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Anyone?
lol
mol
Pity Stephen hasn't mentioned that once over 8 years and still hasn't to date as far as i know and of course the reason we are pursuing our path is to minimise regulatory hurdles...........
nevermind
if it's now only down to labelling
jees thank you for enlightening this bb on the wonderful world of lemmings and the self promotion and hints on here
i might just continue to post what i find foc or maybe not - lol
bw all
mol
Ensuring not insurance
Mol, the importance of insurance the structure, as opposed to just the flavour, had not been impacted by scale-up by an independent panel was so that it still qualified as an innovated dietary fibre. Hence part of the regulatory clearances that each finalised sweetbiotix product is subjected to, will include FDA labelling for the US market
AS, thanks for taking the time and trouble to share your questions and responses. And for reposting info on SweetBiotix and rivals' attempts at getting competing ingredients through regulation. And ultimately to market.
Is it possible SOH's doggedness and attention to detail will finally payoff? I hope so. And, let us not have to wait too much longer.
Whilst i note july 2022 rns and your extract
https://www.optibiotix-ir.com/content/news/archive/2022/200722
and i do note the contents
i draw your attention to the even more recent RNS update - which you and presumably other/s (who i guess prompted your long post) are very much aware of
https://www.optibiotix-ir.com/content/news/archive/2024/300124
and FDA labelling wasn't mentioned (FDA wasn't mentioned) - though perhaps important - not that important for inclusion in an RNS
whilst this was noted
In the last six months, there have been consumer concerns over sugar substitutes which has translated into existing and potentially new industry partners (including PepsiCo) discussing the use of natural, safe sugar substitutes like SweetBiotix® for both new and existing products. In anticipation of this need, OptiBiotix initiated development of its own finished product brands containing natural sugar substitutes and flavourings in mid-2023. The Company believe that natural products will be an increasingly common requirement throughout 2024 both in existing and new products. In recent months, products have been developed and successfully taste-tested with natural sweeteners for a large US company and a large Indian pharmaceutical company.
i await the launch of our own products in relation to our recent anticipation of this need - jees i thought that was the whole purpose of sweetbiotix some 6 years or more ago (c8 i think)
mol
Whilst on most occasions i very much appreciate your input Aquae
completely over the top this time
I've voted up your first succinct post and very much look forward to FDA product submissions re sweetbiotix but even more so news re products on sale this year
mol
Just thought I'd follow up on this group
https://optibiotix.com/optibiotix-announces-three-major-deals-with-partners-in-us-asia/
https://pierceesim.com/products-2/
as presumably three year deal exclusive has expired?
at least I haven't noticed to contrary by way of rns - perhaps missed something - which is possible
anyway perhaps someone here can enlighten us?
mol
Post 3 end
So bearing in mind Optibiotix Health recently announced that discussions are ongoing but are likely to involve a phased introduction of SweetBiotix® products as a direct bulk sugar substitute and the importance the FDA place on scientific evidence in classifying new products under the Innovative Dietary Fiber definition, the significance of the recent Independent verification of the structure and taste of scaled-up sweetbiotix from the US Partner, and the Optibiotix Health Commercial and Scientific Update RNS on 22nd July 2022 in supporting the Sweetbiotix application, cannot be understated.
“SweetBiotix® Publication: The Company is pleased to announce the publication of a study on the prebiotic activity and sweetness of one of its SweetBiotix® products in a peer reviewed journal (see https://pubs.acs.org/doi/10.1021/acs.jafc.2c01363). The study reports that enzymatic synthesis of modified mogroside and galacto-oligosaccharides (GOS) from lactose was able to generate products which positively modulated the microbiome with a sweetness profile similar to sugar. The products sweetness, bulking and prebiotic fibre properties could make it a suitable replacement to sugar in everyday products. This is one of a number of SweetBiotix® products developed for different application types in food, beverages, and dairy. Publications by independent authors in peer reviewed journals are critical in establishing industry awareness and credibility in the Company's products and provide valuable marketing assets to support product launches. “
https://pubs.acs.org/doi/10.1021/acs.jafc.2c01363
Post 3 continued
What evidence does the FDA use when determining whether an ingredient is classed as an innovative dietary fibre?
The FDA (U.S. Food and Drug Administration) evaluates evidence carefully when classifying a new ingredient as an innovative dietary fiber. Here are the key steps and considerations:
1. Scientific Research: The FDA reviews scientific articles that assess the physiological effects of the proposed ingredient. Researchers study how the ingredient interacts with the human body and its impact on health.
2. Elimination Process: Studies that do not provide clear scientific conclusions about the ingredient are eliminated from consideration. Only robust research is taken into account.
3. Beneficial Effects: The FDA evaluates the strength of evidence to determine whether the ingredient demonstrates beneficial physiological effects on human health. These effects must be relevant to dietary fiber.
4. Health Claims: If there is sufficient scientific support, the FDA may issue health claims related to the ingredient. For example, diets high in fiber-containing foods have been associated with reduced risk of certain cancers1.
5. Recent Additions: Over time, the FDA has added several isolated or synthetic non-digestible carbohydrates to the definition of dietary fiber. For instance:
◦ In December 2021, acacia (gum arabic) was included.
◦ In January 2020, glucomannan was added.
◦ In March 2019, cross-linked phosphorylated RS4 was recognized.
◦ In June 2018, the FDA responded to citizen petitions and identified eight fibers for potential inclusion2.
Remember, this process ensures that innovative dietary fibers meet rigorous scientific standards before being classified as such
Post 3 continued
So what does the FDA Class as Innovative Dietary Fibers?
The FDA defines innovative dietary fibers based on specific criteria. Let’s break it down:
1. Intrinsic and Intact Fibers:
◦ These are naturally occurring fibers found in plants, such as whole grains, fruits, and vegetables.
◦ They must be intrinsic (part of the plant’s structure) and intact (not significantly processed).
◦ Examples include cellulose, hemicellulose, and lignin.
2. Added Isolated or Synthetic Non-Digestible Carbohydrates (NDCs):
◦ These are non-digestible carbohydrates that are intentionally added to food products.
◦ To be considered dietary fiber, they must meet two criteria:
▪ Have at least 3 monomeric units (building blocks).
▪ Demonstrate beneficial physiological effects on human health.
◦ Companies must provide evidence of these health benefits to the FDA.
3. Examples of Added NDCs Recognized by the FDA:
◦ Acacia (gum arabic): Recently added to the list of dietary fibers 1.
◦ Glucomannan: Also recognized by the FDA 1.
◦ Cross-linked phosphorylated RS4: Another recognized fiber 1.
◦ These fibers contribute to the total dietary fiber content on nutrition labels.
4. Enforcement Discretion:
◦ While awaiting formal rulemaking, the FDA exercises enforcement discretion for certain fibers.
◦ Manufacturers can include the recognized fibers when calculating the amount of dietary fiber to declare on labels.
◦ For instance, polydextrose (a recognized fiber) is assigned a caloric value of 1 kcal/g 1.
In summary, the FDA classifies dietary fibers as either naturally occurring intrinsic fibers or added NDCs with proven health benefits. So, when you see “dietary fiber” on a label, it encompasses these diverse components!
Post 3 continued
Why Are Added Sugars Listed on the Nutrition Facts Label?
The Dietary Guidelines for Americans recommends limiting calories from added sugars to less than 10 percent of total calories per day. For example, if you consume a 2,000 calorie daily diet, that would be 200 calories or 50 grams of added sugars per day. Consuming too much added sugars can make it difficult to meet nutrient needs while staying within calorie limits. Added sugars are listed on the Nutrition Facts label so that you can make informed choices, based on your individual needs and preferences.
Coca Cola with Corn Syrup Sweetener
For example, a 12 fl oz can of Coca Cola that includes high-fructose corn syrup contains 39 grams of added sugar which is most of the recommended added sugar daily allowance in just one can, little wonder Coca Cola has been engaged with Optibiotix Health to tailor a version of sweetbiotix to meet their needs over a number of years
What does the FDA classify as low added sugars
Nutrition Facts Label:
◦ On food labels, the number of grams and the percent Daily Value (%DV) for added sugars are listed within the Nutrition Facts label.
◦ If a product contains added sugars, the label will explicitly state it. For example:
▪ “Includes 7 grams of added sugars” in a container of yogurt with added sweeteners.
▪ The %DV helps you understand how much the product contributes to your daily added sugar intake.
4. Low vs. High:
◦ Low source of added sugars: If a food provides 5% DV or less of added sugars per serving, it is considered low in added sugars.
◦ High source of added sugars: If a food provides 20% DV or more, it is considered high in added sugars.
So this is the relatively small win that Tagatose are left with and highlights the advantage Optibiotix seek to hold with a classification of Innovative Dietary Fibers rather than Added Sugars and the excitement that will generate.
Post 3 - FDA Labelling What Does it Mean for Sweetbiotix?
https://www.fda.gov/food/nutrition-facts-label/added-sugars-nutrition-facts-label
What Are Added Sugars and How Are They Different from Total Sugars?
1. Total Sugars
Total Sugars include sugars naturally present in many nutritious foods and beverages, such as sugar in milk and fruits as well as any added sugars that may be present in the product. There is no Daily Value* for total sugars because no recommendation has been made for the total amount to eat in a day.
2. Added Sugars
Added sugars include sugars that are added during the processing of foods (such as sucrose or dextrose), foods packaged as sweeteners (such as table sugar), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices. They do not include naturally occurring sugars that are found in milk, fruits, and vegetables. The Daily Value for added sugars is 50 grams per day based on a 2,000 calorie daily diet.
For most Americans, the main sources of added sugars are sugar-sweetened beverages, baked goods, desserts, and sweets.
Post 2 continued
*Post receiving the answer a bit more digging through the additional large investor route, revealed that Hershey subsequently tried to persuade the FDA that Tagatose should be classified as a rare sugar so avoiding the dreaded added sugar label but this was rejected by the FDA on the following grounds ”In its seven-page response, the FDA agrees with the health research submitted by Bonumose, but says tagatose has too many calories to be exempted from the label designation. Tagatose has 1.5 calories per gram, while allulose — another rare sugar that the FDA has exempted from the Added Sugars designation — has 0.4 calories or less per gram. “
https://www.thehersheycompany.com/en_us/home/newsroom/blog/bonumose-groundbreaking-advancing-rare-and-innovative-sugars-for-betterforyou-snacking.html
https://www.fooddive.com/news/fda-tagatose-added-sugar/624410/#:~:text=Tagatose%20has%201.5%20calories%20per,calories%20or%20less%20per%20gram.
So noting the residual albeit subdued excitement surrounding Tagatose (see links), because despite being classified as added sugars, it attracts the label “low added sugars”, what does this mean for the opportunity afforded to Sweetbiotix on launch?
Post 2 – Tagatose – Rival to Sweetbiotix?
Having come across a Company, Bonumose who appeared to have a similar product to Sweetbiotix I posed the following question via Lemmings:
“Bonumose who list ASR Group amongst their backers (took over Tate & Lyle Sugars) seem to have a sweetbiotix like product derived from Mogroside using a similar one-step process to produce Tagatose. That said it has not been exempted from listing as “added sugars” on the label by the FDA despite the company claiming they are fibres, has sweetbiotix cleared this hurdle with the FDA or will Opti suffer a similar fate and have to settle for lean on the labels in which case this appears to be a serious competitor?”
https://www.foodnavigator-usa.com/Article/2022/07/14/IFT-First-Bonumose-gears-up-for-commercial-production-of-rare-sugar-tagatose-this-fall-It-really-does-stand-apart-in-terms-of-its-taste-and-its-functionality
https://www.foodnavigator-usa.com/Article/2021/02/18/Sugar-reduction-game-changer-Hershey-ASR-Group-invest-in-startup-paving-way-for-mass-market-adoption-of-allulose-tagatose
Lemmings duly forwarded the question to SOH who with impressive knowledge of the product especially as he was abroad, and hence out of office at the time, having presented at the Probiota event in Milan, responded “‘Tagatose is not classified as a fibre as it is predominantly disaccharide, which is where the problem lies.’
The key differentiator was the largest technical challenge, as fibres are long-chain oligosaccharides. The other point is that it is a prebiotic fibre, i.e., a fibre that produces a health benefit. The technology allows us to build different types of fibre chains. This family of products is based on a platform technology that enhances its value.
These effects are all validated independently by Universities and industry. They are outlined in the published articles we have shared, one of which concludes, ‘This new ingredient could provide health benefits when evaluated in human studies by combining sweetness and prebiotic fibre functionality.”
Post 1 – FDA Nutritional Label Changes to Include Added Sugars
The Food and Drug Administration (FDA) introduced added sugar labeling on the Nutrition Facts Label to help consumers make informed choices about the foods they eat. The first Nutrition Facts label debuted in 19941. However, the specific inclusion of added sugars became more prominent in recent years.
Here are the key points about added sugars on the Nutrition Facts Label:
1. Total Sugars include both naturally occurring sugars (such as those found in milk and fruits) and any added sugars present in the product. There is no specific Daily Value for total sugars because no recommendation has been made for the total amount to consume in a day.
2. Added Sugars specifically refer to sugars that are added during food processing, packaged as sweeteners (like table sugar), derived from syrups, honey, or concentrated fruit/vegetable juices. Naturally occurring sugars in milk, fruits, and vegetables are not considered added sugars.
3. The Daily Value for added sugars is 50 grams per day based on a 2,000 calorie daily diet. For most Americans, the primary sources of added sugars are sugar-sweetened beverages, baked goods, desserts, and sweets.
4. On the Nutrition Facts label, added sugars are listed separately, along with the percent Daily Value (%DV). The word “includes” before added sugars indicates that they are part of the total sugar content. For example, a yogurt container might list: “Total Sugars: 15g (Includes 7g of Added Sugars, representing 14% DV)”.
Remember, the goal is to limit calories from added sugars to less than 10% of total calories per day. For a 2,000 calorie diet, this translates to 200 calories or 50 grams of added sugars2.
Manufacturers were required to comply with added sugar labeling on the Nutrition Facts Label based on their annual sales:
• Manufacturers with $10 million or more in annual sales were required to update their labels by January 1, 2020.
• Manufacturers with less than $10 million in annual food sales had to comply by January 1, 202112.
This labelling requirement aims to provide consumers with clearer information about the amount of added sugars in food products. It’s a step toward making informed choices about our diets!
The FDA’s decision to include “added sugars” on the Nutrition Facts labels of packaged foods was met with some political debate. While big candy companies like Mars and Nestle eventually signed onto it, the Grocery Manufacturers Association, a significant food lobbying group, also supported the change. However, there were holdouts:
1. Sugar Industry: Represented by the Sugar Association, they opposed the FDA’s dietary guidance, calling it “Agenda based, Not Science Based.”
2. Soft Drink Makers: They were also against the added sugar labeling.
Members of these associations include the ASR Group. American Sugar Cane
It has been a marathon journey for LTH’s following the sweetbiotix gold trail, but we appear to have entered the stadium at last for the final lap. The posts that follow will illustrate how the more hurried approach taken by others to try and achieve FDA “healthy” fibre sweetener status has seen them end up crossing their eyes and dotting their t’s, whilst SOH’s Scientific and more measured approach, dotting the i’s and crossing the t’s as he has gone along, should ensure there are no such slip ups with sweetbiotix product submissions to the FDA.
Perhaps you will have to ask Alex for an increase in your pocket money. ;) I hope you have more luck in that regard than me. :(
Thanks. That looks like sweetbiotix is available to purchase?
For anyone new
https://www.knowde.com/stores/optibiotix-health-plc
mol
PG,
Indeed, I am close. Alex is proving to be persuasive.
In case you missed it. Alex has added an addendum to his "added sugar labelling" after a conversation with SOH. It adds important context to what appears to be a SweetBiotix purchase portal.
https://lemminginvestor.substack.com/p/optibiotix-health-plc-0bd
Skid, what have you contributed , apart from insults .
Elrico, the investing equivalent (and similar intellect) of Liz Truss
Excellent sweet piece. Surely elrico you must close to buying back in now?
Thanks also to aqua for his part in the update.
I love Alex's writing, he is so descriptive.