Member Info for AquaeSulis01

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.

He was also the sole shareholder so perhaps he was returning the residual shares out of his 100,000 consolidated up from original 100 found down the back of the sofa; not really sure why you are so interested though?

https://s3.eu-west-2.amazonaws.com/document-api-images-live.ch.gov.uk/docs/v9SOjl_HDIldD0d4wIx52rv0DI_JzRoS0i42-DVoVzY/application-pdf?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=ASIAWRGBDBV3D63O2VHR%2F20240211%2Feu-west-2%2Fs3%2Faws4_request&X-Amz-Date=20240211T194452Z&X-Amz-Expires=60&X-Amz-Security-Token=IQoJb3JpZ2luX2VjEG8aCWV1LXdlc3QtMiJHMEUCIDM%2Fjbl5bdpi9Qdlo5fqjC1rb14hakuqv1m%2F%2FEjK9kpgAiEA6HRGhafKeF%2BI7l38rzKJmHHhOPhlcEKuOyetKfidOXwquwUISBAEGgw0NDkyMjkwMzI4MjIiDKb8sV7TfG29JoYD6iqYBXjRLrwBeTOJn%2Fx%2BllbvTucq09jhwWotAe%2BIyFFCpC33x0ZbctLS7a%2FeX%2B%2Fkb5KK4mfbAVNIivf8W9Kq2U7DEhCBG08dGieN9qPZBQXv1d5UMe3ib94Txy5JDyCFT15okcmGBQ%2FfVaWF%2FGEsyYFdS1S%2BMk%2FDeT1RQ%2BBkbBIlHMY%2BfAWoHf%2FZymXbdHqt%2BkmjJkzDxdq1BbSTrDm8pc2SaqWAow4HHWiZLcOB8vj2VZt%2BZDmXtOlzVJYxqDmNrQ6jD%2BEVwtbySeNqtNKsQNs3uhzPWRHNK8%2F9BYPlN1pSNzYZhGlPXduDx5JOBPxFhBzd4eWNTDpxZfEbOkTUuS5Rk%2F10QKoeR2J7sxVVc8aJL7%2Bea5IZqpyK0DVX4e7SzuEsQdKmQrF2y5qiQirDl0y3Ud3DyWBEkyBrdMCmlq3tx9NE55jlSyhJk8waIX5OmgtN78GioiuQ47QhSzvUbWYzKz9GYSbE7%2Fyub27%2F7Ca1YTgkrEWe%2BXaTF2QYvsn%2BguwQHw2Df7KOSBVOCzIQJfKZqT68%2B4axPhkCWuxiTo2oWVisYMjIEk0ewjIFeOSNw%2FKFvfVQEikM4Wa1%2F0RFtz%2FeFOzy5O48T20mWn1uA8xYN%2FJdEhVMVdHyBs3UzGiHl9GgQIOTQspN4hPQc5862W4IMiDEZKSqvGNqXsbW9uDpFrotFWmG%2FIsgOAI59iZ5JVB4n385L1Fn%2BnFhBPaqnOQlOUvN8lkevDGByZUzocwHyFcDXSyeeB0IJBN3twbApaSQDiiCgYCNUz%2FfEpE98bGRqNh%2F8Xdy4hYrouDH7bKG1a%2BKmxhN3uLzMKI5AS%2BsAu8ATYSIZHoXJwcQt%2Fdn98W%2FDzHadQioP5KXNvVqtkAdjFu2KzwCI2JhjswwvcGjrgY6sQHhAdCAJ51muVCXlf9n%2BfCEpWmC6MZXY3UN2D%2FiPxcZGpnZVc5Dkf976Ld3VHotnaqTjy3OFR%2F2l7AhYa6zrkdhm6mFMupbTGxX3E%2FYlxPmgAHOzWBnty%2Frxx2krKasLWPZKr6pNw5sJeROdq8HUP%2BLjaBXa1uGpZq9lTb40CjpY7%2FefuIbcbDhJ%2FK6umQVManniqd8ZDrVsDY7ngTFEaCRPd%2B7couYpCxwK4Mg%2FY3vuoU%3D&X-Amz-SignedHeaders=host&response-content-disposition=inline%3Bfilename%3D%22companies_house_document.pdf%22&X-Amz-Signature=c3bc37303932114e4f2183e93125a3d410c6537d96cf5f4d88f24dd7027eab3f

Not sure you are directing your question to the right Board mol, but I would suggest as Greg Andrell was designated a person with significant control and now Skinbiotherapeutics have assumed that mantle, then that represents the transaction.

https://find-and-update.company-information.service.gov.uk/company/06472144/persons-with-significant-control

Nice finds on the Prairie Naturals Slimbiome Cardio mol. Canada is known as a idea woke Country so made a smile to see Prairie promoting itself as Woman owned by a Ms Tran, could not make it up :)

Yes Cellhi. Trial is underway and results expected end q1

Basic should read £140,414

Thomas, let's nail one myth that all Director's fees have gone up. Douglas Quinn our part time CFO received £240,414 basic salary but also charged £125,606 in consultancy fees making a grand total of £266,023 for FY Jun 2022 which means Manprit's salary of £261,480 in FY end Jun 2023 compares very favourably when allowing for inflation. Also, Manprit has been brought in for his Acquisition experience and only time will tell whether that is money well spent. So cut SA and Manprit some slack until we see how this plays out

Mol, I have not contacted SOH directly myself, except for questions posed on Investor Meets, but have received responses via both TW and Lemmings in the past. The latest teaser, which I stress is not something that should be in a RNS, is none-the-less illuminating for all LTHs and helps to illustrate the difference between sweetbiotix and alternatives that generate excitement but are inferior.

Lol, nice one Friedman.

Couldn't agree more lord but in this case perhaps you would care to explain what market sensitive news you think has been released via some old boys network as opposed to someone (me) doing their own research and then clarifying what they believe has been released via RNS?

You need to read the sep 2020 rns detailing the agreement bk "The agreement grants the US Company an exclusive worldwide license in return for it bearing the costs relating to product manufacturing, marketing, and all future costs relating to the commercialisation of a number of SweetBiotix® products."

No doubt Dawn interpretive text!