Home Cosmetic Science Talk Formulating Cosmetic Industry Modernization of Cosmetics Regulation Act 2022

  • Modernization of Cosmetics Regulation Act 2022

    Posted by PhilGeis on December 21, 2022 at 12:29 pm

    The act (https://www.congress.gov/bill/117th-congress/senate-bill/4348/text#toc-id892EB13582A94F5DAD4DA611C1E88DC4)  establishes GMP’s, registration of facilities, formal approval of ingredients, safety substantiation  etc.
    Small business are largely exempt (see below), BUT  NOT  from safety substantiation of products (“ensure and maintain records supporting”)-  
    “(1) ADEQUATE SUBSTANTIATION OF SAFETY.—The term ‘adequate substantiation of safety’ means tests or studies, research, analyses, or other 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.

    Exemption

    “(a) In General.—Responsible persons, and owners and operators of facilities, 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, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.

    “(b) Requirements Applicable To All Manufacturers And Processors Of Cosmetics.—The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:

    “(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.

    “(2) Cosmetic products that are injected.

    “(3) Cosmetic products that are intended for internal use.

    “(4) 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.

    PhilGeis replied 1 year, 2 months ago 4 Members · 13 Replies
  • 13 Replies
  • markbroussard

    Member
    December 21, 2022 at 4:28 pm

    @PhilGeis

    Thanks for posting this Phil.  Looks like Patty Murray is following up where Sean Patrick Maloney left off.

  • oldperry

    Member
    December 21, 2022 at 6:11 pm

    It seems like if they exempt small businesses, they are solving a problem that doesn’t exist. Aren’t big companies already following GMP, doing safety testing, etc? The etsy maker who whips things up in their kitchen and sells them on the Internet without any testing or quality control is exempt?

    If this passes, what problem does it exactly solve?

  • markbroussard

    Member
    December 21, 2022 at 6:25 pm

    @Perry:

    It looks like Adequate Substantiation Of Safety is the equivalent of the EU Safety Assessment and small businesses would not be exempt from this.

  • chemicalmatt

    Member
    December 21, 2022 at 6:33 pm

    Thanks for sharing the link here @PhilGeis. Looks like I should have gone into the HRIPT business before now, though I don’t know if I agree with @MarkBroussard. The word “exemption” seems pretty clear, unlike some of this bill’s wording.

  • PhilGeis

    Member
    December 21, 2022 at 7:24 pm

    @chemicalmatt @MarkBroussard
    Thanks! btw - I looked at FDA’s proposed 2022 budget and saw nothing to support all the new stuff this requires.   Maybe I missed it but this looks like an unfunded mandate.
    https://www.fda.gov/media/149616/download

    Last year FDA brought in an industry veteran to train them for cosmetic GMP’s so maybe they saw this coming.

  • PhilGeis

    Member
    December 21, 2022 at 7:33 pm

    @Perry
    Agree - big guys and PCPC supported the bill.  It preempts the California et al.  legislative crazies, and they’re already doing GMP’s, product safety substantiation, etc. and have a bunch of regulatory guys who can file paperwork.
    That this might generally even screw with the guys just over a million in sales could be in the back of their minds.

  • markbroussard

    Member
    December 21, 2022 at 8:11 pm

    Has this bill been voted on and passed Senate and House?

  • markbroussard

    Member
    December 21, 2022 at 8:39 pm

    @chemicalmatt

    Yes, the language has the typical clunkiness of government regulations

  • oldperry

    Member
    December 21, 2022 at 8:41 pm

    @MarkBroussard - No.  I doubt it will get very far. Once Republicans take over the house they’ll ignore it. I predict that unless Democrats control both houses of congress (with a workable majority) and the white house, there won’t be a bill like this that passes.  

  • markbroussard

    Member
    December 21, 2022 at 9:44 pm

    @Perry

    Yes, you are probably right.  Democrats in both houses have certainly made efforts to reform the cosmetics regulations

  • oldperry

    Member
    December 21, 2022 at 11:23 pm

    @MarkBroussard - have they? It seems more like “theater of regulation” than an actual effort to pass anything. But as long as the new regulations just reflect what big corporations are already doing, then it has a chance.  Perhaps I’m just too cynical. lol

  • PhilGeis

    Member
    December 22, 2022 at 1:57 am

    They’ve stuck it in  the Omnibus Spending  Bill - so it appears to be a go
    At >4000 pages so who would know it what else is in there - no doubt with a lot of pork, ear mark’s  and legislator pathways to millions.

  • PhilGeis

    Member
    December 22, 2022 at 8:41 pm

    https://www.khlaw.com/insights/omnibus-bill-fiscal-year-2023-hr-2617-cosmetics-summary?language_content_entity=en

    It’s in the budget bill that no one will read before or after they vote.

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