Supplement Expiration Dates: California’s AB 2779 and What Comes Next

Todd Harrison, co-chair of Venable’s FDA group, discusses California’s AB 2779 amendment, which exempts dietary supplements from the state’s standardized food date-labeling requirements. He says the exemption is appropriate because supplements can lose potency over time, and a “best by” date could leave consumers with the mistaken impression that a product remains effective after that date.

Harrison emphasizes that expiration dates need support from appropriate stability testing or a reasonable scientific basis; supplier certificates alone are not enough. Unsupported shelf-life claims can result in products failing label claims, potential recalls, and consumer lawsuits.

Brand owners remain responsible for verifying product quality, accurate labeling, and contract manufacturers’ compliance with current good manufacturing practices, Harrison emphasizes, stating that those duties cannot simply be shifted to a contractor.

Looking ahead, he expects states to continue introducing product and ingredient legislation and urges companies to educate lawmakers. He calls on Congress to establish nationally uniform labeling rules, arguing that a patchwork of state requirements is difficult for national businesses to manage. He also advises companies to watch developments in New York.

Transcript is below.

Erin McEvoy: Hello, everyone. I'm Erin McEvoy, associate editor for Nutritional Outlook, and I'm joined today by Todd Harrison, co-chair of the FDA group at Venable LLP, here to discuss more on updates to California's Assembly Bill 660. Thank you for joining us today, Todd.

Todd Harrison: Thank you. Glad to be here.

McEvoy: Thanks for taking the time to talk with us. So jumping right in, you published a client alert earlier this month explaining the effects of an amendment, AB 2779, to California's standardized food date labeling law. The amendment exempts dietary supplements, and overall, what would you say is the significance of this action for the supplement industry?

Harrison: Well, the significance action is that the best by date that was being required of food never made sense for dietary supplements. Dietary supplements were our expiration dates, and in fact, under that bill, if they were to require supplements go away from expiry dates, it could actually be misleading to the consumers because consumers may think that best by means, oh I could use it 6 months from now. It just says best by by then, but you could be significantly less under potent 6 months later, but it just says best by, so I could keep on using it, so it's I think a very good move by the legislature. They should have done it in the first place, but I don't think they ever intended it to be impacting dietary supplements until people pointed out, well, it's a supplements are technically foods, so it could impact them. So why it took them so long to get a, you know, 4 months to get around to it, I don't know. But it's the right. It was the right decision.

McEvoy: All right. The amendment excludes the products that meet the definition of a dietary supplement. How clear is that boundary for products that sit between foods and supplements, like functional beverages, gummies, and powders, and where could companies still be uncertain about which line they fall on?

Harrison: There's a clear line. If your product is a dietary supplement, says dietary supplement label, and it has a Supplement Fact box, it's a dietary supplement. Gummy products that are gummies and they are marketed as dietary supplements; those are clearly dietary supplements. Potentially functional beverages that are saying that they are dietary supplements, but market the market themselves as a refreshing beverage. Well, now you get this idea: Are you really a dietary supplement, or are you really a conventional food? So there could be that gray area because FDA would say if you look like a duck, you walk like a duck, you quack like a duck, you're a duck, so you can't market yourself as a conventional food and say you're a dietary supplement. So you will have to be careful if you're a, if you are a dietary supplement and you're a beverage, but you're acting like you are a conventional food.

But those are going to be, I think, the rare occasion because most of the functional beverages have Nutrition Facts boxes on them, and so there's not going to be too much confusion there. Powders, you know, most creatine powders, most protein powders, most powder products are generally marketed as dietary supplements, but there are a few that are marketed as food products. And again, the differentiation is: what do you have on the PDP? What are you saying the back of the product? Do you have a Supplement Facts box, or do you have a Nutrition Facts box? Again, there's maybe a gray area, but the minute you call yourself a meal replacement, you are no longer a dietary supplement. You are a food. So if you say you're a meal replacement and you slap your you slap a Supplement Facts box on it, well, FDA would treat you as a food, not as a supplement. So I can see an erstwhile plaintiff attorney arguing, no, that's not a, they may say they're a dietary supplement, but they're really a food, and therefore they have to have the best by date. But this really comes down to companies making sure they have product discipline, not trying to have their cake and eat it too. But for the vast majority of products, like the gummy products, things like that, they should not have an issue.

McEvoy: Those are good points and good things to look out for, for sure. So, with supplements now outside AB 660's terminology rules, what does a defensible, well-supported date label look like, and what mistakes have you seen companies make?

Harrison:Well, I think the biggest mistake companies do is they don't do the appropriate stability testing. So, the minute you put a expiry date on the label, and by the way, if you want to market your products in brick and mortar stores or on Amazon, they require expiration date. What is the basis of that date? You can't just say, well, I got a bunch of C of A's from a supplier, and they said their ingredients good for 2 years or 3 years, and I just put these ingredients together, and that's my stability data. That's not going to be sufficient. You have to have a reasonable basis for those expiration dates. You need to do appropriate stability testing, or if you can't because it's a complex formula difficult to test, you gotta have a reasonable scientific rationale for it. And I think that's some places where the industry fails to do it. Some people go, well, I just want a two-year expiration date. I'm fine, especially with some forms of supplements stability is very difficult, and you and if you if you misstate your stability and somebody tests it outside of that date and you fail label claim, well now your product is misbranded and you could be subject to FDA could ask you to recall the product. You could be subject to consumer class action lawsuits. Also, understanding when you don't use expiry date, that means you're pretty much ensuring that your product at the date that's bought is going to meet label claim.

So again, I try to emphasize to my clients: you need to have a reasonable basis that at least through shelf life that your product's going to meet label claim. And I think the industry is starting to understand that. But it's amazing that a lot of people don't understand that, and they just think, oh, you know, 2 years, that's standard practice. No, 2 years is not a standard practice. Two years needs to be based on data or reasonable scientific basis. Just simply saying that, oh, the contract manufacturer told me it was two years. That's not a basis.

McEvoy: That's a good point too. It does feel like substantiating label claims has been coming under a lot more scrutiny in the industry lately.

Harrison: It has, and we get more, we see more and more demand letters saying we tested your product and you don't meet label claim, and this is very true because certain matrices, in particular, are not necessarily the most stable matrices to put ingredients in, and so if it means shorting your shelf life and not producing as big of runs, that's what it means, and that's what you do. But that's what you do for transparency purposes. You just don't say, well, my contract manufacturer says okay. Well, what's your contract manufacturer's basis? Well, they said it's okay.

What I have found throughout the last 30 years of practice is how many brand owners do not realize ultimately they're responsible for whatever their contract manufacturer tells them. So they think, well, that's the contract manufacturer's problem. No, it's not. It's your problem. It's your name on the label. Therefore, you must do your due diligence. That means you need to make sure that your products meet label claim. You got to make sure your product is not misbranded. You got to make sure your contract manufacturer is following CGMPs. That's your job. It's you can't you cannot contract that away.

McEvoy: Yep, absolutely. I've seen transparency be a lot more emphasized as well on like the consumer side.

Harrison: That's what they're looking for. Transparency is important.

McEvoy: And then one final question: Should supplement companies expect similar exemptions in other states or even federally, and what should they ask of any future legislation to avoid another round of uncertainty like this one?

Harrison: Well, I think that, you could be, right now, all we're seeing is states after state, more states introducing more legislation. As you know, California just passed legislation on weight loss products and muscle products, building products and ingredients and so forth. So I think that this is going to continue to be a trend in certain states.

I think that it's important to educate legislators, but I also think it's important that at some point Congress step up and go, we need national uniformity in our laws, and we can't have everything state by state by state because national industries need uniformity. It's impossible to have 50 different state rules for labeling. It's impossible to comply with. So at some point you have to get together and say to Congress, we need uniformity. With the new law in California, it's one thing for California to say to retailers that we want you to restrict sales in store. It's another thing for me to say in your label, you must say on your label that you only sell for children 18 and over. Two different issues. You can separate those out, but the ingredients to everything. I think you're going, you're seeing more and more of this happen at the state level, and I think federally, we need the federal government to step in and say we can't have this. These are national industries. National industries need uniform laws.

McEvoy: That's definitely a good point. It'll be interesting how the trends, you know, continue to shape out and how everything actually develops.

Harrison: Yeah, and I would pay attention. New York still has their GRAS document out there. We don't know what's going to happen there. Something has to happen by December, so we'll see. They have an election coming up. Something probably will happen right after that election.