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Under FDA’s new Cosmetic Reg. authority
Re. regulation for the sake of regulation - and litigation lawyers, I imagine most here will be partially exempt as small businesses (avg < 1 million in gross sales over last three years).
You’ll still need to:
1) adverse events - maintain records and report serious reports
2) comply to “simplified” GMP’s - FDA has to write ’em (they’ve got 2 years)
3) maintain records justifying product safety - safe is not defined
4) label fragrance allergens (18 months) and contact info for “responsible party”
5) FDA can demand your records (if they have a concern for product safety). Other general food reg’s may cover this to allow any demand. -
8 Replies
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So adopting what the EU is doing & what big companies already do. Killing the middle sized guy I guess.
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Right Perry.
The big guys and PCPC are all in support - allegedly because it preempts the states. That mid sized guys are screwed with useless paperwork and administrative burden is just “sad” collateral damage. -
I read through the entire magilla last week and reckoned same. Made me think I may earn more compliance consulting gigs in my post-retirement years. BTW, the following mammoth section of the same bill deals with holding human clinical trial managers responsible for inclusivity/diversity protocols being met in their trials. Why? No science involved there, just politics.
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@chemicalmatt
Thanks for the details - what total garbage. -
@chemicalmatt
Did you see any funding for the FDA to cover these new responsibilities. -
Affirmative, they include some numbers near the end. A few million this year, a few million more the year after, etc., Etc.
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Is there a list of fragrance allergens which would have to be included on packaging?
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@GeorgeBenson
Not yet - FDA has one year to generate.
I’d look at what’s in Cosm Directive.
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