The Introduction of the Personal Care Products Safety Act 2019 in the United States Senate
It's been a while since our last update on cosmetics regulations reform when the Personal Care Products Safety Act in the Senate saw a hearing. Since this year marked a new session of Congress, we expected new bills related to cosmetics reform to be submitted in both the House and the Senate sometime this year.
A couple of weeks ago, we hosted a briefing call for our tribe to talk over the previous bills and how to stay informed about legislation that comes this year. As mentioned previously, the possibility of an overhaul of cosmetic industry regulations is not a new endeavor, as bills have been constantly introduced since 2008.
The bill introduced in 2011 was my introduction to advocacy in our industry and led to finding and joining the Indie Business Network as well as getting in touch with fabulous people in our industry who work tirelessly to advocate on our behalf.
Lo and behold, Senator Feinstein & Senator Collins introduced their cosmetics reform bill, the Personal Care Products Safety Act, in the Senate on March 7th, 2019. If you recall, this is not the first introduction of a bill by this name introduced by Senator Feinstein.
Personal Care Products Safety Act History
In May 2017, Senator Dianne Feinstein (D-Calif.) introduced the Personal Care Products Safety Act of 2017. (She has to be a psychic, as she introduced a similar bill during my previous move in 2015!)
While this bill was similar to the Personal Care Products Safety Act of 2015, it did grant greater small business exemptions than previous versions. This was largely thanks to huge lobbying efforts by small business organizations in our industry in the past and present, including the Coalition of Handcrafted Entrepreneurs, the Handmade Cosmetics Alliance, and the Handcrafted Soap & Cosmetics Guild.
In March of 2019, the latest version of the Personal Care Safety Act was introduced. The latest PCPSA can be tracked on Congress.gov by clicking here or by referencing its assigned identifier, S.726.
What is in the new Personal Care Products Safety Act?
Here's a brief summary of some of the important changes the Personal Products Safety Act would make if it were passed into law:
While current registration is voluntary, the Personal Care Products Safety Act would make it mandatory to register and pay registration fees for cosmetics manufacturers.
Fee amounts are dependent on the annual gross revenue of the business. The lowest fee provided in the bill is $500 and applies to small businesses with $10,000,000 to $20,000,000 in gross annual sales.
Registration information would include the facility name, physical address, business trading names, the nature of the business, emergency contact information, a statement precluding that the FDA will be permitted to inspect the facility, ingredient listings for all products manufactured, and written assurance of the substantiated safety of the products manufactured. (It also requires maintaining records of substantiated safety for several years.)
IMPORTANT: Please note that there are exemptions for small businesses in regards to registration and fees, see below.
FDA Review of Ingredients
With the exception of color additives, there are not currently any mandated reviews of ingredients used in cosmetics. The PCPSA would require the FDA to review at least five cosmetic ingredients annually for safety in a cosmetic formulation, beginning with diazolidinyl urea, diethyl phthalate, methylene glycol, propylparaben, and quaternium-15. ‘
Mandatory Good Manufacturing Practices
Good Manufacturing Practices (GMP) would no longer be a guideline or suggestion for manufacturers, and the FDA will need to develop and finalize actual GMP requirements that will become mandatory within 3 years of the legislation passing.
IMPORTANT: Please note that there are concessions for small businesses in regards to good manufacturing practices, see below.
Mandatory Adverse Event Reporting
Extensive adverse event reporting would become mandatory, including individual reports on a short timeline and an annual report summarizing all adverse events, which is currently encouraged by the FDA but not required.
FDA Authority for Records Inspection & Recalls
Product recalls would fall under FDA jurisdiction, and the agency would be given authority to order recalls if a voluntary request for a recall is not upheld. The FDA would also be given the authority to inspect relevant records, as well as facilities.
The PCPSA would institute more extensive labeling requirements, including ingredients not appropriate for children or for professional use only, versus the current broad warning statements. Internet websites must also include product labeling that appears on the packaging.
This section also provides the addition of domestic telephone or electronic contact information to the current contact information requirements.
A small section of the bill mentions that the US cosmetic industry should phase out animal testing, but does not specify any further requirements or timelines.
Like the previous PCPSA bills, this bill would prevent individual states from enacting cosmetics legislation in the areas of registration, GMP, recalls, or adverse event reporting. It does grandfather existing state legislation into the act (like those in California and Florida).
Small Business Concessions in the Bill
However, as I mentioned, this bill does give a lot of leeway for small business exemptions, including:
Registration Fee Exemptions
If you have less than $10,000,000 in average gross annual sales for the previous 3-year period, you will not be required to pay a registration fee.
You would not qualify for this exemption if you make products intended for application to the eye, lip products that contain color, products that are intended for internal use, or products that alter the appearance for greater than twenty-four hours.
If you have average annual sales of $500,000 to $2 million (over the 3 previous years) or a private residence business with $1,000,000 to $2,000,000 in gross annual sales, you would be required to register your business. However, it would be simplified to business name, address, phone, email, and consumer product line categories. The FDA would be required to provide you guidance and additional resources.
Below those annual revenue amounts, you would be exempt from registration.
Again, you would not qualify for these exemptions if you make products intended for application to the eye, lip products that contain color, products that are intended for internal use, or products that alter the appearance for greater than twenty-four hours.
Simplified GMP requirements will be developed by the FDA and SBA (Small Business Administration) for small business owners that take into account the size and scope of a small operation. Additionally, small businesses will be given two years to comply, rather than 180 days given to larger manufacturers, and will be provided additional guidance to reach compliance.
Please keep a few things in mind:
Legislation does not tend to move quickly. This bill was introduced at the beginning of March, read twice, and referred to the Health, Education, Labor, and Pension committee. In the past, the bill has sat in committee until the end of the session of Congress. However, this is a much earlier introduction and much more solid draft than previous bills.
Co-sponsors are not an indication of the likelihood a bill will pass. When Representatives or Senators cosponsor a bill, they are showing support for the measure. It may encourage a committee to take action on the bill in some manner, such as holding a hearing or issuing a report. This bill currently has one co-sponsor.
Once a bill leaves committee, it can be scheduled by the Majority Leader of the Senate and brought to the floor whenever a majority of the Senate chooses. Typically, bills are debated, amended, and then voted on.
Even if a bill passes in the Senate, a similar measure must also pass in the House for it to be signed by the President and become law.
The Next Steps
Just because the bill was just introduced doesn't mean you should sit idly by if you feel strongly about the legislation. In fact, now is the best time to act! Here are some suggested actions:
Read the bill for yourself. Seriously! The biggest issue when it comes to legislation in our industry is that the vast majority of business owners do not actually read the regulations and bills themselves.
Don't rely on me or anyone else to tell you what is in any bill or piece of legislation, we may not mention a detail that could be important to your business. This is a summary of almost one hundred pages of text! Nothing can replace your own personal understanding of the bill by reading it yourself.
Stay informed. You can sign up for email alerts for movement on the PCPSA at GovTrack, which will notify you if someone else cosponsors the bill, if it has a hearing, or if it moves to the floor.
Check up on Congress.gov regularly (I have reminders on my calendar to check in once a month).
If you want more ideas for staying informed, read our top four tips to staying up to date on cosmetics regulatory reform.
Share the information with others. Whether you share this blog post, someone else's blog post, or your own blog post (yes! free blog post idea!), sharing information helps us work together and stay informed as an industry. Discuss how the legislation will affect you, what you do and don't like about it, etc. Don't be afraid to talk it out!
Get in touch with your legislators. You can call or write to your Congress members to voice your opinion on the PCPSA. Your opinion matters because you are from this industry! Tell them whether you oppose or support the legislation and explain why or how it will affect you.
Use CallMyCongress.com to enter your address and it will give you the phone number and a little bit of information about each of your representatives. Or use ContactingCongress.com to enter your address and receive the phone numbers, mailing addresses, and social media accounts for your legislators.
Start working on your GMP compliance now. Whether it's this bill or one in the future, updated cosmetic regulations reform is inevitable and will likely require good manufacturing practices. Marie Gale's book on good manufacturing practices is a wonderful primer to get you started. We also have a growing collection of templates and checklists in Next Level. Don't wait until you are told you have to be GMP compliant, get a jump start and start working on it now.
And last but not least, don't panic - but don't stick your head in the sand either. We're in this together.
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