New US FDA regulations for Bath & Body

[paradisi]

The US Congress passed a new law updating cosmetics regulations, which include all bath & body except true soap. It's called the Modernization of Cosmetics Regulation Act of 2022.

Small businesses are exempt from part, but not all of the changes.

What will apply to all makers: safety will have to be substantiated (they haven't decided how yet), severe adverse reactions reported, and fragrance allergens listed on labels. Those haven't been decided on yet either; the FDA has until December 2024 to come up with rules on both.

Newly Passed Law Tightens US Cosmetics Regulations

Modernization of Cosmetics Regulation Act of 2022
Text - H.R.2617 - 117th Congress (2021-2022): Consolidated Appropriations Act, 2023 | Congress.gov | Library of Congress
https://www.congress.gov/bill/117th-congress/house-bill/2617/text

 

[AliOop]

Thank you for sharing this!

 

[Arimara]

A lot of people may not like what is going to come out of that. Oh well.

 

[BWt]

The US Congress passed a new law updating cosmetics regulations, which include all bath & body except true soap. It's called the Modernization of Cosmetics Regulation Act of 2022.

Small businesses are exempt from part, but not all of the changes.

What will apply to all makers: safety will have to be substantiated (they haven't decided how yet), severe adverse reactions reported, and fragrance allergens listed on labels. Those haven't been decided on yet either; the FDA has until December 2024 to come up with rules on both.

Newly Passed Law Tightens US Cosmetics Regulations

Modernization of Cosmetics Regulation Act of 2022
Text - H.R.2617 - 117th Congress (2021-2022): Consolidated Appropriations Act, 2023 | Congress.gov | Library of Congress
https://www.congress.gov/bill/117th-congress/house-bill/2617/text

Thank you for posting this. Excellent info to know.

 

[paradisi]

A lot of people may not like what is going to come out of that. Oh well.

I'm not wild about the probable costs for the safety proof compliance for tiny businesses, myself. Labeling looks to be straightforward, just need to wait for the lists.

But I don't see the mass benefit to public health in the US of making tens or hundreds of thousands of people each get their lip balm formula approved, and their bath bomb formula, and their lotion bar formula, their bath salts formula.. anhydrous things with many decades of safe use.

The time, paperwork & likely expense to individuals and agencies would be imo ludicrous. And the opportunity for empire building by assesors looking to gouge Mom & Pop size businesses.

If it can be done along the lines of the OTC monographs, or the USDA health district procedures in many states where jams, breads, fruit pies & such are classed as 'non potentially hazardous', that would be good.
To me, a catalog of classes of items like that which would receive status like GRAS for food would make sense.

Things requiring preservatives would be different -- though there too, cosmetics in the US have the best safety track record of everything the FDA oversees already. It's not like crowds of people are being injured by Sally and Ted and the stuff in their Etsy shops.

Recalls I've seen reported are usually imported commercial products found to contain things like mercury or having no or ineffective preservative. .. not lotion from a craft fair seller.

So I'm concerned this might be implemented with a hammer to the small fry but with no net benefit to the consumer.

The indie cosmetics industry has some advocates like the HMSG and I expect they will have comments and suggestions for the FDA as the new rules get written, to try to keep micro businesses from being impossibly burdened. And individuals will be able to comment as well.

 

[Arimara]

I'm not wild about the probable costs for the safety proof compliance for tiny businesses, myself. Labeling looks to be straightforward, just need to wait for the lists.

But I don't see the mass benefit to public health in the US of making tens or hundreds of thousands of people each get their lip balm formula approved, and their bath bomb formula, and their lotion bar formula, their bath salts formula.. anhydrous things with many decades of safe use.

The time, paperwork & likely expense to individuals and agencies would be imo ludicrous. And the opportunity for empire building by assesors looking to gouge Mom & Pop size businesses.

If it can be done along the lines of the OTC monographs, or the USDA health district procedures in many states where jams, breads, fruit pies & such are classed as 'non potentially hazardous', that would be good.
To me, a catalog of classes of items like that which would receive status like GRAS for food would make sense.

Things requiring preservatives would be different -- though there too, cosmetics in the US have the best safety track record of everything the FDA oversees already. It's not like crowds of people are being injured by Sally and Ted and the stuff in their Etsy shops.

Recalls I've seen reported are usually imported commercial products found to contain things like mercury or having no or ineffective preservative. .. not lotion from a craft fair seller.

So I'm concerned this might be implemented with a hammer to the small fry but with no net benefit to the consumer.

The indie cosmetics industry has some advocates like the HMSG and I expect they will have comments and suggestions for the FDA as the new rules get written, to try to keep micro businesses from being impossibly burdened. And individuals will be able to comment as well.

I was definitely thinking of vendors that repeatedly market and sell with less-than-ethical methods. but I do have to disagree a bit with testing. Anhydrous items aren't any safer due to lack of water if people still use ingedients that can be questionable. I think EOs in particular should be scrutinized more and regulated for quality and consistency.

 

[MelissaG]

Does this mean we will need to get our recipes approved like they do in the UK?

 

[Johnez]

Does this mean we will need to get our recipes approved like they do in the UK?

This is the question I was wondering.

 

[MelissaG]

This is the question I was wondering.

Also, am I reading this right in that we will need to go through annual inspections of the location we make them? And does that mean we can't make them in our kitchens anymore? What about small micro businesses like me where I make about $800 a month? How does that impact me? I just broke even last year. Increasing my cost will make things much more difficult. Where is this registration thing that we are supposed to sign up for? Is my kitchen considered a "facility"? Do I have to have a dedicated room with nothing else in it but my business stuff? I can only see this hurting small businesses.

Does the FDA really have the man power to investigate the many many thousands of micro businesses every year or twice a year or even every couple of years?

The labeling stuff is stuff I already do so not a big deal. If I had the money, I'd join the HSCG now just to keep up with everything.

 

[paradisi]

Does this mean we will need to get our recipes approved like they do in the UK?

We don't know yet. That part won't be known til they put it out for comments and adjustments.

So now's the time to contact HMSG etc with questions & ideas, and one's Reps/Senators.

 

[Zany_in_CO]

A few years ago when this Cosmetic Regulation Act was being discussed, Debbie May, President of WSP collected money to pay for a representative to lobby congress. She asked customers to donate change by rounding up the total on our orders. Which, I for one, was happy to do.

She and the president of HSCG were actively advocating for small handcrafted business. Debbie May is retired now. The last I heard was that the new regulations would apply to those who sold $1,000,000 a year and above.

Read more: HSCG ADVOCACY

 

[paradisi]

No on inspections or registrations.

Also, am I reading this right in that we will need to go through annual inspections of the location we make them? And does that mean we can't make them in our kitchens anymore? What about small micro businesses like me where I make about $800 a month? How does that impact me? I just broke even last year. Increasing my cost will make things much more difficult. Where is this registration thing that we are supposed to sign up for? Is my kitchen considered a "facility"? Do I have to have a dedicated room with nothing else in it but my business stuff? I can only see this hurting small businesses.

Does the FDA really have the man power to investigate the many many thousands of micro businesses every year or twice a year or even every couple of years?

The labeling stuff is stuff I already do so not a big deal. If I had the money, I'd join the HSCG now just to keep up with everything.

 

[paradisi]

Eo quality is a separate thing from cosmetics manufacturing. Unless you are distilling and using your own eo's.

I've yet to see any truly anhydrous item correctly packaged become a disease vector like the current eyedrops that are blinding and killing people.

I was definitely thinking of vendors that repeatedly market and sell with less-than-ethical methods. but I do have to disagree a bit with testing. Anhydrous items aren't any safer due to lack of water if people still use ingedients that can be questionable. I think EOs in particular should be scrutinized more and regulated for quality and consistencis a separate

 

[MelissaG]

We don't know yet. That part won't be known til they put it out for comments and adjustments.

So now's the time to contact HMSG etc with questions & ideas, and one's Reps/Senators.

Given I know my senators, that will NOT happen. They are useless. But I will be asking HSCG. I just signed up for their newsletter. Wish I could sign up for a membership with the guild but $200 a year is beyond me right now.

 

[paradisi]

No, tiny ops are still exempt from those new GMP rules and site registration. We're not 'facilities' under this rule.

The parts of this change that apply to the average Etsy seller type crafter are the labeling changes (allergens listing; those are still to be chosen) and severe adverse event reporting, and substantiation of safety. ("Severe" is defined in the rule and I'd be shocked if there was ever such a reaction to a home crafted item, especially an anhydrous one.)

*How* the safety is substantiated is yet to be determined. Tests? Assessment? Documentation? Industry and manufacturer guidelines?
What about that formula you bought on Etsy? Will you be responsible for the safety of products made by people who buy your formula on Etsy, from your blog? Etc.

So we can have input on that now and when the rules get put out for public comment.

I subscribe to FDA recalls by email and on twitter, and the only cosmetic ones I can remember in the past few years that weren't food or medical were the bath gel or micellar water, whatever it was, from Walmart last fall that was contaminated (poor preservation) and nobody had died from that. There have been others also due to poor preservation of hydrous products.

The lack of recalls for anhydrous products by comparison is why I personally favor a tiered approach.

Also, am I reading this right in that we will need to go through annual inspections of the location we make them? And does that mean we can't make them in our kitchens anymore? What about small micro businesses like me where I make about $800 a month? How does that impact me? I just broke even last year. Increasing my cost will make things much more difficult. Where is this registration thing that we are supposed to sign up for? Is my kitchen considered a "facility"? Do I have to have a dedicated room with nothing else in it but my business stuff? I can only see this hurting small businesses.

Does the FDA really have the man power to investigate the many many thousands of micro businesses every year or twice a year or even every couple of years?

The labeling stuff is stuff I already do so not a big deal. If I had the money, I'd join the HSCG now just to keep up with everything.

 

[MelissaG]

A few years ago when this Cosmetic Regulation Act was being discussed, Debbie May, President of WSP collected money to pay for a representative to lobby congress. She asked customers to donate change by rounding up the total on our orders. Which, I for one, was happy to do.

She and the president of HSCG were actively advocating for small handcrafted business. Debbie May is retired now. The last I heard was that the new regulations would apply to those who sold $1,000,000 a year and above.

Read more: HSCG ADVOCACY

Ohhh thank you thank you zany. I was freaking out. It really seems like something that would effect the big companies, not the little ones.

 

[paradisi]

I'd love that to be true but don't see
an exemption from the safety substantiation for small businesses in the bill as it became law. Can someone point me to it?

A few years ago when this Cosmetic Regulation Act was being discussed, Debbie May, President of WSP collected money to pay for a representative to lobby congress. She asked customers to donate change by rounding up the total on our orders. Which, I for one, was happy to do.

She and the president of HSCG were actively advocating for small handcrafted business. Debbie May is retired now. The last I heard was that the new regulations would apply to those who sold $1,000,000 a year and above.

Read more: HSCG ADVOCACY

 

[Johnez]

I'd love that to be true but don't see
an exemption from the safety substantiation for small businesses in the bill as it became law. Can someone point me to it?

https://www.akerman.com/en/perspect...gulatory,of cosmetic products and facilities.
8) Small Business Exemptions
The exemptions offer small businesses flexibility, simplified requirements, and a longer compliance period. For example, certain small businesses may be exempt from CGMP, facility registration, and product listing requirements. And as for the event records retention, some small businesses will need to maintain records for only three years rather than six years.

 

[Johnez]

Also these guys have a detailed PDF:
https://www.afslaw.com/perspectives/alerts/modernization-cosmetics-regulation-act-2022

Small Businesses (Effective date: December 29, 2022)
− Responsible persons, and owners and operators of facilities, whose average gross annual sales in the
United States of cosmetic products for the previous three-year period is less than $1,000,000, adjusted for
inflation, and who do not engage in the manufacturing or processing of the cosmetic products described
below, shall be considered small businesses and not subject to the MoCRA requirements regarding good
manufacturing practices, facility registration, and product listing.
− The above exemption does not apply to any responsible person or facility engaged in manufacturing or
processing any of the following products:
o Cosmetic products that regularly come into contact with mucus membrane of the eye under
conditions of use that are customary or usual.
o Cosmetic products that are injected.
o Cosmetic products that are intended for internal use.
o 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.

Curious about the cosmetics rules as it applies to shave soap. From the looks of it we should be able to manufacturer it without too much hassle.

 

[paradisi]

Here it is.. the small business exemptions are for GMP (606) and 607 (registration) only. The rest apply including safety and labeling.