New US FDA regulations for Bath & Body

[AliOop]

The good manufacturing process thing is the only part that would include inspections and that's section 606, which does not apply to small businesses . We're not facilities under that. No registration , no GMP enforcement .

In fact a text search for the word inspection only comes up with records inspection if a product is found to be adulterated , or upon causing a serious adverse health event (i.e., if someone dies or is hospitalized or the like, from your product). Which seems right & proper, and also vanishingly rare.

My reading was that they could conduct inspections related to adverse events, but maybe I'm assuming too much there?

 

[paradisi]

My reading was that they could conduct inspections related to adverse events, but maybe I'm assuming too much there?

All I see is *records* inspections. And remember, a serious adverse event is a big hairy injury, or death; not something I've ever heard of a small crafter's product ever causing.

If you're (general you) making a product that can cause death or hospitalization, you're not making a product I've ever heard of a US home crafter selling to the public and a site inspection would be the least of your worries.

 

[paradisi]

An infection I could see happening from an ill preserved lotion, but am not aware of the FDA having had to intervene in such a case. It may have happened , don't know.

 

[paradisi]

But those are all good questions to ask; the more clarity, the better; the COHE (Coalition of Handcrafted Entrepreneurs) and Marie Gale seem like places to start.

 

[MelissaG]

It says facilities are subject to inspections. So how can small businesses not be facilities but still be subject to inspections? I'm confused. The labeling is a whatever kind of thing, it just makes the font size smaller. Also, I thought small businesses are exempt from registration, so how would they know to inspect us?

 

[paradisi]

It says facilities are subject to inspections. So how can small businesses not be facilities but still be subject to inspections? I'm confused. The labeling is a whatever kind of thing, it just makes the font size smaller. Also, I thought small businesses are exempt from registration, so how would they know to inspect us?

We're not subject to inspections. Nor registration . Unless you make over a million a year or whatever that astronomic level is.

If one injures someone in an adverse event, their *RECORDS* are subject to inspections .

The facilities inspections mentioned in this law (which covers enormously more than cosmetics) are for drug making facilities.. overseas ones.

 

[MelissaG]

Paradisi, you're awesome.

 

[AliOop]

Paradisi, you're awesome.

Agreed!!

 

[paradisi]

Oh you folks are making me blush. I'm glad to try to be helpful and spread hope not fear.

 

[olivia322]

Any more news on this one?

 

[paradisi]

Some of the MOCRA features are being implemented as scheduled, but some are having delays.

The allergens in fragrance list hasn't been released yet, and there will be a comment period after that, so labeling implementation is still waiting.

Substantiation of safety still hasn't been detailed, though I think the largest firms will be just doing what they've been doing (they have facilities & budget for testing etc.) and ... purely my assumption... the FDA don't seem to have put a lot of energy yet into describing the methods of substantiation they'd require from the home businesses, which are a tiny % of cosmetics made in the US. Sort of the least of their worries at the moment, probably working out the kinks on the businesses affecting the most consumers first.

There was supposed to be a list of most common cosmetics ingredients and their safety, put out by the Guild, I think, for small business documentation, but if it's out yet I have missed it. Thanks for the reminder, I'll check.

So as far as I am aware, nothing much new on our end of the spectrum.

And as always, a US soaper who only makes & sells true soap, with no cosmetics claims, is exempt from *cosmetics* regulations.

 

[paradisi]

Some of the MOCRA features are being implemented as scheduled, but some are having delays.

The allergens in fragrance list hasn't been released yet, and there will be a comment period after that, so labeling implementation is still waiting.

Substantiation of safety still hasn't been detailed, though I think the largest firms will be just doing what they've been doing (they have facilities & budget for testing etc.) and ... purely my assumption... the FDA don't seem to have put a lot of energy yet into describing the methods of substantiation they'd require from the home businesses, which are a tiny % of cosmetics made in the US. Sort of the least of their worries at the moment, probably working out the kinks on the businesses affecting the most consumers first.

There was supposed to be a list of most common cosmetics ingredients and their safety, put out by the Guild, I think, for small business documentation, but if it's out yet I have missed it. Thanks for the reminder, I'll check.

So as far as I am aware, nothing much new on our end of the spectrum.

And as always, a US soaper who only makes & sells true soap, with no cosmetics claims, is exempt from *cosmetics* regulations.

The fragrance allergen list was due June 29, they said in July it would be in October. They'd better get cracking if they hope to meet that deadline.

I saw in one interview on the safety substantiation topic that supposedly the FDA doesn't intend to issue more rules on that.

I follow fda cosmetics on twitter and no news there.

Oh, and no ingredients list out yet from the Guild either. Perhaps they've forgotten .