High Pressure: Gas and Cryogenic Industry Podcast · 2025-05-01 · 13 min
Key moments - from our scoring
Substance score
54 / 100
Five dimensions, 20 points each
The FDA finalized medical gas regulations in summer 2024 after a decade-long effort by CGA and industry advocates to modernize rules that hadn't been updated since 1979. The new requirements, effective December 18, 2025, mandate specific label changes for medical oxygen and medical air products. For oxygen labels, manufacturers must add 'no smoking and no vaping' statements with accompanying pictograms (either expanded with three separate graphics or condensed into one), and change the prescription statement from 'RX only' to 'RX required.' For medical air, the emergency use option without a prescription has been eliminated entirely. Concurrently, OSHA is updating to GHS10 compliance, with a 2026 deadline for those changes. CGA has released Position Statement 79 with sample artwork, and Tom Bad Stubner recommends starting label transitions early to avoid December bottlenecks, while also updating FDA drug listings and internal SOPs to reflect the dual-label authorization period before the old labels are retired.
Medical oxygen labels must add a 'no smoking and no vaping' statement with pictograms, and change 'RX only' to 'RX required.' CGA offers two pictogram options: an expanded version with separate graphics or a condensed single image.
The FDA specifically prohibited emergency use of medical air without a prescription in the new regulations, eliminating the previous allowance for such use on the labels.
All labels shipping after December 18, 2025 must be compliant; manufacturers can transition early, and both old and new labels are authorized until that date.
CGA Position Statement 79, released last week, contains sample artwork for FDA and OSHA-compliant oxygen and medical air labels, or label suppliers can provide proofs.
Manufacturers must update their FDA drug listing, label master records, and SOPs to reflect the new label versions during the transition period.
Our reviewer’s read on each dimension, with quotes from the episode.
The episode delivers concrete regulatory information (FDA deadline of December 18, 2025; OSHA GHS10 requirements; specific label changes like 'RX required' and no smoking/vaping pictograms) that operators in medical gas need to know. However, the substance is relatively narrow - it's primarily a compliance checklist rather than exploring business strategy, operational challenges, or nuanced decision-making around the changes. The content is useful but not densely packed with novel insights per minute.
The new medical gas regulations cover a lot of things about establishing a quality unit, about your personnel training, about the buildings, about facilities, uh, and included in that is a little piece about labels.
The FDA is requiring the statement no smoking and no vaping along with a pictogram that Describes no smoking, no vaping.
The episode explains regulatory changes in a straightforward manner but offers little contrarian or first-principles thinking. The framing is largely 'here's what the FDA/OSHA is requiring' - useful for compliance but not pushing boundaries or offering fresh perspective on why these rules matter or how to think strategically about them. The historical context (2012 CGA/FDA meetings) adds some depth but remains conventional regulatory narrative.
We have no idea why the FDA made this change, but they now say that the able that the label needs to say RX required.
CGA, uh, through a lobbyist and got, uh, FDA actually got Congress to tell the fda, hey, you really need to update these medical gas regulations.
Tom appears to be a legitimate industry consultant with deep regulatory expertise and direct involvement in CGA standards committees (referenced as working on medical gas and cylinder hazard communication committees). However, the transcript provides minimal credibility signals - no company affiliation, no track record details, no examples of past projects or companies served. He's a real practitioner but presented with thin context.
CGA, uh, the medical Gas committee and the cylinder committee or Hazard Communication Committee, uh, worked on getting the labels fit for medical gas use.
If you want the artwork or not artwork, but sample artwork. And then you can find that in P.S. um, 79 position statement 79, which is a publication that just came out last week from cga
The episode provides strong specific regulatory details: exact deadline (December 18, 2025), specific label requirements ('RX required' vs 'RX only', no smoking/vaping pictograms), reference to CGA Position Statement 79, and clear implementation guidance (old and new labels can coexist until the deadline, FDA drug listing must be updated). However, it lacks business examples, data on costs, or case studies showing implementation challenges.
The deadline is December 18, 2025, so we have about the rest of this year in order to get into compliance with that.
the labels that ship after November 8th or December 18th need to have these new pictograms and statements on them.
The host (Marie) asks straightforward, procedural questions that follow a predictable path: what changed, what to look for, timing, anything else? There are no challenging follow-ups, no probing into implementation difficulties, cost implications, industry pushback, or why certain design choices were made. The tone is friendly and deferential; Marie thanks Tom repeatedly but never presses for depth or alternative perspectives. This is a soft compliance primer, not a tough interview.
Excellent. And are those all? So are those all the changes then?
Is there anything else you think that the. You know, this, the industry should know about these changes before we wrap up?
Computed from the transcript - who did the talking, and the words that came up most.
Are you up-to-date on the latest FDA and OSHA label changes for medical oxygen and air? These changes, driven by the need to modernize regulations, impact labeling requirements, and it’s crucial to ensure your labels are compliant. In this Solution Session, host Marie Williams and labeling expert Tom Badstubner discuss the recent FDA and OSHA updates to medical gas labeling requirements. They explain the reasons behind these changes, outline the specific changes to oxygen and medical air labels, and provide guidance on ensuring compliance. In This Episode: FDA and OSHA label changes overview New “No Smoking, No Vaping” requirement Updated “RX Required” statement for oxygen Removal of emergency use for medical air Compliance deadlines and implementation Where to find sample label artwork Find out more about Ratermann Manufacturing
Transcribed and scored by The B2B Podcast Index.
Speaker A: Foreign
Speaker B: welcome to the High Pressure podcast with me, George Raderman and me, Marie
Speaker C: Williams, brought to you by reliably Routerman,
Speaker B: bringing you industry news and trends plus
Speaker C: insightful conversations with industry leaders.
Speaker B: Let's get to today's show.
Speaker C: Hello everyone. Welcome back to another solution session here on the High Pressure podcast. These are quick 10 minute episodes where we bring in an industry expert. And today we are bringing in Tom Bad Stubner who is a got a consultant and guru of all labels. As, uh, some of you may or may not know, there have been changes from the FDA and osha, um, for medical label, medical oxygen labels and medical air labels. Um, if you're a rather than customer labels, guess what? You have the easiest job ever. All you have to do is sit back and relax. We're taking care of it for you. Um, our team stays up to date with all consultants and making sure that we are in compliance so that you're in compliance. And if you're a potential new customer for Routerman and labels, um, please reach out to us again. We are in clear communication and lockstep with what industry news is coming out and updates that have to be done to our labels. Um, and I just want to give a little update on a little pitch here of um, what Radterman offers for our label capabilities. So everything is in house. Um, we have a design team in house, we have a production team in house and we have a brand new printer in house that prints up to 1200 dpi. And you may be thinking to yourself, what the heck is that, Marie? And to give perspective, um, competitors labels are at 600 dpi and that basically gives the amount of clarity to your label. Um, we're pretty. We're also at the point in our label, uh, machine and label production capabilities where if our machine spots one little smudge on a label, it stops, it points out what label it is, it pulls it from the rack and then continues printing to make sure that you're getting flawless labels. Um, because everything is in house, that means that you're getting a very quick turnaround time from design to production. Um, we're also in complete control of the sources, uh, that we use to create our label. So our adhesives are tested and true for pretty much snowstorm, rainstorm, sun beaten down, it, whatever you need, that label is going to stick onto that cylinder. M and our inks are the best, the best inks that are UV cured, which means that they get stronger in the sun so you don't have to worry about, you know, those oranges those reds or those greens fading in the sun. Um, if you're interested in getting custom labels from Routerman Manufacturing, please reach out to us. We're here to help you. Again, we have an amazing relationship with, um, the consultants of our industry that work with osha, fda, um, cga, and we make sure, again, we're compliant. So you're compliant. So now let's dive into our conversation with, uh, Tom Badstoodner, who is going to be discussing with us where these changes came from, what you have to look out for, and, um, a little bit of advice for you. Thanks, Tom. Welcome.
Speaker A: Welcome. Sure.
Speaker C: And, uh, funny enough, I have a story with Tom. So when was that, Tom? 2014. The GHS label changes, that happened.
Speaker A: Yeah, it was about that time. Yeah.
Speaker C: Yes, I remember I had just started at Ratterman in the marketing department, running the marketing with. For Ratterman, and, um, I put some email blast out, and the wording was so delicate at that point. I think I use like as instead of is or something like that. You called me and you're like, marie, this isn't good. That's not. That's not what it is. And I remember sitting there telling you, oh, my God, my dad's gonna fire me over this. I can't believe I put this out. And you're like, no, no, no, it's gonna be okay. So it's funny, all these years later, here we are again, and I'm going right to the source for what, what information we need. And that's you. Um, you've been so wonderful in guiding our label department in the right direction. So thank you for joining.
Speaker A: My pleasure.
Speaker C: All right, so let's talk about what's happening. Okay, So a lot of folks within our industry that deal with, um, medical oxygen and medical air are worried about what that means for them when it comes to labels. Would you mind explaining, um, how. Why this change came about and what's changing?
Speaker A: Sure. So it goes back to 2012, actually. Uh, before that, CGA, uh, and GADA were trying to get the FDA to modernize their regulations, not just for labels, but for everything. And so in 2012, we had a series of public meetings and at the cga, at fda, rather. And we explained to FDA why their existing regulations just didn't work for medical gases. We weren't specifically thinking about labels. We were thinking about the FDA requirement to do theoretical, uh, yields and expiration dates, which are just not appropriate for medical gases. And so we encouraged the fda, uh, to update the medical gas regulations, which they had actually committed to do way back in 1979. And so we're in 2012 and they still hadn't done it. And so they said, okay, yeah, yeah, we will. And uh, they didn't take a lot of action. So cga, uh, through a lobbyist and got, uh, FDA actually got Congress to tell the fda, hey, you really need to update these medical gas regulations. And so July of um, last year or summer last year, FDA finally came out with a new medical gas regulation. And they had to surprise them, uh, about uh, the labels, which we did not anticipate. We never had asked them to change the oxygen or medical air label, but it's something that had been on their list, uh, to do. And so they slipped that into the new medical gas regulations. The new medical gas regulations cover a lot of things about establishing a quality unit, about your personnel training, about the buildings, about facilities, uh, and included in that is a little piece about labels. And that's the part that's probably been most troubling for us because we have so many millions of labels out there and uh, they need to be changed at least for oxygen and for air. So in addition to the FDA's initiative, uh, which they published last summer, and um, the deadline is December 18, 2025, so we have about the rest of this year in order to get into compliance with that. In addition to the FDA's initiative, OSHA also is making some label changes and they're updating their OSHA compliance to something called GHS10. And that required some very subtle changes to, uh, labels. Most of them are not real significant and they're not really due right now. They're due, I think 2026. And so CGA, uh, the medical Gas committee and the cylinder committee or Hazard Communication Committee, uh, worked on getting the labels fit for medical gas use. And as long as we're going to have to make a label change, why not update these labels, uh, for OSHA use as well? So that process has taken several months for CGA to actually develop the new OSHA compliant and FDA compliant medical, uh, gas labels. And really right now all it affects is medical oxygen, liquid and cryogenic or liquid, and uh, high pressure and medical, uh, air. Those are the only ones that are released right now.
Speaker C: Okay. And um, my next question was going to be, what should people be looking for to make sure that their labels are updated and compliant? What are the changes that are being made to them?
Speaker A: So for oxygen, uh, the FDA is requiring the statement no smoking and no vaping along with a pictogram that Describes no smoking, no vaping. Now, the FDA never said that they would write the pictogram. They expected industry to write the pictogram. And so CGA came up with a pictogram that describes no smoking, no vaping, and no fires. And that actually takes quite a bit of space up on a label. And so there's an alternate pictogram, uh, that has no smoking, no vaping, and the pictogram all in one image. And so you could choose the either expanded image with the words and then three pictograms or one pictogram with some, uh, smaller words. So those changes need to be on your oxygen label. There's another change that's required for the oxygen label. The oxygen label right now has the statement RX only, which means prescription only. We have no idea why the FDA made this change, but they now say that the able that the label needs to say RX required. So we have to change that RX only to RX required. And we need this no smoking, no vaping statement. And we need the pictograms on the labels and so on. Medical Air, there's also a change, and that is the current medical air label allows for emergency use of medical air without a prescription. The FDA specifically said you may not do that. And so the emergency use option for medical error has been removed. And so that will require changing most medical error labels as well.
Speaker C: Excellent. And are those all? So are those all the changes then?
Speaker A: Those are all the changes that are required right now. If you want the artwork or not artwork, but sample artwork. And then you can find that in P.S. um, 79 position statement 79, which is a publication that just came out last week from cga, which shows sample labels. Or you can contact your label supplier. Right? And your label supply, uh, proofs of what the labels ought to look like. Marie, let's talk about one other issue, and that is timing for this, all right? We have from until December 18th to be compliant, uh, uh, medical gas manufacturers can change their labels early, no problem. But the labels that ship after November 8th or December 18th need to have these new pictograms and statements on them. So you can start early. And I would encourage you to start early, uh, because otherwise it's going to be very, very painful to change all those labels. If you do, be sure that you update your FDA drug listing and, um, contact us at asterisk. We can tell you how to do that. Uh, you need to update your drug listing with the new labels as well. You can have your old label listed and your new label listed all at the same time. You also want to have your label master record in your SOPs updated so that it includes the new labels as well. And so until December 18th, you're going to have two authorized oxygen labels. You'll have the old one and the new one. And then on December 18, you'll retire the old oxygen labels.
Speaker C: That's fantastic. Um, yeah, great, Great point. And they can reach out to you if they have questions around that, which is fantastic. If you are a GADA member, um, that's, I think, one of the best resources. Well, there's so many great resources of being a GADA member, but I think having you at their disposal is just incredible. And, um, I can't thank you enough for all the help and guidance you've given Ratterman over the years.
Speaker A: Well, it's, um. We're glad to do it. We're glad to do it.
Speaker C: Well, Tom, is there anything else you think that the. You know, this, the industry should know about these changes before we wrap up?
Speaker A: No, that covers it. Uh, give me a call if you have any questions or Marie, and we can get them answered for you.
Speaker C: Great. Well, thank you, Tom. I really appreciate you taking the time to meet with us and I hope you enjoy the rest of the CGA meeting there. I know it's a fantastic meeting, so I'm sure a lot of great things are coming from it.
Speaker A: Yeah, thanks.
Speaker B: Thanks for watching. Stay up to date with the latest news in the gas and welding industry by clicking on the subscribe button and
Speaker C: check out one of our other videos to learn more. Find out more about reliably radderman@rmiorder.com.
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