Supplement Facts Panels and FDA Regulations

Q&A session if your question is not answered during the Q&A session Audrey will reach out to you via email following the webinar in order to enter your questions into the queue click on the questions in the section panel of the webinars and type your question into the text box and press Enter it is now my pleasure to introduce today's presenter miss Audrey first Audrey Audrey is a senior project manager for dietary supplements at the eurozone's nutrition and houses Center in Des Moines Iowa these were coming to your offense miss frist worked as a laboratory manager in academic research for 20 years miss frist has a Bachelors of Science in microbiology from Mississippi State University and has done postgraduate molecular cellular biology work as a University of Alabama at Birmingham address Audrey the floor is all yours good morning everyone I want to thank you all for joining me here today as Chloe mentioned I'm the senior project manager specializing and dietary supplement here at European nutrition analysis Center so this morning I plan to discuss with you specifics regarding supplement tax panels as well as go through the new FDA regulations that have recently been enacted hopefully we will cover all the information you need but if not if she mentioned you can submit questions online and I'll be happy to address as many of those as I can at the end of the presentation you may also feel free to email me with future questions so in my role here at eurozone's I would say the most common questions that I'm asked by clients are in regards to the differences between nutrition and supplement tax panels and which type of panel a client needs for their product to be able to answer the second question we need to address the first so first let's take a moment to look at the similarities for the FDA conclusion of the same nutrients is required regardless if you have a food or a supplement you may commonly hear these referred to as b2 ingredients and for those of you who are curious about where that gets its name it's simply the location in the subsection of the Code of Federal Regulations where the information is found but this information is required and it is required to be in a specific order on your facts panel please note that these notes okay I'm going to show you here for current these are the current sorry please note that the nutrients I'm showing here are for the currently compliant label these are not for the new FDA guidelines which I'll discuss shortly we'll revisit those in the future slides as you see here there's different items required you have calories you have calories from fat different types of fat like total saturated trans fats cholesterol you also have a couple of proximate such as your protein and your carbohydrates you have sugars fibers a couple of vitamins and a few minerals that's pretty much where all the similarities and these are mandatory on the nutrients on a nutrition facts panel no matter what their daily value or their quantity is so for example on a nutrition facts panel you will see here that cholesterol is zero milligrams and a zero percent daily value but it's still present and required to be on a label however only nutrients that are considered to be significant or present and what they call a measurable amount are included on a supplement panel which if you think about it that makes sense because these nutrients are meant to supplement your normal diets so if you're below a certain level it's not really considered to be a supplement if it is an insignificant amount it's actually considered by the FDA to be zero and it's not allowed to be on the facts panel at all this measurable amount varies by the nutrient but it's generally considered to be approximately two percent of the daily value so if we use the same example on the previous slide of zero milligrams of cholesterol you will notice that nutrient is not shown on the supplement label in fact a lot of information is missing proteins are missing as well as some of the fat information the most significant difference is in the information that is allowed for each type of panel nutrition labels are limited to the previously listed mandatory nutrients as well as some voluntary vitamins and minerals which are shown here in the order that they would be present on a neutral nutrition nutrient packs down easily you may also want to add in a vitamin D vitamin E you can add B vitamins and you can add just a handful of other minerals such as magnesium zinc or iodine but this is the extent of the information that the FDA will permit or allow to be on a nutrition facts panel however there's really not much of a limit to the nutrients that are allowed for supplementation for example you can have a greater variety of minerals you can have one such as manganese you can have selenium you can have fluoride and many others you can also include fatty acid information such as epa DHA you can include omega-3s omega-6s astaxanthin some of these nutrients are especially important for those of you with fish oil supplements and the no acids may also be listed on a supplement tax Channel these are generally three amino acids that are used to fortify your product such as l-glutamine or possibly branched chain amino acids I refer to the next category as active ingredients this includes as you can imagine a rather long list of possibilities you can have items such as coenzyme q10 you can have collagen you can have polyphenols you can have resveratrol pretty much just any active ingredient that you would like to list it's in your product you may also list the tentacles so you have anko or you have echinacea that's allowed as well as proprietary blends an auto label you will see that most of these items have an asterisk or other notation to the side that indicates that there is no daily value established for that particular nutrient which is not expected which is not unexpected one other note if you're making any type of label claim that becomes a mandatory nutrient as well so let's say you want to claim that your product is high in vitamin E then you are going to need to test for and include vitamin E in your facts panel so to go a little more in-depth on some of these the source of vitamins and minerals may be listed in parenthesis next to the nutrients look excuse me next to the nutrients um for example vitamin b12 is listed as so at Sian O cobalamin and potassium as potassium chloride you can also use multiple sources for one nutrient with you know in the respective contribution so for example let's say you have 30% cyano cobalamin but 70% methylcobalamin for your b12 if that's the breakdown for your product you can put both of those in parenthesis if you do not show this information on the panel next to the nutrient it must be shown in the ingredient statement itself this may pertain more if your nutrient is naturally found within an ingredient instead of it actually being the ingredient itself so say for example your source of iron may be for spinach so you would have spinach listed in your ingredient statement and not in parentheses next to our panel when listing a botanical there are only two requirements that you really need to keep in mind you must list both the Latin name of the plants as well as the part of the plant that it's derived from in an example shown here you will notice that the grapeseed extract is shown to be from the seeds of Vitis vinifera followed by the amount of the botanical and that survey which is a hundred milligram followed by the cross notation indicating that it does not have a daily value i also want to point out that we cannot really test botanicals as far as being able to quantify or quantitate them most of the by so tentacles that we do here are for identification purposes only the exception might be if there's an active ingredient in a botanical that you would like to test for as for proprietary blends the same guidelines apply here in regards to the order as they would in an ingredient list so in other words you're going to list the most abundant by weight first and that's going to be followed in order followed by the remaining remainder in decreasing order of weight the total amount is listed by the blends name and you can name it anything you want they even say you can give it to sort of fanciful name but it's but you are not required to list the quantities of each individual component within your proprietary blend many clients choose to use this instead of listing items individually because it helps protect their recipes you may by now have decided which type of panel works best for your product if not I often advise clients to ask themselves this how do you plan to market your product do you plan to mark it as a supplement or do you plan to try and market it as a food product if you have many nutrients that are not allowed on the nutrition facts panel that make your product unique then you may want to opt for the supplement type for the supplement panel but please keep in mind that your product must then be labeled on the front as a dietary supplement and this decision will also impact where in the area of the store that your product can be shelved so this is going to bring us to the next topic I'd like to discuss which covers the recent changes made on e FDA this is the greatest change made to labeling and you have 20 to 25 years and it was done primarily to better educate the consumer and to make facts panels easier to read and to understand by the general public please note that these changes apply to both nutrition and supplement effects panels equally just as in previous versions now while these changes I'm about to describe have already and as of July of this year they are not yet mandatory if your company has ten million or more in annual sales then you have two years to become compliant with the new labels guidelines and regulations whereas smaller companies do not have to be compliant until 2019 now remembering back to a few slides ago when I was showing you the what is currently compliant and showing you the list of b2 ingredients for the new regulations vitamins A and C are no longer required this is primarily because they have found that there are very few deficiencies in these vitamins taking their place are going to be both vitamin D and potassium these are nutrients that some people in the population are not getting enough of and putting them at risk for chronic disease so they believe that this is more important and now needs to be included on the label keep in mind though that vitamin A and C is now becoming a voluntary nutrient so they've gone from mandatory to voluntary I also want to mention that calories from fat is no longer even permitted it cannot be considered a voluntary nutrients calories from fat they believe the type of fat is more important than the amount of fat so they have removed this from the labels these aren't the only changes that have been made most notably is the addition of the added sugars and some changes regarding dietary fiber and I'm going to discuss those two a little more in detail in just a moment the FDA is also moving away from using international units as a unit of measure they don't believe that the general population really has an understanding or grasp as to what international units are so they're going towards milligrams or micrograms depending on the vitamin so vitamin D for example is moving from international units to micrograms folic acid is also micrograms but it's in a microgram DF email which stands for dietary fiber which stands for uh so again equivalents there are some other changes which aren't as prominent that aren't going to affect a label quite so much some of the daily values for some of the minerals and some of the vitamins have changed they've also implemented being able to use dual labels so you can show both per serving amounts and daily values as well as per package because I think they do realize that sometimes people indulge themselves a little bit and we'll eat an entire package of something instead of just one serving for the added sugars this is one that's quite difficult for our industry at least this is information that the client must provide to us if we're going to make you a label the reason being is that our sugar profiles are performed by HPLC and hplc is not able to differentiate if the sugar is naturally occurring or if it has been added to the product and added sugars don't include just white sugar or brown sugar it also includes other sugar sources such as honey counts molasses syrups corn syrup even a concentrated fruit juice if it's not being used specifically to make a juice product those are all considered to be sources of sugar and as for dietary fiber there are a few guidelines outlining which fiber is considered to be beneficial or not beneficial this is list right now is expected to grow there's only eight fibers currently listing but they are expecting that there will be up to approximately 25 so if a fiber is considered to be not beneficial according to the FDA please note that this is not considered part of dietary fiber and it needs to be subtracted out from your total it is however still considered to be a carbohydrate so it will be subtracted from the fiber that will still be included as a carbohydrate on your labels as far as the current list that's concerned the only insoluble fiber that's considered non beneficial is inulin and the ones that right now they're considering beneficial are beta glucan soluble fibers psyllium husks cellulose guar gum pectin locust being and hydroxypropyl methylcellulose now depending upon the type of fiber that you have in your product you may prefer to have your dietary fiber analyzed by HPLC instead of our crude total dietary fiber analysis the HPLC method will actually break down your fiber into soluble and insoluble and it will further break down to soluble into low and high molecular weight fractions this is important primarily if you've added some low molecular weight soluble dietary fiber to your product reason being is that that fraction is actually washed out of the fiber in our normal protocol so that's in your product and you do not do the high the more detailed HPLC package standing your fiber totals aren't going to be quite right we're going to be accurate so your essence can help you navigate these changes in several ways first of all we want to let you know that we have generated several packages nutritional packages for both the current and the newly compliant FDA requirements and we are aware that there's quite a few tests involved with each of these packages so we have heavily discounted them over the cost of what it would be for each individual test and the current packages will actually be available until the mandatory compliance date at which time their bows will be discontinued we also can provide these packages with a few customization customizations to include fatty acid profile or to include the more complete dietary fiber now I also want to emphasize that we do generate sex panels here at irritants using ashes Genesis program and we can either generate the panel using a CoA from a product that we've tested for you from a specific sample or a lot or we can also use a CoA provided from your manufacturer we're also able to generate dual labels as well as bilingual ones when a client requests one of our new FDA compliant packages we do ask that you complete a questionnaire and I know several of you on have already encountered this and had questions about it so I want to take a few minutes to go over specifics and discuss this with you we realize that this is not the most convenient for you but we ask that you do this so we can guide you in selecting the most appropriate analysis for your product also the FDA is stressing record-keeping more than ever for this newer format so we're hoping that the questionnaire can also be beneficial in this respect we need several pieces of information obviously serving size information this would include say your product is 500 milligrams we also need to know what the standard household measurement equivalent is so that's one tablet or three capsules per serving and we also need to know how many servings per container you have the next question on our questionnaire actually asks if you have added oligosaccharides to your product this is actually going back to the previous slide when we were discussing dietary fiber this will help us if you answer yes that means we would like to advise you to use the more detailed dietary fiber analysis we also ask if you have added dietary fiber which kinds you've added so that we know whether or not those need to be subtracted from your fibers and we also ask if you've added sugar again going back to the previous slides where we would know that we need to include that on your label as well please note that our questionnaire will hopefully be available online by the end of the month once completed online it will go directly to our client service inbox to be addressed and then the client service representative can get back to you if you ever have any questions about the questionnaire or any issues feel free to contact us and ask any of us we'll be glad to help guide you through it so lastly there are a few other tests that you may want to take into consideration for the new facts panel we've already discussed the dietary fiber choices so I won't revisit that but for vitamin E vitamin E now reports as milligrams alpha tocopherol so if you are expecting vitamin e on your product you will probably need to have a test for the to Cal profile so that we can break them down into the different directions if you've added niacin to your supplement we'll also need to perform analysis for tryptophan actually the body is able to convert tryptophan into niacin so if you have so to be able to give you an accurate niacin quantity 60 milligrams of tryptophan actually equal one milligram of niacin so we would take those two values and add those together to get your total niacin for your panel lastly want to take into account sugar alcohols such as mannitol or sorbitol you may want to have a sugar proof sugar alcohol profile performed as our HPLC will also recognize these as sugars so to be able to have an accurate sugar quantity those with me need to be subtracted from your total sugars so I guess at this time I'll take any questions you may have um do you know if there are any Chloe yes we do have one question asking can you please repeat which fibers are considered beneficial sure one problem okay the list of beneficial fibers those are there's only seven of those at the moment it's beta glucan soluble fiber psyllium husk cellulose guar gum pectin locust bean gum and hydroxypropyl methylcellulose I was hoping I wouldn't have to say that one twice and then can you go over the regulation you were citing for the supplement needed at all what regulation for supplement needs all the nutritional info oh okay if I'm understanding your question correctly as far as where you can find information specifically regarding dietary supplement regulations it is 21 CFR 101 dot 36 and if you go on to the FDA website and type that in and it should send you to that information you can find overall really all the information there that you need it can be quite cumbersome to try and pour through but it'll give you the order of nutrients that need to be on the panels as well as what's mandatory and what's allowed and then lastly I've already had my product tested following the old FDA guidelines do I need to completely retest following the new regulation the answer to that should be no if you've had the product tested and you still have that lot number that you tested you can only you only really need to go back and test for the vitamin D and potassium and then that you should be able to then put them on the panel and have a new one generated perfect and if we did not get to your question and Audrey will send you an email personally to discuss your question and that wraps up today's webinar and we'd like to thank Audrey for her time sort of in her very informative presentation and thank you to all of you for joining us have a great day

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