It’s a scenario no health product manufacturer wants to experience: a nationwide product recall involving a baby and toddler product. The executives at Standard Homeopathic Co. faced this nightmare on Oct. 23, after the U.S. Food and Drug Administration issued a warning about the safety of its most popular product: Hyland’s Teething Tablets. The warning was triggered by an FDA review of Standard Homeopathic Co.’s manufacturing processes and adverse event reports; it resulted in the company voluntarily recalling all lot numbers of its Hyland’s Teething Tablets.
John P. (Jay) Borneman, PhD, Standard Homeopathic Co’s CEO, spoke with NewHope360.com to explain why he made the call to voluntarily pull Hyland’s Teething Tablets from the market, what he’s learned from the experience, and when consumers can expect to find the popular teething remedies back on the shelf.
newhope360: Standard Homeopathic Co. has stated publicly that it recalled its Hyland’s Teething Tablets “in an abundance of caution” after an FDA review found varying levels of belladonna in the product. Did this discovery by FDA signal any safety issues for infants and children?
Jay Borneman: I personally believe that Hyland’s Teething Tablets is a safe product. This product has been on the market for 85 years with no safety issues. Where the situation became complex for us is that we were interpreting data in one way, and the FDA was interpreting data in a slightly different way. They [the FDA] found one tablet that had more belladonna in it than we had on the label. That really was the essence of problem. Their view was that that was an unacceptable risk. Our view was that, even with that risk, there was still a very large margin of safety with the product.
newhope360: So why pull it from the market?
JB: If anybody at any time introduces me to information that would make me believe that I might be wrong about the absolute safety of a product, I need to act on it—and that is what we did. If there is any possible defect whatsoever, particularly related to an infant product, the FDA gets pretty concerned about that. That is a good thing. I fully admit that if their data is correct—and we have not yet had the chance to corroborate their data—then we acted appropriately, even if the safety of the consumer was not put at risk.
newhope360: What actions are you taking moving forward?
JB: We are rolling out a new formula that is built basically on the same technology platform but that has slightly different homeopathic potencies in it.
newhope360: The original formula was very popular with many consumers. How is the new formula different?
JB: The potencies in this better-than-ever Teething Tablets formula have been tweaked in such a way that the issue of belladonna alkaloids—which occur in low-potency belladonna but not in higher-potency belladonna—will be removed. This will make the product more powerful homeopathically while reducing the belladonna alkaloids in it. From my view, a slightly higher-potency belladonna makes Teething Tablets an even better product for children from a homeopathic perspective. The belladonna still serves its purpose of easing irritability, redness and inflammation, while at the same time the issue of belladonna alkaloids has been obviated.
The original Hyland’s Teething Tablets formulation was really an artifact of the time when it was formulated. The way products were formulated 85 years ago was different from how they are formulated now. If you look at some of our newer products—such as our Teething Gel, which we rolled out in the last decade or so—you will see that the homeopathic potencies are generally higher and the bases are a little bit different.
newhope360: Are you making other changes to the product?
JB: We are adding a child-resistant cap, which is a packaging change that was due to roll out this quarter—before the recall occurred. We’ve been discussing child-resistant packaging around here for the last 25 years, and I will say that I’m still conflicted about this change.
JB: Because, to me, a child-resistant cap signals to parents that a product might not be safe—which is not the case for Hyland’s Teething Tablets. But moms now are used to everything having child-resistant caps on them and that is the direction we are moving in, too. The good part is this new packaging might provide more peace of mind to parents.
newhope360: When can consumers expect to see the new Hyland’s Teething Tablets on the market?
JB: The formulation was already through a lot of the preliminary work and the packaging piece is already there. We do, however, need to put this through a new process, which is going to require quite a bit of process validation—and you can’t rush that. So the new Teething Tablets product won’t be out until 2011. When in 2011? Hopefully it will be earlier rather than later—that is the objective.
What are customers saying?
newhope360: How have consumers responded to the recall?
JB: We are seeing a lot of consumer passion out there for Hyland’s Teething Tablets. One of the early online posts we saw from a consumer said, “You’ll get your Teething Tablets back from me when you peel them out of my cold, dead hands.”
The Hyland’s Teething Gel [which was not affected by the recall] is a good alternative to the Teething Tablets, and based upon some of the metrics we’ve already seen, it is very clear that moms are making a fairly quick shift to the Teething Gel. Still, frankly speaking, moms like the tablets and the kids like the tablets, and it is our obligation to get these kids taken care of as soon as possible.
newhope360: What are you hearing from retailers?
JB: The retailers have been supportive. Some retailers have called us and asked, “Is it OK if we don’t take this stuff off the shelf?” The answer is, “No, that is not OK.” The bottom line is that if FDA says a product should be taken off the shelf, it should be taken off the shelf.
Learning from recalls
newhope360: NewHope360: What have you learned from this recall?
JB: This was our first product recall in over 100 years of operation, so we have learned many things over the course of the last week—but a couple of things stand out. First, you find out about the strength of an organization—and more particularly about the strengths of the folks you have in that organization—when you stress it. We certainly have been stressed. I cannot tell you how spectacularly well the folks who are leaders in our organization did under that stress. They did what they needed to do. We needed to build eight or nine teams that took responsibility for different parts of this program in four or five hours on a weekend in the middle of the night. We had developed over the years, external relationships with people who could help us with pieces of this who took cell phone calls or participated in conference calls in the middle of the night.
By Sunday morning, Oct. 24, we had our teams in place to address reverse logistics, internal logistics, pharmacy, medical, legal, trade relationships, consumer relations and social media. We even switched our own call center over from our regular work to almost entirely doing work related to the recall in three locations. So our IT guys were working on this and coming up with novel IT solutions in real time. Folks who weren’t directly involved—such as the new product developers—would jump in and do other things that were necessary. By the best assessment we can have so far, our response to the decision to do the recall was about as efficient as you can expect in a company of our size.
The second thing I learned was that the relationships we have built over the generations with folks who are Hyland’s products users are robust. Those relationships really came out and are continuing to come out. We also learned that our trade relationships with competitors and relationships with our stores are robust. A lot of people asked, ‘Can I help?’ The medical community around homeopathy, the physicians and nurse practitioners, have all been very supportive. Most of the messages we’ve seen online have said, “You didn’t have to do this, but we think you did the stand up thing.”
newhope360: Has there been a silver lining to this event?
JB: The silver lining is that it has been a jump off point for us to build even stronger relationships going forward. It’s also provided an opportunity to go to moms and kids with a better-than-ever Teething Tablet product. Our primary focus through all of this is the consumer: How do we best serve her and her teething baby?
newhope360: What has been the financial impact of this?
JB: The honest answer is that we don’t know yet. We have benefitted from the fact that Teething Tablets is not the only thing that we do. Were we the Hyland’s Teething Tablets company, this probably would have been an existential blow. But it’s not. We make 3,500 different products. Our baby family, led by Teething, has done very, very well over the years, but it is one component of a number of components. Another factor mitigating the impact is that consumers are switching over to Teething Gel. The Teething Gel is a great product, but from a distribution and turn perspective, it has always been behind the Teething Tablets. The gel is a more modern homeopathic formulation, so it contains significantly lower concentrations of alkaloids. The recall of the Teething Tablets is pushing trial rates of the Teething Gel.
The recall is significant, but we are pretty confident that we should be able to absorb the financial impact. We are only through week one of this situation, but looking at last week’s numbers, our sales were up compared to the same period last year—even without selling Teething Tablets.