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Webinar and Q&A

Changes to the Nutrition Facts Label

 
 

The Food and Drug Administration (FDA) has changed the regulations for the nutrition and supplement facts panels in order to combat some of the health problems in the country and provide people with better solutions. Its goal is “to assist consumers in maintaining healthy dietary practices.”

In addition to material covered in the regulation itself, FDA has also responded to questions and comments from the public. The federal register publication is over 200 pages long, and much of the regulation interpretation can be found in FDA responses to comments.

Transcript

Introduction

It's just about two o'clock, so we'll get started. Good morning, or good afternoon to everyone, depending upon what area of the country you are joining us from. We still have a few people logging in, we're going to give them a minute or two to get settled in and then we'll get underway. In the meantime, I just want to go over a few of the necessary items. I am Moira Watson, the Vice President of Marketing and Communications here at Watson, and I'd like to thank you all for joining us today for our webinar on the Nutrition Facts Label Changes. Today's webinar is being presented by Watson, we're one of the highest quality suppliers of value-added ingredients formulated to enhance human health and nutrition. Before I introduce our speaker, I just want to go over a couple of housekeeping topics. We encourage you to share your comments and ask questions. Please look for the Q&A chat box on your screen. If you have a question just type it in there and I'll hold it for discussion at the end of the event. Because of the topic, we're anticipating a lot of questions. We're going to do our very best to answer as many as possible at the end of this webinar. We also plan to do some follow up e-mails to answer additional questions if we run out of time. Today's webinar is also being recorded. We will be able to share a link with you via an email tomorrow, and also tomorrow we're going to post a link of the recorded webinar on www.labelchanges.com

We invite you to revisit the content yourself and also share it with colleagues. We have a comprehensive 18-page guide. It's also available for download on www.labelchanges.com. And there's a link where you can request a hardcopy be mailed to you and I really encourage you to do that because it's a very handy Desk Reference and it's nice in the printed form. Today's presenter is Alice Wilkinson, one of the industry's leading experts in nutrition. I have had the pleasure of collaborating with Alice over the past 15 years at Watson, where she's currently our Vice President of Innovation. At this time I'm going to hand over the floor to Alice who is going to start today's presentation.

Background

OK, Good afternoon everyone.

So like Moira did, I also want to thank everyone for taking their time to join us today. I understand everybody's schedules are very busy and it's not easy to carve another hour out to learn something new, but I think that this will be good for all of us. It will be good for us to review the new nutrition and supplement facts panels. Our timing today is a little interesting to say the least, with respect to some uncertainty surrounding the date of compliance for these new laws and with all that excitement in Washington yesterday, we may have missed that we actually do have a newly confirmed commissioner to the FDA in Dr. Scott Gottlieb. He was confirmed yesterday in a Senate hearing, so he will have a lot on his plate as he starts to join the FDA. But that includes responding to a number of these, of recent requests to postpone the date of compliance for these regulations, and there's a lot of unknowns around that, but I did think it might be worthwhile for us to go and do a quick review of the things that we do know, and hopefully that will help you draw your own conclusions as to where we might be going in regards to the compliance on these regulations. So firstly, we do know that the compliance date for menu labeling has already been postponed, and it's been pushed out indefinitely right now, even before Gottleib's confirmation. We also know that during the Senate hearings that Dr. Gottlieb did say he would be open to adjusting rules that were passed under the Obama administration.

So we do know that there is some flexibility on his side there. We also know that there's been a number of different requests from the industry requesting a number of different types of postponements, either a three-year delay, straight-out three-year delay, in compliance dating for this, or an aligned compliance date that would be aligned with the pending GMO-labeling regulation. So there's been a couple of different requests there that are out there. In addition to that, we also have an ABA petition. American Bakers Institute had put together a petition to the FDA to actually rescind the current definition of dietary fiber altogether, so there's been some controversy over that. And so they had just actually asked that to pull the definition as it is. For every request that there's been from the industry to make some adjustments or to delay the compliance of the regulation, there has been other industries, you know, petitioning the opposite... you know requesting that the timing stay as it is, namely the American Medical Association has said that "We're really overdue for these changes. Please don't postpone them." There's also been information going back and forth with CSPI or the Center for Science in the Public Interest, and they've been the most vocal about making sure that these regulations do get let out as they were originally intended. So, you know, this does kind of all effect how this might affect our day-to-day business, but I figured that this would be a good place for us to start our first survey question, which is really: What's your company's position on changing the labels? Are you interested in getting into compliance right now?

Are you going to wait to see what Dr. Gottlieb does in regards to his changes and then decide, you know, what you're going to be doing with your labels? Are you not decided yet? Or are you just unsure? It should be pretty easy for you guys to complete this poll here.

The poll's currently open, let's see, here....

So right now it looks like over half of you are looking to get into compliance right now, 16 percent of you are cutting 'waiting to see what the FDA is actually going to do'. We have some people still just totally undecided yet or unsure of what they want to do, and I would say that's kind of a safe place to be, you know, it is changing every day, so we don't know exactly what is going to happen. So one of the things that Commissioner Gottlieb has stated is that he has said that he is very committed to providing clear, accurate, and understandable information to the American consumers so that they will have the information they need to have healthy dietary choices. So exactly how will that be done... you know it may be really premature to speculate. It's likely that we will have a striking similarity to what we're reviewing today. My guess is that there might be some small adjustments to it, but my guess is the other piece of it would be that the compliant state may change. So... we're still going to review it as it is today. With that in mind, I kind of did want to remind you that we're reviewing a government regulation, right, so this is 21 CFR 101.9, which is Nutritional Labeling of Food. And there's 101.36, out of - again out of 21 CFR, that's the Nutritional Labeling for Dietary Supplements. The regulations themselves are fairly short, you know, we have 15 pages on the nutrition labeling side, and an additional five on the supplements side, but the entire federal registry publication is just over 260 pages.

So you take away the 20 pages of actual regulation - most of which is actually examples of the panels and how they should print - and there's 240 pages of comments and the FDA's responses to them. So a lot of what we're reviewing today is kind of my interpretation of what was put into those comments, and that information that was buried within the FDA's replies to those comments, so there is there's quite a bit of information in there, a lot of interpretation of how we might expect the FDA to enforce these regulations going on. So, before we get into the actual nitty-gritty of the presentation, I did want to have a second survey question for you, asking which type of labels you're using now. Are you using nutrition facts labels, supplement facts labels, or are you using both? Let's see here... looks like probably most of you, about 70 percent of you are actually working off the Nutrition Facts panels. Now we do have some supplement people here as well, and some of you another 25 percent are using both, so I'll make sure that we do cover both today. A lot of the information for the supplement is actually based off the Nutrition Facts panel, so that's a good place for us to start anyway. But in regards the whole presentation today I'm going to give you a little background of where this all came from, then we're going to do a quick review of the dietary guidelines, because that kind of was the basis for this. We'll go through Nutrition Facts panels and then we'll also go through Supplements Facts panels.

I really wanted to start with what was driving this and it really came down from the FDA as, you know, a way to assist our consumers in maintaining healthy dietary practices. And I wanted to kind of leave this off with a quote right out of the preamble for the regulation, and the FDA is saying that they were amending their labeling regulations to provide updated nutritional information on the label to assist customers or consumers in maintaining healthy dietary practices, and that updated information should then be consistent with current data on the association between nutrients and chronic disease, health-related conditions, physiological endpoints, and/or maintaining healthy dietary patterns, and that this should all be current with what our population is using right now, so corresponding to new information, and consumer understanding, and consumption patterns, as well. This is all around trying to update things. Realize our last... the backbone of our current regulations, our current labeling regulations, are based on information from 1993. So to say that they're a little out of date is probably an understatement, to say the least, so it was time. So where does all this information come from. And I really did kind of want to give you the background of all of the alphabet soup that this is, but a lot of the information really comes from the Institute of Medicine, and they're constantly collecting all sorts of data from publications and national surveys, and then they're compiling that and putting it together into dietary reference intake reports, and they publish these on a kind of a regular basis. But these are the DRIs of the day, they come out of them as dietary reference intakes. They are actually broken into four different categories.

Quick Review of the Dietary Guidelines

The DRI is broken into four categories, the first one being an EAR or an 'Estimated Average Requirement'. So this is a very individual requirement... Let me go back, here... So you had the 'Estimated Average Requirement'. Then you also have RDAs or 'Recommended Dietary Allowances', AIs - which are 'Adequate Intakes', and then you have the UL's ('Upper Tolerables') and I will go through all four so you understand the differences. So, starting with that EAR, the EAR is really an individualized level, so these are.. they're median requirements but they're for an individual within a specific life-stage group, so they'd break that down into categories: infants, children, males, females, all by age categories. If there's pregnancy or lactation, and there's different needs within those specific life-stage and gender groups, and this would be the top of the bell curve. So that's the amount, the estimated amount, needed to meet the requirements of half that population. So it's really a statistical probability number, a statistical probability of adequacy. Of course, that's not a number that we're ever actually going to use for labeling, because we don't want to meet the needs of half. So the next number that they provide is an RDA or 'recommended dietary allowance' and that target intake's again individualized. But again now this time designed to meet the needs of 97-98 percent of individuals within those life stages. So it generally is, the RDA is the EAR, plus two times the standard deviation. So this is the entire bell curve. If you think of it in that way.

The next one that we're going to talk about quickly is 'Adequate Intake', and Adequate Intake is really where all this information starts, so these are levels that are determined for a nutrient when there's really not enough evidence to calculate a complete EAR, so there some less-certainty do it, but it's still based on a variety of data, scientific evidence, the essentiality of the nutrient itself, and there are some experimental data on risk and... risk and the reduction of chronic disease. But there's just not as much information out there for them to be sure that they could set a full EAR on it. Some of our daily values are still set based on Adequate Intakes. And then the next piece is an Upper Tolerable intake level. And these are 'the highest average daily intake that's been proven to have no risk'. So it's never a recommended level of intake but it's... of all the data that out there, this is the highest level that's ever been out there, that's proven to not have any adverse health risk. So then I also want to go through the DGA, the Dietary Guidelines for Americans. Now this is not from the Institute of Medicine, but this is a joint development between the USDA and the U.S. Department of Health and Human Services. So these are recommendations on dietary patterns and quantitative intakes for both macro- and micro-nutrients. The last full DGA was issued in 2010. Now I bring that up, because there has been some interim information that has come out, but not a complete DGA, and so you'll see some, you know, information like "Wow that seems like that's a little bit older information." and that's because the full last DGA from the USDA and U.S. Department of Health and Human Services was really from 2010. So it's a little bit older already.

So in February, that's when we did have a dietary guidelines Interim Committee report, and that was... WILL be used to develop the complete 2015 DGA, a little bit of that information was used, but not too much of it. OK. So the FDA takes all of this information, from the DGA as well as from the IOM, and it puts it together to develop DVs. So now, we had some of that information out there that was for individuals, right, in life stages. The FDA has to take that and kind of round it all together to meet our entire population's needs, because we can't have you know daily values for each individual life stage and gender group. So they're not precise for individuals. There are general guides, and they're really used as a guide for content as well as comparison of food-to-food. So it's the daily value is really the nutrient-amount provided by a recommended intake of food. This is the piece that we're actually using on our labels. So within the daily values, they're broken into two subcategories, we have RDIs versus RDAs. So this is RDI, reference daily intakes, and these are for more your micronutrients of vitamins and minerals, they're general food-labeling reference values and they're based on that IOM data, and they are normally set based on RDAs. Sometimes they'll also use AIs, where the RDA was not available. But again rounding all that information from all the lifestyles and gender groups. Then you have DRVs, or Daily Reference Values, which are really typically nutrients to limit, things like saturated fats, cholesterol.. and they're also the other nutrients based on specific calorie intake, so fats, carbohydrates, proteins, fibers... things along those lines. And again it's those daily values both from the DRV and the RDI that becomes our Daily Value. These are the headings we use on fact panels, so being in the fortification business, we get requests every day to put together premixes for people and they will come to us and say "Hey can we use the RDI?" or "We'd like to use this RDA." That's really never what we're formulating to, because at the end of the day, it amounts to what we're putting on the label, so we're always formulating to Daily Values.

5 Principle Guidelines

That's a little bit of background as to where the Institute of Medicine and the DGA come from, and I do think it's worthwhile to review the last Dietary Guidelines for Americans. There are some key recommendations that came out of this, that have been published, but there's five principle guidelines that they're using. So if you think this as kind of replacing the old plate or the old pyramid, so five guidelines being that there's healthy eating patterns that we should all be following, and that those healthy eating patterns really need to span across the entire lifespan. They really shouldn't be something they're just done for the month of January. It's every food and beverage choice and it's every time. So choosing healthy pattern, appropriate calorie level, going down to things like serving size, and helping in achieving/maintaining healthy body weight, supporting nutrient adequacy, and really important here, reducing the risk of chronic disease, and this is kind of the first time we've really seen that link between diet and chronic disease being as public as it is here. The next key principle is focusing on variety. The focusing on a variety of nutrient-dense food and amounts, so back to serving size again, but to meet your complete nutrition needs within calorie limits, you need to choose a variety of products that can't be one or another. They need to be nutrient-dense products. They need to be across all food groups and they need to be in recommended amounts. And again not over-large serving sizes.

The third key principle here is limiting calories, specifically from added sugars, saturated fats, as well as reducing sodium intake. These are items that come directly over into our new labeling law. The fourth principle is shifting to healthier food and beverage choices. So every time there is a choice, to choose a healthier choice. And five is supporting healthy eating patterns for all, which is really kind of indicating that it takes more than one touch. So everyone has a role in creating and having a support group for healthy eating. It can't just be done at the school lunch level it also has to be at primary care, as well as colleagues, from home to school to work. It takes a whole community to make these types of dietary 'pattern-shifts' that we really do need to make.

Key Recommendations

So those are the five principle guidelines of the DGA. Within those guidelines, there are some key recommendations, and the key recommendations are around consuming healthy eating patterns for all the different food groups and beverages within appropriate calorie levels, and that healthy eating pattern should include: vegetables from all of the subgroups (different colors), fruits - especially whole fruits and not just fruit juices, grains - at least half of which should be whole grains, and have dairy products here being fat free and low fat dairy, including milk, yogurt, cheese and/or fortified soy beverages.

So two things to point out here. Realize we're still talking about fat free and low fat dairy. Remember I told you that some of this information is based on some 2010 data. And so this might have changed or been more recently-released around the low fat piece of it, but this is still how it's been written. And then lastly, a variety of protein foods, including seafood, lean meats, poultry, eggs, legumes, nuts, seeds, soy products, and then healthy oils including olive oil and they called out soybean oil as well. So there are components that we really do need to limit as well. Can't just eat just healthy things, we also have to limit some other things, and call out specifically added sugars and very specifically consuming less than 10 percent of calories per day from added sugars. And note that I say '10 percent of calories per day' this got a little convoluted on the labels. Next piece being saturated fats, again consuming less than 10 percent of calories per day from saturated fats, and this reduction in sodium: consuming less than 2,300 milligrams per day of sodium. The current daily value is actually 2,400 milligrams, so it's a 100 milligrams decrease there. And this translates directly to our label as well.

So then there are some ways for us to get about that. So the DGA emphasizes individuals should really meet their nutrient needs primarily from foods. They did acknowledge fortified foods and beverages and supplements can help me unachievable nutrient levels. I'm glad they did that.

They also did call out under-consumed nutrients, so... those nutrients being potassium, dietary fiber, choline, magnesium, calcium, vitamins A D E and C, and then iron also being under consumed by adolescent girls and women.

But of course of all those under-consumed nutrients there are four that they consider nutrients of public health concern, because those low intakes are associated with health, and they would specifically be calcium, potassium, dietary fiber, and vitamin D. And those will translate directly into the labels as well. So they did say there's lots of different ways you can meet your nutrient needs, just through food.

They called out fortified milk, also called out fortified salt, which I think is a very wise thing. You know we do have some pockets of inadequacies of iodine within our country, and iodine is a pretty difficult nutrient to get naturally. One of the few areas that we are getting it is in fortified salt, but we have asked people to decrease their sodium intake, and most of us have done a pretty good job of that at home by reducing our use of table salt. Processed food is still the number one place that people are getting their sodium from. Unfortunately, we're not using iodised salt in processed foods, so this iodine issue may become a larger problem.

And then they called out, you know, eating a healthy... a healthy plate, you know, mixing everything up in small portions.

So they did present three dietary principles applying to meeting the key recommendations: that eating patterns should represent totality of all foods and beverages consumed, that your nutrient needs should be met primarily from food, and that your healthy eating patterns should be adaptable as well. And they gave us three eating patterns that would help us get to those needs. They called out a healthy US-style eating pattern, a healthy Mediterranean-style eating pattern, and this healthy Vegetarian eating pattern. Now I've tried to balance these diets to 100 percent of the daily value. It's pretty difficult to do within one day. Over the course of a week or seven days, I can balance that pretty well, but it's difficult to do it just by food. The first diet that they recommended is really that healthy US-style pattern, is really the old DASH diet. So it's built on types of foods and proportions of foods that would be typical in America, and would promote the consumption of nutrient-dense foods. The secondary one was that healthy Mediterranean style, which really does kind of increase the fruits and seafood consumption, there's less dairy in this than in the U.S. healthy-style pattern. The downfall on this one is, they did have a problem kind of balancing the calcium and vitamin D. And the third one being the healthy vegetarian pattern, they did include within this dairy and egg products, and that was really how they were able to balance this product, comparatively the vegetarian approach is great in calcium and fiber but they did have issues meeting vitamin D in the healthy vegetarian pattern.

Now like I said, I tried to put together USDA diets that would meet 100 percent of the nutrition needs within one day and it is a very difficult thing to do. So we're going to be expecting our average American consumer to do that on their own.

Food Nutrition Label

So the next piece that I want to go to is really the new food nutrition labels, and I think this is a good time to break into another survey question and that question would be 'Which changes are most important to you right now, in regards to these label changes?' Is it really the daily values and how those changes may impact your front of label claims? Is it the sugaring and the including of added sugars? Is it serving size or the multiple serving products? Is it dietary fiber? We've certainly heard a lot about dietary fiber and that's a concern for a lot of food manufacturers, or is it the additional manufacturing records we're going to keep? If I can help you answer those... the poll is open now. Ok, here...

So it looks like sugar labeling, the additional labeling around added sugars is definitely something of interest, dietary fiber is secondary behind that. The daily value is also... OK so I'll try to make sure that I cover as much as I can. Had also gotten some questions early on in regards to sugar, added sugars, as well as there was some questions about conversion rates in the vitamins. I'm going to try to touch on all that during the presentation. So we'll go through those as well and then like I said, you know, we'll answer as many questions as we can at the end. So on the nutrient, the food nutrient label, there's really nine kind of categories of changes, and we'll go through all of them. The first being though was like why did we actually need these changes? And this is the FDA using the DGA information, and saying really again, repeating this, a large proportion of the US population who was at risk for chronic disease continues to be at risk for chronic disease. They really wanted a label that'd be easier for people to understand, that would hopefully make it so that we would have an increased use of the labels themselves. And that would help the population make more-informed choices. So, if Americans can make healthier food and beverage choices, that definitely is good for everyone.

Serving Size

So we'll go through all these different categories of changes and we'll talk about different things as we go through. But let's start with 'serving size'. The serving size on the new label now is more a reflection, reflective of what people are actually consuming.

And this is a little controversial because I've heard some people say "Hey, you're letting people eat larger servings, you know that's not good for anything, we were talking about controlling portion sizes." And I agree, but this is really the idea of not allowing people to fool themselves.

So, for example, on a condensed soup, it used to be a can of condensed soup was two servings, but it was through national survey data, you could see that most people would consume the entire can as one serving. So now it's one serving so that people aren't fooling themselves into thinking that they had half the calorie consumption than they actually did.

So that's a new change.

Calories

Next piece that's been of significance is really around this calories. So now the total calorie count is highlighted. It's much larger, it's supposed to be more noticeable to the consumer. And you also have the.. the serving size declared right there, so amount per serving now is going to 'amount per' and the actual serving. So in this case it's two-thirds of the cup. And then again using household measures, so it's easier for people to determine how much they're actually consuming.

Multi-Serving Products

Third big area of change, is this ability to have multi-serving products, so products that could be consumed in a single sitting, or MAY be consumed over multiple sittings, you've got that ability to have a second column on that. So that, you know I think of, like, the sleeve of Thin Mint cookies from the Girl Scouts, right? You know... I really know I should have two cookies, but you know there's the chance that you could eat the sleeve, and this is probably more designed for, like small servings, like the six small donuts in a container, it could over twice or could be eaten as one. But this will give the consumer all that information right in front of them, so that they know what they're actually consuming.

Added Sugars

The fourth area that we're talking about is really this added sugars. So this new category, it was really meant to help cut down on sugar intake, measured in grams and percentage. So this change was going to enable consumers to tell the difference between the sugars that were inherent in a product, and the sugars that were added. Now, remember, I said that on the DGA, they actually had asked for consumers to consume less than 10 percent of their calories from added sugars, who have actually taken that piece off of the label so we're no longer declaring calories from sugars or added sugars. Now we're measuring it in grams and percentages. So there's a little bit of discrepancy there. So, probably some more work needs to be done in regard to marketing that message there, and there has been a lot of questions about what is an added sugar, and there was a pretty decent guidance that came out in January this year around declaring exactly what is an added sugar. Talking about like fruit juice as an example, you know fruit juice is an added sugar, when it's added to any product it's not a juice. So if you're adding fruit juice to a muffin mix, if you're adding it as a sweetener, it's added sugar. So there are some things we need to do around that. So in regards to the scientific data, it does show that it's very difficult to meet your nutrient needs if you stay within your calorie limit and you consume more than 10 percent of your calories from added sugar. It's pretty hard to get the nutrients you need from your nutrient-dense foods This goes to reducing your empty calories. But the thing that really affects us, in regards to the food manufacturing side, is that ability to distinguish between sugars that were added and sugars that were naturally occurring, in regards to an analytical test. So then we also have the sugars that we might add, but they're reduced through non-enzymatic browning, or they're reduced from fermentation, and how can we kind of, you know, negotiate our label against what was added to our product. So it does require this additional recordkeeping, in addition to us actually just knowing how much is going on the label. In regards to adding those additional manufacturing records, something was really buried in the comments and I don't know if there's been too much observation around how this is going to work, but you're going to have additional manufacturing for added sugars, again anything that we need to distinguish between multiple sources, where analytically you can't really distinguish them. And so it's added sugars. It's dietary fiber for both soluble and insoluble fibers. It's vitamin E, for synthetic versus natural, and the different eight isomers that they're... they're calculating, and it's for folate versus folic acid, because there some calculations around bioavailability of folic acid versus food folate.

And I think that we're probably all prepared to have those types of records, these are our typical 'batching' type of records. It will be on a lot-specific, you know it has to be lot-specific, it can't just be in the master file, it does have to be lot-specific. And it also has to be maintained for a different type of timing than we're typically used to. So it's two years after the food is last introduced into interstate commerce.

So this is different for us most of the time we keep our records for a certain date or a certain amount of time to an expiration date of a product. This is different. They set it around this introduction of the food into interstate commerce, so we just need to be aware of that ahead of time, and make sure that we're maintaining the records that we need to, and have that time period right, so that we don't get caught having, you know, not having the records we need when the FDA comes to look at them.

I do know we had a lot of questions around added sugars and if we have some time at the end we can go into some more detail on that.

Vitamin Daily Values

The next area I want to go through is these Daily Value footnotes. So while everything is still based on a 2000 calorie diet, the explanation at the bottom is supposed to be more streamlined, I don't know if we actually got to that, with the new footnotes as a percent Daily Value, or DV, tells you how much of a nutrient in a serving of food contributes to a daily diet. 2000 calories per day is used for general nutrition advice.

I don't know how that became more streamlined than what the old one was, or if our general consumer is really going to see that, but that's what we have now. So that's the new footnote. The area I want to spend the most time on it, is... I think that it's kind of been lost in regards to... to... that the controversies around sugars and fibers, is really the changes to our vitamins and minerals.

Vitamins

So, starting with Vitamin D and potassium are now required on labels and this is really since those deficiencies, when we said they were under consumed nutrients, the deficiency about these really do represent public concern, public health concern, because of their link to chronic disease. And then they're saying now that Vitamins A and C are no longer required. So why would we say A and C are no longer required?

And they said that you know back in the early '90s, when they were doing this, you know, they had problems A and C, but right now Vitamin D and Potassium are nutrients Americans really don't get enough of. It's estimated that 95 percent of the population is not getting the current daily value for Potassium, which is very low compared to what the new Daily Value is going to be. But according to their survey data, you know, there are people who aren't getting either enough Vitamin D or potassium. We know Vitamin D is important for its role in bone health. And we certainly know about Potassium's role in blood pressure and heart health.

They also said that in the early '90s when they set the last regulations, they had good information, saying that American diets lacked vitamins A and C, but the deficiency in these vitamins now are fairly rare, although we did call out vitamin C is still an under-consumed nutrient. They did say, you know, "Hey you know as manufacturers, we're not expecting anybody who's fortified with Vitamin A and C to remove them, and you have the ability to still list them voluntarily." I can tell you from my standpoint, being somebody who formulates premixes, there are certainly plenty of companies who are removing them, because they're not the easiest vitamins to formulate with, and if they're no longer required on the label, you know, some companies don't see the value of adding them. The other thing that's a little controversial is that the FDA didn't keep any data back in the '90s when they changed the regulation to require Vitamins A and C, they didn't keep any data of how many companies added it, or went back and fortified with it because it was required.

They did note that this time they do plan on keeping records to see if people who start to add Vitamin D and Potassium, as well as who might remove Vitamins A and C, but I don't know how exactly they plan on collecting that data or how they would publish that data to us. So we may end up with some issues in the future around vitamins A and C again, because I do see it being pulled out of food products now. So, in regards to all the vitamins and minerals, there are some differences now, we'll be declaring quantitative amounts, as well as percent daily values, which is good, so you'll be telling the consumers exactly how much is there and then how that relates to percent DV, realizing that, of course those rounded absolute values really could be inconsistent, because you're rounding one and then the other, and that those daily values might not be exactly lined up with the quantitative amounts, and the FDA recognized that and they did say just as long as less than 2 percent of the daily value still shows a zero, they're OK. So as long as it's aligned at that lower level, they know they've got some discrepancies at the higher levels and they're OK with that.

I do want to kind of go through all the different vitamins and minerals because I think there's a lot of changes here. We do have all this information in the guides that are available to you so you don't have to take crazy notes on it. And like Moira said, we're happy to answer your questions after the presentation as well. So starting with Vitamin A, the current daily value for it is in international units, and that was 5000 international units. The new daily value is a new daily value, but also a new unit of measure, so we're measuring now in micrograms of 'retinol equivalencies'. And the new daily value is for 900 mcgs of retinol equivalencies. So that turns into about 3000 international units, so a decrease in the daily value, and then I've given you the conversion rates here, so one microgram of retinol activity equivalents is one microgram of retinol, or two micrograms of supplemental beta carotene, 12 of naturally occurring Beta Carotene and 24 mcg of Alpha, or Beta Cryptoxanthin.

On vitamin C: the daily value actually went up. We went from 60 milligrams to 90. So, under-consumed nutrient no longer required on the label, but the daily value did go up for that product. Vitamin D We have a new unit of measure for it as well as a new daily value. So the old daily value was 400 international units. The new daily values in micrograms of 20 micrograms which is the equivalent of 800 international units, so a doubling of the daily value. One international unit is 0.025 mcg so a nice easy conversion rate for us there, and voluntarily they did allow food manufacturers to declare it in international units, in addition to micrograms. So you cannot just label in IUs, but they recognize that a lot of physicians were kind of helping their patients by telling them how many international units of Vitamin D they should be intaking. So there are some people who are familiar with IUs now that maybe weren't five or 10 years ago. So they do recognize that and allow you to do it in both units.

In Regards to Vitamin E, Vitamin E is a little complicated. So the old daily value is in international units it was 30 IUs, the new daily value is now measured in milligrams of Alpha-Tocopherol (with an O-L at the end). That's 15 milligrams of Alpha-Tocopherol. That's the equivalent of about 22 international units. The daily value is actually going down. And then it gave you the conversion rate there, so one milligram of Alpha-Tocopherol ('O-L') would be one milligram of RRR Alpha-Tocopherol or two milligrams of All-Racemic-Tocopherol.

And that really is kind of the FDA's indication that you know there really are eight isomers of vitamin E that we deal with. They try to kind of divide them into two different groups and give two different levels of calculation or conversion rate for us.

So historically RRR-Alpha-Tocopherol would be our natural D Alpha-Tocopherol, and All-Racemic Alpha-Tocopherol would be our traditionally synthetic or DL Alpha-Tocopherol. So your conversion rate is: natural is one-to-one and synthetic is two-to-one, so you'll be adding twice as much synthetic Vitamin E to have the same amount of natural Vitamin E. Now some of these conversion rates are similar to what we were using in Canada in the past. So if you use these in Canada, those are similar calculation rates up there. But this is a change for the FDA and then them trying to take into account the fact that there are different eight different isomers on Vitamin E.

The vitamin K is a little simpler. You know we have the old daily value of 80 micrograms, the new daily value has gone up to 120. Vitamin K-1 is the only nutrient that you can use in traditional foods. You know there is really no specific definition of Vitamin K and the other thing is that Vitamin K is only really based on adequate intake.

There's not enough data out there for them to put together a full EAR or an RDA for vitamin K, so this is one of the nutrients where we have a daily value set off of Adequate Intake. There is a lot of interest in the industry on K2 and K3 products, and those are both very good products, but they are only allowed for use in supplements. There are not allowed for use in conventional foods right now.

So we'll go through some of the B-vitamins quickly, B1; most of the B vitamins dropped a little bit, so B1 dropped from 1.5 milligrams down to 1.2, Riboflavin dropped from 1.7 to 1.3 milligrams. Niacin has a change in units of measure, although it's not a huge effect for us, who are now measuring in 'Niacin equivalents' instead of milligrams. So the old daily value was 20 milligrams. The new daily value is the equivalent of 16 milligrams of Niacin equivalents, and a milligram of Niacin equivalent is one milligram of Niacin. But it also equates to 60 milligrams of Tryptophan. So that's a good thing to keep in mind if you're working on a product that contains a lot of protein, because at 19 milligrams of Tryptophan, you now need to declare the amount of Niacin that you have, and you also need to be aware that when you're doing testing of your product, you need to test for Niacin as well as any Tryptophan that's there, and it's the additive component that becomes your amount of B-3 in your product.

Next one will talk about quickly is B-6 Pyridoxine and it dropped a little bit from 2 milligrams to 1.7 milligrams, and then Folic Acid has changed a little bit. So now we're measuring Folate in micrograms of Dietary Folate Equivalents, the old daily value was 400 micrograms of Folic Acid, which would be equivalent to 667 microgram equivalent. So the daily value actually is decreased. The new daily value of 400 micrograms of DFE is actually less, because of the conversion rate. So one microgram of food Folate is equivalent to one dietary Folate Equivalencies, or 1.7 times the amount of synthetic Folic Acid added. So because you have this inability to distinguish it analytically, this will also require additional recordkeeping. So however much Folic Acid you're adding to your product, your new label claim would be that multiplied by 1.7. Again in the industry we've seen a lot of interest in other types of synthetic Folates (Methylfolate, etc.) There are no official conversions for any other Folic Acid other than synthetic Folic Acid. They do recognize that there may be other conversion rates that people would like to use, but you cannot exceed 1.7 so even if you had information in your in your database showing that Methylfolate is more bioavailable than synthetic Folic Acid, you still cannot convert at a rate higher than 1.7. The other thing to remind everyone as well is that these new Folates that are out there also cannot be added to conventional foods. They are not approved food additives.

They can be used in supplements.

Now we'll go through some other B-vitamins that had some larger changes to them. So vitamin B-12, that daily value went down significantly, from 6 micrograms to 2.4 And Biotin drops tenfold from 300 micrograms down to 30. Pantothenic Acid or B-5 that one dropped in half, from 10 milligrams down to five.

And then lastly you know we did have a really great achievement here it's we finally set a daily value for Choline. Choline is really known for its use in brain health, an important nutrient, definitely an under-consumed nutrient, certainly one of public health concern, in my mind. And we finally set the daily value for it 550 milligrams. I just wanted to note here that you know egg yolk will actually contain choline and 147 milligrams of it.

Pretty difficult to get this nutrient naturally as well unless you're consuming multiple eggs on a daily basis.

So let's go through some of the minerals, so calcium as we said it continues to be required nutrient on the label, the old daily value with a thousand milligrams, which is tough because it takes up a lot of space. You know looking at something like calcium carbonate is one of your most active sources of calcium, which is only 40 percent calcium as a daily value, and a high daily value you're adding an awful lot of calcium carbonate to meet that. The new daily value is actually going up by 30 percent, we're now at 1300 milligrams for the new daily value. So this will be a concern you know this is a flavor-muting ingredient so as we do fortify with it we might have some challenges. Iron is actually a new trend that's remaining the same on one of two times you'll hear me say that throughout this entire presentation, iron remains the same at 18 milligrams.

Phosphorus went up a little bit as we might expect, you know calcium went up so phosphorus is going with it. So from a 1000 milligrams up to 1250 milligrams on phosphorus. Iodine again second time, and the only... and only last time I'll say it. Iodine will remain the same in 150 mcg. Magnesium went up just a hair from 400 milligrams to 420. So those are the ones that might be your challenges. Ones that went up significantly. But we do have some exchanges for that. The zinc goes down, from 15 milligrams down to 11.

It's kind of difficult to fortify with a being an active mineral like that, it can cause a lot of oxidation. Selenium dropped significantly from 70 mcg down to 55 micrograms. Copper is less than half, it went from 2 milligrams down 0.9.

Manganese also was a small change but in the opposite direction up just a little bit from 2 milligrams to 2.3 milligrams per day. Chromium is a significant change in the downward side, from a 120 mcg down to 35. Molybdenum also went down, from 75 mcg down to 45 mcg. Chloride went down. So this is might be significant in regards to Potassium, which we'll be talking about next. The old daily value for Chloride was 3400 milligrams, the new daily values now 2300 milligrams, so you know some things where we're talking about sodium reduction - that's in line. The Potassium went up significantly and lots of times we use Potassium as Potassium Chloride. So there are some some discrepancies there that might make it difficult for us. And potassium on its own is going to be difficult for us. Now potassium is now a required nutrient. It was one that we didn't label very often on the old labels, because it's so difficult to fortify with and it's difficult to get any significant amount naturally. So it moved from DRV to an RDI, and is based on adequate intake. The old daily value was 3500 milligrams, it was huge, difficult for us to work with. The new one is now 4700 milligrams. So just to put that in alignment: a banana's 422 or a skin-on baked potato is 1600. So that's an awful lot of bananas to try to get naturally to to achieve that potassium level. Now I talked about earlier they're estimating that 95 percent of the population wasn't getting the current daily value of 3500.

So we have this new daily value of 4700 milligrams, so probably even more of the population will not be achieving that. And like I said potassium is difficult to fortify with because it takes up so much space and it does have some major flavor concerns, as well PH adjustment, so we have at Watson been working on some thin-layer encapsulation, to try to be able to fortify some food products with potassium. So Fluoride is another nutrient that they gave us some information on as well, so Fluoride is still... it's never really been permitted as an ingredient that we could use in the past it was not required on, or even allowed on, our old labels to use fluoride. But you know there is this understanding and we have quite a bit of Fluoride that can come from products that use a lot of city water. So it's still considered a non-essential nutrient but they did kind of recognize that it plays its role in dental caries. And maybe it's time to do something about Fluoride so they give us a voluntary declaration, so no daily value really set for it, but they did give you some rounding rules on it. So, if it's less than 0.1 milligram it's still 0. If it's between 0.1 and 0.8 it can be declared in 0.1 milligram units. And if it's between, above 0.8 then it can be declared in 0.2 milligram units. So you can voluntarily declare it, they are not expecting anyone to add fluoride or even permit people to add fluoride to their products. It's not something to be fortified with. But you can declare what's naturally occurring from city water.

That's a brief on the vitamins and I'm sure that there'll be some more questions regarding those when we finish.

Sodium & Dietary Fiber

The next area were going to be talking about is sodium and dietary fiber. So percent for daily value for sodium actually went down, dietary fiber went up. So a daily value for fiber went to 28 grams instead of 25. Again it was an under-consumed nutrient at 25 grams, so we'll probably have some difficulties there with that. And then sodium dropped from 2400 milligrams down to 2300. Now, fiber has been something that had a little controversy on it in regards to the new label. So there is a definition, this is the definition that the ABA has asked to rescind, but the definition as written in the regulation is 'non-digestible soluble and insoluble carbohydrate, determined by the FDA to have physiological effects that are beneficial to human health'. So the ones that were actually printed in the regulation include Beta-Glucan, Psyllium Husk, Cellulose, Guar Gum, Pectin, Locust Bean, and HPMC. There had been a ton of other petitions that have been filed for some of these other traditionally-used fibers that we've declared as 'fibers' for years in the food industry. We were hoping to have an additional, around 20, fibers approved by the end of 2016. That did not happen and the federal registry is kind of basically not publishing right now, so we're in a little bit of limbo as to what's going to happen with these additional fibers. But this will be a challenge for the food industry, because we are going to be trying to declare that extra 3 grams of fiber on our products.

Meanwhile, things that we've been using as fiber sources for a long time, like inulin and fiber corn fibers, etc., are now off of our list of what we can currently declare as fiber, so this might be where a postponement, or at least a little additional information around the regulation, could be really helpful for the industry.

Calories from Fat

The next area we're going to be talking about is really these calories. And so we talked about calories from fat. They removed the 'calories from fat' line, basically saying new research really shows the type of fat's more important than amount of fat. I don't disagree with that, but we will be declaring the amount of total fat, saturated fat, trans fat, and that will be measured in grams as well as percentage, but not in calories. So this is again. not quite in alignment with what the DGA guidelines had been, in regards to consuming less than 10 percent of your calories from fat, saturated fat specifically.

Odd-Sized Packages

And the last area we we'll be talking about is these odd-sized packages, so really going back to better reflect what Americans are currently eating. You can't say that you have a serving-and-a-half any more, if your serving size is anything between 1 and 2, it's now 1 serving, so labeled as one serving. Like these two would be both one serving per bottle for either bottle size. So no in-between on that. That's the basic on the food nutrition label.

Supplement Facts Label

There are some differences when we're talking about the supplement label and I want to go through those as well. Some of it's a little easier for the supplements and some of the makes it a little bit more difficult.

Calories

Well, let's start with this piece on calories, there's a lot of confusion around the calories piece, and calories that are in supplements are really only declared when there's a significant contributor anywhere. And they're also not required to be in a larger font.

So that was actually printed wrong in the regulation, and cleared up in the comments. So, supplement facts panels will not be required to have the calories in a larger font like the nutrition side will, and they did say that when they come up with their future amendment they'll correct it there. So both of these examples are acceptable when you have calories declared or not, if it's an insignificant source of calories.

Dietary ingredients to be Declared

Another difference on the supplement side is in regards to the ingredients that need to be declared. So where they're not present, or they're present in amounts that are less than 2 percent of the daily value, they can be declared as 0. Important thing to note here that they cleared up on the supplements side is that protein cannot be claimed when you're adding individual amino acids.

And that was done as it was a little confusing in the past, you know, an individual like... a Creatine: is it counted as protein or not? And so the official ruling on that is it will not be claimed as a protein if it's added as an individual amino acid.

Quantitative Amounts

Third big change on this is really their quantitative amounts being listed in addition to percent daily value. It's nice on the supplement side as we can put this all onto a table it makes it a little easier. So the ingredients can be identified right within that table, or in an ingredient list at the bottom. That's their choice, to put it either way. It does kind of make it nice on the supplements side to be able to show that something like Vitamin C might have a nasty name like ascorbic acid.

And so sometimes those names are a little difficult for consumers to understand on the supplements side, it's a little bit more clear.

Order of Vitamins and Minerals

The fourth area that they gave you, they gave you this 'order of vitamins and minerals'. And really, this is not a significant change for anything that we've seen in the past, but they did show you that choline should drop in at the bottom of the vitamin list, right after Pantothenic Acid, and that Fluoride if you're going to voluntarily declare it, that it would be at the bottom after Potassium on the supplement label.

Units of Measure

What they were talking about was really units of measure. So this is buried in comments as well. The only units of measure that were allowed in the actual nutrient tables are things like milligrams and micrograms and dietary folate equivalencies, etc. But there's other units of measures that are used in food products and specifically in supplement products, and this came up with a lot of comments from the probiotic manufacturers, saying "look we measure things in organisms". But the FDA recognized that there's a need. They said that they would plan to issue some information related to the subject at a later date, but no later dates been mentioned. But in the meantime, they said they declined to permit other units of measure. So they kind of made it sound like maybe they wouldn't have any harsh reaction to it, because they know that there's a need to fix it. But the same time that they weren't just going to let people use whatever they wanted.

So hopefully that will be straightened out soon too.

Supplement Panel Daily Values

Next thing is on daily value, the footnote for supplements is just slightly different. So they can claim total fat, saturated fat, total carbohydrate, dietary fiber, protein, or added sugars.

And then they do use a footnote, and that footnote is percent based on a 1000 or 2000 calorie diet and another sub note: if a product is designed for children from 1 through three years of ages.

And then there are some things that kind of change altogether in regards to the supplements, you know... And this came out really in the comments on the supplements side.

Overages

So you know they mentioned things like 'overages' and there was some questions about overages. You're required to have a nutrient at 100 percent of label, but to test to 100 percent of label is really complex. And they did note that, that does warrant further consideration. So the question was, "If we have to test at 100 percent of label and they haven't made an allowance for any overages that we're adding, then how can we be at 100 percent label if we have to be at minimum 100 percent of label?" So they didn't call out that there's some work that they need to do on that side in regard to what happens with overages, and how much of an overage is allowed, but nothing further than that.

They also called out that add-in nutrients are typically synthetic, and that products would be misbranded if they label.. actually, implied... that a natural vitamin was superior to synthetic or an added vitamin. Another thing that they noted that anything outside of nutrient panels, because there is a lot of confusing comments around content claims and structure function claims, anything else that's outside of the panel itself is outside of the scope of this rule-making and they made no comment on it. They did note there are some discrepancies, specifically on the USDA side, between this labeling regulation and some of the units of measures in the daily values that they're using, and comparative to the USDA regulations in regards to fortification of things like flour, et-cetera. Those regulations are no longer in alignment. The FDA did recognize that, and they said that they will address those complications later. OK, so another thing I want to talk about briefly here is Potassium on the supplement side. So I have had a lot of questions about you know 'what do we do with potassium as new the value is really high at 4700 milligrams, and we had this thing where we had to put a warning label on our supplement products if we had above 99 milligrams in a tablet or in any sort of single swallow item.'

And really the FDA, you know that was based on some gastrointestinal injury information from the early 1970s and they had a 1975 position on it saying that you had to put a warning label saying that our product could be a risk for Gastrointestinal Injury if it had better than 99 milligrams of potassium in it.

And there's a need now. We're not going to be getting our potassium naturally how we're going to be able to do it, it's difficult to get it into food, but we could probably put it into tablets, and the FDA said you know 'look that that statement still stands unless you can prove that your product is safe. You'd have to ensure that your dietary supplement would not cause any sort of gastrointestinal injury, and then you don't have to use the warning statement.' But that's a pretty big 'ask' on the FDA side, because you're basically you know asking FDA to come see you (invite them for an audit) and then review your data and hope that your data meets what their requirements may be. And they haven't declared what their requirements are. So, just a little bit of a warning there that we, as far as I can see you would still be required to have that warning statement if you have above 99 milligrams in the tablet, in the supplement. OK.

So that's your overall on the dietary guidelines on nutrition and supplement facts panels. You know this all rolls into a lot of work for everyone. We have a lot of change ahead. You know if you have a fortified product something needs to change, and we have either we have to change all of our labels or we have to change our premixes that we're adding, you know either way it's a significant change we don't know how our consumers are going to accept either a change in label or a change in our product. You know, one or the other will change. We have to try to keep our labels the same change premixes to keep the same daily value as the product might taste different or look different than we're used to. And if we just keep the product as it is and we change the labels, the consumers may be like 'hey, how did my daily values change, what was going on here?' So there's a lot of unknowns about it. But, regardless we have quite a bit of work to do in front of us.

So Watson is a premix supplier, this is what we do and we're here ready to help you. Now there's some information here for you to contact us as well.

Q&A

And I do think we're going to have a question-and-answer period here as well.

We do have some questions that have been submitted by the audience and as a reminder, if you have another question that you haven't submitted yet, please enter it in the Q&A box and we'll get through as many questions as time allows. Alice?

Okay, so let's see what we have for questions here.

Okay. So I did have some questions about label changes being delayed for three years. "Do I think that this delay will help our industry while hurting consumers?" You know, I can see both sides of it. If the regulation was delayed as it is without any changes to it, delayed for three years. I think that that really is only helping the industry. You know, I have some customers who are on top of this already. They're ready to launch their new labels an I have others who just haven't even started to look at it. So you know the industry is kind of definitely looking at this from two different ends. If there's some changes to the regulation between now and when we get a final ruling, and they change some things around for things like dietary fibers etc. This could be better for consumers. Like I said you know if we could straighten out that piece even where we're supposed to get a max amount of our calories from sugars and fat, if we could get that straightened out so that the consumer could understand it a little better and actually make this clearer for them, I think that would definitely help consumers. So you know it depends on what changes. So I think that that's a good question to ask and you know a lot of it is to be determined with what happens with our new commissioner.

Here. 'Do food service products need to have a nutrition facts panel on the label?' I don't know if that's the requirement or not, I'm going to have to go back and look into that specifically for you. I think most of them do just because it's easier for people if it's there, it's certainly not a difficult thing to develop one, if you've got access to that type of information, but I'll have to go back and check that specifically. And another question about added sugars here, in regards to added sugars: 'Would honey show up as added sugar if I were running a label just on a bottle of honey?' So that's a good question. So on honey itself, if you have a pure, 100 percent honey product, there would be no added sugar to it. It is Honey. If you were taking that honey and adding it as a sweetener to a beverage, then the amount of honey added to that beverage would be added sugar.

So on the bottle of honey it would not be. Let's see, what other types of questions do we have?

Oh this is a really good question: 'Comparing the old daily value of vitamins and minerals to the new daily values - Does a 100% across the board cost more or less?' That's a really really interesting question. I would say, you know some of the more-expensive nutrients are actually decreased, right, so things like vitamin A, that's always been an expensive nutrient, and you've got this nice conversion on Folic Acid, which means that you'll actually be adding less Folic Acid to products. I'm guessing it would probably be less would cost you probably less. It might be physically harder to do though, if you start looking at things like those minerals, like calcium going up as much as it did, as well as something like potassium having the big jump that had, those are going to be pretty difficult for us to do unless we can get really creative with some of the value-adding that we do the nutrients to make it so that we can have them in there, but not change our products so much that our consumers don't want to come back and have the second time. What other questions do we have? (I'm trying to read this as we go through here.) So we have one here about sugars in corn syrup and rice syrup needing to be declared as added sugars: Yes they absolutely would have to be declared as added sugars wherever they are added, unless that was a single product that only contained you know, it was just a bottle of corn syrup. 

OK we had another question about Niacin and Tryptophan. So the deal with Niacin and Trypotphan: Tryptophan actually is kind of a source of vitamin B3.

And the conversion rate is 60 milligrams to 1. So if you have 60 milligrams of Niacin or 60 milligrams of Tryptophan, that would count as one milligram of Niacin equivalencies. So if you have as low as 19 milligrams of Tryptophan, that would translate to 2 percent of the daily value on the Niacin side. So just be aware of that, you know high protein products you just want to be sure that you're counting to see what Tryptophan you have, because it might be changing your daily value that you're declaring on the Niacin.

'Is there a source to find the status of the fiber-source petitions?' I really wish there were, that be great if we knew what the status of them was. But there's been very little publication out of the federal registry, so I think that we're kind of in a very quiet period there. There has been some mention of changes there. Heard people from FDA continue to say that they'd like to have an additional list added to that, but I can't get anyone to put that in print for us. So I have not been able to find anything about the status of fiber petitions, we certainly have lists of all the fiber petitions that are out there, but nothing from the FDA saying where they are or how close they are to approving those. Wow have ton of questions here too, and I apologize if you're waiting for me to read them.

I have a question here 'Has Watson developed ready-to-use premixes for supplement manufacturers, to deliver 100 percent of the DVs for adults and/or pregnant women in tablet forms?' You know most of what we do here at Watson is really custom-manufacturing. And so 100 percent daily value could be helpful for someone, but then maybe we don't want to be putting the potassium in there. So most of what we do really is 'custom', and depending on where a customer is using a product, where it's being sold to, does it have non-GMO labeling on it. Is it required to be kosher. Is it going to be sold into Whole Foods, and all those things come into play in regards to how we're actually going to put together a pre-mix. You know, is that tablet going to be single-swallow, is it going to be chewable? If it's chewable, I definitely want to taste-mask some of those nutrients so that the product's more acceptable. So... lots of questions back and forth in regards to developing premixes. It's pretty rare for us to have one pre-mix that meets the needs of multiple customers, and so we are kind of a custom manufacturer. That's what we do. 

So.

Lets see here. What other kind of questions do you have...

So there was a question about claiming fiber. So we can't claim fiber if it's not on that list, even if a third party has provided a C of A, saying it contains fiber, that would be true right now, and we're hoping that that changes so that some of them are more traditionally-used fibers are also on that list. But, yes my understanding is that you cannot claim fiber from something like a resistant corn fiber or resistant maltodextrin or an insulin, even if you have a third party certificate of analysis, or analytically have that information, saying it is declared as a fiber, you cannot declare it as fiber on the current regulation the way it's written. So another thing on that, you know is that that regulation is effective, the effective date was July 26 of last year. So it's effective. The compliance date is really July 26 of 2018 right. So we have another year plus a little bit to be compliant with it. If it stays as is. So within that, you know if you have had less than 10 million dollars worth of sales in any of the years of the last five prior years, you'd have an additional year on that for compliance. So that compliance is different than the effective date, but realize this regulation isn't like it's proposed regulation it is an effective regulation. So we would need to have change to the regulation around that, to get those fibers added, or some sort of further publication allowing us to use those additional fibers.

So here is an interesting question, so it looks like that... They're a provider of some sort of bulk product and asking you know 'Look do we need to have these new nutritional information?' And what I would say with that is, you know yes you're right. New labeling does not necessarily affect raw materials, bulk drums et-cetera, because you don't have to have that label on a raw material. But your customers are still expecting you to be able to understand the product and be able to help them with that.

So they're going back to you, as a supplier of an ingredient, asking you for the information that they need to calculate their new labels.

And so it's more of a service-thing, versus a regulatory piece. So you know, you're correct you probably do not, you're not required to provide that information. But I would say if you want to be helpful to your customers, you probably do need to be able to go find that information to be able to provide it to your customers. Because they're just... everybody is kind of reaching out now. There's been a lot of misunderstanding around some of the conversion-rates. On vitamin E, it's been very difficult. Vitamin A has been difficult for people as well, and so everybody is kind of looking for this information in regards to how can we do the calculations for our new labels, the new Genesis program from Attia that's out there you know that helps, but you know everybody is looking for information. So I think that the best thing we can do as an industry, is try to help each other through this. You know we're really all in this together and getting these labels right is really in all of our best interests. You know, have them more aligned so the consumer actually is less confused would be good for everyone. So I would say that yes, it's not a requirement, but I would probably take the extra effort to try to figure out what your customers need so you can help provide it to them. 

'Are the RACCs changing just depending on the serving, of the container itself?' The RACCs as I understand it are not changing and like I said this particular regulation is only about the panel itself, like I said, it goes back to the panel itself. So

is it just depending on the serving container itself? And I believe it's depending on the serving container itself, that's something I could go back and review for you as well.

What kind of questions do we have here... 

And I think the last question I'll take here is, we had another one, 'If we could create some type of table or chart to help people with the conversions, that would be really helpful for people.' And that's something that Watson is definitely happy to provide for you. So that's something I'm sure that we can follow up to this webinar with that, to give you some conversion charts there, and like Moira's said, we're always open to questions from all of the industry, as to how Watson can be helpful to you. So... yeah our sales team will also be following up with some of these additional questions. I have to say here, there's way more questions than I could possibly get read in the amount of time that we have here we are about 10 minutes over already. So I did want to thank everybody for their time today. Moira, did you have some more information in regards to how they should contact us?

Yes, you know, they can use the contact information on the screen but I just wanted to remind people that we're going to have a link to the recording of this webinar, as well as our comprehensive guide to the label changes, it will be available at http://labelchanges.com. We expect to have the webinar available tomorrow afternoon. It takes a little bit time to do some editing and get it there, but check in the afternoon it should be there. Also, anyone who is an attendee, you should get an e-mail from us tomorrow afternoon, also with the links. And again I just wanted to thank everybody for joining us. And Alice, thank you so much for sharing your insight and your expertise. This is obviously a really important topic for the industry and obviously, there's a need for more clarity on the changes and some additional discussions. And like you said, we'll be following up with e-mails this afternoon and responding to as many additional questions as we can off-line. So thank you, everyone, for participating, and we hope you have a wonderful rest-of-your-day! 

Thanks, everyone!

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