross sales over a three year period do not the meet the definition of a facility and are exempt from the legislation.
- Handcrafted Soap & Cosmetic businesses that average between $500,000 (or $1M for home-based) and $2M in gross sales over a
three year period will provide a simplified registration to FDA and are exempt from user fees. (Simplified registration includes only the name,
company name, address, email, phone and categories of cosmetic products produced).
- Handcrafted Soap & Cosmetic businesses that average more than $2M in gross sales over a three year period are subject to all
of the provisions of the bill including registration and user fees.
- These small business provisions do NOT include companies with over $500,000 in gross sales over a three year period ($1M for home-based businesses) that produce:
- Products that are intended to go on the eye-area;
- Lip products with color;
- Products that are injected;
- Products that are intended for internal use; and
- Products that are intended to alter the appearance for more than 24 hours.
What we are doing
Since 2008, Congress has shown an interest in updating the 80 year old Food, Drug, and Cosmetics Act. Many bills have been released, sometimes as
many as three per term. The HSCG has been involved in Federal Advocacy since 2008 and has had the benefit of working with a Professional
DC Advocate (currently Debra Carnahan) for many years.
The HSCG’s position is that no new cosmetic regulations are needed in the United States and that the handcrafted cosmetic industry is
safe. We recognize, however, that Congress will pass updated cosmetic legislation sometime in the very near future. The HSCG advocates
to educate Members of Congress about the industry and the people and businesses that make it up. We also work with lawmakers to ensure
that any legislation that is passed will protect these businesses, products and people and not create burdensome or costly regulations.
Working with COHE and HCA, we are confident that the provisions in The Personal Care Products Safety Act of 2017 will ensure that
handcrafted soap and cosmetic businesses can continue to operate, grow and thrive in the United States.
More information
For additional information, please read our joint letter,
dated May 9, 2017, to Senators Feinstein and Collins and
the full text of the bill.
We will continue to monitor the legislation and provide updates as warranted.
