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.