The Personal Care Products Safety Act of 2017 (S. 1113), introduced in the United States Senate by Senator Diane Feinstein and Senator Susan Collins, is supported by the Handmade Cosmetic Alliance (HCA). The bill recognizes the unique needs of small companies producing handmade cosmetics and provides appropriate exemptions to allow small producers to build their business without burdensome regulations.
The HCA began working closely with Senators Feinstein and Collins three years ago after it became clear that new legislation being pushed by FDA, consumer groups and large cosmetic companies was going to be introduced. Throughout the process, the HCA’s mission was to make sure that small and emerging handmade cosmetic companies were protected and the exemptions provided in the Personal Care Products Safety Act of 2017 accomplish that goal. Exemptions are:
- Very Small Businesses Exemption – Very small companies with average annual sales of less than $500,000 (over the previous 3 years) do not meet the definition of a cosmetic facility and are totally exempt from requirements of the legislation.
- Home-based Business Exemption – Private Residence (home-based) businesses that meet the customary definition of a private residence and have average annual cosmetic sales of less than $1,000,000 (over the previous 3 years) do not meet the definition of facility and are totally exempt from the requirements of the legislation.
- Simplified Facility Registration – Small businesses with average annual sales of $500,000 to $2 million (over the 3 previous years) and private residence business over $1,000,000 would be required to register only business name, address, phone, email (If available) and product groupings (soap, lotion, scrub, bath bombs, etc) as long as products produced are not intended to stay on the skin more than 24 hours or are produced with the intent for internal use (injectable, feminine hygiene, tattoo ink).
- Serious Adverse Event Reporting – Small businesses subject to registration (those with average annual sales of $500,000 over the three previous years and home-based businesses with average annual sales over $1 million over the three previous years) would report any serious adverse reaction (such as blindness, loss of hair, or requiring hospitalization) to the Food and Drug Administration (FDA).
- Good Manufacturing Practices (GMP) – Small businesses subject to registration (as described above) would be required to comply with Good Manufacturing Practices developed by the FDA in consultation with the Small Business Administration so that the GMP requirements are reasonable for the size and scope of the small business.
- Larger Small Businesses – Businesses with annual average sales greater than $2,000,000 (over the previous 3 years) would be subject to full facility registration including product ingredient filings, fees and all other provisions contained in the Act. Annual registration fees for companies with annual average sales of $2 million to $5 million will not exceed $250.00 per year.