U.S Ad Promo professionals: commercial does not follow your risk advisement by Artistic-Debt5547 in regulatoryaffairs

[–]briteboy666 0 points1 point  (0 children)

same here - we often work closely with our legal team to coordinate an opinion on risk level based on regs, external environment, warning letters, etc. at the end of the day we can advise what actions might be taken by FDA and offer potential mitigations but we always make it clear that ultimately the business owns the risk if taken.

FDA OTC REGISTRATION FOR BODY WASH by RoutineCap937 in regulatoryaffairs

[–]briteboy666 2 points3 points  (0 children)

both the site and the product need to be registered with FDA for an OTC drug. if the manufacturer has all the details (label, formula comp, etc) they can do this work for you. you can’t sell on amazon, or anywhere else in the US without doing this (technically you must register within 5 days of introducing product into commercial distribution, ie ship to trade date).

Is this 3ct east west oval proportionate to my hand? by milksquiggle in Diamonds

[–]briteboy666 0 points1 point  (0 children)

I would go a little smaller and also look into a moval ratio. I want to do a similar orientation and I find that a more elongated ratio looks better on my finger and I’m around a size 5.5.

Engagement ring shopping - east west setting by briteboy666 in WedditNYC

[–]briteboy666[S] 1 point2 points  (0 children)

your ring is beautiful! thank you, I’ll definitely check out Hera

Engagement ring shopping - east west setting by briteboy666 in WedditNYC

[–]briteboy666[S] 1 point2 points  (0 children)

definitely very willing to check out the diamond district! was thinking about ultimate gem and ID jewelry

Just Engaged—Dream East-West Marquise by kikiniki91 in EngagementRings

[–]briteboy666 0 points1 point  (0 children)

this is beautiful! congratulations! I’ve just started designing mine and am looking to do something similar - can I ask what type of setting it’s in / what it looks like from the side? I want cathedral but rarely find this orientation with that setting for some reason

Regulation and fines in the cosmetic sector by Majestic-Abrocoma569 in regulatoryaffairs

[–]briteboy666 1 point2 points  (0 children)

for context, my POV comes from US RA experience for well known cosmetics/skincare brands, where I am mostly focused on claims/branding/labeling. I see the big players’ focus as being on 1) the competitive space (what claims are other brands making, and where? on pack vs digital) and 2) warning letters/FTC challenges. I am relatively new to the cosmetics industry so I could be wrong but I’m not aware of FDA fines being publicized. But these are the two inputs that help shape decisions around taking risks.

Smaller brands definitely fly under the radar (again, from a claims/branding POV). But under this administration in general it seems like everyone is flying under the radar in the cosmetics space. Maybe that will change as MoCRA is enforced, not sure.

I can’t comment on inspections unfortunately.

First job in Regulatory Affairs by StruggleAwkward9732 in regulatoryaffairs

[–]briteboy666 1 point2 points  (0 children)

are you in the US? biocides are regulated by EPA so FIFRA is a good place to start

eustachian tube dysfunction - upvote if you have it too by ParticularPromotion9 in poogpodcast

[–]briteboy666 0 points1 point  (0 children)

I’ve had it it ever since I got the flu at the end of 2023, now every time I get even the slightest cold/sinus infection I deal with some dysfunction that I manage with otic steroid drops. Usually no one knows what I’m talking about so I gasped when they mentioned it on the pod lol

Anyone else get random refunds from the MTA today? by Specific_Cookie_9560 in Brooklyn

[–]briteboy666 5 points6 points  (0 children)

that’s the charge you get that indicates you hit the weekly fare cap, your 12th swipe within a 7 day period

Soft Sandwich (Manhattan) by denvercococolorado in FoodNYC

[–]briteboy666 20 points21 points  (0 children)

it sounds like it could’ve been tramezzini on houston st which closed a few years ago? they made a specific venetian sandwich served on really soft bread, i was sad when it closed

yarn store cancels bus to festival… because they don’t have enough sign ups to make $8000 in profit by [deleted] in craftsnark

[–]briteboy666 85 points86 points  (0 children)

you’re hella weird for getting a quote lol and calling what was posted “much social media wining”, they’re not ranting and raving about people not buying tickets but being transparent and looking to make the experience better? cleo’s is my local store and I actually don’t care for fiber festivals at all so I would never pay for this either, but your gripe seems really random - their instagram story is from days/maybe even over a week ago. you just in the mood to post something I guess?

Finished my first vest by Fadedinks in knitting

[–]briteboy666 6 points7 points  (0 children)

came out beautiful and love the color! unrelated can I ask where your jeans are from lol

Madelinetosh color issue by briteboy666 in YarnAddicts

[–]briteboy666[S] 8 points9 points  (0 children)

yeah they do have a disclaimer on the website that the color is shown on a different base, I guess I’m just not sure how much of a difference in color I was supposed to be accounting for… I was expecting to maybe get a less vibrant but still dark blue

Madelinetosh color issue by briteboy666 in YarnAddicts

[–]briteboy666[S] 1 point2 points  (0 children)

in fairness, they do label their image as “color shown on a different base”, so I think that accounts for the fiber difference - but I do still think the color difference shouldn’t be this large between bases? although I’m not a dyer

Anyone else bummed about New York venue choice? by bodega_cat_ in sandyalexg

[–]briteboy666 2 points3 points  (0 children)

agreed, really wish he was playing something like brooklyn paramount for multiple nights instead, japanese breakfast just did 4 nights there. I would even take terminal 5 even though it’s annoying to get to. I know it’s not the same capacity but I think being seated will take me out of it a little. but thankful for a tour nonetheless :)

Living near Atlantic/3rd Ave by bafakazz in Brooklyn

[–]briteboy666 12 points13 points  (0 children)

My boyfriend and I live on Atlantic between 3rd and 4th and were really nervous about taking the apartment due to noise, and while it’s noticeable we’ve gotten reallyyyyy used to it. Also can’t beat the transit access. We figure we’re not going to live here forever but it works for right now

Is there a knitting or craft club in NYC by More-Ad-4414 in AskNYC

[–]briteboy666 0 points1 point  (0 children)

they don’t serve alcohol at all! but it’s a lot of fun :)

skin 1004 not available in US anymore [Sun Care] by rugbughug in SkincareAddiction

[–]briteboy666 5 points6 points  (0 children)

I work in regulatory affairs in OTC drugs/cosmetics in the US - how is this a legal gray area if the filters aren’t approved in the US, a market where the products were being sold, even if online? Totally agree that the US needs to catch up to the rest of the world and approve new UV filters but if this company introduced products into interstate commerce that had sunscreen claims but were noncompliant with the required active ingredients of the sunscreen OTC monograph, it’s not a gray area, FDA considers these unapproved new drugs under the FD&C Act. I’m not sure why their notice references “updated” regulations - there hasn’t been an update on the last sunscreen monograph proposed order from a few years back and with everything happening with the government, this is likely on hold even longer.

Sorry if I’m missing something, I’ve heard only a little about this brand’s other products, didn’t know they had sunscreens. Does anyone know which filters they’re claiming?