Meet the compliance challenges for Supplements in Europe and in the US thanks to R&D Insight
21 May 2024 | FoodChainID
There are so many regulatory sources to check if an ingredient is authorized for nutritional purpose in the European Union with national specificities. The regulatory frameworks governing ingredients for nutritional use in food and dietary supplements as well as Health Claims, differ between the European Union and the U.S.
Our digital solution Supplements R&D Insight summarizes the European and American regulatory status of ingredients (authorized, restricted or forbidden). In addition to a great source for product ideation, the scientific part enables to determine whether sufficient data exist to support your pending Health Claims in Europe and structure/function claims in the U.S.
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Hello.
Welcome to our webinar.
Today we are going to explain how to, how the supplements can meet the challenge in Europe and in the US of compliance with supplementary insights.
So my name is Gail Donaghy.
I am the head of the regulatory department in the food chain ID and the presenter today will be Dr.
Jerome Lebloc, the head of our scientific department, and myself.
So before handing over to Jerome, I would like to say a few words about food chain ID for the attendees who are not familiar yet with the group.
So Food chain ID is the leading provider of solutions to the food industry for a safe and transparent food chain supply.
Here is a view of our business capacity.
We provide solutions and services organized in 5 main business units.
So firstly, product development.
So our solution will help you manage receipt, the development, supplier and label requirements, as as speed up your NDP and formulation.
The second one is a food safety solution.
We deliver essential certification and auditing services, including those recognized by DFSA.
Indeed.
We are able to provide all the solutions to get your company certified such as ISO, BSCDS, etc.
We also provide regulatory compliance solutions.
We provide indeed suite of solutions that help accelerate processes and manage compliance risk through the product life cycle.
The solution will help you with market intelligence, management of regulatory data, and compliance.
We also have some product certification.
We manage food product certification such as non-GMO project, organic, plant-based, or vegan.
And finally, we have a testing solution, so our teams follow your sample from start to finish to help you select the most efficient and cost-effective approach to meet your specific testing need.
For instance, we can cover DNA based services, GMO and contaminating tests.
So here is an introduction of the supplement part of Fuchain IED, formerly Nutraviri.
So we help our clients thanks to our consulting expertise and our solution.
We assure the compliance and substantiation of efficacy and safety in all the European member states and in the US market.
We have two dedicated team of experts focusing on regulatory and scientific requests.
We work for instance in the compliance of a finished product related to the composition, label and registration, novel food and health claim, as as the organization of training.
The first solution, supplementary insight, helps our customers to create products thanks to three categories regulation, science, and marketing.
It gives to our customers access to the regulatory statue of around 3000 ingredients, a complete view on health claims.
It can help them also to find scientific evidence and the trends in terms of food supplements in the marketing part.
The second platform, supplement compliance, allows a customer to launch their product in Europe and to work on specific formulation.
It generates the labeling and updates the formula in a few seconds.
Now we are going to go deeply into the subject of today, and firstly we are going to see what are the regulatory sources to check in order to know if an ingredient is authorized for nutritional purpose in the European Union.
So in this slide you can see a summary on the ingredient classification in the European Union for food and food supplements.
So there are several sources to cross in Europe in the legislation to be able to know which ingredients are usable.
Indeed, depending on the food category, you can have some common legislation such as the legislation about food additives to know what are the additives usable in food supplements.
And after for the ingredients for nutritional purpose, you will have several sources depending on the food category.
For example, so if we focus on food supplements, you will need to check in the directive.
2002446 if the authorized form of vitamins and minerals are leased, and you will need to double check at national level if there is a maximum daily dose for other ingredients and vitamins and minerals.
There is a European negative list of ingredients forbidden, and there is also the novel food regulation to check to know if an ingredient is authorized or not.
But for ingredients which are not listed in this document, you will need to check at national level if the substance or the botanical is authorized.
Now if we look at the different category of ingredients you can find in a food supplement, firstly, vitamins and minerals, we will see how they are regulated in the European Union.
So vitamins and minerals are regulated in this directive as amended in Europe.
In the document, you can find in Annex 1, the list of vitamins and minerals that can be used in food supplements, and in the Annex 2, the intake form of these vitamins and minerals.
Regarding maximum daily dose, for now they are not harmonized at European level.
It means that you will need to check for each country if there is a maximum daily dose for vitamins and minerals and what is its maximum daily dose.
In this map, you can see in which country in Europe you can you have maximum daily dose for vitamin and mineral fixed by a national authority.
Let's say most of them.
So, and additionally, this maximum daily dose can be updated often.
In a supplementary inside, so one of the two platforms I explained previously, you can find the scientific and regulatory information for the ingredients usable in Europe, and then you will be able to check for vitamins and minerals, what are the authorized forms and if there are some maximum daily dose.
So if I take the example of selenium and I open the regulatory statue of these ingredients.
Firstly, you can find the reference intake for this ingredients.
It's a value that you will need to have your label ready for a rope.
The second information will be the upper limit fixed by EFSA.
So this upper limit isn't isn't an official maximum daily dose, but for a country where you don't have a maximum daily dose fixed, it will help you to take into account this upper limit to ensure the safety of your product.
After in this database, you can find also the authorized form of vitamins and minerals at European level.
As as the maximum daily dose, indeed for each country you will know what are the limits, what are the maximum, the maximum amount of vitamins or minerals authorized, and if there is some specific warnings to add or.
Or other specificities such as other maximum daily dose for children, for example.
So now that we saw how vitamins and minerals are regulated in Europe, we are going to focus on the other ingredients.
So substances with a nutritional or physiological effect, including botanical.
So the European Commission has not established an exhaustive European positive list of substances other than for vitamins and minerals.
In this European regulation 1925 to 2006, there is in the Annexus 3 a negative list of ingredients forbidden or under restriction for use in.
In food, including food supplements, so some substances are clearly prohibited.
It is a case, notably for ephedra, or also preparation from the leaf of aloe species.
And there are also some other ingredients which are under restriction, such as a trans fat or monocholine from radiate rice or also EDCD from greens.
Also, at European level, there is the novel food regulation to check and indeed it will list some numerous novel food authorized ingredients at European level.
But for all the other ingredients, you will need to check at national level the positive negative list.
It means which ingredients are forbidden or also the positive, the possible positive list, which ingredients are authorized in which country, and you can have some conditions for the use of this ingredient, such as a maximum daily dose, warning, specific form, etc.
So in this second map, you can see in which country there are some positive or negative list of substances with a nutritional or physiological effect, excluding botanical.
So it will be a case by case analysis for each country to know which substances is authorized and what are the conditions of use of these substances.
A lot of this, a lot of these positive lists and negative list only concern the food supplement and not the other foodstuff in general.
If I take one example, so here it is an extract from a supplementary inside the platform, you can see the regulatory statue of melatonin, so a substance through the different country in Europe.
So.
This ingredient is forbidden, for example, in Denmark and Austria, but will be authorized in other countries such as Belgium, Croatia, Cyprus, or France, but here again the.
The maximum daily dose will not be the same depending on the country.
So in Belgium you can have 300 mcg of this ingredients, where in France you can go up to 1.8 mg of this ingredient with some specific warnings to add on your label.
Now if we look at the same things for botanicals we saw previously in which country there are some positive list of of.
Of substances and here it is a map to show in which country there are some positive and or negative lists of botanicals.
So here again we can see that there are a lot of nationalists concerned only food supplements with some information regarding botanical.
What are the plants authorized, the plant of parts, if there are some specific maximum daily dose of some substances, for example.
And it is also information that you can find in a supplement already inside.
So here for the example of a ginkgo biloba, we can see that the leaf of ginkgo biloba is authorized in food supplements in several countries such as Austria, Belgium, Croatia, or Czech Republic, but in the Czech Republic you will have a maximum amount for leaf preparation.
And you can have other restrictions in other countries such as a warning in Belgium and some maximum amount of substances that needs to be monitored.
So, now I'm going to let Jerome present now how the novel food regulation works.
Thank you, Gael.
Effectively, I will speak about the novel food regulation in Europe and we will see after the same level of information for the US.
So, firstly, the definition of a novel food, as most of the companies working in the dietary supplement market know.
A novel food in Europe is defined as any food or food ingredient which has no history of consumption in Europe before the 15th of May 1997 when the first regulation on the food came into force and it can be really new ingredient innovative.
Food in this case it's quite easy to understand that it's a novel food, but it can also be food ingredients produced with new processes, new technologies.
In this case it's more difficult to estimate if the ingredient is novel or not, and also all the food and food ingredients traditionally eaten outside Europe.
So on the paper it's quite easy to understand.
We have this cut-off date of 15 May 1997, and all the ingredients present in the European market before this date are traditional and not novel.
All ingredients that enter the market.
After May 1987 are innovative and may be considered as a novel food and of course the marketing of this kind of ingredient of new ingredient requires the submission of an application at the European level and a specific authorization before using the ingredient in the European market.
So indeed we have 3 options for an ingredient, whatever the ingredient vitamins, minerals, probiotics, botanicals, etc.
The first option is when the ingredient is not novel, it's the best case, of course, but what is difficult is to be able to justify in case of requests from authorities that this ingredient is not novel and so to justify the history of consumption of the ingredient.
The second option is when we don't have this history of consumption and so we are, we have a clear novel food, a new ingredient, and this ingredient has no history of consumption outside Europe also, so it's totally new and in this case only the full novel food process applies to obtain the authorization for this ingredient.
And the third option.
Which is the less common possibility is when the ingredient is novel in Europe, so no history of consumption in Europe, but we have a history of consumption outside Europe in at least one country, and in this case we can apply for what we call the traditional food from third country, which is the simplest way to obtain the authorization.
So the, the main question we have when we are working on new ingredients is how I can define if my ingredient is novel or not.
The first regulation to check in Europe is what we call the Union lists on novel Food Regulation 20,172,470.
This is a list of all.
Ingredient authorized as novel food in Europe since 1997, so we have now a lot of ingredients listed in this regulation, and indeed in this regulation we have two lists.
The first one here, for example, we have the example of calcium methylfolate.
The first list presents.
Ingredients and the condition of use of this ingredient with the food categories and the maximum level authorized for each category for this ingredient and the labeling requirements, etc.
So this is the first level of information from this list.
The second one is the characterization of the food ingredients.
So here is the example of calcium methylfolate.
And as soon as you are compliant with this specification, this the composition of the ingredient.
You can use it in the condition of use listed in this regulation, so the food category and the maximum use level.
If you are not compliant with the specification or if you want to use the ingredients in another food category or at a higher dosage, etc.
This means that you need to apply for a new application to change the.
Condition of use of the ingredient and to request a new specification or a new food category.
So when you are working on an ingredient which may be classified as novel food, this list is the first source to evaluate, to check if you are compliant with a notarized novel food and in which condition you can use this ingredient.
The second information provided by the European Commission is what we call the novel Food Catalog.
So this is a list of ingredients and substances on which the European Commission and European member states have already.
This worked on the regulatory statutes, so this is not an exhaustive list.
It's not because the ingredient is not listed in this catalog that it means that the ingredient is new.
And it's only informative purposes.
This is not a legal document, but indeed all the member states are following the, the decision listed in this, in this catalog.
We have 5 possibilities now in this catalog.
The first one, is the best one, for example, here for Asophyllum noosum, the algae.
It's not novel in food.
That means we have a significant history of consumption of the of the algae in Europe before 1987, so it can be used either in food or and in food supplements.
You just need to check if there is any specific legislation at the member state level, but it's not novel.
The second situation is when we have a history of consumption only in food supplements, and in this case, the ingredient is authorized only in this food category and not in other food categories.
To obtain an authorization in other food categories, we need to apply for a new novel food application.
The third possibility is the lack of history of consumption of the ingredients, and in this case it is considered as a novel food in Europe and there is no possibility to use the ingredients.
You need to apply for a full novel food application.
And then we have two other information in this novel food catalog.
The first possibility or the fourth possibility here, it's when we have a notarized novel food, so that means the ingredient is novel food.
But a company already applied for an authorization which has been approved by the authorities, so it's the same information as the union list of novel foods I presented just before.
So you have all the information in the same.
Yeah, in the same document, but since the Novel Food catalog and the union list of novel Food are not really updated, we always recommend to check both sources to ensure we have the latest information.
And the final possibility in the novel Food catalog is when a company is currently.
Has submitted an application what we call a consultation process.
I will present this possibility just after.
That means a company asked a member state about the status of an ingredient to define if it's novel or not novel.
So this is the 4 of the 5 possibilities in the novel food category, and it's also really important information to check, to evaluate if your ingredient is novel or not.
So as I said, we have in Europe a possibility to consult a member state to obtain clarification about the status of an ingredient.
Is it novel or is it not novel.
This is what we call the consultation process.
It's indicated in Article 4 of the Novel Food Regulation, and we have an additional regulation, so 2018456, which explains the process for this kind of application.
Indeed it's quite simple.
It's The aim is to provide evidences about the history of self consumption of the ingredients in Europe before this cut-off date of May 1997, and for this we need to provide sale documents, import documents, publication, any information that shows the history of consumption in Europe of this ingredient.
And this ingredient should be characterized.
That means we need to provide a certificate of analysis to show the lack of variability among the batches, to define the specification, and we need also to present the manufacturing process.
The aim is to substantiate or to demonstrate the history of consumption of one specific ingredient.
And not a general ingredient to obtain the opinion from an authority about novel food or not novel food statues.
To date we have 115 decisions on this kind of processes.
So this is something which is more and more common.
We have three possibilities in the decision.
The first one is when there is no history of consumption.
In Europe of this ingredient before 1997 or the ingredient is not equivalent to something already authorized and in this case, member states conclude that the ingredient is novel in food and in food supplements once again in all food categories.
The second possibility, and we have only 8 applications will succeed, it's when we can substantiate a history of consumption only in food supplements.
And in this case, we can use this ingredient in food supplements but not in other food products.
If we need to use it in other foodstuff, we need to apply for a novel food application.
And the final possibility, which is the best one for the food business.
It's when there is a history of consumption in food and in food supplements, and in this case we can use this ingredient in every food category without any problem and both in food and in food supplements.
What is important is that all decisions are public and so this is a risky process because if you have a doubt and if the conclusion is negative, that means the only possibility to use the ingredients will be to submit a novel food application in Europe and to wait for the approval from the European Commission.
So now we will start, to, to speak about the US and the regulatory sources to check, to ensure that your ingredient is authorized, in the US, and I will let, Gael, to present firstly the source, different sources to check, and after I will speak about, NDI and the grass application.
Thank you, Gerald.
So in the US the classification of ingredients may differ depending if you would like to use them in food in general or only in a dietary supplements.
So ingredients added in food should be authorized food additive or color additive or should be grass.
It means generally recognized as safe.
So numerous ingredients are already listed as grass in the Code of Federal regulation.
But each company may have also the proper grass dossier notified to the FDA or self-affirmed grass.
And for the technological ingredients used in dietary supplements, you also have to be compliant with those general rules.
However, for active ingredients used in dietary supplements, so like we saw previously, vitamins, minerals, substances, botanicals called dietary ingredients, you should determine if the dietary ingredient is an ODI or a new dietary ingredient.
All dietary ingredient, ODI or new dietary ingredient for NDI.
If it is an NDI.
It means that the ingredients weren't sold on the US market in dietary supplements before 1994.
NDI notification is required.
It is interesting to note that a NDI notification isn't required if the substance has been present in the food supply.
Such as in a conventional food, as an article used for food in the US or outside the US and is used as a new dietary ingredient without chemical alteration, as example, a NDA notification isn't required for a grass substance that can be used in conventional food and is to be used as a dietary ingredient without a chemical alteration.
So for example, here in supplementary inside for a dunk added, adding to food, there are several specific forms already authorized.
In food according to the CFA.
If we look in the dietary supplement category, the evaluation will depend on the specific form used.
Indeed, numerous forms of zinc are listed as ODI in the UNPA ODI list.
They were sold on the US market in dietary supplements before October 1994, so there is no need of NDI notification for those forms.
It is also possible to use the form of DIC already authorized in food in general without an NDI notification.
But for other specific forms of zinc that were not on the US market in dietary supplements before 15 October 1994, some NDI notifications have been submitted to the FDI.
It is the case, for example, for zinc carmazine, which isn't listed as an ODI and isn't listed in the CFL list.
So now we are going to see, and Jerome is going to explain how to, how is the novel food application and also how it is for the grass dossier and the NDA notification, what is in common in this procedure and what are the main differences.
So I will let the parole to Jerome.
OK, so now, we will have a short summary about the content of this kind of application, Novel Food, grass, and NDA notification.
As already explained, in Europe, we have a single process to obtain authorization for new ingredient either to be used in food and in food supplements.
It's a novel food process, and after we define if we are using the standard novel food process when we don't have any history of consumption of the ingredient outside Europe or the traditional food from third country when we have this history of consumption.
In the US, the choice between grass and NDA application depends on the condition of use of the ingredient, and notably in which food category you want to use your ingredients.
If the ingredient is for food products, you can apply for a grass application.
And if you are targeting only dietary supplements, you need to apply for an NDI application.
So for the novel food procedure, we have here the content of the application.
We have 3 main parts.
The first administrative part, where this is a summary of the application and all the contacts for the business operator.
The second part, which is really the main part of the application with all the data related to the ingredients, and after all the annexes in the 3rd part, and for the main part, the second part of the application, we can also divide this section in 3 main parts.
The first part will be related to the identity of the novel food, this production process, and the compositional data.
That means to present the ingredients, its characterization, and to understand what is the ingredient, how it is obtained, to finally obtain the specification of the ingredient.
Then we have all the sections related to the history of consumption and the proposed uses, so we need to present what is the history of consumption of the normal food outside Europe or of the source of the ingredient, but also to present and to present a request about the condition of use.
That means what is the daily intake, in which food category, what is the target population, etc.
And the third part is related to, oops sorry, to the safety of the ingredients.
With the pharmacokinetics data, the nutritional information, all the toxicological information, and a part related to the allergenicity.
So this is for the full novel food process in Europe.
When we are working on the NDI procedure, it's quite the same level of information.
The way to present the data is different, and we need to go further in the justification of the safety of the proposed condition of use.
But when we have a novel food application.
We can apply directly for NDI application.
The opposite.
It's not always possible because a novel food in Europe requests more data than an NDI application in the US.
So for the NDI, the first part is also related to the presentation of the ingredients with the identity of the new dietary ingredient and the manufacturing process.
The second part is related to the dietary supplement, and here this is a main difference between NDI and novel food.
For novel food, we don't need to characterize the final ingredient which will be or the final product which will be on the market, while for the NDI we need to present.
The dietary supplement, which will be on the US market, it can, we can avoid this section, but the recent update from the FDA on the NDI on the NDI guidance remains that normally this part should be completed by the applicant.
Then we have the story of.
Of use and all the evidences on safety, so it's still the same level of information, the pharmacokinetics, genotoxicity, oral toxicity in animals, etc.
So all these parts require the same information as the novel food in Europe, and the fourth section of the NDI is only for NDI and do not apply.
For the no food because we need to justify that the proposed condition of use, the, the maximum level we propose for the ingredients is safe for human consumption, and so we need to determine the safe level in animals.
We need to determine the safety factors, etc.
So this is a section that applies only for NDI and not for.
Finally, for the grass application, so it's when your ingredient is you're targeting all the food products, not only dietary supplements, but food products, and here we have two possibilities, what we call the self-affirmed grass, that means you are, you prepare the application, but This application, it's not submitted to the FDA for an evaluation, or the second option is the grass notification.
When you submit the application to FDA for an evaluation, of course this is more complicated to obtain an approval from FDA, and most of the companies are performing only self-affirmed ones, and the content of the application is quite similar.
We need to present the ingredients, the process, the manufacturing process, etc.
The composition.
We need also to estimate the dietary exposure to present the safety data, etc.
So this is the same level of data except for the self-affirmed grass when we need what we call an expert panel review, that means we need to have.
An evaluation by independent experts, generally toxicologists, who will evaluate the application and will conclude on the safety of the ingredient in the proposed condition of use.
So if we summarize these three applications, food, NDI, and grass, we need to provide strong evidence of the safety of a -characterized ingredient.
So in terms of evidence, we can consider, of course, a toxicological test to to demonstrate the safety of the ingredient and also certificates of analysis performed if possible in external laboratories to.
Perfectly characterized the ingredient to understand what is the ingredient and what is the composition of this ingredient.
In terms of safety, there is, there is no doubt we should present only negative results according to the valid.
Toxicological test and for the characterization of the ingredient we need to show the lack of variability among the batches, the stability of the ingredient, and to define the specification of this ingredient.
So what are the key points for this kind of ingredient?
The first one is to perfectly characterize the ingredients, notably when we are from natural sources, botanicals or microorganisms, etc.
We have more viability for this kind of ingredient compared to an ingredient obtained by chemical synthesis.
So this is really important to perfectly characterize this ingredient.
We need to show a complete manufacturing process.
So for the novel food, we need, we need to show all the details of the manufacturing process.
For NDI and grass, we have more possibility to to avoid the disclosure of confidential information to authorities.
We need to show the stability of the ingredient and at least in Europe, but we recommend also the same analysis in the US for NDI and grass.
We need to analyze 5, at least 5 independent batches to show the lack of viability.
The second important key point is the definition of the condition of use of the new ingredients on the NDI with the definition of the target populations, the food matrix, the daily dose, etc.
If we do not cover all the needs from the food business operators, the ingredient supplier.
And if we need to update after the application, this will request a new application, a new evaluation by EFSA or by FDA, and this is a significant Loss of time and of money, so we need to anticipate all the potential uses of the ingredient.
And finally, the, the, the most important key point is the safety.
Of course, the aim of this kind of application is to demonstrate the safety of the ingredient and so there is no doubt allowed.
Both FDA and EFSA requires at least genotoxicity and oral toxicity in animals.
Depending on the target population, we may need also to provide reproductive and developmental toxicity.
We need to show the lack of allergic reaction or allergic risk with with the food ingredient, and if possible, this is always difficult, but to provide also pharmacokinetics data.
The chance we have with novel food application is that we are aware about the application under evaluation by EA.
This is not the case with NDI.
We are only aware about the application after evaluation by the FDA.
So this is.
Interesting in Europe to know what are the main ingredients subject to this kind of application.
To date, the most important category is cannabidiol, CBD with more than 40 applications, and after we have a large range of different ingredients as shown in this slide with botanical substances, etc.
So this is the way we obtain authorization for new ingredients and all the information you need to check for.
For regarding the status of the ingredients, now I will let Gay introduce the part related to the health claims in Europe and in the US.
What are the various categories and what is allowed and not allowed in terms of communication.
Thank you, Jerome.
So firstly, we are going to see how communication works in Europe.
So, in Europe, there is a list of authorized nutrition and health claims.
So this regulation about nutrition and health claim will concern commercial communication, whether in the labeling, presentation, or advertising of food to be delivered as such to the final consumer.
So it will concern all the food products, including food supplements, and so this communication is regulated with the European regulation 1924 of 2006.
In this regulation, the claims are classified.
So firstly, there are some nutrition claims.
So there are 30 authorized nutrition claims that will explain if a food contained in a higher quantity or in a reduced quantity a nutrient or a substances.
It can be, for example, high fiber.
There are also some health claims, so health claims are going to establish a relationship between an ingredient or a food and an effect on the health of the consumer.
So there are several types of health claim.
There are some generic claims, so there is more than 200 authorized health claims.
And there is also some specific health claims.
So there are 3 categories of specific health claim.
The first one is the ones based on a new developed scientific evidence.
So there are 12 authorized health claims in this category.
There is also a health claim related to the reduction of disease risk.
So there are 15 authorized health claims in this category, and after there are some, , health claims referring to children's development and health.
So 12 authorized.
So we can see that for the generic claim there are 2.
229 authorized claims, but more than 2000 requests.
Indeed there are some claims about botanical coal.
We haven't been assessed yet and have been put on hold, so we are going to see that just after.
Because after a positive assessment of EFSA, the authorized claim with the wording and associated condition of use are published in a European regulation, and this claim on hold are not listed yet in this regulation.
So there are more than 2000 claims on botanicals on hold.
Indeed, according to the transition period of the health claim regulation, on hold claims on botanical assessed by EFSA or not may continue to be used until a European regulatory decision on them.
Only if they comply with the general provisions of regulation and if they comply with the specific national provisions.
So for this claim on hold, concretely, in most of the European countries they are usable if you are compliant with one of the conditions of use submitted for this on old health claim.
If you are not using therapeutic wording, indeed it is forbidden to use wordings that suggest a therapeutic action.
And you must have some scientific substantiation of the honored claim used, so a dossier should be available for the administration in case of control in order to justify the use of this honored claim.
All the claims usable in Europe, which mean the authorized but also the honored claim, are listed in supplementary inside, and they are classified by ingredients and also by health effects.
It's quite different in the US.
Indeed, in the US there are lists of authorized nutrient content claim and authorized health claim in the Code of Federal regulation.
And some qualified health claims accepted by the FDA.
Health claims refer to the reduced risk of disease and need pre-approval by the FDA.
However, there is no pre-approval needed for structure function claims such as contribute to the immune system.
That's why there isn't a list of structural function claims, each company should be able to justify the claim used.
So for structure function claim used in dietary supplements, the manufacturer must have substantiation that the claim is truthful and not misleading and must make a notification with the text of the claim to the FDA no later than 30 days after marketing the dietary supplement with the claim.
So the submission can be made electronically at a CFSN online submission module.
And if a dietary supplement label includes such a claim, it must state a disclaimer.
This disclaimer must be that this statement hasn't been evaluated by the Food and Drug Administration.
This product isn't intended to diagnose, treat, cure or prevent a disease.
The wording or structure function claim can be, for example, help promote digestion, help maintain cholesterol level.
That are already within normal range, so they will look like the health claim in a hoop.
Now Jerome is going to explain how you can substantiate pending claims in Europe and US structure function claim.
Yes, so to close this webinar, we will see how to substantiate the pending claims in Europe and structural function claims in the US and indeed.
Indeed there is no real guidelines from authorities and we need to perform a case by case evaluation and the aim of this scientific dossier is to provide the evidences of the efficacy of the ingredient or of the product on the effect based either on your data, proprietary data, or on.
Publicly available clinical studies, you need to take care about the population in these studies to ensure that clinical studies have been conducted in healthy subjects or a specific health condition which corresponds indeed to the target population of your product.
You need to.
Also to ensure, of course, that the clinical studies have been conducted with an ingredient similar to your ingredient or to your product and also, and it's sometimes more difficult to ensure the quality of the studies and you need to consider the design, the supplementation, the outcomes, the statistical analysis, etc.
So regarding the content of the dossier, our proposition is.
Firstly, to present the product, to describe the ingredients, the daily dose, and to present either the pending health claim for the European market or the secure function claim in the US to present also in the second part, the traditional use.
It's always interesting to present this traditional use to reinforce the quality of the dossier, but the main part, of course, it's the scientific.
Data, the human clinical data, and what is required by authorities is to have a clear understanding about how the literature has been analyzed, what is the methods used, and after to present the pertinent studies, so you can present preclinical data to address the mechanism of action, but The main, the most important part is the clinical studies, which should be randomized double blind and controlled to show the efficacy of the ingredient.
And at the end, you, you need to conclude about the effect of your ingredients.
A similar ingredient on the health effect you are, you are targeting for the European market, we recommend to have at least one pertinent study at the same dosage for compared to your product.
For the US structural function claim, at least 2 -designed clinical studies are required to, to ensure to avoid any comment from from authorities.
So indeed you have two possibilities either to perform your own literature or research.
The second possibility is to use our summary sheets in supplements inside.
We have today 120 different ingredients for which we analyzed all the detail.
And on which you can directly obtain the data about the scientific substantiation of the claims.
So this is a gain of time and you are always up to date on, on, on the efficacy of the scientific data on this kind of ingredients.
What you will find in this summary sheet, firstly, a jointly to the regulatory statutes in Europe or in the US to ensure that you can use this ingredient and to see if there is any limitation in terms of regulation.
You will find also a summary of the health effects with an evidence level, the dose, and the kind of extract which can be used in.
To obtain an efficacy, so we, we evaluate all the clinical data and we, we, we define what are the best or the most substantiated health effects to obtain, to evaluate the data and to conclude on the efficacy of the ingredient.
Then we already for the European market evaluated if the pending health claims are substantiated or not by the available clinical evidences, so the work which is needed in case of control from authorities has been already done and you have a direct access to the right study that substantiate the health claims.
Then you have access to all the clinical studies with a short summary of the designs, the subjects, the supplementation of the main results, and if needed, you have access to a more complete description of the, of the study directly in a, in a workroom.
So this summary sheets, helps to evaluate, to, to, helps you to define what are the best clinical studies for your, your product and helps you to directly substantiate the pending health claim in Europe.
Or the US structure function claim, so it's a gain of time and, and you are sure to be up to date and to have the, all the clinical data for your products.
The last solution to make this kind of review is to have a direct evaluation of the study directly in our tool in supplementary insight.
We have more than 78,000 studies on food ingredients authorized in Europe and the US in the database, so a huge.
Level of information, on, on science, on food ingredients, and if you want to find, more information about the specific ingredient or if, the summary sheet.
Is not available on your ingredients.
You can use this, this tool to identify the clinical studies on your ingredients.
You can search by ingredients, by health effect, and by design of the studies so you can have a direct access to the right information.
And for each clinical study, this is here a presentation of the information you will find.
So firstly, you will have a short title and a summary of the, the design of the study.
Then the ingredients, the health effect, we have a short summary to simplify the, the original abstract and to understand directly what is the aim of the study, what are the main findings.
And you have, of course, access to the information of the original publication.
And finally, a link to the publication.
So to conclude on this webinar, what are How can a supplementary inside help you for both the regulatory aspect of new ingredients, what are the, the ingredients authorized in the US and in Europe, and how it can also help you for communication.
So firstly you need to remind that it's necessary to check many legal sources to define the status of one ingredient to be used either in food or food supplements and to consider also the specific process to get authorization.
So all these sources are listed and available in the supplementary sight.
There are large differences in terms of authorization, in terms of regulation between Europe and the US with a specific consideration between food supplements and other food categories.
So you need to consider this when you are developing new products or new ingredients.
Regarding communication, so in the US there is no listing of.
Structure function claims, but in Europe we have specific authorized claims, but also pending its claims.
So this is not easy to define what is the best communication, what is the best claim, and a supplementary insight can help you in the justification, in the identification of the right claim for your product.
And finally, What is important and interesting in terms of development is that even if we have strong differences between Europe and the US in terms of regulation, most of the data required to obtain an authorization or to substantiate the efficacy of a product are the same.
Either we talk about safety with ecological study or efficacy with clinical studies.
We are using the same information both in Europe and in the US.
So clearly, in addition to supplementizing insight, our experts can help you to ensure the compliance of the product.
With the tool you can have access to up to-date information for regulatory information and scientific information, with, for example, the authorized claims, the condition of use of this claim, the new ingredients authorized, etc.
And we can also help you to submit, to prepare, to submit any application for authorization of new ingredients like novel food application, NDA application, of course, in the US, but also health claim application in Europe and to ensure the scientific substantiation of such function claims in the US.
So thank you for your attention in on, on this webinar.
I think we have time to answer some questions.
And the first one I can directly answer this is the question is if an ingredient is an OGI, so all dietary ingredients in the US, does it justify that it's not novel in Europe?
So an ODI means that the Ingredient has a history of consumption in the US so it can be used in the US, but this does not, does not mean that the ingredient has a history of consumption in Europe.
So clearly this is not because you have an ODI classification in the US or an NDI application.
With a positive FDA evaluation that the ingredient is authorized in Europe.
This is totally independent.
You need to firstly check the status of the ingredients in Europe and if needed to perform a novel food application if the ingredient is novel and has no history of consumption.
The second question, will be for, for Gail, and is related to, to the notification of dietary supplement.
Is there a mandatory notification of dietary supplements, in the US and in Europe?
So in the US, companies are responsible for ensuring that supplements are safe and properly labeled.
And FDA doesn't approve DNA supplements on their labeling before they are sold to the public.
So for the moment in the US there isn't a notification requirement for finished dietary supplements except if an NDI is present on the product or if a structure function claim is used.
However, there are ongoing discussions on the FDA proposal for a mandatory product listing of all dietary supplements in the US in the future.
In Europe, it is different.
It's quite different because the process of commercialization differ depending on the country.
So at a national level you can have a process of notification or registration of food supplements.
For example, in France, Belgium, or Italy, you will need to proceed to notification prior to the commercialization of the food supplement.
OK, thank you.
And last question, it's related to the maximum limits of vitamins and minerals.
Which are defined at member state level in Europe, we heard that there is an intention to to have one maximum limit for vitamins and minerals across all European states.
So can you explain a little bit more what is the current discussion about this maximum level of vitamins and minerals in Europe?
Indeed, there are discussions at European level to to fix maximum limit for vitamins and minerals that can that will apply to food supplement but also to fortified food.
So for now we didn't have a clear vision of the amount that that can be authorized if it's a maximum limit will be fixed.
But we know that this amount can be lower than some authorization in some country, so there are some discussion currently, but we don't have a clear vision of the timing or the amount that can be authorized in the future if there is a European maximum daily dose.
OK, thank you.
So we don't have any, any time for, for more questions, but, , our contacts, our other email.
Email address on the slide, so do not hesitate to contact us if you have any questions about regulation and about food supplements in Europe and the US and thank you very much for joining.
We remain at your disposal if needed.
Thank you.
Le Bloch
Jerome
Le Bloch
