November 2023
FDA Delays Implementation
This is a quick update regarding the implementation of The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) by the FDA; as we’ve discussed in previous postings to the blog, MoCRA mandates the registration of cosmetic manufacturing facilities and products with the FDA.
In an update on November 8th, the FDA announced a postponement of the MoCRA requirement enforcement for facility and product registration until July 1, 2024. The delay is intended to help ensure that the industry has sufficient time to submit such facility registration and product listing information.
Cosmetic manufacturers must register their facilities, while responsible parties (either the manufacturer or the person named on the label) must register their products. Notably, small businesses enjoy an exemption; those with an average annual revenue of less than $1 million are only obligated to register their facilities or products if dealing with high-risk cosmetics (ingested, injected, eye-contact, or altering appearance for over 24 hours).
More detailed information produced by the FDA regarding cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) can be found here:
Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
Also, our good friends at the Handcrafted Soap and Cosmetics Guild have put together a very useful set of online tools to assist small business owners in understanding their obligations under MoCRA. That information can be found here:
About Mocra (soapguild.org)
COHE remains committed to aiding your understanding of these requirements. We will continuously update our resources and disseminate announcements as new information becomes available!
August 2023
ALL about Mocra
On Tuesday, August 7, The Food and Drug Administration (FDA) released draft guidance regarding Registration, Listing of Cosmetic Product Facilities, and Product Listing. This draft guidance has been issued in support of the FDA’s process for implementation Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For a full picture of the work the FDA is performing with regarding to MoCRA implementation, you can visit their MoCRA website which outlines the law and provides updates regarding the FDA’s approach to implementation and engagement opportunities with the agency. The agency has also produced a webinar that identifies key terms and provisions regarding the new law. Both are available here: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022
The website also has the transcript (https://www.fda.gov/media/169954/download?attachment) from the Good Manufacturing Practices listening session the FDA held on June, 1. COHE leadership presented at the session with Anne Marie Faiola stating, “Promotion of GMPs and adherence to safe standards is appropriate. It promotes safe work environments, safe products, and provides confidence to consumers, but in developing and applying GMP standards going forward, the FDA should acknowledge and apply these standards in a way that works for small businesses.” The full text of Anne Marie’s testimony can be found on page 55 of the transcript document.
You can also read the draft Registration and Product Listing guidance on the FDA website, but a couple of things are worth pointing out:
1. As we’ve long advocated, small businesses who do not engage in the manufacturing or processing of certain cosmetic products and whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, are exempt from registration and listing requirements. If you engage in the manufacture or processing of any of the following types of products, you are required to fulfill the registration and listing requirements of the law:
A. Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary and usual;
B. Cosmetic products that are injected;
C. Cosmetic products that are intended for internal use;
D. Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
2. If you previously registered your facility under the FDA’s voluntary registration program, your registration will NOT be transferred over to the new system.
The FDA is taking comments on the draft Registration and Listing guidance. While comments can be submitted at any time, if you want the agency to consider them timely in informing formation of the final guidance, please submit by September 7, 2023. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-1716 and title of the guidance document.
December 2022
SMALL BUSINESS EXEMPTIONS INCLUDED in DRAFT
After over 15 years of work, it looks as though we are days away from getting cosmetics reform passed by the Congress as we close our 2022 and Congress completes its work.
Before we get into the details, I want to share a note of thanks for all of you who have engaged over the years by telling your story and standing up for our industry. It has meant the world to be able to work together as a community to advocate for what we believe in.
I want to share some special thanks for Leigh O’Donnell and her team at the Handcrafted Soap and Cosmetics Guild. Leigh and the advocates she had on board have been fantastic partners and tireless supporters of the industry. It has been a great honor to work with Leigh and the Guild over these many years.
I also want to give a shout out to Donna Maria with the Indie Business Network. Donna and many of her members have been important collaborators in engaging members of Congress and their staffs and we would not be where we are today without her contributions.
Over the years, Lela Barker from Lucky Break Consulting and Kayla Fioravanti from Ology Essentials have been consistent helpers, from reading rough drafts of letters to coming to Washington DC on advocacy missions on behalf of small business crafters nationwide. It took the voices of all of us + your consistent support and letter writing to get to where we are today. Thank you.
What’s Happening
As the 117th Congress wraps up, members and Senators are working to pass a so-called “Omnibus Appropriations” bill. The bill funds the government for the remainder of the fiscal year, ending September 2023, and also contains a number of other provisions, including cosmetics reform.
The language in the bill largely mirrors what we saw emerge from the Senate earlier in the year.
For small businesses, “whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation,” are not subject to the GMP or registration requirements of the legislation. These exemptions do not apply for manufacturers of products that:
“regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual,”
“are injected,”
“are intended for internal use,‘
“are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual”
In another win, the bill also contains no fees levied against business. As you may recall, there had been both members of Congress and other stakeholders who wanted to force industry to pay the FDA directly to support implementation of these new regulations. We were successful in keeping that concept out of the final bill.
The bill does have a serious adverse event reporting requirement for all manufacturers with “serious adverse event” defined as an adverse event that “result in”:
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant dis21 ability or incapacity;
(v) a congenital anomaly or birth defect;
(vi) an infection; or
‘(vii) significant disfigurement (including serious and persistent rashes,
3 second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described.
The bill also contains a requirement for safety substantiation of cosmetic products. It should be noted that under current law, cosmetics manufacturers are responsible for substantiating the safety of their products and ingredients before the products are marketed to ensure that they are not adulterated or misbranded. The new bill defines “safe” as, “not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or us.” The good news for the handcrafted industry is that we should be able to largely rely upon existing sources of data and information to meet the test. The relevant section of the bill includes the following as a source of substantiation: “evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.” We will want to monitor and work with the FDA around the regulations they intend to apply in interpreting this section.
The bill gives the FDA mandatory recall authority and requires some changes in labeling with an emphasis on fragrance allergens.
Where Do We Go From Here?
The Senate is expected to pass the bill no later than Thursday of this week which would send it to the House to be approved on Friday, after which we would expect the President to sign it into law almost immediately.
While the bill creates a strong national standard going forward that will help provide clarity and certainty for small business, we will want to monitor how the FDA goes about interpreting and implementing provisions of the law.
This is not over until it is over, but it looks very close to being done. We’ll provide further updates later this week.
PS - A big thank you to each of you that wrote your elected officials in October to urge them to protect small business exemptions! The full $1M exemption is included in this bill.
Edited 12/23/2022 to add:
It’s official. The House has passed the bill containing cosmetics reform sending it on to the President for his signature, which we expect he will affix imminently, turning it into law.
After over a decade of advocacy we’ve managed to preserve the handcrafted industry’s ability to remain a vital business opportunity for entrepreneurs, an important source of consumer choice, and a pillar of our local communities.
Thank you thank you thank you for all of your support, engagement, and endurance. We would not have been successful in protecting what is dear to us without everyone pitching in.
There is more to come on this as the FDA works to implement the new law, but for now, savor the fact that we were able to preserve our unique industry and the contributions we make can continue to endure.
Happy Holidays and Happy New Year!
September 2022
Small business exemptions threatened
As we close out September, we find ourselves at a critical moment in the cosmetics reform debate. After over a decade of work and advocacy we are close to having a cosmetic reform bill that meets the needs of small business, but we need to make another push to try and get it done.
As last reported, the Senate Committee on Health Education Labor and Pensions (HELP) included cosmetics reform as part of a larger legislative package called the FDA Safety and Landmark Advancements (FDASLA) Act. Thanks in large part to your advocacy, this bill contained an exemption for small businesses “whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation.” The House version of this bill did not contain cosmetic reform provisions.
Unfortunately, when the House and Senate met to reconcile the differences between the competing versions of their FDA bills, cosmetic reform was dropped from the package. The FDA bill was taken up and passed by the Senate yesterday, by the House today and is now on its way to the President’s desk to be signed into law.
The Congress is now recessed until after the election and members are scheduled to come back to Washington in mid-November for what’s called a “lame duck” session. There remains an opportunity for cosmetics reform to be passed by Congress during the lame-duck session.
We’ll let you know as we hear more, but in the meantime, it’s important for everyone to call, write, and email their Members of Congress and Senators and tell them three things:
1. We need to get cosmetics reform done.
2. By passing the Senate version of cosmetics reform, we have a unique opportunity to pass a law that protects consumers and small business.
3. Congress should pass the Senate version of cosmetics reform and ensure that it contains the $1 million exemption for small business.
You can use this link: lookup.coalitionofhandcraftedentrepreneurs.com to find contact information for the senators and members of the House who represent you.
JULY 2022
FDASLA Act - cosmetic reform bill
As we head into the holiday weekend, we wanted to provide you with an update on where things stand regarding the effort to advance cosmetic reform legislation through Congress. As we reported in our last update, the Senate Committee on Health Education Labor and Pensions (HELP) was expressing strong desire to advance a bill on cosmetic reform and was working with stakeholders, including us, to ensure that they understood our interests and what we thought was at stake for the handcrafted industry in any reform effort.
The good news is that our advocacy on behalf of the handcrafted industry has been heard. As part of a larger legislative package called the FDA Safety and Landmark Advancements (FDASLA) Act, the Senate HELP Committee has taken up and passed a cosmetic regulation reform bill. And the bill contains strong protections for small business.
What’s in the Bill for Small Business
Importantly, small businesses “whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation,” are not subject to the GMP or registration requirements. These exemptions do not apply for manufacturers of products that:
“regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual,”
“are injected,”
“are intended for internal use,‘
“are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual”
In another win, the bill also contains no fees levied against business. It also creates a strong national standard going forward that will help provide clarity and certainty for small business.
The bill does have a serious adverse event reporting requirement for all manufacturers with “serious adverse event” defined as:
“an adverse event that results in”
‘‘(i) death;”
‘‘(ii) a life-threatening experience;”
‘‘(iii) inpatient hospitalization;”
‘‘(iv) a persistent or significant disability or incapacity;”
‘‘(v) a congenital anomaly or birth defect; or”
‘‘(vi) significant disfigurement (including serious and persistent rashes or infections, second- or third-degree burns, significant hair loss, or permanent or significant alteration of appearance), other than
as intended, under conditions of use that are customary or usual.”
And the bill also contains a requirement for safety substantiation of cosmetic products. It should be noted that under current law, cosmetics manufacturers are responsible for substantiating the safety of their products and ingredients before the products are marketed to ensure that they are not adulterated or misbranded. The new standard requires that a product be, “not injurious to users under the conditions of use prescribed in the labeling thereof.” The good news for the handcrafted industry is that we should be able to largely rely upon existing sources of data and information to meet the test. The relevant section of the bill includes the following as a source of substantiation: “evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.” If this language, or something like it, becomes law we will want to monitor and work with the FDA around the regulations they intend to apply in interpreting this section.
Where Do We Go From Here?
Passage by the HELP Committee is the first step in the process, but we expect the rest of the process to move pretty quickly. As mentioned above, the cosmetics reform legislation is part of a bigger bill that focuses on existing FDA programs related to prescription drugs and medical devices called “user fee acts.” The current law guiding these policies is set to expire on September 30 of this year so this legislation is considered “must pass.” And we expect it will.
What we don’t know yet, is what the House will do. As you’ll recall, the Chair of the House Committee on Energy and Commerce, Rep. Pallone, introduced a bill on cosmetic reform in late 2019 but has not revisited the policy since. The version of the legislation that passed the HELP Committee is narrower and more focused – and much better for small business - than the version Chair Pallone produced a few years ago. What we don’t know is if he will want his own version to pass so that he will have something to negotiate with the Senate. The House doesn’t have a lot of time to act if they want to get this done by September 30, but we’ll be keeping a watchful eye on their intentions here.
Thank You
We still have a ways to go, but this is the furthest a piece of legislation like this has made it through the process. And it is a strong bill for the handcrafted industry. We want to thank Senator Murray (D-WA), the Chair of the HELP Committee, and Senator Burr (R-NC), the top Republican on the HELP Committee, and their staffs for listening to us and incorporating our thoughts and inputs into the bill.
But we would not have been successful at that without you!
So thanks for your advocacy and support – and if you get a chance – let your senators and representative in the House know how important it is to keep these pro-small business provisions in the bill. You can go here:
To use our advocacy tool to help facilitate that engagement.
FEBRUARY 2022
INCREASED INTEREST in cosmetics reform
It’s been a while since we’ve provided an update, but that’s because the Congress has mostly been focused on other things besides cosmetics reform. We sense that is about to change.
As we suggested in our last update, unified government with Democrats in charge of both Congress and the White House has meant a big change in orientation for the government with significant investments made in responding to the continuing pandemic and passage of a bipartisan infrastructure package. With those things out of the way, and portions of their agenda stalled, Congressional Committee Chairs are starting work through some other priorities. One of those appears to be cosmetics reform.
We recently had a sustained engagement with a bipartisan group of staff members representing Senators Murray and Burr, the Chair and Ranking Member of the Senate Committee on Health Education Labor and Pensions, which has jurisdiction over cosmetics regulation. We’ve had a wide-ranging exchange related to small business provisions including exemption levels, GMP, and adverse event reporting.
The good news remains the fact that the Senate has been and remains much more attuned to the needs of small business. When last Senator Murray was involved in putting a bill together for consideration back in 2018, HELP Committee leadership agreed in principle to a $1 million exemption for companies like ours in the handcrafted industry. But we will need to remain focused on expressing our needs and interests as the discussion continues.
When and how the Congress takes up personal care product reform legislation remains a little unclear. While there is some activity on the Senate side, Representative Frank Pallone, Chair of the House Energy and Commerce Committee, which has jurisdiction over cosmetics policy, still has not tipped his hand on how he intends to proceed.
As the legislative activity picks up, it’s more important that ever to tell our story and why protecting the handcrafted industry is important. We need to show the face of the industry, explain our commitment to safety and consumer protection and choice, and ensure that our interests and needs don’t get swept aside in the debate.
You can go to our action page here:
https://www.coalitionofhandcraftedentrepreneurs.com/action
to see suggestions on how best to tell your story and the Senators and Representatives who you should to tell your story to. It takes just a few minutes, but it is important to take the time to make sure your voice is heard.
Because of the Committee’s that their representatives and senators sit on, it is particularly important that handcrafters from the following states share their stories:
Alabama, Alaska, Colorado, Connecticut, Indiana, Kansas, Kentucky, Louisiana, Maine, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, Pennsylvania, South Carolina, Utah, Vermont, Virginia, Washington, and Wisconsin.
All stories are important, so if you are from a state not listed above, please also go ahead and share. And when you share your story with your senators and representatives, please also share it with us by sending it to “legislation at brambleberry dot com” (replace at with @ and dot with . to creative the email in any email system).
As always, we will work hard to help put your interests front and center on any legislation that could impacted the handcrafted industry. We want to help your voice be heard.
JUNE 2021
Cosmetics Reform BILL INTRODUCED
Today, Senators Feinstein and Collins re-introduced a new version of their Personal Care Products Safety Act. We at COHE have been working hard with those offices to help craft a bill that would meet the unique needs of handcraft entrepreneurs.
We have been joined in that effort by our friends and colleagues with the Handcrafted Soap and Cosmetics Guild (HSCG Home (soapguild.org)), who have been stalwart champions on behalf of handcraft entrepreneurs. Going forward, we will continue our joint advocacy efforts on behalf of the industry. In the past, we have previously joined with the HSCG and endorsed the measure put forward by Senators Feinstein and Collins, and based on the protections provided to our industry and other important aspects of the bill, we anticipate doing so again this year.
As all you know, handmade cosmetic products are among the safest on the market and we’re glad to say that the bill introduced by Senators Feinstein and Collins today contains protections for our industry, including:
Exemptions for Very Small Businesses – Cosmetic producers with average annual sales of less than $500,000 (annually, over the previous 3 years) do not meet the bill’s definition of a facility and therefore are not subject to many of the provisions in the Act. The Very Small Business exemption does not extend to entities that make products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Private Residence Exemption – A private residence that meets the customary expectations of a private residence and with average annual sales of less than $1,000,000 (annually, over the previous 3 years) that is also used to manufacture, process, package and sell cosmetic products does not meet the definition of facility and need not register. The private residence exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Simplified Facility Registration – Small businesses with average annual sales of $500,000 to $2 million (annually, 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 consumer product-line categories. The Simplified Facility Registration exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Good Manufacturing Practices - The Food and Drug Administration, in consultation with the Small Business Administration, will create simplified good manufacturing practices for small businesses that take into account the size and scope of the operation.
Serious Adverse Event Reporting – all serious adverse events – those causing serious bodily harm, disfigurement, or death – must be reported to the Food and Drug Administration.
Mandatory Recall – the bill grants the FDA the authority to implement mandatory recalls on products they deem unsafe.
Fees – producers are exempt from fees until they earn more than $10 million in annual sales.
There is still a lot that has to happen before any new proposal become law, but we will continue to keep an eye on things and advocate for the industry. As always, we will keep you apprised of developments as they occur.
JANUARY 2021
Prospects for Cosmetics Reform in 2021
Joe Biden will be sworn in as President on January 20th. While it got a little lost in the turmoil from the siege on the capitol and fallout from that, there was another big election development last week that holds significant implications for the policy landscape going forward; the Democrats won both of Georgia’s Senate seats giving them a 50-50 split with Republicans in the Senate, and a narrow majority with soon-to-be Vice President Harris breaking the tie (the Constitution designates the U.S. Vice President as President of the Senate and has a vote only when “they be equally divided”).
Unified government with Democrats in charge is a big change from where we’ve been, and we expect a flurry of policy activity over the next months and years. In anticipation of a renewed interest on the part of Congress to update and amend the law relating to regulation of personal care products, we are ramping up our efforts along with our advocacy partners at the Handcrafted Soap & Cosmetic Guild. As part of that effort, we encourage you fill out this survey here. Completing the survey only takes a few minutes and doing so will help us understand you and your needs better so that we can perform better advocacy on your behalf.
With the new Congress now sworn in, and a new President and Vice President about to be, the legislative agenda is already shaping up. When the Senate reconvenes, it will need to decide how to handle the articles of impeachment the House just sent over and begin the confirmation process for President-elect Biden’s cabinet picks. We expect another first order of business to be further consideration of another installment of policy and investment in response to COVID.
When and how the new Congress takes up personal care product reform legislation remains a unclear as of this writing. Per our last update, Representative Frank Pallone of New Jersey continues as Chair of the House Energy and Commerce Committee, which has jurisdiction over cosmetics policy. As you all probably recall he held on hearing on personal care products legislation in late 2019 and has been floating a bill. We expect him to revisit reform legislation sometime this Congress.
With Democrats in charge of the Senate, Senator Patty Murray of Washington becomes Chair. The good news here is that the Senate has been much more attuned to the needs of small business and HELP Committee leadership has already agreed in principle to a $1 million exemption for companies like ours in the handcrafted industry. But we will need to be vigilant with the shift in power.
As always, we will work hard to help put your interests front and center on any legislation that could impacted the handcrafted industry. We want to be your voice. To help us be a better-informed voice, please remember to fill out the industry survey HERE.
December 2020
Prospects for Cosmetics Reform in 2021
After a nail-biter of a campaign, the dust has finally settled on the 2020 elections. While President Trump still continues to contest the outcome, Joe Biden has secured enough votes to be sworn in as the 46th President of the United States next January. And while House Democrats retained their majority, albeit narrowly, which party controls the Senate will be determined by a pair of runoff elections in Georgia on January 5.
With the election counting now over, Congress has returned for a “lame-duck” session in order to finish the year’s business. At the top of the list is funding the Federal government for the remainder of the fiscal year and seeing if agreement can be reached on another installment of policy response to the wreckage and misery the COVID pandemic is generating around the country. Reaching consensus on these issues between the outgoing Trump Administration, Senate Republicans, and House Democrats has proven challenging.
When and how the new Congress takes up personal care product reform legislation is a little unclear as of this writing. Representative Frank Pallone of New Jersey will continue to Chair the House Energy and Commerce Committee, which has jurisdiction over cosmetics policy. He has been joined by a new Ranking Member, Representative Cathy McMorris Rodgers, of Washington State. The Committee has broad jurisdiction over many policy areas that the incoming Biden Administration is keen to make progress on. We know that Chairman Pallone has an abiding interest in advancing cosmetics reform legislation, but where it will fall on his priority list of action items is hard to tell at this point.
If Republicans retain their majority, the HELP Committee Chairmanship is likely to transfer from retiring Senator Lamar Alexander of Tennessee to Senator Richard Burr of North Carolina with Senator Murray of Washington continuing to serve as the Ranking Member. If Democrats sweep the Georgia runoffs, those roles are likely to be reversed. The Senate hasn’t budged much since we last checked in on their efforts to update personal care products regulations. The good news here, however, is that the Senate has been much more attuned to the needs of small business and HELP Committee leadership has already agreed in principle to a $1 million exemption for companies like ours in the handcrafted industry.
The new Congress may bring new ideas and action so we will continue to invest our time and energy in educating senators and their staff on the important contributions the handcrafted industry is making to both consumer choice and our economy. And as always, we will keep you apprised of the goings on.
December 2020
New Survey
Help us, Help you! 😊
The Handcrafted Soap & Cosmetic Guild (HSCG) and The Coalition for Handcrafted Entrepreneurs (COHE) need your help with our Advocacy Efforts in the United States. We have been monitoring all legislation that could affect the handcrafted soap, cosmetic and candle industry for the last twelve years.
This is a very short, 5ish minute anonymous survey that will give us the information we will use to plan our advocacy for 2021 and beyond.
Currently, Congress is seeking to update the over 80-year-old cosmetic law in the United States, The Food, Drug & Cosmetic Act of 1938. In doing so, they are looking heavily at the larger cosmetic industry, companies that make millions, if not billions, of dollars in annual gross sales. Our industry has been swept up in this effort and would be very adversely affected if (eh hem, modestly said) not for our lobbying efforts on your behalf. Members of Congress need to be told that you are out there and what impact this would have on you, your business and your family if legislation was passed without due consideration for the unique issues facing small businesses.
The HSCG and COHE are against any legislation that does not contain adequate small business provisions and protections. We actively meet with Members of Congress to educate them about this marketplace and all of the people, products, and businesses that make up our unique, cool and innovative industry.
Both organizations are under contract with a professional DC Advocate (Lobbyist) to assist us with our efforts. With their guidance, we have been able to affect real change to proposed bills, ensure there are small business provisions and we were even asked to testify before Congress last year at a Hearing on Cosmetic Safety in the United States.
Your responses to these questions will give us a clearer picture of the industry overall.
Please take the short 5ish minutes to fill out this survey and help us to help you. Thank you! 😊🙏
December 2019
Hearing Recap
The House Energy and Commerce Committee’s Subcommittee on Health held its hearing on “Building Consumer Confidence by Empowering FDA to Improve Cosmetic Safety” on Wednesday, December 4. The night before, Energy and Commerce Chairman Pallone (D-NJ) introduced his version of cosmetics legislation, H.R. 5279, the “Cosmetic Safety Enhancement Act of 2019.”
Both the hearing and the bill represent meaningful steps as the Committee explores the important issue of cosmetic safety and consumer protection.
First, it must be said that Leigh O’Donnell, the Executive Director of The Handcrafted Soap and Cosmetic Guild and our partner in advocating for the handcrafted industry, did a great job testifying at the hearing and fielding questions from members of Congress. If you missed the hearing, you can get information about it (including watching it) on the Committee’s website: https://energycommerce.house.gov/committee-activity/hearings/hearing-on-building-consumer-confidence-by-empowering-fda-to-improve
Committee member questions, as well as the contents of the Chairman’s bill, indicate that our advocacy is making a difference and that our efforts to represent the hundreds of thousands of mostly small, handcrafted businesses needs to continue.
COHE and The Handcrafted Soap and Cosmetic Guild continue to prioritize that any new law ensures the safety of personal care products. We have stood firmly in support of reforms that enhance consumer safety and transparency, including: requiring reporting of adverse events; giving the FDA recall authority; and improving the clarity and consistency of product labeling.
But, as we’ve been discussing for some time, we are concerned with some of the approaches that have been advocated because they would place undue burdens on small businesses by requiring ingredient reporting and final product testing, along with other forms of new regulations and procedures that would add costly new burdens on the handcrafted industry.
The simple fact is that holding small businesses to the same standard of record keeping, ingredient filing, and testing as large, multi-national corporations is simply not fair and very likely would cause a significant negative disruption in the handcrafted industry. In our view, consumer choice is enhanced by the presence of handcrafted products in the personal care products industry. A one-size-fits-all approach seems to be a solution in search of a problem that will only result in less consumer choice by forcing thousands of small businesses out of the marketplace.
We believe that any changes to the existing regulatory structure should recognize that a majority of ingredients used today by the handcrafted industry are substantially similar to off-the-shelf products available at your local grocery store, and even for those not readily available, many have already undergone a high degree of research and analysis associated with safe use and handling.
The good news, is we’ve made progress. We need to spend more time analyzing the language and seeking clarity, but it’s clear that the bill introduced by Chairman Pallone represents movement on the Committee’s part in recognizing the unique needs of the industry.
We’ll provide a more detailed update on that legislation in a little bit. In the meantime, please keep adding your voice to the debate. It’s important.
December 2019
Hearings scheduled December 4
The House Energy and Commerce Committee has announced that it will hold a hearing on updating cosmetics regulations at 10:00 AM eastern on Wednesday, December 4. The hearing, entitled "Building Consumer Confidence by Empowering FDA to Improve Cosmetic Safety," will be lead by the committee’s Health Subcommittee and will feature testimony by five witnesses, including Leigh O’Donnell, Executive Director of the Handcrafted Soap and Cosmetics Guild. Other witnesses will include representatives from the Food and Drug Administration (FDA), the Environmental Working Group, National Women’s Health Network, and Beautycounter.
You can watch the hearing via livestream by going to the Committee’s website: https://energycommerce.house.gov/. For more details in advance of the hearing you can go to this page on the committee’s website. For background on the House Committee’s approach to this hearing, you can read this background memo put out by the Committee’s Chairman, Representative Frank Pallone (NJ-6).
The hearing is one step in the long process that the Congress has undertaken over the course of many years to examine ways that it might update cosmetics regulations. We expect that Chairman Pallone will move to introduce and advance a bill regarding cosmetics regulations sometime soon after the hearing.
Your advocates with the Coalition of Handcrafted Entrepreneurs (COHE - http://www.coalitionofhandcraftedentrepreneurs.com/) and the Handcrafted Soap and Cosmetics Guild (HSCG - https://www.soapguild.org/) have been actively engaged at all levels of legislative advocacy work for the last 10 years, working side by side to ensure that any potential regulation changes fit how the handcrafted soap and cosmetic industry looks today. Our members have different needs and concerns when it comes to regulations than companies that are larger in scope and size. COHE and HSCG have worked for over a decade to educate Members of Congress about handcrafted soap, including the people and businesses that make up our industry. We're very clear with Members of Congress and their staff that handcrafted industry supports and makes safe cosmetics.
But we need help, and that’s where you come in. As owners and operators of your own handcrafted small business you are the expert on your products and why you started making them to sell, and, how you're different than the average product at mass-market retailers across the country. Your real-life stories help to paint the important picture for our lawmakers about how fees, reporting requirements and paperwork will affect your business and your ability to make and sell products.
Now is a good time to engage your member of Congress and let them know that as they consider cosmetics legislation, that protecting the handcrafted industry should be front of mind. If you want help finding your representative and resources for how to contact them, you can use this tool on the COHE website: http://www.coalitionofhandcraftedentrepreneurs.com/action.
Thanks for your interest, and we’ll continue to keep you updated as events unfold.
August 2019
LEGISLATIVE ADVOCACY DAY OCTOBER 2
COHE is joining with the Handcrafted Soap & Cosmetic Guild (HSCG) to host a fly-in Advocacy Day on October 2, 2019. I'd love to have you join us.
COHE and leadership at HSCG have been actively engaged at all levels of legislative advocacy work for the last 10 years, working side by side to ensure that any potential regulation changes fit how the handcrafted soap and cosmetic industry looks today. Our members have different needs and concerns when it comes to regulations than companies that are larger in scope and size. COHE and HSCG have worked for over a decade to educate Members of Congress about handcrafted soap, including the people and businesses that make up our industry.
That's where you come in. We're very clear with Members of Congress and their team that handcrafted industry supports and makes safe cosmetics and, putting a face to that message is another great way to do that. We need you because you own and operate a small business in the cosmetic industry. You are the expert on your products and why you started making them to sell, and, how you're different than the average product at mass-market retailers across the country. Your real-life stories help to paint the important picture for our lawmakers about how fees, reporting requirements and paperwork will affect your business and your ability to make and sell products.
We will be attending meetings in small groups of 5 to 6 with a leader from either HSCG or COHE as a guide. Meetings will run all day on October from 9 a.m. to 5 pm.
We've set up a Facebook Page to keep you updated on logistics, timing and more. You can join that page here
Activity in the area of cosmetics reform continues to draw attention and your voice is needed. We'd love to see you in Washington DC on October 2. As always, we will keep you apprised of developments as they occur in this space
March 2019
Two new bills - Overview
It’s been a big week in Congress regarding efforts to reform the cosmetic regulations.
First, Senators Feinstein and Collins re-introduced a new version of their Personal Care Products Safety Act yesterday. And as you know, we in the handcrafted industry have been working hard with those offices to help craft a bill that would meet the unique needs of handcraft entrepreneurs. Based on the protections provided to our industry and other important aspects of the bill, we provided an endorsement for the measure in the last Congress, and have done so again this time.
As all you know, handmade cosmetic products are among the safest on the market and we’re glad to say that the new version contains the same protections for our industry as the last version introduced, including:
Exemptions for Very Small Businesses – Cosmetic producers with average annual sales of less than $500,000 (annually, over the previous 3 years) do not meet the bill’s definition of a facility and therefore are not subject to many of the provisions in the Act. The Very Small Business exemption does not extend to entities that make products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Private Residence Exemption – A private residence that meets the customary expectations of a private residence and with average annual sales of less than $1,000,000 (annually, over the previous 3 years) that is also used to manufacture, process, package and sell cosmetic products does not meet the definition of facility and need not register. The private residence exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Simplified Facility Registration – Small businesses with average annual sales of $500,000 to $2 million (annually, 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 consumer product-line categories. The Simplified Facility Registration exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Good Manufacturing Practices - The Food and Drug Administration, in consultation with the Small Business Administration, will create simplified good manufacturing practices for small businesses that take into account the size and scope of the operation.
Serious Adverse Event Reporting – all serious adverse events – those causing serious bodily harm, disfigurement, or death – must be reported to the Food and Drug Administration.
Mandatory Recall – the bill grants the FDA the authority to implement mandatory recalls on products they deem unsafe.
Fees – producers are exempt from fees until they earn more than $10 million in annual sales.
The second big thing that happened was in the House. Representative Pallone of New Jersey, the Chair of the House Energy and Commerce Committee, and Representative Shimkus of Illinois, released a “discussion draft” of a bill they are considering to reform cosmetic regulations. A “discussion draft” is just that; it is not a formally introduced bill, but rather a close to final product that members of Congress will circulate to elicit stakeholder feedback prior to introduction. Based on the feedback received, bills will often evolve between the “discussion draft” version and what gets introduced. We at COHE will be working with our other partners in the handcrafted industry to submit comments.
While many aspects of the two bills are similar, unfortunately, there is less good news in the “discussion draft” put out by the House than the current Senate version introduced by Senators Feinstein and Collins. We have been working with members of the Energy and Commerce Committee, but we have more work to do to get the bill to a place that wouldn’t harm the handcrafted industry. Some of the more concerning aspects of the proposed draft include:
A Low Exemption Level – unlike the Senate, the House discussion draft would require every producer with average gross sales above $100,000 annually to register and comply with the new requirements including submitting ingredient statements and safety substantiation of final products.
A Disproportionate Fee Burden – the House draft seeks to collect $20.6 million in fees to fund their program and the starts fees at $500,000 in average annual gross sales. Of particular concern is the percentage of the overall budget burden that small businesses would be expected to carry. While fees paid by firms grossing $500,000 - $2.5 million would be capped, fees paid by small business are estimated to amount to 2.4% of overall budget; this is just under the percentage of the budget (2.9%) that companies making between $2 - $3 billion are expected to contribute and over double (1.2%) of the burden identified for firms making between $2.5 – 20 million.
There is still a lot that has to happen before any of these efforts come close to becoming law, but as we predicted late last year, activity in the area of cosmetics reform is picking up. As always, we will keep you apprised of developments as they occur.
November 2018
Post-midterm legislation analysis
The midterms are over. The Democrats now have a majority in the House, and Republicans retain a majority in the Senate. What does that mean for cosmetics regulatory reform?
First, it means that even though there will be a so-called “lame duck” session of Congress to complete this year’s work before the next Congress is sworn in at the beginning of next year, cosmetics reform is dead for 2018. The simple facts are that there is simply not a consensus on how to move forward at this point, and there are too many other priorities that need to get done before Congress can adjourn for the year. But expect the debate to return in full next year.
Many of the senators and members of Congress who have been most active on this will be returning, but some have retired or lost their re-election bids. But the new Congress will bring some significantly changed dynamics due to the fact that the majority in the House is shifting. With Democrats in control beginning next year, we expect Representative Frank Pallone from New Jersey to Chair the House Energy and Commerce Committee, the committee with jurisdiction over the cosmetics reform. Representative Pallone has prioritized reforming the law related to cosmetics regulations in the past, and we expect him to make it a priority for the committee in the next Congress.
On the Senate side, the change will be less dramatic, but there will still be some. Senator Lamar Alexander is expected to remain Chair of The Health Education Labor and Pensions (HELP) Committee, the Senate committee overseeing cosmetics laws. But with a bigger Republican majority, and the retirement of committee member Senator Orrin Hatch of Utah, there will be some new faces on the committee.
If anything is going to get done, it means that a bipartisan group of House members and Senators are going to have to agree on how to move forward. So far, that bipartisan consensus has eluded them, but we expect them to keep trying.
It will be important for handcrafted entrepreneurs and advocates to stay engaged moving forward. We’re planning some trips to DC to try and get the lay of the land in the next couple of weeks – we’ll keep you posted on what we hear.
July 2018
Pre-emption and the Discussion Draft
Since our last update, progress toward a “mark up” of a cosmetics regulatory reform bill has slowed down in the Senate, and time is running out if they are going to try and get it done this year.
At our last update, we described the process that Senators Lamar Alexander (R-TN) and Patty Murray (D-WA) had undertaken to advance a bill through the HELP committee, which they lead for their parties, respectively. They had published a “discussion draft” that was quite favorable in its treatment of small business, but still left some policy questions open. Chief among those open items was that the discussion draft did not address federal pre-emption of state laws.
Pre-emption is the concept that federal authority supersedes state authority where that authority hasn’t been explicitly delegated to the states. Where it becomes tricky is when states enact laws on a subject – like cosmetics regulations – prior to the federal government passing or updating its own laws and regulations. In that case, the question of allowing previously enacted state laws to remain intact and enforced, and not become pre-empted by a new federal law, becomes an issue.
In the case of cosmetics regulations, several states have acted to strengthen their regulatory regimes in advance of federal government acting and they want to keep those laws in place even if the federal government enacts new regulations which apply to the whole country. This is often an item of controversy when new rules are being considered in regulating an industry, and this time is no different, with many members of Congress insisting that a new federal provision should pre-empt existing state laws, while others hold the opposite position. So far, a compromise on this subject has not been reached.
While important to the handcrafted industry, we have not made pre-emption central to our cause, placing greater emphasis on ensuring other aspects of the proposed regulations worked for small businesses. When COHE and other handcrafted advocates signed on in support of Senators Feinstein and Collins’ proposed legislation, it contained a provision that would grandfather existing state laws; keeping them from being pre-empted by the new federal law. We continue to stand by our support of the Feinstein-Collins bill. We also believe, quite strongly, that the entire industry will benefit from a uniform federal standard.
On the House side, there is not a lot to report. While there is still discussion of members putting forward legislative ideas, there has been little tangible activity recently.
If new cosmetics legislation is to get enacted this year, something will have to happen fast. While we’re only a little past the middle of the calendar year, there isn’t a lot of time left on the legislative clock. There are several “must pass” pieces of legislation the Congress must contend with, including the budget, which is always controversial, and the Senate will be embroiled in the debate over the new Supreme Court nomination for some time. That to-do list, coupled with November’s elections, means that a consensus will need to be reached soon if cosmetics legislation is to stand a chance of passage this Congress.
We’re keeping our eye on the process and will keep you updated as we hear news.
March 2018
Mark-up on cosmetic reform legislation
Since our last update, there has been significant movement on cosmetics reform legislation in the Senate.
Chairman Lamar Alexander and Ranking Member Patty Murray of the Senate Health Education Labor and Pensions Committee (HELP) announced their intention to draft, or “mark-up”, cosmetics reform legislation on April 18. As part of that process they have sought input from other senators, as well as numerous stakeholders. As you know, we, along with our industry partners, have been very engaged in helping senators and their staffs understand the unique role the handcrafted industry plays in the cosmetics marketplace, and how changes to regulations could impact the handcrafted industry’s ability to remain viable and grow.
The good news is that our message concerning the need to protect small business continues to be heard. Senator Feinstein, Collins, and Hatch have introduced bills that accommodated the needs of small business. And in preparation for the mark up, the HELP Committee staff, on a bipartisan basis, released a “discussion draft” that included a $1 million dollar exemption for small businesses in complying with the most burdensome of the newly proposed reforms.
We still have work to do. Before any of this becomes law, it needs to pass out of committee and both houses of Congress, and get signed by the President. We need to keep our engagement level high in order to ensure that adequate protections for the handcrafted industry remain in place as this legislation moves through the process. And, as always, your voice will be an important one in this debate.
Thank you for all of the support and advocacy on this.
November 2017
New Bill Introduced
Senator Hatch from Utah has entered the cosmetics regulatory reform debate in a significant way, by introducing his own legislation, which he is calling the “FDA Cosmetic Safety and Modernization Act” It has been assigned the bill number, S.2003.
This is a much different bill than the Feinstein-Collins plan. Under Senator Hatch’s bill, small businesses would be exempt from registration if they are home based or have less than $1 million in “net” revenue. While “net” is not defined in the bill, it is a term that typically incorporates the deduction of certain costs of operation from the overall or “gross” amount of revenue a business takes in. In this way, Senator Hatch’s bill continues to recognize the importance of protecting small business from impacts that could harm their ability to grow.
Like the Feinstein-Collins bill, the Hatch bill does require small business to comply with the adverse event reporting requirements and also would obligate producers to provide contact information so that consumers can contact the manufacturer in the instance of an adverse event. The bill also has a GMP requirement, but, if adopted, would require the Secretary of Health and Human Services to come up with special guidance for small business and extra time for compliance. The bill also calls for research into the safety of cosmetic ingredients.
Significantly, Senator Hatch’s bill does not include many of the other components of the Feinstein–Collins effort such as ingredient uploading, safety substantiation, and perhaps most significant, fees.
Congress’ plate is pretty full for the remainder of the year with budget and tax related issues so we don’t expect to see near term action on this, but we will continue to monitor.
While we continue to believe that our industry is among the most safe industries in the world and do not believe additional regulation of our industry is necessary, we recognize that legislation is moving and we must continue to monitor the situation and advocate for the unique needs of the small manufacturer.
Do you have questions? We'll be holding a briefing call before the end of the year. Submit your questions to legislation (at) bramble berry (dot) com
We will have another briefing call as this process progresses and update you with any movement on this bill.
May 2017
Bill Introduced + briefing call SCHEDULED
As we’ve reported the last several months, Senators Collins and Feinstein have been working to re-introduce the Personal Care Products Safety Act. The handcrafted industry has been concerned about the negative impacts the previous version of the bill would have had on our industry.
Those concerns have been heard, and for the last several weeks representatives of the Coalition Of Handcrafted Entrepreneurs (COHE) and other handcrafted industry leaders from the Handcrafted Soap & Cosmetic Guild and the Handmade Cosmetics Alliance have been in discussion with the two Senators’ offices. After multiple meetings and hours exchanging ideas and proposals, we have been able to make significant improvements to the bill that will protect the handcrafted industry now and into the future.
Handmade cosmetic products are among the safest on the market and while we don’t believe further regulation of our industry is necessary, the exemptions we have been able to negotiate will allow small and emerging handmade cosmetic businesses to continue to produce quality products while continuing to support your families and Main Street jobs in communities across the country.
The negotiated proposed exemptions are as follows:
Very Small Businesses – Cosmetic producers with average annual sales of less than $500,000 (annually, over the previous 3 years) do not meet the bill’s definition of a facility and therefore are not subject to the provisions in the Act.
Private Residence – A private residence that meets the customary expectations of a private residence and with average annual sales of less than $1,000,000 (annually, over the previous 3 years) that is also used to manufacture, process, package and sell cosmetic products does not meet the definition of facility and need not register. The private residence exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Simplified Facility Registration – Small businesses with average annual sales of $500,000 to $2 million (annually, 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 consumer product line categories. The Simplified Facility Registration exemption does not extend to entities that produce products: (1) intended for application to the eye; (2) lip products containing color; (3) intended for internal use; and (4) alters the appearance for greater than 24 hours.
Good Manufacturing Practices - The Food and Drug Administration, in consultation with the Small Business Administration, will create simplified good manufacturing practices for small businesses that take into account the size and scope of the operation.
Serious Adverse Event Reporting – all serious adverse events – those causing serious bodily harm, disfigurement, or death – must be reported to the Food and Drug Administration.
In addition to the discussion regarding the substantive policies that would apply to small businesses, we also discussed some of our concerns about the process moving forward. We expressed our concerns that other members of Congress or stakeholders may not share the same commitment to protecting small businesses and might look to water down or alter the small business provisions we have jointly crafted. We were assured by Senators and their staff that they would fight for these provisions in their entirety throughout the duration of the legislative process.
Again, while we do not believe additional regulation of our industry is necessary, we recognize that legislation is moving forward no matter what. Thus, we believe that these adjustments represent meaningful progress for the handcrafted industry, and as such, are prepared to back the bill being introduced by Senators Collins and Feinstein. We will be holding a conference call next Thursday, May 18 at 11am PST to provide additional details and answer questions you have.
While this is a long way from over, we would not have been able to make the progress we have without your support and effort these last several years.
Do you have questions? We’re holding a call and would love to answer them.
Thursday, May 18, 2017
11:00am PST
Conference dial-in number:
+1 712-832-8327
Participants access code:
375 5598
Some users will hear a recording saying that they may be charged $0.01/minute. This is dependent upon some people’s cell phone plans that may not include conference calls.
We will have another briefing call as this process progresses and update you with any movement on this bill.
February 2017
update + briefing call SCHEDULED
Representative Pete Sessions of Texas has re-introduced legislation, H.R. 575 or the “Cosmetics Modernization Amendments of 2017”, that would amend existing laws regarding cosmetics regulations. The bill is nearly identical to the one he introduced last Congress, “The Safe Cosmetics Modernization Act.” H.R. 4075 The effort by Representative Sessions is the first of what is sure to be several initiatives that have the potential to impact the handcrafted industry.
As you’ll recall, Senators Feinstein of California and Collins of Maine introduced cosmetics regulation legislation during the last Congress as well, and the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the subject. We have expressed concerns about the impacts that the approach taken by Senators Feinstein and Collins would have on small businesses, particularly those of us in the handcrafted industry.
The bill crafted by Representative Sessions is much better for the handcrafted industry and contains specific provisions designed to lessen the impact on the entrepreneurs in our industry who are trying to grow their businesses. Significantly, the Sessions bill exempts any manufacturer operating out of their home and also provides an exemption for any business making less than $1 million in revenue. The Feinstein-Collins bill only exempted businesses making less than $100,000. The $1 million threshold is more reasonable and is in alignment with other rules that the FDA has recently developed for the Food Safety Modernization Act.
Other components of the Sessions bill, including ingredient reporting, safety substantiation, and adverse event reporting are all written in a way that will make it easier for businesses to comply, while ensuring consumers that the products they purchase and use are safe. Also, and very importantly, the bill does not impose fees on small businesses to pay for the implementation of these provisions.
We expect Senator Feinstein and Collins to introduce their bill again this Congress, and we also anticipate a companion to that bill to be introduced in the House.
We're are continuing to advocate for the unique needs of the handcrafted industry and will keep monitoring developments as Congress continues its work on this important issue.
We'd like to touch base with you at the beginning of the year to review 2016 and discuss what we expect in 2017. We have scheduled a briefing call on February 16 at 11 a.m. PST/2 p.m. EST.
Dial-in: 712-832-8327
Access Code: 6344642
November 2016
update + briefing call SCHEDULED
This is a brief update to bring you up to speed on legislative issues regarding potential cosmetic regulatory reform. While there wasn’t much formal progress on cosmetics reform legislation, it was a busy fall for our issue.
The Senate Health, Education, Labor and Pensions (HELP) Committee held its cosmetics hearing in September, and while no announcements were made, it appeared that there was a consensus on the part of senators who participated in the hearing that they would attempt to pass legislation at some point in the future. Senators Collins (R-ME) and Feinstein (D-CA) continue to push their legislation, S.1014, the so-called “Personal Care Products Safety Act.” Representatives Frank Pallone and Leonard Lance, both of New Jersey, continue to work on the “discussion draft” they released in September.
While we don’t expect legislation to advance during the lame-duck session of Congress when members return in December, we expect both the House and Senate to work on cosmetics reform legislation next year.
We'd like to touch base with you at the beginning of the year to review 2016 and discuss what we expect in 2017. We have scheduled a briefing call on February 16 at 11 a.m. PST/2 p.m. EST.
Dial-in: 712-832-8327
Access Code: 6344642
If you have any questions to submit for the briefing, please submit them through the Contact Us page here.
September 2016
Discussion Draft + Hearing Scheduled
A lot has been happening in a short amount of time. COHE was back in Washington, DC this week and the timing coincided with some major events in the cosmetic regulatory reform discussion on Capitol Hill.
First off, Representatives Frank Pallone and Leonard Lance, both of New Jersey, released what they are calling a regulatory reform bill “discussion draft” on Wednesday, September 14. We are going to spend more time analyzing the draft, but on first read, we have some pretty serious concerns. While there are some common sense measures contained in the bill, we are very concerned about many of the proposed measures and their potential to impact the handcrafted industry in a deeply negative way. We are especially concerned at the exemption levels for regulatory compliance and fees, but also the sweeping new demands and expenses that would be placed on small business owners to comply with the proposed new requirements.
Second, while we were meeting in the Senate, we were informed that the Senate will be holding its first hearing on this issue next week, Thursday, September 22. The hearing is titled “Exploring Current Practices in Cosmetic Development and Safety” and is scheduled to be held at 10:00 AM eastern time. For those of you who are interested, you can watch the hearing online here: https://www.help.senate.gov/hearings/exploring-current-practices-in-cosmetic-development-and-safety.
While we were in DC we had a number of very productive meetings with member offices, both Democrat and Republican, in both the House and the Senate. All are interested in hearing about our industry and committed to working with us to protect our craft and our livelihoods.
We’ll have more updates next week as events continue to unfold.
As always, thanks for your interest and thanks for your involvement in helping to ensure that the industry we love can continue to thrive.
February 2016
Short update on lay of the land
Happy 2016! I wanted to provide our coalition with a quick update as we kick off what is sure to be an exciting year.
There were two bills – one in the House and one in the Senate – introduced last year having to do with reforming cosmetics regulations, and we closed out last year with a trip to Capitol Hill to talk with the offices of key legislators regarding how that legislation would affect the handcrafted industry and to gain insight into what they anticipate for this year. It was a good trip and we covered a fair amount of ground.
While Congress has a short window to accomplish things this year due to the election, we’re going to continue to stay on top of it because it feels like activity is growing around our issue.
On a safety and compliance note, the FDA continues to enforce and monitor cosmetics, including home-based businesses. One Washington based home cosmetic and toiletry manufacturer recently received a surprise inspection of her home-based manufacturing space. Read more about that visit and compliance tips here.
We’ll continue to keep you up to date on our activities and what we hear.
November 2015
Pete Sessions Introduces H.R. 4075,
The Safe cosmetics modernization act
Representative Pete Sessions of Texas has introduced H.R. 4075, “The Safe Cosmetics Modernization Act”, the latest development in the ongoing discussion in DC about modernizing the rules and regulations for cosmetics manufacturing.
As you’ll recall, Senators Feinstein of California and Collins of Maine introduced cosmetics regulation legislation earlier this year. At the time, we expressed concerns about the impacts that their legislation would have on small businesses, particularly those of us in the handcrafted industry.
The bill crafted by Representative Sessions is much better for the handcrafted industry and contains specific provisions designed to lessen the impact on the entrepreneurs in our industry who are trying to grow their businesses. Significantly, the Sessions bill exempts any manufacturer operating out of their home and also provides an exemption for any business making less than $1 million in revenue. The Feinstein-Collins bill only exempted businesses making less than $100,000. The $1 million threshold is much more reasonable and is in alignment with other rules that the FDA has recently developed for the Food Safety Modernization Act.
Other components of the Sessions bill, including ingredient reporting, safety substantiation, and adverse event reporting are all written in a way that will make it easier for businesses to comply, while assuring consumers that the products they purchase and use are safe. Also, and very importantly, the bill does not impose fees on small businesses to pay for the implementation of these provisions.
We're are continuing to advocate for the unique needs of the handcrafted industry and will keep monitoring developments as Congress continues its work on this important issue.
August 2015
The Coalition of Handcrafted Entrepreneurs (COHE) Visits Washington, DC
COHE recently visited Washington DC for some targeted meetings around the Personal Care Products Safety Act (S 1014). We spent considerable time on the House side. No news yet on when (or if) a House bill will be dropped, but it didn't happen before Congress recessed for their August break. Activity will pick up again once Congress returns in September, and we will continue to track and engage.
We also spent time in the Senate, where we are engaging member offices' to help us to encourage the Small Business Administration to assist us in better understanding the impacts to small businesses of the legislation proposed by Senators Feinstein and Collins and make the case for better protections for the handcrafted industry.
We also spent considerable time with the Majority and Minority staffs on the Senate Health Education Labor and Pensions (HELP) Committee to articulate to them the problems we have with the current draft and understand from them how the Committee intends to approach this issue.
Look for additional updates and news when we get more feedback. With your help, our voice is being heard. If you haven't taken a moment to educate your elected officials about how important handcrafted beauty and soap products are to you - either as a consumer or a small-batch producer - that information (including an easy way to look up your elected official and their contact information and basic letter structure) is here.
April 2015
The Coalition of Handcrafted Entrepreneurs (COHE) Responds to the Introduction of The Personal Care Products Safety Act
In an effort to update the nation’s regulations of personal care products, Senators Diane Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act. The Act as drafted is broad in scope and potential impact for consumers and every sector of the personal care products industry.
While the proposed legislation makes attempts to accommodate the needs of small business, COHE believes it must go further to take into account the thriving small business sector in the personal care space. This group of mostly women-owned small businesses is driving choice in the marketplace and producing safe soap and beauty products. Any new regulatory regime contemplated for the cosmetics industry should recognize the unique role and needs of the handcrafted industry, as well as the choice the industry provides for consumers.
COHE appreciates the efforts the senators made to recognize the importance of small businesses, but believes there is more that should be done to ensure the continued vitality of this important sector of the industry.
In response to the introduction of the bill, COHE President Anne-Marie Faiola, said, “The handcrafted industry strongly believes in consumer safety and the integrity of the personal care products used by Americans. In fact, that’s how many handcrafted businesses get started – by people who want to know exactly what ingredients are used to create their personal care products and ensure that they are of the highest quality.” Faiola went on to say, “We appreciate the effort by Senators Feinstein and Collins to update cosmetics regulations to reflect today’s diverse marketplace, but we believe more needs to be done to recognize the handcrafted industry, the economic opportunity and jobs we create, and the choice we offer consumers. We will continue our efforts to improve the legislation to achieve that outcome.”
January 2015
While the last Congress wound down without a bill being dropped, we expect Senator Feinstein to continue to explore crafting legislation affecting the cosmetics industry. And while we appreciate the efforts Senator Feinstein and her staff have made so far to accommodate small businesses, COHE believes we must do everything we can to ensure that the Congress avoids placing undue burdens on small businesses or erect substantial barriers to entry and growth.
And while no bill has been introduced, the discussion and activity around this issue is an indication that the Congress remains interested in exploring changes to cosmetics regulations continues and we’ve got to be vigilant in explaining how changes could affect our industry if and when a bill moves forward.
December 2014
Director Anne Marie Faiola provided feedback to Senator Feinstein’s staff regarding their ideas for changing cosmetics regulations. She indicated that while the craft cosmetics and soap industry fully supports legislative provisions that close existing loopholes and ensures transparency for the consumer, the unique nature of the industry requires accommodations in order to protect it as well as the jobs and economic development the industry supports. Specifically, she focused on three key areas: exemption levels, ingredient and product testing and reporting, and adverse event reporting.
Fall 2014
The COHE team, led by Director Anne Marie Faiola, spent time in DC making the rounds. In particular, we spent considerable time engaged with Senator Feinstein’s staff as they worked to prepare draft legislation.