Week 4 FDA Misbranding Challenges and Dietary Supplements



in our second component we're going to continue to look at the FDA but look at a specialized category of dietary supplements and really there is enough law and regulation of dietary supplements that it could be its own cores its own complete discussion of what that looks like and what I'd like to do is go ahead and add it here in terms of misbranding because a lot of the claims that we see in the readings about First Amendment challenges and the like involve FDA regulations of dietary supplements because those are the products that generally try and push the boundaries and make really novel aggressive claims and so it is good to look at dietary supplements in that context but given our six weeks we have together and so much to cover we won't get too far into the realm of dietary supplements as big as that industry is so we always have to start with definitions and what are we talking about when we say what a dietary supplement is and I'm not going to put the definition up on the slide it was in our reading about First Amendment challenges that gave us the different cases that we'll talk about in terms of First Amendment challenges to dietary supplements but in general we have our conventional food definition that we looked at and we have looked at a couple of times very broad including things you know even a call out for chewing gum and really really broad we have this emerging term that you may hear an industry called the functional food there's such a desire in the market for foods to be in some way more than aroma taste and nutrition and in looking to see a better description of what that nutrition is how that functions in the body what function that can have in the body and so we're seeing conventional foods that are not quite getting to the level of dietary supplements but are making more advanced claims in so this term has emerged not a statutory term but it's something that you may hear as functional foods and functional foods for our purposes are really going to be conventional foods that are making aggressive or novel claims and then we get into this specialized term in the statutory language it's in the readings and you can pull up the subsection F F for dietary supplements and what's really interesting is that we still have this definition of dietary supplements from the 1906 1938 Act where a dietary supplement is not really what we think about being today it truly is when we're talking about a dietary supplement under the Act something that supplements the diet if I'm not getting enough fruits and vegetables for example maybe I'm low on folic acid and so I want to supplement my diet by taking a capsule of folic acid and that is what the Act has envisioned and really means in that statutory definition today we think of dietary supplements is a much broader term for alternative medicine for herbal medicine for a whole wide range of things and I can really get a lot of industry in trouble because at the core what we're talking about is something that is regulated as food and if it's regulated of food we only eat food through our mouths so we need to have something that's ingested there's lots of examples we can talk about where things are going on the skin and hailed through the nose put into the eyes all of these sort of things and calling themselves dietary supplements for our purposes we're not going to get into that discussion but we just want to make sure that we're on the same page and narrowing our scope of what a dietary supplement is to think about that that traditional vitamin that's swallowed in the nutrients ingested through the stomach so when we get into dietary supplements we have just as we did on the conventional food side this entire realm of labeling on the principle display panel the information display panel and really its own set of requirements and one things that you'll notice right away is we don't have a nutrition fact panel on a dietary supplement we have a supplement fact panel and there's all sorts of nuances to labeling dietary supplements and of course miss labeling by missing those technicalities can be misbranding but for our purposes it's good just to know that there are differences and we'll get into one of the slides where the why these differences matter and why it's important to make sure that you're distinguishing a conventional food from a dietary supplement but for our purposes we really do want to get into the constitutional challenges the Administrative Procedures Act challenges as well so it's really great to talk about dietary supplements because as I mentioned they're the ones that typically are making the claims that we have here these type of claims that are again not talking about the technical what's in the nutrition fact panel but actually how this product works for you now the one that you'll probably see most commonly on conventional foods as well as on dietary supplements is nutrient claims and nutrient claims is something we've seen a really big explosion of there's an example on the slide where we talk about if a food product has omega-3 fatty acids we talked about the nutrient content and we can talk about what that nutrient means what the presence of that specific nutrient that level means these are all statutorily these are all excuse me administrative legal aid so those rules around what nutrient claims you can make so if you have a new novel ingredient the FDA is not going to have set a specific nutrient level for that and so a lot of times you'll see in labels where you'll see the daily value is not set and that's what we're talking about you know what is the recommended daily intake and with the daily what's the intake that's in our product so we don't see a lot of challenge on nutrient claims because they are so technical and and regulated by the rules that they don't really get too far out of bounds and if they are if they do it's very easy to bring them in because they should follow the rules health and qualified health claims are those that we see in the readings and this is taking our nutrient and applying it to the body and applying it to talk about what that nutrient is traditionally good for what that nutrient and maybe not traditionally but scientifically we've demonstrated as we see in the readings we have this evidence threshold of what this nutrient does and so in this example calcium reduces osteoporosis risk you'll see some conventional foods that will start to make these claims again trying to meet that market demand where people are trying to make a determination is there cereal good for their cholesterol is ice cream they're going to have a great source of calcium and therefore a great way to reduce the risk of osteoporosis those sort of things are starting to expand it in conventional foods and as well as dietary supplements and one of the examples in the reading is green tea and green tea would be a conventional food or beverage and it's starting to make these claims even about cancer so it is something that we're seeing expand and there's this relationship for health claims about the level science you need to support and the level of science you need for a qualified health claim what's important to stop and remember about health and qualified health claims and we'll get into this is there needs to be a scientific study and so if we're going to have a successful challenge to a FDA regulation of a qualified health claim we need to make sure that the science is there to support it and and that's something that's good to pause and to know the next group of claims really are unique to dietary supplements most conventional foods don't talk about this there's some that will of course but for the most part when we talk about structure-function claims we're really talking about dietary supplements and this is an area where dietary supplements you've seen the commercials you've seen the products on the shelves really go out there and what structural functional claims are talking about is what that either that nutrient that's in the dietary supplement or the dietary supplement as a whole how it's affecting the structure of the body or how it's affecting function of the body and so here an example is helps promote urinary tract health so this is having an effect on the structure of the urinary tract and the function of that urinary tract for you know normal maintenance and good health we can think of a lot of examples that are really outlandish and this is where I spend a lot of time in my practice when it with the dietary supplement company is bringing these claims into check so it pretty unique to dietary supplements but it won't be unusual to find these on a conventional food product every now and then so at the very beginning of the reading you may have noticed that we see this definition of new drug claim and what the FDA has said is that if you if a product and typically we see this with structure-function claims if a product makes a disease claim and that is a claim that attempts to offer treatment and prevention or cure for specific disease if for example instead of saying helps reduce + helps reduce cholesterol it would say stops heart attacks wrenching heart attack specific ailment condition disease we've made a disease claim what the FDA has said is that this is disease claim leads to what is called a new drug designation and as we know just generally of our knowledge of drugs drugs need to go through it's all an approval process we've all heard of clinical studies and the like and so anytime we have a disease claim and this new drug designation the FDA is saying bring this claim down to food the food claims that we can make or go seek drug approval and these claims can be both implied and direct I gave a direct example by mentioning heart attack but the FDA has said in and several roles one focus solely on structure-function claims that certain symptoms are so associated with a particular ailment that it is to imply the name of the disease itself and one example is inflammation and with the FDA said is if you if there's a product that's talking about joint joints and talking about arthritis we're talking about and those sort of areas rheumatoid arthritis and you're mentioning inflammation you can remove if you just have an image of joints and inflammation that's enough as if you're implying our thright us and and you've made an implied disease claim and they have a new drug designation so that's in part why this is important as well not well only will the FDA as we see in the readings attempt to modify the claims but they can also prohibit the claims on this basis that it's a new drug so here's a little bit more information we didn't get really from the readings but also from the article but we did get from some of the readings about what claims can be made so nutrient claims we're talking about nutrient levels we again are limited to the regulations for dietary supplements it's going to require a disclosure on the supplement facts panel if we have this on the conventional food products will have that disclosure on the nutrient facts panel there are in the regulations whole host of requirements on characterizing that nutrient level is it high is it low is it comparative to another product is it relative to your product everything that we need to know about nutrient claims is in the regulations and so anytime we want to say high source of fiber high source of calcium we need to look at the regulations and make a determination of whether or not that fits with the current rule so as we see in the article the health claims and qualified health claims require evaluation and authorization prior to use and that's why we see so many challenges with these claims the FDA as we seeing the article will come back and either add a huge disclaimer they'll completely prohibit a claim and so on and so that's why we see a lot of challenges here because this is the one type of claim that requires pre-approval the nutrient claims and the structure-function claims do not require pre-approval so as we mentioned these have to be based on some sort of scientific evidence we have two thresholds for this type of evidence and it has to be some authoritative statement of from a scientific body a lot of times as the NIH studies used but we can use other authoritative studies to support these claims as I mentioned these are so widely used you go into any health food store you can go to any really grocery store that sells dietary supplements and walk down that aisle and you'll be really surprised I always enjoy it when I get flyers in the mail from different you know grocery stores or different places that are selling or marketing dietary supplements and I'll go through and I'll read the ads and circle the amount of structure-function claims and which ones are in compliance or not it's amazing to see what gets put out there there is this requirement that the claim be substantiated meaning it also should be supported like a health claim but there isn't a pre-notification necessarily you were voluntarily allowed to go and to make a get an approval for claim but most companies don't do that so we've seen this issue in the first component and talking about misbranding about where is this jurisdictional boundary between what is a label and what is advertising and the FTC is supposed to be the area that enforces advertising and is unique that it does provide some guidance on claims for dietary supplements and what has been interesting in that development they haven't done that necessarily for conventional foods other than what we saw in the first component talking about that they will use a reasonableness standard and not the ignorance standard that's used by the FDA and judging misbranding but that here they've actually given specific guidance on dietary supplements and what we see is there's this little bit of daylight the sliver of daylight between the guidance that we get from the FTC and the guidance we get from the FDA so there is this gray area where a claim can be FTC compliant but not FDA compliant but generally the FTC has said that the FDA will tell it what is a permissible claim and the FTC if it finds one of those violations will work with the FDA to bring an enforcement action so it is still a jurisdictional question and it's one that's more prominent than what we see in conventional food items so what this slide really I want to get to is it's really important to understand whether or not we're talking about a dietary supplement or a conventional food item says we'll get into next week with food additives is there is the standard that additives to food should be generally recognized as safe what's called gross and there's this distinction of what is recognized as safe for conventional foods is not what's recognized as safe for dietary supplements and so if the packaging and the way that the product is marketed is pushing that envelope for conventional food item or conventional beverage and it starts to look like a dietary supplement you can move from misbranding issues to adulteration issues and so it's really important to at the labeling stage make sure that the labeling is grounding the product into the category that would keep it away from adulteration and we see that most with liquid dietary supplements Monster Energy 5-hour energy that whole gamut of products out there that is talking about energy drinks melatonin drinks hemp drinks we've seen just an explosion of products that are really pushing that boundary and we can look and see the comparison for a nutrient facts and a supplement facts and one and those items but new guidance document that's just talking on this distinction distinction between liquid dietary supplements and conventional beverages and you can see on the nutrient facts panel that you know we have this serving size is one can and then on this energy drink we have the supplement fact panel and it says serving size one hand so you know this is one factor that we're looking at but if we're looking at this dietary supplement looking to see if these ingredients would make it adulterated or not you know we can call it a conventional food on this factor because it doesn't what what dietary supplement in your cabinet we know if we're thinking about a traditional vitamin has a serving size of what can most dietary supplements will say one capsule one teaspoon something to that effect so here we can say this product potentially is a conventional food it's a conventional food as we'll talk about next week are the food additives approved so it is an issue where labeling can lead to adulteration issues that's important to raise again here's an example of a traditional vitamin and you see that the serving size is actually down to one tablet so definitely something to think about so the article was really fantastic and talking about the First Amendment challenges and dietary supplements and there's a few takeaways that we can get from that what we see in most of those cases that we were looking at there was three cases is this blend of a constitutional and a statutory challenge and that's not uncommon you have one chance to to fight the FDA on this issue they're bringing disclaimers or prohibiting claims and so really you're going to throw the kitchen sink at them and make every argument possible and see which one sticks and so what we saw is a blend of both the free-speech elements prevailing as well as the Administrative Procedure Act challenges surviving and one of the lessons we learned is that the FDA can't just say that claim is prohibited that claim isn't supported next and just move on the FDA has to provide a rationale has to provide a reason explanation for what's occurring and if it doesn't then it's meeting this arbitrary and capricious standard that we found and it's going to be in violation of the APA and and validated or given back to the agency to say give us a reason and then we'll evaluate under the constitutional element whether or not that that meets free-speech standards and so what we see is when we're making a claim dietary supplement conventional food we need credible evidence we don't need the best evidence it just needs to be something that is scientifically valid and if we have that then it's sufficient to make and to support that claim it's very interesting to see in the cases that the the cost-benefit analysis that's proposed we spent some time talking about economic adulteration and there we said really that's an economic cheat you know we're maybe making a consumer pay more for a product or buy a product because they think it's something else and here the judge is saying if we're misleading the consumer into buying a product based on this claim what's the damage okay they're going to spend that 350 that 1050 they shouldn't have spent whatever it is but if we don't allow the company to make that claim are we in essence putting the company's constitutional rights beneath the economics of you know the potential economic harm to the consumer and what the court is saying really we need to elevate free speech above economic damage so it's interesting that that cost-benefit analysis goes on that's prime not surprising that constitutional rights are going to be trumped especially in a situation where we don't have physical harm to the consumer so we see under this commercial speech doctrine is is this talk about reasonable fit also called least restrictive means excuse me and the requirement that the FDA regulate these claims and the least restrictive means possible so that isn't always going to mean completely banning a claim and the court is clear and saying it's going to be very narrow circumstances when a claim can be completely banned and they give the example where there's no qualitative evidence if there's going to be harm to the consumer if the potential from is the crimson would be mislead you know we're going to see a very narrow slice of cases where this is going to happen and because we have this credible evidence standard the court is saying we have a preference to let that credible evidence be out there put a disclosure on that and let the consumer decide let's not treat the consumer as ignorant let the consumer make the decision here's the claim here's the disclosure and we'll see you know that that is enough to balance that economic harm and that right to free speech what's important to see on a lot of these cases is we hear so much about the deference to the agency and providing that deference on their determinations in their actions we saw that with warning letters in particular you know the reviewability Borden letters there was a big difference deference to the FDA and making it determination and what the courts are saying here is we're not going to step in the shoes of FDA in terms of regulating public health and understanding the science of these claims or the science than supporting these claims but we will make our own determinations about whether or not the FDA has violated free speech rights or other constitutional rights and so the FDA it's deference only goes so far which is important because the FDA attempts to to occupy the entire field and say what it is about science and as well about the constitutionality of what they're doing so finally the two real important lessons that we see is that when we create this disclaimer we have a disclaimer that basically says everything that claim just made is completely false we don't agree with it there has to be again this reasonable fit this least restrictive means and we have to create a disclaimer that allows the consumer to make their own choice and provides an appropriate warning to them to say this scientific evidence isn't the best the scientific evidence isn't conclusive whatever that is but we can't necessarily have a disclaimer that negates as the court says the claim that's being met being met and then finally what we learn is a lot of times in these areas if we have a new dietary ingredient we have some conflicting scientific views on a particular nutrient what what the court is saying is if that evidence is inconclusive then we have to allow free speech to to prevail and to allow the consumer again to make that choice based on the evidence are they going to say well I've looked at the claim and I've researched it and now I've made the decision I'm on the side that says this is a benefit and so the court says if it's inconclusive then we have to allow free speech to go and you know you can see the breadth of the claims the breadth of these challenges and how these cases of go back and forth we haven't going once or twice to get the full decision rendered so it's a very complicated process and it's one that's going to continue to expand as we look at conventional foods trying to meet the market demand of consumers you want products that are doing more for them than that base of aroma tasting and nutrition that we've talked about being a traditional food so this is our entire discussion of dietary supplements as well as getting into some misbranding for constitutional challenges what we'll do in the final component is look at the USDA and its radically different model for misbranding and labeling and then we'll move on to our final two components in the final two weeks

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