June 1, 2020
Once upon a time in probiotic history, the probiotic genus lactobacillus had 261 species, but as of mid-April 2020, it was reclassified into 23 novel genera as well as the previously known lactobacillus, paralactobacillus and pediococcus (Int J Syst Evol Microbiol. 2020 Apr 15. DOI: 10.1099/ijsem.0.004107). This reclassification has a huge impact on products made with probiotics that fall into this family, since this change can cause confusion among regulators, consumers and formulators.
In this podcast, Ivan Wasserman, managing partner, Amin Talati Wasserman, discusses what probiotic brands need to consider given this change, as well as other pressing legal concerns. With Sandy Almendarez, content director, Informa Markets, Wasserman covers:
The legal implications for brands that sell probiotics that are now classified under a new genus.
The challenge to get FDA’s permission to label probiotic products with probiotic colony forming units (CFUs), rather than by weight.
The class action lawsuits we’re seeing in (or not seeing due to settlement) in the probiotic space.
Wasserman will be speaking at the SupplySide Education series webinar “Probiotic regulations and class action lawsuits” on Thursday, June 4. Register for free on naturalproductsinsider.com to view live or on demand.
Editor’s note: This podcast was recorded before the International Journal of systemic an Evolutionary Microbiology officially reclassified the lactobacillus genus, but Wasserman knew it was imminent so is still able to explain the legal implications.
Sandy Almendarez, content director, Informa Markets: Hi, and welcome to a Healthy Insider Podcast. I'm Sandy and on the phone, I have Ivan Wasserman, who is managing partner at a Amin Talati Wasserman. Hi, Ivan.
Ivan Wasserman, managing partner, Amin Talati Wasserman: Hi, Sandy. How are you?
Almendarez: I'm super excited to talk with you about probiotics. We're going talk about regulations and class action lawsuits.
Ivan is an attorney that focuses on health, wellness, beauty and other consumer products. He helps client launch products and create advertising campaigns that matched clinical evidence while also paying close attention to the changing rules governing internet marketing, consumer testimonials and social media. He advocates for clients subject to the jurisdictions of FDA, FTC and the U.S. Consumer Product Safety Commission. He regularly represents companies before the National Advertising Division and the electronic retailing self-regulation program. He has been included in the best lawyers in America from 2007 to 2020.
So, Ivan, greater specificity in probiotic classification has led to a rise in a number of probiotic species classified under the Lactobacillus genus, and there's discussion that the classification will be split into many new genera with new names. What are the legal implications here for brands that offer lactobacillus products?
Wasserman: Thanks, Sandy for the kind introduction and yeah, this is an issue that's been talked about a lot. It's going to happen. It's not a matter of “if,” it's definitely matter of “when.” And “when” actually could be could be any day, from what we understand. I’ll explain how it works: the new classifications of the species of the genus have been submitted for publication, so they are under review. Any day now, they should be published in the International Journal of systemic an Evolutionary Microbiology, which I'm sure everyone listening subscribes to. That's the official journal where they publish the new taxonomy for bacteria.
Just by way of background, probiotics are bacteria defined or identified by their genus, species and strain. Lactobacillus is a genius, one of those common species within the Lactobacillus genius is acidophilus, so Lactobacillus is the genus, acidophilus is the species, and the strain typically has a few numbers or letters as part of the designation. As you can imagine, it's quite a microbiological task to figure out which family any particular bacteria belongs to. Lactobacillus has been around for a while and as of now, there's about 269 species within the Lactobacillus genus, and some research was done that looked at all these different species and saw that in fact, they have very distinct or unique characteristics. Due to some advanced microbiology, it's been decided that it's time to subdivide the Lactobacillus genus into different genera—which is plural of genus—and that is going to happen. Pretty soon probably they're going to publish that will see the Lactobacillus genus divided between 10 and 23 new genera, all with new names. And so that's going to happen. The species will stay the same, the strain will stay the same, but the genus name will change.
What legal implications does that create? Some countries require the genus to be identified on labels; under those rules, they will require that to be changed on your supplement facts label or food ingredient label, Canada for example, being one. The U.S. doesn't necessarily subscribe or say you have to use those names, but nevertheless you cross border, and the same product would need to be labeled the same way, so eventually people are going to start switching over to the new nomenclature. We met with the International Probiotics Association (IPA) yesterday with FDA. And they're certainly aware of this change, but they're not saying, “You have to change your labels by dates.” Unlike other countries, it's not actually mandatory to use this new nomenclature. What they are going to do that's useful is there going to keep the letter L to the start of all the new genera. To the extent your labeling your product's right now “L. acidophilus,” you'll be able to keep that.
Legally what's going to happen? I think it's more confusion. What's going to happen. It is a potential to be very confusing to regulators, consumers and health care practitioners. For stuff coming over the border, for example. Most countries have lists of what bacteria are GRAS (generally recognized as safe) or subject to NDIs (new dietary ingredient [notifications]). All of a sudden, some products they come across with a new name possibly some customs person or border person is going to look and it's not going to be on the list because it's going to be under new name. It's going to cause all sorts of confusion, possibly for consumers who are used to seeing Lactobacillus and all of a sudden, your product as a different name. There's going to be some confusion for a Federal Trade Commission or an advertising regulator that you're making a claim, “improves digestion” or something like that. They're going to a pub Med search for the bacteria that under the new name that you're using, and they won't find anything because there not using “Lactobacillus” that if they did a search under pub Med for that there would be dozens or hundreds of studies. It is a potential to be very confusing until everyone gets used to the new nomenclature. I think that the best thing to do is be prepared for it. It's coming down the pike if you have a Lactobacillus bacteria. Start educating your customers, if you're an ingredient supplier. Start making plans to educate your customers, if you're a finished product manufacturer.
I often analogize it to Prince when he famously had to change his name. Prince didn't change being; he was still the same human, the same organism belonging to the same genus, but he went under new name in for a long time. Just so you don't get confused, he was called “the artist formerly known as Prince.” We all remember that, so the “formerly known as” maybe an import documentation and even on product labeling, so consumers understand it's not a whole new product. It's the same thing, just with a new name.
Almendarez: I love the comparison to Prince; that's something I can certainly get behind. And I'm also curious if scientists are holding a contest for all those new “L” names and how they're going to turn in 10 to 23 new names.
Wasserman: I know it's got to be fun. I wish I was involved with that, like I wish I was one of those Crayola Color Identifiers. It's got be much more fun gig than this law stuff.
Almendarez: Moving on to other probiotic news. Dr. Steven Hahn was sworn in as the new FDA commissioner in December 2019. Do you expect this appointment will have an effect on probiotic action or enforcement from the agency?
Wasserman: I think we really need to see what happens with the new commissioner. We don't have any indication that he's particularly for or against probiotics, or for or against dietary supplements generally. He's a very accomplished cancer researcher, very published and seems like a very smart guy. I don't foresee his appointment as really changing FDA stance on probiotics or toward supplements generally. I think he's got, from his perspective at least, bigger fish to fry. I think he's going to be spending a lot of time dealing with the opiate issues with drug pricing. Vaping is obviously going to be a continued to be a big issue at FDA—and electronic cigarettes. On the supplement side, those three letters: CBD I think are much more likely to take up his focus on being supplemented food ingredient side than the probiotic category. For better or worse because obviously the probiotic category is a hot topic, and an incredibly important ingredient, so obviously, we want positive support from FDA, but certainly don't want any unwanted negative attention either.
Almendarez: Yeah, that certainly makes sense. Will FDA ever let probiotic brands label their products in CFU rather than by or in addition to weight?
Wasserman: Sandy, you've hit on one of the craziest regulations in my long experience dealing with FDA. It’s one of these things that just makes no sense. FDA requires dietary supplements to identify the amount of dietary ingredients in your product by weight. There is not a separate section dealing with live microbial ingredients, aka, probiotics. There's not even a definition of probiotics in the Food, Drug and Cosmetic Act or in the regulations. For the purposes of inclusion in a dietary supplement, probiotics live microbials are treated like any other ingredients like calcium, which is a rock. Technically, labels are supposed to identify how much probiotics or any product by weight. Now, weight, as you may know as a living thing, isn’t nearly as important other things. Two batches of the same probiotics may weigh completely different, but provide the same amount of live microbials also known as CFUs—colony forming units from batch to batch.
Just like you weigh different amounts, Sandy, perhaps from time to time, I certainly way different amounts depending on what and how much I ate. Depending on how these bacteria are grown in fermented, they can change weight at different times. More importantly, a probiotic has to be alive. That's the definition of a probiotic. But in any sort of spoonful of probiotics. You're going to have a lot of deceased bacteria in there. Deceased bacteria continue to have weight, but they're not of any value to consumers in a probiotic product. It really doesn't make any sense.
Every research paper out there on probiotics is done on CFU count, not on weight. As a result of that, if your consumers are looking at two different probiotic products, and one says 20 grams, and one of those says 15 grams. They might be more likely to think well, “The 20-gram product might be better.” But as we just discussed weight isn't nearly isn't really relevant with respect to live microbials.
Recognizing that, the International Probiotic Association petitioned FDA to allow enforcement discretion in order to let companies instead of the required milligrams to label their product by CFU. In response to that petition, FDA issued a draft guidance document, it's probably about two years ago now. There was a little bit of give, but it's an odd one. They basically recognize that they won't object to including the CFU count as long as you do it in addition to weight. I don't think that makes sense. As I said, weight is irrelevant. That's still a draft guidance. The International Probiotic Association and others have submitted comments to the draft guidance. We are waiting to see if FDA agrees with that it can be CFU in lieu of weight.
Almendarez: So, let's move to class action lawsuits. What class actions have we seen against Probiotic companies in the past year, and are there any greater takeaways? From a consumer standpoint, I am always watching the kombucha class action lawsuits because I love kombucha. I'm not seeing a lot of other movements here with probiotics.
Wasserman: Yeah, I think that's right. Those are the ones that we have seen actually be filed. And the ones we're aware of lately have been focused on a kombucha, and the health benefits of that, as well as the content of the probiotics in in a consumer product.
There was one case recently settled, well actually dismissed, in February last year, which was against the Tropicana Essentials Juice product that was claimed to have probiotics. And it's interesting, some of the allegations in that is they call it probiotic essentials, probiotic juice, where they basically were adding probiotics to orange juice, and the arguments that the plaintiffs made included that probiotics where an essential nutrient, which they're not under FDA's use of that term. They really they really tried to attack the science behind the benefits of just adding some probiotics to orange juice. That case was filed, but it was dismissed, so we don't know exactly why it was dismissed. The settlement terms were confidential. Other than that, we haven't seen a lot of filed cases in the probiotic space.
Of course, most often, these cases start with a demand letter from a from a plaintiff’s lawyer—typically, in California—saying, “We're going to sue you unless we settled,” and if those demand letters are settled prior to litigation, we wouldn't be aware of them. I still don’t want to not give anyone listening to this comfort by the lack of file cases because our little law firm is seeing no let down in those type of letters coming toward our clients. Obviously not just probiotics, but across the spectrum, so continue to be diligent, continued to make sure your claims are substantiated, continue to make sure your CFU counts are accurate whether it's a beverage or a supplement.
Almendarez: Right, and lastly, in all this, I have failed to mention that you are the official Probiotic comic, so how can folks find your comedy?
Wasserman: My next live performance will be at SupplySide West in Las Vegas. Book your tickets now. I think there is there selling out, standing room only. My agent tells me that I don't have a lot of bookings between now and then, but if you want to see some prior performances, you go to YouTube and search “Probiotic Comic.” Surprisingly, I'm the only the only one. There's a couple of my old performances from SupplySide West and my more recent performance in Ireland.
Almendarez: Well, thank you so much, Ivan, for joining me on this podcast and talking probiotics. I really appreciate it.
Wasserman: Thank you so much, Sandy .
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