In this 15‑minute episode of SKUcast, host Bobby Lehew interviews Rosanne (Roseann) Webster, the CIO of Snuggs USA who oversees product compliance and IT, to help distributors navigate the surge in hand‑sanitizer demand while avoiding safety pitfalls. The conversation begins with recent FDA warning letters about hand sanitizers containing methanol, a toxic contaminant that can cause blindness or death. Rosanne explains why compliance matters for promotional‑product brands and outlines the regulatory landscape: personal‑care items are split between cosmetics (no therapeutic claim) and over‑the‑counter drug products (e.g., hand sanitizer, sunscreen) that must meet FDA monograph specifications and CDC efficacy standards. She then provides a concise, actionable checklist for vetting suppliers: verify FDA registration, confirm Good Manufacturing Practice (GMP) adherence, request ISO‑certified audits, demand efficacy testing for any claim, and obtain a Certificate of Analysis (COA) for recent batches. The discussion also touches on the benefits of bringing testing in‑house to shorten microbiology turnaround from five to two days, and on the pandemic‑driven supply‑chain disruptions that forced Snuggs to source alternative raw materials, containers, and logistics. Rosanne shares that the company recently achieved ISO certification for GMP, and emphasizes periodic re‑verification for large contracts. The episode closes with a brief personal note about Rosanne’s favorite biking trip, underscoring the human side of the compliance work.
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Welcome to Skucast, the podcast for entrepreneurs in the promotional products industry. Skucast shines a light on our industry's best work, features maverick personalities, and discusses what's really involved in running a modern promotional products business. Skucast is the official podcast of Common Skew. We don't normally focus on a product category on the Skewcast. We share stories from entrepreneurs and their journey or tackle product categories within the context of a bigger idea, which is what we're doing here today. Occasionally we'll hear about a shift happening that's representing a microcosm of our industry as a whole. In this case, it's both positive and negative news. Headlines are filled with the FDA's news about some hand sanitizers that can be toxic when absorbed through the skin, even life-threatening if ingested. On the positive side, the global market for hand sanitizer is set to surpass a value of $1.4 billion and anticipated to double in the next 10 years. It's nearly impossible for distributors to become experts in safety for such a wide and diverse range of product in our industry. So I invited Roseann Webster, to hop on the program and give us a fast way we can vet our vital supplier partners for safe products. The reason this is so critical is that we just wrapped up a series on the future of work and the future of the client in particular, and what new demands are emerging through this experience. Safety, security, comfort, and expertise are traits they will value exponentially in the upcoming months and years. It's a fast 15-minute informative episode, and Rose breaks down how to make the vetting process simpler. I first met Rose a few years ago during a visit to the Snuggs factory, and her analytical insight into ops was impressive, and her foresight has guided her and Snuggs USA through many seasons. An experienced exec, she has held a variety of leadership roles over the past 15 years. Currently, she serves as the Chief Information Officer overseeing product compliance and information technology. Prior to this role, she spent 9 years as the company's Chief Operating Officer and 2 years as the company's Vice President of Finance. An amazing talent. This is not a paid advertisement. It just so happens to coincide with our series on what the customer will value in the future. You can check out that series at community.commonsq.com. It's called The Future of Work. Today's episode is brought to you by CommensQ, the work-from-anywhere platform that powers your connected workflow, enabling you to process more orders and dramatically grow your sales. To learn more or to begin your free trial now, visit commonscue.com. Now here's my conversation with Rose. Rose, the reason we're chatting today, or at least one of the reasons, is what I mentioned in my intro about the skyrocketing hand sanitizer sales. But also, there's some real danger lurking in that opportunity. And recently your phone blew up and end users started calling you. What was that about?
So recently the FDA has started issuing warning letters in regards to potentially hazardous hand sanitizers. So they've started testing some products, pulling them off the shelves, and they found some items originating out of Mexico that are— these companies are actually using methanol instead of ethyl alcohol, also known as ethanol. Methanol is super dangerous. It can even cause blindness to If it's ingested or inhaled, and even it's not great even to put on your skin topically. So they've started mandating some recalls, and I think they're testing more than ever to ensure that hand sanitizers are not containing methanol above the limit that's part of the USP guidelines.
Since hand sanitizers will continue to be a huge category for us, what other concerns are sort of occupying your time around this product?
Most of our concerns revolve around supply chain, quality, and the availability of goods that we're able to receive. So during this pandemic, we did have to source outside of our regular channels with different suppliers, alternative ingredients. So really making sure that we were testing those to ensure that they were like for like and as identical as we could be to make sure that all of our formulations were still stable. That was part of our biggest challenge outside of, you know, container availability and making sure it was compatible with the container.
Some distributors are, how should I put this, careless about compliance. Part of my job is to ask the dumb questions, which is not hard. Why is compliance important? Why should I care? And how and why should I make that important? To my clients?
You know, promotional products, because we are logoing for various companies and their brand really relies on our ability to be compliant and watch out for what we're putting out in the market. Yeah. Even with this recall, I think it's more obvious than ever why compliance is so important. And that your suppliers are doing the necessary testing on not just their raw materials coming in, but on all of their finished goods as well, making sure that the product is meeting CDC guidelines. Do they have the correct amount of alcohol in there? The CDC says you have to have a minimum of 60% alcohol. You know, how do you know that it meets the label claim, that it actually has that much alcohol in there? Are they doing the necessary testing? To make sure. So, I just think it's really important for any drug product to make sure that your suppliers are doing their due diligence and making sure that they're putting out a quality product.
It's really difficult for us distributors to suddenly become experts in everything safety, and that's the big challenge right now. Everybody's juggling with that and compliance and suddenly finding ourselves vetting suppliers in new and complicated ways. Can you help us simplify how we can more easily vet our supplier partners for compliance practices? I know that's a big question. Are there— is there simple criteria we can use for this?
But just kind of a quick down and dirty for all things personal care are regulated by the FDA.
Personal care includes basically what?
So personal care includes cosmetics, which are anything that's not making a claim. So like just moisturizing lip balm, hand lotion, any topicals of that nature, lip gloss. Drug products are personal care products that make a claim that are considered like an over-the-counter drug. Like sunscreen is an over-the-counter drug because you're making a claim that you're blocking, you know, UVA and UVB rays. And sanitizer is considered a drug because you're claiming that it will kill germs and bacteria. So you've got to make sure that when you're, when you're looking at personal care products that you know if it's a drug or a cosmetic. There's different labeling requirements, but your suppliers should know the difference. But first and foremost, you got to make sure that they're registered with the FDA, their products are registered with the FDA. So you should be asking for things like, what's your registration number? Distributors commonly ask for our approval letter from the FDA.
Okay.
And the FDA doesn't approve products that are made within monograph. So what that means is for hand sanitizers, the FDA kind of lays out some almost like a recipe that's like pre-approved. So as long as you're using these ingredients at these concentrations, you don't have to go through a formal product approval. Same thing for like sunscreen. So most over-the-counter drugs are made within monograph, so as long as they're made to those specifications, they don't have to undergo FDA approval. So we get a lot of questions about, you know, send us your approval letter from the FDA. Well, there isn't one, and the FDA doesn't approve facilities you're registered with them and they audit you periodically. So there is no FDA approval letter. So a lot of, a lot of companies will actually seek outside accreditations to prove that they're doing everything necessary and following all the FDA guidances.
Okay, so if FDA is not necessarily a key criteria for us, then what are some of those other outside outside approvals?
When you're vetting, you know, make sure that they are following good manufacturing processes and practices, so which, which is also known as GMP. This is kind of the foundation of all things, you know, cosmetic manufacturing, pharmaceutical manufacturing, um, even as you get into nutraceuticals of that nature. So companies should be able to provide like a quality manual that outlines, you know, what they're doing internally to follow GMP.
Okay, and is this something— there's some kind of certificate or something I can pass on to my client in case they ask?
Yeah, so that you can also undergo like an ISO accreditation, and there's various like third-party auditing firms that will come in and audit to, um, the GMP guidelines. And they'll issue like an ISO certification saying, hey, we've been in, you know, sometimes they're like 3-year contracts and they'll come every 3 years and audit your firm and say, and they'll give you a list of findings and say, you know, here's something that we need to work on and you kind of clean them up just like you would a social compliance audit.
Okay. And you recently went through an ISO audit for cosmetics and GMP, right?
Yeah, we did actually. So we just got our ISO certification for GMP in April of this year. And so that's something that we're really excited about.
What about efficacy testing? What is that?
So efficacy testing is actually testing that's required. So anytime you make a claim, it has to be backed up by testing. So if you're making a sunscreen claim that it's blocking or that it's an SPF 30, then you have to run a test that, you know, that will come back and say, yes, this does test to be an SPF 30 sunscreen product. Same thing for hand sanitizer. You're claiming that it kills— well, that it is even hand sanitizer, and you're claiming that it kills germs and bacteria. There's an efficacy test that you have to do to prove that your formulation is effective.
Quick criteria is: are they GMP compliant? Do they do efficacy testing? And then check the label or rely on really rely on those other two because, you know, it's really hard for distributors to become experts in every single category.
Right.
But are those general— are those specific enough but yet general enough for us to do a quick criteria when we're vetting suppliers?
Yes. Yeah.
Okay.
Those are the biggest ones. Make sure they're registered. Make sure they're following GMP. Yeah. And they should be able to provide you proof of something on the GMP front. Feel free to ask for efficacy testing. Also feel free to ask for a C of A of one of their most recent batches, which proves that they're testing them.
What is that?
A C of A stands for certificate of analysis. Okay. It will actually show you everything that they're testing their products for.
Okay.
So does it have the right alcohol content? You know, is it the, is it the right pH? Is it the right color? Does it have the right viscosity? So different things of that nature. They'll check for micro, making sure that there's no other living organisms in there.
Okay, I would— so in other words, I could turn to my team and we could make sure, you know, right now— it doesn't have to happen every time, but every time you probably engage a new supplier— but right now, check and make sure those suppliers that you're working with that handle things like hand sanitizer and personal care products have these 3 or 4 criteria. And that's a process that you can do once, one and done.
Yeah, and I think maybe ask periodically, especially if you get like a large contract.
Yeah, right, that's great advice.
You testing for that specific order.
Yeah, great idea. You, you just brought all of your testing in-house. Why did you do that? Why is it important for us to even know that?
So we brought a lot of our testing in-house just so that we could turn things more quickly. We actually bought some new equipment that turns a micro in 2 days, and that's typically a 5-day lead time, which is really exciting. So It's very geeky and nerdy, but it's just allowed us more flexibility and more real-time data so that we can address things and get them fixed more quickly.
There was a massive disruption in the supply chain. We all know that, like demand exceeded supply for all kinds of reasons. Has it somewhat settled now? Do you feel like you're kind of getting, getting a grip on forecasting?
Yes.
It's been a very difficult season.
It really has been. And, you know, we are just so grateful that we have such an amazing team. But our procurement department really had the challenge of their lives. Like, our normal supply chain was completely disrupted. We couldn't find containers. We couldn't find closures. Even the raw materials, and I— because China was down for so long before we were, this— it just took a really long time for the supply to catch up. You know, some of our containers come from there, some come domestically as well, but even during the shutdown, some places decided not to keep working. The raw materials were really tough. I think a lot of those were allocated for the big pharma companies that were supplying hospitals. And so we are like small in the whole scheme of things. So if you didn't buy up their supply right away, you couldn't find it. And so that really put us in a backlog just trying to vet new suppliers, test new raw materials coming in to make sure that they would conform. So it's been really challenging, but we feel like we're on the, on the back end of that and things are starting to return to somewhat normal, even as cases begin to pick back up.
There's so many people on your team I love. I can't even start naming names because I'm going to miss people, but they're really truly some of the best personalities and people in the business, characters too. You know, from Jeff to Steve Varun, Brandon, everybody is just astounding and really good folk. So I want to say thank you for, you know, the work you do for distributors. This is in no way any kind of paid advertising. When I saw this topic come up, it was just really hot and I knew we needed to jump on it. And I remember our conversations from before. So, you know, on behalf of the audience, I think I can say thank you guys for your commitment and work and honestly going through one of the most stressful seasons we've all been through and coming out on the other side, and I just hope it continues to run smoothly. I have one more question.
Okay.
Where's your favorite place to ride?
Oh, so I just went on this ride with my girlfriends and we rode up through Island Park up near Yellowstone, and it was absolutely beautiful. We stopped in Jackson Hole and It was amazing. And even during this weird time, it was just, it was really nice to kind of get away from all of the crazy work life and take a few days with just girls and our bikes. And it was really fun.
That's cool. So go for a big ride and then on your way home, stop at the Red Iguana for moles and one of the best Mexican food experiences you'll ever have.
Yes. Mexican place ever.
It's stunning, actually, in Salt Lake City, Utah. It's stunning. Rose, thank you for your time. Thanks for, for being here with me today. I know you're incredibly busy, so for you to carve out your time and do this was so important to try and educate the industry on a critical topic. So thanks for taking the time.
You're very welcome.
Thanks so much for tuning in to this episode of SKU Be sure to keep up with our latest content by subscribing to SKU Cast on iTunes or to our blog at community.commsku.com. Until next time, friends, thanks so much for listening.
