How would the Personal Care Products Safety Act, introduced by Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) affect small businesses like artisan soap makers?
Q: Would small businesses have to register with FDA or pay a fee?
A: Any small business selling less than $100,000 in personal care products each year—including artisan soap makers—would do not have to register with the FDA.
Small businesses selling between $100,000 and $500,000 in personal care products would have a simplified, flexible registration process.
All companies with annual sales under $500,000 (on average over the previous three years) would be exempt from paying a fee.
Q: For those companies required to pay a fee, how much is it?
A: Only businesses with sales over $500,000 would have to pay a user fee. For companies with sales between $500,000 and $2.5 million (on average over the previous three years), the fee would be capped at $250 per year.
Q: For those small businesses that would have to register, how long would they have to register new products and changes?
A: The FDA would provide small businesses with more than 60 days to register new products and changes to their products.
The FDA could allow small businesses to register all changes and new products during the annual registration period. For example, if the annual registration period is in January, FDA could allow a new soap created in June to be registered up to six months later.
Q: How would ingredients be registered?
A: All businesses have flexibility in registration by providing a range of concentration for the ingredients that they use.
FDA may allow small businesses with sales under $500,000 to complete a simplified registration, such as a basic listing of ingredients without ranges of concentrations.
If a business were to add more of a particular ingredient that would not trigger a registration update.
Q: Would fragrance and color variations need to be registered separately?
A: Fragrance and color variations would not need to be registered separately.
For example, if a small business were to produce two soap formulas, with each formula produced in five colors and five fragrances, it would only need to register two formulas.
Q: What if I make soap that doesn’t claim on the label to moisturize or make someone smell or look better? Does the bill change who regulates my product?
A: The bill does not change the current definition of soap. Only soap products currently classified by the FDA as cosmetics would fall under this legislation.
More information on how soap is classified can be found here.
Q: What if a small business has questions regarding how to comply?
A: FDA and the Small Business Administration would be required by the bill to provide technical assistance to small companies on how to comply with the law in order to ensure the process is simple and easy to understand.