Home Cosmetic Science Talk Cosmetic Industry Modernization of Cosmetics Regulation Act of 2022 (MOCRA) …. How far reaching?

  • Modernization of Cosmetics Regulation Act of 2022 (MOCRA) …. How far reaching?

    Posted by graillotion on January 9, 2023 at 7:36 pm

    I was just curious, how far reaching are the aspects of the new regulations?  (In regards to registration of facility.)  Will this create a ‘Mommy blogger bootlegging network’, or a ‘Dark Web cosmetic supply line’?  ;)

    Does this reach down to the home-crafter that produces a 100 units a year?  If not…where is the cutoff point?

    Aloha

    PhilGeis replied 1 year, 1 month ago 4 Members · 20 Replies
  • 20 Replies
  • oldperry

    Member
    January 9, 2023 at 7:39 pm

    I think this only applies to sellers of $1 million a year or more, but I haven’t read the legislation.

  • graillotion

    Member
    January 9, 2023 at 7:40 pm

    Perry said:

    I think this only applies to sellers of $1 million a year or more, but I haven’t read the legislation.

    Thank you….and BUMMER!

  • PhilGeis

    Member
    January 9, 2023 at 8:52 pm

    Part s that do not appl to < 1 mill annually - registration and formal GMP’s.  FDA will develop small business GMP’s.

    Adverse event record keeping, documented safety assessment and labeling change are for everyone.

  • graillotion

    Member
    January 9, 2023 at 8:56 pm

    PhilGeis said:

    Part s that do not appl to < 1 mill annually - registration and formal GMP’s.  FDA will develop small business GMP’s.

    Adverse event record keeping, documented safety assessment and labeling change are for everyone.

    I was so hoping for some barrier to entry, for the incompetent! 

    What exactly is: documented safety assessment?

    Is that the barrier I am hoping for?

  • PhilGeis

    Member
    January 9, 2023 at 10:19 pm

    Prob not
    Section 608 requires Responsible Persons to ensure, and maintain records supporting, “adequate substantiation” showing a cosmetic product is “safe,” and establishes a safety standard that products must meet in order to be marketed in the U.S. MOCRA defines “adequate substantiation of safety” as meaning “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.”

    Cosmetic products that do not have adequate safety substantiation will be considered adulterated under section 601 of the FDCA.

  • PhilGeis

    Member
    January 9, 2023 at 10:20 pm

    Dont think EWG’s BS will pass but i bet those guys will sell something as shallow but looks better.

  • markbroussard

    Member
    January 9, 2023 at 11:57 pm

    It would have made more sense to just require a Safety Assessment ingredient review by a qualified Safety Assessor as is done in the EU.  But, I guess that would have just made it all too clear as to what exactly was required.

  • oldperry

    Member
    January 10, 2023 at 12:09 am

    @MarkBroussard - The Etsy sellers wouldn’t want that and a large swath of our population would squawk about government regulatory overreach. It still amazes me how unregulated the Supplement industry is.

  • PhilGeis

    Member
    January 10, 2023 at 12:45 am

    @MarkBroussard
    There will be plenty of $$ services to fill the gap.  Be glad they didn’t include a California-style bounty hunter clause.

  • graillotion

    Member
    January 10, 2023 at 2:32 am

    It would have made more sense to just require a Safety Assessment ingredient review by a qualified Safety Assessor as is done in the EU.  But, I guess that would have just made it all too clear as to what exactly was required.

    That is EXACTLY what I was hoping for.  I am TOTALLY not the guy that wants government control of everything…actually the opposite.  However…after looking at INCI’s on ETSY products…and throwing up a little bit in my mouth….something must be done.

  • PhilGeis

    Member
    January 10, 2023 at 2:33 am

    @Graillotion
    those guys will get the least attention

  • markbroussard

    Member
    January 10, 2023 at 3:56 am

    @Graillotion

    The Etsy sellers are not exempt from the Safety Substantiation requirement.  The problem the way I see it is that the definition:  “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” could be anything from an HRIPT to a dossier of CIR Final Safety Reports of each ingredient in the product.

    But, @PhilGeis hit the nail on the head … Etsy sellers will only get attention from the FDA when complaints are filed regarding their products, which is pretty much the way it works at present.

  • PhilGeis

    Member
    January 10, 2023 at 12:15 pm

    The bill is legislation for legislation sake.  The lawmakers know nothing of Etsy - they can’t stand an industry that isn’t heavily regulated.  CFSAN (FDA division responsible for cosmetics) cares about food and knows about nothing of cosmetics. 
    For Safety Substantiation - I see a bunch of cynical “toxicologists” rubber stamping “SAFE” along the lines of EWG’s certification.  

  • graillotion

    Member
    January 10, 2023 at 11:08 pm

    Politicians…are lazy-a$$ bast@rds…. so that means….some lobbyist pushed this through…… Who was that?

    Did you mean….something like this @PhilGeis

  • PhilGeis

    Member
    January 11, 2023 at 11:37 am

    @Graillotion
    They’re some of my friends, so I’d be a bit kinder.
    Who pushed it through?  I know the big guys wanted federal preemption of California and other state crazies and got it here.  The rest of the bill is just what they’re doing now and it dumps on the rest of the industry.  Win Win.

    As for the moronic politicians - I spoke to the cos of the original model bill a few years back and asked “why?”.  response was - this is a unregulated category and we’re worried about things like Wen and hair loss.

  • oldperry

    Member
    January 11, 2023 at 1:31 pm

    Of course, beyond consumer complaints, there was no good evidence Wen caused hair loss. I contend it was the company’s sketchy business practices that caused the consumer complaints not the products themselves.

  • PhilGeis

    Member
    January 11, 2023 at 2:20 pm

    Of course there were ALL those hearings from experts and congressmen read every page before voting.

  • oldperry

    Member
    January 11, 2023 at 2:31 pm

    In their defense, wasn’t the bill was stuffed into another bill covering a much wider range of topics? It seems a pretty challenging job to be a politician.

  • markbroussard

    Member
    January 11, 2023 at 2:41 pm

    Why bother with hearings and actually reading the legislation when you can just stuff it into an essential large funding bill that always gets passed at the very last minute.  Saves every Congressman and Senator time and they get to be home for Christmas.

    As it regards small Etsy/Amazon sellers, I suspect the enforcement mechanism on the Safety Substantiation will fall on Etsy and Amazon.  Sellers will have to provide this info to Etsy and Amazon to get their product listed.  None of this is going to go into effect for another 3 years or so under any circumstances.

  • PhilGeis

    Member
    January 11, 2023 at 2:51 pm

    They accepted the fair accompli of 4000 pages.  It’s on them - but doubt they’d have read it if it was on its own

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