5 unchanged sentences
Our current brand portfolio consists of two marquee brands, FOCUSfactor, a clinically-tested brain
−Removed: health supplement (this study was performed independently and is not related to any FDA-approved IND application) that has been shown
−Removed: to improve memory, concentration and focus, and Flat Tummy, a lifestyle and wellness brand that provides a suite of nutritional products
−Removed: to help women achieve their nutrition and weight management goals.
−Removed: Our products are sold through some of the nation’s leading club,
−Removed: mass drug, and other retailers such as Costco, Amazon.com, Walmart, Walgreens, CVS, The Vitamin Shoppe, Target.com, H-E-B, Meijer, and
−Removed: Additionally, we have expanded into Canada and the United Kingdom.
−Removed: We built our brand portfolio through strategic acquisitions.
−Removed: the FOCUSfactor brand in January 2015 for cash consideration of $6.0 million, including an earnout.
−Removed: In November 2015, we
−Removed: acquired our second marquee brand, Flat Tummy, for AUD $10.0 million (or approximately $7.0 million), using a mix of cash and
−Removed: Our capital structure following the acquisitions of our key brands in 2015 has been highly levered, and our focus has been on paying
−Removed: our debt and, as a result, we do not have the resources to grow our business.
−Removed: We have grown our FOCUSfactor brand from 3 SKUs at acquisition
−Removed: to over 34 SKUs, and our Flat Tummy Brand from 1 SKU to 13 SKUs.
−Removed: Our growth from 2022 to the present was driven by expanded distribution
−Removed: of our FOCUSfactor product line to some of our major retailers, such as Costco, CVS and Walmart, among others.
−Removed: This expansion included
−Removed: SKUs within our FOCUSfactor vision line as well as focus and energy Ready-to-Drink (RTD).
+Added: health supplement (this study was performed independently and is not related to any U.S.
+Added: Food and Drug Administration (“FDA”)
+Added: -approved investigational new drug (IND) application) that has been shown to improve memory, concentration and focus, and Flat Tummy,
+Added: a lifestyle and wellness brand that provides a suite of nutritional products to help women achieve their nutrition and weight management
+Added: Collectively, these brands are referred to as nutraceuticals.
+Added: Our products are sold through some of the nation’s leading
+Added: club, mass drug, and other retailers such as Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe.
+Added: Additionally,
+Added: we have expanded into Canada and Mexico.
+Added: We built our brand portfolio
+Added: through strategic acquisitions.
+Added: We acquired the FOCUSfactor brand in January 2015 for cash consideration of $6.0 million, including
+Added: In November 2015, we acquired our second marquee brand, Flat Tummy, for AUD 10.0 million (approximately $7.0 million),
+Added: using a mix of cash and stock.
+Added: Our capital structure following the acquisitions of our key brands in 2015 has been highly levered, and
+Added: our focus has been on paying our debt and, as a result, we do not have the resources to grow our business.
+Added: We have grown our FOCUSfactor
+Added: brand from 3 SKUs at acquisition to over 34 SKUs, and our Flat Tummy Brand from 1 SKU to 13 SKUs.
+Added: We use the term SKU, or stock-keeping
+Added: unit, to refer to a product with a unique UPC (Universal Product Code), which is the barcode used to identify products.
We intend to accelerate the
−Removed: growth of both our FOCUSfactor supplements and FOCUSfactor energy RTD products.
−Removed: Our asset-light business model, in which we partner
−Removed: with third-party manufacturers to produce our brand offerings, allows us to scale quickly and profitably while satisfying growing
+Added: growth of both our FOCUSfactor supplements and FOCUSfactor energy Ready To Drink (RTD) products.
+Added: Our asset-light business model, in which
+Added: we partner with third-party manufacturers to produce our brand offerings, allows us to scale quickly and profitably while satisfying growing
Our flagship brand, FOCUSfactor, is a brain health nutritional supplement
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Our FOCUSfactor brand consists of over 34 SKUs and is sold primarily through leading retailers in the United States,
−Removed: including Costco, Walmart, Amazon.com, Walgreens, CVS, Meijer, and Albertson’s, in addition to selling direct to consumer through
+Added: including Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe, in addition to selling direct to consumer through
the FOCUSfactor website.
Across three of our key partners, we have increased the number of SKUs sold through the retailer from the single
−Removed: SKU available at the beginning of our relationships, which began in 2015 and 2016.
−Removed: In addition, we have increased our presence in retail
−Removed: locations for these key partners, resulting in a significant increase in points of distribution, being the number of SKUs multiplied by
−Removed: the number of retail locations for each retailer.
−Removed: We have also expanded the brand internationally into Canada (2020), the United Kingdom
−Removed: (2023) and we anticipate being in Taiwan and Mexico during 2025 and in Australia and Asia in the first quarter of 2026.
−Removed: FOCUSfactor has expanded into
−Removed: the beverage market with its focus plus energy RTD.
−Removed: According to Zion Research in January 2024, the beverage market is a large ($176 billion
−Removed: in 2022) and growing (projected 8.6% CAGR covering eight years from 2022 through 2030) market with an expanding range of functional benefits
−Removed: such as energy, hydration, cognition/focus, weight loss, gut health and immunity.
−Removed: Examples such as Celsius and Beyond Raw offer dual-benefit products
−Removed: that deliver fat burning plus energy while C4 Smart Energy and FocusAid deliver focus plus energy.
−Removed: Additionally, consumers are looking
−Removed: for not only refreshing drinks but health perks such as zero sugar and low-calorie drinks.
−Removed: This consumer shift in preferences towards
−Removed: more functional benefits can be seen in the evolution of the energy RTD category where originally competitors like Red Bull and Monster
−Removed: delivered conventional energy, then the category offered more performance energy products with added vitamins and amino acids in products
−Removed: such as Reign and C4 Performance to products with more natural energy characteristics and then to the dual-benefit energy products
−Removed: that we see today.
+Added: SKU available at the beginning of our relationships in 2015 and 2016.
+Added: In addition, we have increased our presence in retail locations
+Added: for these key partners, resulting in a significant increase in points of distribution, defined as the number of SKUs multiplied by the
+Added: number of retail locations for each retailer.
+Added: We have also expanded the brand internationally into Canada (2020) and Mexico (2025).
+Added: FOCUSfactor has expanded
+Added: into the beverage market with its focus plus energy RTD.
+Added: According to Zion Research in January 2024, the global beverage market is
+Added: large ($176 billion in 2022) and growing (projected 8.6% CAGR covering eight years from 2022 through 2030) with an expanding range
+Added: of functional benefits such as energy, hydration, cognition/focus, weight loss, gut health and immunity.
+Added: Examples such as Celsius and
+Added: Beyond Raw offer dual-benefit products that deliver fat burning plus energy while C4 Smart Energy and FocusAid deliver focus plus
+Added: Additionally, consumers are looking for not only refreshing drinks but health perks such as zero sugar and low-calorie drinks.
+Added: This consumer shift in preferences towards more functional benefits can be seen in the evolution of the energy RTD category where originally
+Added: competitors like Red Bull and Monster delivered conventional energy, then the category offered more performance energy products with added
+Added: vitamins and amino acids in products such as Reign and C4 Performance to products with more natural energy characteristics and then to
+Added: the dual-benefit energy products that we see today.
FOCUSfactor is well-positioned to
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FOCUSfactor is looking to attract both existing
−Removed: consumers of supplement products (typically age 50+) to RTDs as well as a younger demographic (age 18-49).
+Added: consumers of supplement products (typically customers over age 50) to RTDs as well as a younger demographic (aged 18-49).
FOCUSfactor has successfully
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From March 2023 through August 2023, FOCUSfactor
−Removed: conducted a 5-month trial of its RTD products in 44 clubs of a warehouse club retailer throughout Texas with sales ranging from $550
+Added: conducted a five-month trial of its RTD products in 44 clubs of a warehouse club retailer throughout Texas with sales ranging from
$550 per club per week to $2,382 per club per week.
−Removed: From April 2024 through July 2024, a second pilot was successfully completed at a major
−Removed: Canadian club retailer throughout Canada with results ranging from C$378 per club per week to C$2,206 per club per week.
−Removed: Our second marquee brand, Flat
−Removed: Tummy, consists of a range of lifestyle and wellness products and accessories including tea, shakes, lollipops, supplements, apparel,
+Added: From April 2024 through July 2024, a second pilot was successfully completed at a
+Added: major Canadian club retailer throughout Canada with results ranging from C$378 per club per week to C$2,206 per club per week.
+Added: Our second marquee brand,
+Added: Flat Tummy, consists of a range of lifestyle and wellness products and accessories including tea, shakes, lollipops, supplements, apparel,
and exercise accessories.
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non-core brands.
−Removed: These developing brands are:
−Removed: ● Hand MD — complete hand care brand to help
−Removed: maintain clean and healthy hands while reducing the signs of aging.
−Removed: ● Perfekt Beauty — beauty line of products
−Removed: for the eyes, lips, brows, cheeks and skin.
−Removed: ● Sneaky Vaunt — a lingerie brand with a line
−Removed: of women’s shapewear, bralettes and panties.
−Removed: ● The Queen Pegasus — eyelash enhancement products
−Removed: for longer, thicker, natural lashes.
−Removed: ● Neuragen — fast-acting topical treatments
−Removed: for neuropathic (nerve) pain.
−Removed: ● UrgentRx — line of fast-acting, portable,
−Removed: powdered over-the-counter medications.
−Removed: While we may elect to promote
−Removed: these brands and commercialize their products in the future, we have prioritized our key brands, FOCUSfactor and Flat Tummy, and management
−Removed: is focused on the growth of these core products.
+Added: While we may elect to promote these brands and commercialize their products in the future, we have prioritized our
+Added: key brands, FOCUSfactor and Flat Tummy, and management is focused on the growth of these core products.
Our Competitive Strengths
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The brain health segment is slated to grow
−Removed: at 8% per year in the United States and 13% per year globally, according to Grand View Research.
−Removed: We believe our focus on lifestyle
−Removed: products has also benefited from the growth and prevalence of social media.
+Added: at 8% per year in the United States and 13% per year globally through 2030, according to Grand View Research.
+Added: We believe our focus
+Added: on lifestyle products has also benefited from the growth and prevalence of social media.
Results Backed by Independent Study for
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has been placed in premier retailers.
−Removed: See ” — FOCUSfactor Study ” for additional information.
+Added: This controlled study was conducted in healthy male and female subjects between the ages of 18 and
+Added: 65 who were randomized in a control group and a placebo group.
+Added: Subjects were compensated for their participation.
+Added: See “ — FOCUSfactor
+Added: Study ” for additional information.
Experienced Management Team with Proven
Track Record of Value Creation
−Removed: Our executive team has a combined
−Removed: 90 years of experience in consumer marketing and distribution and has been instrumental in acquiring and building our core brands.
−Removed: Management has exercised strong financial discipline in its acquisition strategy, with a focus on acquiring brands at attractive valuations.
+Added: Our executive team has a
+Added: combined 90 years of experience in consumer marketing and distribution and has been instrumental in acquiring and building our core
+Added: Management has exercised strong financial discipline in its acquisition strategy, with a focus on acquiring brands at attractive
For example, we acquired FOCUSfactor for approximately 3x trailing EBITDA.
−Removed: Management’s philosophy is to acquire promising brands
−Removed: that fit within our health, beauty and lifestyle offerings, and apply our marketing and distribution strategies to develop brands to their
−Removed: full potential.
−Removed: We believe we are adept at identifying promising opportunities that build out and complement our core brand portfolio.
+Added: Management’s philosophy is to acquire
+Added: promising brands that fit within our health, beauty and lifestyle offerings, and apply our marketing and distribution strategies to develop
+Added: brands to their full potential.
+Added: We believe we are adept at identifying promising opportunities that build out and complement our core
+Added: brand portfolio.
Premier Retail Partners
Our premier retail partners
−Removed: include Costco, BJ’s Wholesale Club, Walmart, Amazon.com, Publix, Meijer, Albertson’s, CVS, Walgreens and others.
−Removed: sell products to these partners under their standard arrangements, which do not include a term or duration as sales under each vendor
−Removed: agreement are generally made on a purchase order basis.
−Removed: Our partners provide a platform to expand the breadth of our current offerings
−Removed: through product line extensions and new product innovation.
−Removed: We continue to introduce new SKUs to our current retail partners, such as
−Removed: the addition of FOCUSfactor RTDs and vision products to our membership club and other channels.
−Removed: Additionally, the international footprint
−Removed: of certain of our various retail partners facilitates our geographic expansion plans.
+Added: include Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe and others.
+Added: We sell products to these partners
+Added: under their standard arrangements, which do not include a term or duration as sales under each vendor agreement are generally made on
+Added: a purchase order basis.
+Added: Our partners provide a platform to expand the breadth of our current offerings through product line extensions
+Added: and new product innovation.
+Added: We continue to introduce new SKUs to our current retail partners, such as the addition of FOCUSfactor RTDs
+Added: and vision products to these retail partners and other channels.
+Added: Additionally, the international footprint of certain of our various retail
+Added: partners facilitates our geographic expansion plans.
Scalable and Flexible Asset-Light Model
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Our Growth Strategy
−Removed: We intend to drive growth and
−Removed: increased profitability in our business through these key elements of our strategy:
+Added: We intend to drive growth
+Added: and increased profitability in our business through these key elements of our strategy:
Broaden Media Advertising Strategy
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we focus on pushing additional SKUs within our retail sales partner network to continue to build brand awareness and increase reach for
−Removed: We also plan to invest in online marketing to promote all of our brands, including social media and influencer driven marketing.
+Added: We also plan to continue to invest in online marketing to promote all of our brands, including social media and influencer
+Added: driven marketing.
We have also experienced significant growth through our increased distribution, which we continue to drive forward.
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to Expand the Reach of Our Products
−Removed: We have established distribution
−Removed: relationships with premier retail partners, including Costco, Walmart, Amazon.com, Walgreens, CVS, The Vitamin Shoppe, Target.com, H-E-B,
−Removed: Meijer, and Albertson’s.
−Removed: Based on the success of our products with these leading retail partners, we believe that we are well positioned
−Removed: to add new retailers that will enhance our distribution footprint.
−Removed: We believe we have expansion opportunities with food retailers, including
−Removed: those focused on health foods.
−Removed: We intend to introduce three to five new SKUs across potential retailers, which would potentially result
−Removed: in the addition of approximately 50,000 points of distribution.
+Added: Based on the success of our
+Added: products with our established leading retail partners, we believe that we are well positioned to add new retailers that will enhance our
+Added: distribution footprint.
+Added: We believe we have expansion opportunities with food retailers, including those focused on health foods.
Diversify Our Geographic Presence through
Entry into New Markets
−Removed: We seek to accelerate our sales
−Removed: growth by expanding and further diversifying our geographic footprint.
−Removed: Our goal is to increase our net revenues generated from new markets.
−Removed: As we target new international markets, our strategy is to develop highly competitive and differentiated products that are produced in-country for
−Removed: ease of entry, with support from our regulatory group and an in-country regulatory consultant to help expedite the approval process.
−Removed: In the United Kingdom, where we have distribution with Costco and Holland & Barrett, we have established relationships with manufacturers
−Removed: who began producing FOCUSfactor in-country in December 2021.
−Removed: We currently plan to enter the Taiwan and Mexico markets during
−Removed: 2025 and in Australia and Asia in the first quarter of 2026, initially with FOCUSfactor, then followed by Flat Tummy.
−Removed: In Mexico, we have
−Removed: identified local manufacturers and will begin connecting with retailers in Mexico in 2025.
−Removed: We then plan to expand our brands into Australia
−Removed: (where we have TGA approval for our FOCUSfactor products) and Asian markets in 2026.
−Removed: In addition, we are developing our marketing plans
−Removed: in compliance with applicable laws, and are initiating retailer meetings as we seek to gain distribution across these new retail markets.
+Added: We seek to accelerate our
+Added: sales growth by expanding and further diversifying our geographic footprint.
+Added: For the year ended
+Added: December 31, 2025, substantially all of our revenue was generated within North Ameri ca.
+Added: Our goal is to increase our revenues
+Added: generated from new markets.
+Added: As we target new international markets, our strategy is to develop highly competitive and differentiated products
+Added: that are produced in-country for ease of entry, with support from our regulatory group and an in-country regulatory consultant
+Added: to help expedite the approval process.
+Added: We entered the Mexico market in the fourth quarter of 2025 and plan to enter Taiwan and Asia in
+Added: 2026, initially with FOCUSfactor, followed by Flat Tummy.
+Added: We then plan to expand our brands into Australia (where we have Therapeutic
+Added: Goods Administration (“TGA”) approval for our FOCUSfactor products).
+Added: In addition, we are developing our marketing plans in
+Added: compliance with applicable law and are initiating retailer meetings as we seek to gain distribution across these new retail markets.
Use Innovative Strategies to Boost Consumer
−Removed: We have made investments in
−Removed: promoting an app for Flat Tummy and view this as a key aspect of growing our customer base and maintaining high levels of engagement.
+Added: We have made investments
+Added: in promoting an app for Flat Tummy and view this as a key aspect of growing our customer base and maintaining high levels of engagement.
We have also focused on developing our social media presence, in particular through Instagram, in order to foster and grow our relationship
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becomes even more efficient at driving sales velocity.
−Removed: This is evidenced by our expanded
−Removed: FOCUSfactor product line, including focus and energy Ready-to-Drink (RTD) and liquid shots that are marketed to a younger adult audience.
−Removed: In 2023, we successfully launched an RTD pilot program in the United States through a major retailer.
−Removed: Additionally, in the second
−Removed: quarter of 2024, we launched three core FOCUSfactor focus and energy RTD products in Canada.
−Removed: In 2025, we plan to introduce an additional
−Removed: FOCUSfactor supplement for Taiwan, RTDs for the UK and focus and energy coffee for the United States.
−Removed: In the first quarter of 2025,
−Removed: we plan on introducing new complementary products to the Flat Tummy line-up, including new protein shakes, gut-healthy ready-to-drink beverage,
−Removed: hydration powder and pre-workout powder.
−Removed: Additionally, we plan to employ this strategy of expanding our brands into international
−Removed: markets that include Mexico and Asia, among others.
+Added: This is evidenced by our
+Added: expanded FOCUSfactor product line, including focus and energy RTD and liquid shots that are marketed to a younger adult audience.
+Added: we successfully launched an RTD pilot program in the United States through a major retailer.
+Added: Additionally, in the second quarter
+Added: of 2024, we launched three core FOCUSfactor focus and energy RTD products in Canada.
+Added: In the first quarter of 2025, we introduced new complementary
+Added: products to the Flat Tummy line-up, including new protein shakes, GLP-1 support products and pre-workout powders.
+Added: In the fourth quarter
+Added: of 2025, we introduced FOCUSfactor to Mexico.
Marketing and Sales
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as part of our marketing strategy:
−Removed: Our FOCUSfactor
−Removed: website helps to educate and inform consumers on our line of products.
−Removed: The website also serves as a direct-to-consumer sales channel
−Removed: for most FOCUSfactor products.
−Removed: social media platform is Instagram.
+Added: Our FOCUSfactor website helps to educate and inform consumers on our line of products.
+Added: The website also serves as a direct-to-consumer sales channel for most FOCUSfactor products.
+Added: Our main social media platform is Instagram.
As of December 31, 2025, we had approximately 332,000 followers.
FOCUSfactor — Brain Hub App:
−Removed: in 2021 we launched our Brain Hub app on the Android and Apple iOS platforms to provide an additional point of engagement with customers.
−Removed: The app contains a library of brain games and guided meditation sessions on topics related to mindfulness and brain health in order to
−Removed: keep consumers engaged.
+Added: Early in 2021 we launched our Brain Hub app on the Android and Apple iOS platforms to provide an additional point of engagement with customers.
+Added: The app contains a library of brain games and guided meditation sessions on topics related to mindfulness and brain health in order to keep consumers engaged.
As of December 31, 2025, we have approximately 17,000 app downloads.
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campaigns to reach our core target segments through a mix of traditional online advertising as well as influencer-based marketing.
−Removed: Our Flat Tummy website acts as a platform
−Removed: for engagement with our customers.
−Removed: In addition to offering a direct-to-consumer sales channel for our products, we also host a lifestyle
−Removed: blog on our website with a focus on health and fitness.
+Added: Our Flat Tummy website acts as a platform for engagement with our customers.
+Added: In addition to offering a direct-to-consumer sales channel for our products, we also host a lifestyle blog on our website with a focus on health and fitness.
Our primary social media platform is Instagram.
As of December 31, 2025, we had approximately 1.7 million followers.
−Removed: Our marketing strategy for Flat Tummy seeks to leverage our
−Removed: large online following to promote products from across the Flat Tummy brand.
−Removed: More recently we have engaged with social media influencers
−Removed: as a new strategy to promote our products.
−Removed: As of December 31, 2024, we had approximately
−Removed: 531,000 followers.
+Added: Our marketing strategy for Flat Tummy seeks to leverage our large online following to promote products from across the Flat Tummy brand.
+Added: More recently we have engaged with social media influencers as a new strategy to promote our products.
+Added: As of December 31, 2025, we had approximately 524,000 followers.
We mainly use the platform to share promotions and to relay content and advertisements.
Flat Tummy App:
−Removed: Our Flat Tummy app had approximately
−Removed: 1.9 million unique downloads as of December 31, 2024, across both the Apple and Android platforms.
−Removed: The app provides customized workouts,
−Removed: nutrition information, and diet plans.
+Added: Our Flat Tummy app had approximately 1.9 million unique downloads as of December 31, 2025, across both the Apple and Android platforms.
+Added: The app provides customized workouts, nutrition information, and diet plans.
The app is currently free to customers;
−Removed: however, we are exploring different strategies to monetize
−Removed: our large user base.
+Added: however, we are exploring different strategies to monetize our large user base.
FOCUSfactor Study
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project management, site monitoring, data management, statistical analyses, and preparation of the final study report.
−Removed: The primary endpoint was sum
−Removed: recall for five trials of the Rey Auditory Verbal Learning Test (RAVLT), a standardized neuropsychological test of memory.
−Removed: one of the most commonly used tests of memory in psychopharmacology research.
−Removed: The test was originally developed in the 1940s and has proven
−Removed: useful in evaluating verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus retrieval,
−Removed: and subjective organization.
−Removed: The standard RAVLT begins with a subject being read a list of 15 unrelated words at the rate of one word
+Added: The primary endpoint was
+Added: sum recall for five trials of the Rey Auditory Verbal Learning Test (RAVLT), a standardized neuropsychological test of memory.
+Added: is one of the most commonly used tests of memory in psychopharmacology research.
+Added: The test was originally developed in the 1940s and has
+Added: proven useful in evaluating verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus
+Added: retrieval, and subjective organization.
+Added: The standard RAVLT begins with a subject being read a list of 15 unrelated words at the rate of
+Added: one word per second.
The examiner then asks the subject to recall as many words as possible.
−Removed: This procedure is then repeated four more times with
−Removed: the same list of words and the number of correct responses is summed.
−Removed: This summed score was chosen as the primary outcome measure, or
−Removed: endpoint, for the current study.
+Added: This procedure is then repeated four more
+Added: times with the same list of words and the number of correct responses is summed.
+Added: This summed score was chosen as the primary outcome measure,
+Added: or endpoint, for the current study.
The study demonstrated that,
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as a wholly-owned subsidiary.
−Removed: We were a public reporting
−Removed: company until July 17, 2020, the date on which we filed a Form 15 to voluntarily suspend our duty to file reports under Sections
−Removed: 13 and 15(d) of the Exchange Act.
+Added: We were a public reporting company until July 17, 2020, the date
+Added: on which we filed a Form 15 to voluntarily suspend our duty to file reports under Sections 13 and 15(d) of the Securities Exchange Act
+Added: of 1934 (the “Exchange Act”).
As a result of our public offering in October 2024, we became subject again to the information
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Manufacturing and Related Operations
−Removed: Our company collaborates with
−Removed: external manufacturers, known for their reliability, to produce our diverse range of products.
−Removed: We carefully select partners based on their
−Removed: expertise and manufacturing capabilities, ensuring our products are of the highest quality.
−Removed: The FOCUSfactor line is produced by several
−Removed: respected manufacturers, such as Nutrition Formulators Inc., Vit-Best Nutrition, and ProTab Laboratories, to ensure supply continuity
−Removed: and support brand growth.
+Added: Our company collaborates
+Added: with external manufacturers, known for their reliability, to produce our diverse range of products.
+Added: We carefully select partners based
+Added: on their expertise and manufacturing capabilities, ensuring our products are of the highest quality.
+Added: The FOCUSfactor line is produced
+Added: by several respected manufacturers, including Nutrition Formulators Inc., Vit-Best Nutrition, Multi-Pak Packaging, ProTab Laboratories
+Added: and Tailored Bottling Solutions to ensure supply continuity and support brand growth.
For the Flat Tummy line, we work closely with manufacturers,
−Removed: Caraway Tea Company to make our teas, Vit-Best Nutrition
−Removed: for shakes and capsules, Global Widget for gummies, and Clever Foods for appetite suppression lollipops.
−Removed: Most of our revenues are generated
−Removed: through the retail channels, primarily due to our FOCUSfactor brand which is sold mainly through leading retailers.
−Removed: These retailers include
−Removed: club, mass, drug and other retailers such as Costco, Walmart, Amazon.com, Walgreens, Meijer, Albertson’s and CVS.
−Removed: brands are also sold directly to consumers through their respective brand websites.
−Removed: nutritional supplements
−Removed: retail industry is a large and highly fragmented industry with few barriers to entry.
−Removed: We compete against other domestic and international
−Removed: manufacturers, specialty retailers, mass merchants, multi-level marketing organizations, mail-order and direct-to-consumer companies,
+Added: including Caraway Tea Company, Nutrition Formulators Inc., and Clever Foods.
+Added: Most of our revenues are
+Added: generated through the retail channels, primarily due to our FOCUSfactor brand which is sold mainly through leading retailers.
+Added: These retailers
+Added: include club, mass, drug and other retailers such as Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe.
+Added: of our brands are also sold directly to consumers through their respective brand websites.
+Added: supplements retail industry is a large and highly fragmented industry with few barriers to entry.
+Added: We compete against other domestic and
+Added: international manufacturers, specialty retailers, mass merchants, multi-level marketing organizations, mail-order and direct-to-consumer companies,
and e-commerce companies.
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safety, manufacturing, packaging, labeling, advertising and distribution of our products in the United States are subject to regulation
−Removed: by several agencies, including the U.S.
−Removed: Food and Drug Administration (the “FDA”), the Federal Trade Commission (the “FTC”),
−Removed: the Consumer Product Safety Commission, and by various agencies and programs of the states and localities in which our products are sold.
−Removed: The FDA, which exercises regulatory authority over foods, dietary supplements (a subset of the foods category), and cosmetics, is the
−Removed: regulatory body for the product categories in which we participate within the U.S.
−Removed: While the FDA doesn’t
−Removed: mandate pre-approval or registration for dietary supplements or food products, it does stipulate that these items must adhere to
−Removed: current good manufacturing practices (“cGMPs”) and be produced in FDA-registered and audited facilities.
−Removed: Additionally,
−Removed: the FDA exercises regulatory oversight of ingredients and labeling of these products.
−Removed: All FOCUSfactor products and
−Removed: Flat Tummy products are governed by the FDA regulations in 21 CFR Part 111 (dietary supplements) or 21 CFR Part 117 (foods).
+Added: by several agencies, including the FDA, the Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission,
+Added: and by various agencies and programs of the states and localities in which our products are sold.
+Added: The FDA, which exercises regulatory
+Added: authority over foods, dietary supplements (a subset of the foods category), and cosmetics, is the primary U.S.
+Added: regulatory body for
+Added: the product categories in which we participate within the U.S.
+Added: While the FDA doesn’t mandate pre-approval or registration
+Added: for dietary supplements or food products, it does stipulate that these items must adhere to current good manufacturing practices (“cGMPs”)
+Added: and be produced in FDA-registered and audited facilities.
+Added: Additionally, the FDA exercises regulatory oversight of ingredients and
+Added: labeling of these products.
+Added: All FOCUSfactor products
+Added: and Flat Tummy products are governed by the FDA regulations in 21 CFR Part 111 (dietary supplements) or 21 CFR Part 117 (foods).
Neuragen (NDC 15377-010-04) is a homeopathic product and has not been evaluated by the FDA for safety or efficacy.
47 unchanged sentences
manufacturer/distributor has submitted NDIN to the FDA.
−Removed: The FDA or other agencies could
−Removed: take actions against products or product ingredients that, in their determination, present an unreasonable health risk to consumers that
−Removed: would make it illegal for us to sell such products.
−Removed: In addition, the FDA could issue consumer warnings with respect to the products or
−Removed: ingredients in such products that we sell.
+Added: The FDA or other agencies
+Added: could take actions against products or product ingredients that, in their determination, present an unreasonable health risk to consumers
+Added: that would make it illegal for us to sell such products.
+Added: In addition, the FDA could issue consumer warnings with respect to the products
+Added: or ingredients in such products that we sell.
Such actions or warnings could be based on information received through FD&C Act-mandated reporting
59 unchanged sentences
related to any future removal or recall.
−Removed: The FD&C Act permits structure/function
−Removed: claims to be included in labels and labeling for dietary supplements without FDA pre-market approval.
−Removed: However, companies must have
−Removed: substantiation that the claims are “truthful and not misleading,” and must submit a notification with the text of the claims
−Removed: to the FDA no later than 30 days after marketing the dietary supplement with the claims.
−Removed: Permissible structure/function claims may
−Removed: describe how a particular nutrient or dietary ingredient affects the structure, function, or general well-being of the body, or characterize
−Removed: the documented mechanism of action by which a nutrient or dietary ingredient acts to maintain such structure or function.
−Removed: labeling of a product marketed as a dietary supplement may not expressly or implicitly represent that a dietary supplement will diagnose,
−Removed: cure, mitigate, treat, or prevent a disease (i.e., a disease claim).
−Removed: If the FDA determines that a particular structure/function claim
−Removed: is an unacceptable disease claim that causes the product to be regulated as a drug, a conventional food claim, or an unauthorized version
−Removed: of a “health claim,” or, if the FDA determines that a particular claim is not adequately supported by existing scientific
−Removed: data or is false or misleading in any particular way, we would be prevented from using the claim and would have to update our product
−Removed: labels and labeling accordingly.
−Removed: We have an in-house regulatory team that reviews the scientific literature and develops substantiation
−Removed: as part of the product development process to ensure the crafting of compliant structure-function claims and product positioning.
−Removed: Our regulatory team engages in the review of web copy, e-commerce copy, and other marketing copy at the request of the brand directors
−Removed: of each respective brand.
+Added: The FD&C Act permits
+Added: structure/function claims to be included in labels and labeling for dietary supplements without FDA pre-market approval.
+Added: companies must have substantiation that the claims are “truthful and not misleading,” and must submit a notification with
+Added: the text of the claims to the FDA no later than 30 days after marketing the dietary supplement with the claims.
+Added: Permissible structure/function
+Added: claims may describe how a particular nutrient or dietary ingredient affects the structure, function, or general well-being of the
+Added: body, or characterize the documented mechanism of action by which a nutrient or dietary ingredient acts to maintain such structure or
+Added: The label or labeling of a product marketed as a dietary supplement may not expressly or implicitly represent that a dietary
+Added: supplement will diagnose, cure, mitigate, treat, or prevent a disease (i.e., a disease claim).
+Added: If the FDA determines that a particular
+Added: structure/function claim is an unacceptable disease claim that causes the product to be regulated as a drug, a conventional food claim,
+Added: or an unauthorized version of a “health claim,” or, if the FDA determines that a particular claim is not adequately supported
+Added: by existing scientific data or is false or misleading in any particular way, we would be prevented from using the claim and would have
+Added: to update our product labels and labeling accordingly.
+Added: We have an in-house regulatory team that reviews the scientific literature
+Added: and develops substantiation as part of the product development process to ensure the crafting of compliant structure-function claims
+Added: and product positioning.
+Added: Our regulatory team engages in the review of web copy, e-commerce copy, and other marketing copy at the
+Added: request of the brand directors of each respective brand.
In addition, DSHEA provides
53 unchanged sentences
For example, Canada and Australia require a product submission
−Removed: packet and approval from Health Canada (“HC”) and the Therapeutic Goods Administration (“TGA”), respectively,
−Removed: for products that would be considered “Natural Health Products” (in Canada) or “Listed Medicines” (in Australia).
−Removed: In the United Kingdom, on the other hand, no formal regulatory submission or pre-approval is needed for products within the food
−Removed: supplement category.
+Added: packet and approval from Health Canada (“HC”) and the TGA, respectively, for products that would be considered “Natural
+Added: Health Products” (in Canada) or “Listed Medicines” (in Australia).
+Added: In the United Kingdom, on the other hand, no formal
+Added: regulatory submission or pre-approval is needed for products within the food supplement category.
Launch timing varies by country.
−Removed: In the United States and United Kingdom, once a formula is established and
−Removed: labeling has been approved by our regulatory and legal advisors, the product can be launched upon production.
−Removed: The Australian approval
−Removed: process generally takes four to eight weeks from the time the packet is submitted, while in Canada the approval process can take
−Removed: from six to twelve months from submission.
+Added: In the United States and United Kingdom, once a formula is established and labeling has been approved by our regulatory and legal
+Added: advisors, the product can be launched upon production.
+Added: The Australian approval process generally takes four to eight weeks from the
+Added: time the packet is submitted, while in Canada the approval process can take from six to twelve months from submission.
In Canada, HC has oversight
24 unchanged sentences
not currently sold in the United Kingdom.
−Removed: In Australia, FOCUSfactor products
−Removed: are “Listed Medicines” that are regulated by the TGA and require an AUST L (Australia Listed Medicine) number.
−Removed: Listed Medicines
−Removed: are regulated by the TGA, and the advertising of these products is also regulated by the TGA under the Therapeutic Goods Administrative
+Added: In Australia, FOCUSfactor
+Added: products are “Listed Medicines” that are regulated by the TGA and require an AUST L (Australia Listed Medicine) number.
+Added: Medicines are regulated by the TGA, and the advertising of these products is also regulated by the TGA under the Therapeutic Goods Advertising
Code (“TGAC”).
13 unchanged sentences
develop in the United States from time-to-time.
−Removed: Once such bill, the New York Weight Loss Products Bill, effective as of April 22, 2024,
+Added: One such bill, the New York Weight Loss Products Bill, effective as of April 22, 2024,
imposes stricter regulations on weight loss and athletic performance products.
6 unchanged sentences
by the California Office of Environmental Health Hazard Assessment (OEHHA).
−Removed: On a federal level in the United States,
−Removed: repeated legislative attempts have been made within the last several years to introduce a mandatory product listing (MPL) for the
−Removed: dietary supplement industry through the FDA, which would require notification to the FDA before bringing a product to the market and for
−Removed: label information to be submitted to and maintained in a central database.
−Removed: While the most recent MPL attempt failed in 2022, the FDA’s
−Removed: outlined budget and legislative proposals for 2025 continue to include the modernization of DSHEA regulations and the introduction of
−Removed: Several trade association groups within the dietary supplement industry continue to express opposition to the current proposal,
−Removed: citing a clear lack of scope and definition of what it ultimately may require.
−Removed: In Canada, Health Canada is
−Removed: in the process of reviewing and updating the database of ingredient and product monographs.
−Removed: While this effort is considerably focused
−Removed: on the clarification and harmonization of existing monographs and resources, the changing of certain ingredient monographs may have the
−Removed: potential to impact formulation or labeling, if any such ingredient is included in one of our licensed products.
−Removed: If this does occur, Health
−Removed: Canada is expected to provide phase-in and guidance for any such changes.
−Removed: Health Canada has also provided updated labeling formatting
−Removed: for Natural Health Products (NHPs), with a compliance date for existing products of 2028.
−Removed: Concurrently, Health Canada is in the consultation
−Removed: period for an updated fee schedule for Health Canada-related activities, such as the review of product submission packets, site licensing,
−Removed: and other activities relevant to maintaining operations and regulatory compliance in Canada.
−Removed: These discussions are still ongoing, but
−Removed: present potential additional future expenses to companies with natural health product registrations in the Canadian regions, as well as
−Removed: manufacturers or importers of such products.
−Removed: The benefit of this proposed pay scheme is that it may significantly reduce the number of
−Removed: product submissions from other companies in the Canadian market, which may reduce competition in the Canadian market and perhaps reduce
−Removed: review timelines by Health Canada for new product registrations and other such activities, therefore decreasing the time barrier to entry.
+Added: On a federal level in the
+Added: United States, repeated legislative attempts have been made within the last several years to introduce a mandatory product listing
+Added: (MPL) for the dietary supplement industry through the FDA, which would require notification to the FDA before bringing a product to the
+Added: market and for label information to be submitted to and maintained in a central database.
+Added: While the most recent MPL attempt failed in
+Added: 2022, the FDA’s outlined budget and legislative proposals for 2026 continue to include the modernization of DSHEA regulations and
+Added: the introduction of an MPL.
+Added: Several trade association groups within the dietary supplement industry continue to express opposition
+Added: to the current proposal, citing a clear lack of scope and definition of what it ultimately may require.
+Added: In Canada, Health Canada is in the process of reviewing and updating
+Added: the database of ingredient and product monographs.
+Added: While this effort is considerably focused on the clarification and harmonization of
+Added: existing monographs and resources, the changing of certain ingredient monographs may have the potential to impact formulation or labeling,
+Added: if any such ingredient is included in one of our licensed products.
+Added: If this does occur, Health Canada is expected to provide phase-in and
+Added: guidance for any such changes.
+Added: Health Canada has also provided updated labeling formatting for NHPs, with a compliance date for existing
+Added: products of 2028.
+Added: Concurrently, Health Canada is in the consultation period for an updated fee schedule for Health Canada-related activities,
+Added: such as the review of product submission packets, site licensing, and other activities relevant to maintaining operations and regulatory
+Added: compliance in Canada.
+Added: These discussions are still ongoing, but present potential additional future expenses to companies with natural
+Added: health product registrations in the Canadian regions, as well as manufacturers or importers of such products.
+Added: The benefit of this proposed
+Added: pay scheme is that it may significantly reduce the number of product submissions from other companies in the Canadian market, which may
+Added: reduce competition in the Canadian market and perhaps reduce review timelines by Health Canada for new product registrations and other
+Added: such activities, therefore decreasing the time barrier to entry.
Intellectual Property
−Removed: We own 23 trademarks that have
−Removed: been registered with the United States Patent and Trademark Office and have filed applications to register additional trademarks.
+Added: We own 27 trademarks that
+Added: have been registered with the United States Patent and Trademark Office and have filed applications to register additional trademarks.
In addition, we claim domestic trademark and service mark rights in numerous additional marks that we use.
17 unchanged sentences
even some of our trademarks in every country in which we conduct business or intend to conduct business.
−Removed: Patent 8,329,227
−Removed: covering FOCUSfactor’s proprietary formulation “for enhanced mental function.” This patent was issued by the United States
−Removed: Patent and Trademark Office in December 2012 and expires in April 2025.
+Added: We owned U.S.
+Added: 8,329,227 covering FOCUSfactor’s proprietary formulation “for enhanced mental function.” This patent was issued by the
+Added: United States Patent and Trademark Office in December 2012 and expired in April 2025.
In addition to this intellectual
10 unchanged sentences
packages, working to continuously improve fairness in internal compensation practices.
−Removed: As of December 31, 2024, we
−Removed: had 21 full-time employees.
−Removed: We intend to grow our employee base in response to the demands and requirements of the business.
−Removed: that the employer-employee relationships in our Company are positive.
−Removed: We have no labor union contracts.
+Added: As of December 31, 2025,
+Added: we had 28 full-time employees.
+Added: We believe that the employer-employee relationships in our Company are positive.
+Added: We have no labor
+Added: union contracts.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.