An Overview of the Personal Care Products Safety Act of 2015, S. 1014
As luck would have it, a new bill was introduced during my move to Arizona from Missouri while I was completely missing in action! On April 20, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act. The PCPSA can be tracked on Congress.gov by clicking here or by referencing its assigned identifier, S.1014.
The possibility of 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.
While this bill does allow for more small business exemptions than previous bills, there are still significant changes that could impact the handcrafted cosmetics industry (if passed in it's current form, which is unlikely) in comparison to current legislation.
Here's a brief overview of the Personal Care Products Safety Act:
As a disclaimer, I'm not a lawyer, a lobbyist, or any other political or legislative expert, so this summary is provided from my own interpretation of the bill's whopping 98 pages and extensive online research.
- Any cosmetics manufacturer with less than $100,000 in gross annual revenue (as determined by a three year average) would be exempt from compliance with the bill.
- This bill would not change any definitions as provided by the current legislation of what constitutes a soap, cosmetic, or drug.
- This bill would require electronic filings online to comply with the registration, ingredient statements, adverse event reporting, and other facets.
- While current registration is voluntary, the PCPSA 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, and the bill provides a cap on the fee amount for small businesses with anywhere from $500,000 to $2,500,000 in annual gross revenue ($250 fee.) Businesses with greater than $100,000 and less than $500,000 in annual gross revenue would be exempt from fees, but would still need to register.
- Registration information would include the facility name, physical address, business trading names, the nature of the business, emergency contact information, and a statement precluding that the FDA will be permitted to inspect the facility. This information would become a part of public record, with the exemption that registered facilities with residential addresses would not have their location disclosed publicly.
- With the exception of color additives, there are not currently any mandated reviews of ingredients used in cosmetics. This bill would introduce a provision that the FDA reviews at least five cosmetic ingredients annually for safety in cosmetic formulation, beginning with these five: diazolidinyl urea, lead acetate, methylene glycol, propyl paraben, and quaternium-15. A committee will be formed to advise the FDA on ingredient safety assessment.
- Manufacturers would be required to file annual ingredient statements which include the facility's identification number tied to their registration, the facility's name, the product's name, and the product's full ingredient list (with a range of percentages of each ingredient), name and contact information of the person filing the statement, and any additional information required (alluding to the safety substantiation section of the bill further in which is entirely confusing at the present, and not included in this summary.)
- This section does make note of exceptions for small business under the definitions of the Small Business Act for a non-specific timeline leeway, but it's unclear to me what exact exceptions are available and what requirements/determinations are needed for compliance as a small business. It later goes on to provide the FDA the ability to permit manufacturers falling under $500k annual sales to submit "simplified" ingredient statements, but does not mandate that exception.
- Good Manufacturing Practices would no longer be a guideline or suggestion for manufacturers, and the FDA will need to develop and implement actual GMP definitions that will become mandatory for all manufacturers. Small businesses will be given two years to comply, rather than 180 days given to larger manufacturers.
- 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.
- Product recalls would fall under FDA jurisdiction, and the agency would be given authority to inspect records and order recalls if a voluntary request for recall is not upheld.
- More extensive labeling requirements, including ingredients not appropriate for children or for professional use only, versus the current broad warning statements, additionally, internet websites must include the product labeling that appears on packaging. This section also provides the addition of domestic telephone or electronic contact information to the current contact information requirements.
- A new section of this bill in comparison to previous bills is the preemption portion. It would prevent individual states from enacting cosmetics legislation in the areas of registration, GMP, recalls, or adverse event reporting, however, it does grandfather existing state legislation into the act (like those in California and Florida) and does not specifically mention labeling regulations.
Please keep in mind that this is a brief summary of the full 98 pages, and while it's full of legalese, it's not too terribly bad. I highly encourage you to take an afternoon to sit down with a nice helping of artisan chocolate (or really good wine!), and give it a read. It can be tracked on Congress.gov by clicking here or read in full by clicking here.
Read up on the Personal Care Products Safety Act:
If you are really into research (like I am!), you might be interested to see what other folks are saying about this piece of legislation, so I've compiled a few press releases, blog posts, and the like for you below:
- The Personal Care Products Council Press Release
- Independent Cosmetic Manufacturers and Distributors Press Release (not a direct link, it is available for download on their home page currently.)
- International Fragrance Association, North America Press Release
- Handcrafted Soap & Cosmetics Guild Information & Press Release
- Indie Business Network Overview & Information
- Coalition of Handcrafted Entrepreneurs Statement
- Lucky Break Consulting's (More InDepth!) Overview
- Cosmetics & The Law Brief Overview
- Handmade Cosmetic Alliance Press Release
- Environmental Working Group Press Release
As you may know, the legislative process is a long one. While this bill is new and has not gone anywhere yet, and certainly isn't the law of the land yet, I do not believe this means we should sit idly by and wait to see what happens.
If you've made it this far, here's what I'd love to see you do next:
- Read the bill. Yes, I already said that, I know! From personal experience, the biggest issue when legislative activity gets kicked up in our industry is the hearsay and opinions the run rampant and can cause misinformation. Nothing can replace your own personal understanding and reading of the bill as it stands.
- Spread the word. Share this blog post, your own blog post (look at that, a freebie idea: blog about how the act would affect your business if passed in it's current form!), or those I've linked above. Discussing the legislation and sharing it in Facebook groups, forums, and other areas will help more cosmetic manufacturers stay informed and allow more of us to have our voices heard.
- Write to your legislators. Both the Coalition of Handcrafted Entrepreneurs and the Handmade Cosmetic Alliance provide easy form letters to help you get started. The more letters our representatives receive, the more attention they will provide in listening to our concerns and consider how our small businesses will be influenced by legislation.
- Start getting GMP compliant NOW. Even if you work from home, you are entirely capable of getting GMP compliant to the current guidelines available. Plus, there are great resources available out there to help you, including a book by Marie Gale and an online course by Lucky Break Consulting. While GMP is not at the forefront of my area of expertise (I am not and could not write a book or create a course), I have helped clients navigate these waters and would be happy to chat.
- Stay informed. Keep your ears on the ground, and pay attention to what is happening by joining a trade organization or advocacy group (mentioned above!), and stick with tracking the bill on Congress.gov (S.1014).
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