NASDAQ: SNYR
Synergy CHC Corp.CIK 0001562733 · Pharmaceutical Preparations
Unless the context otherwise requires, for purposes of this section, the terms “we,” “us,” “the Company” or “Synergy” refer to Synergy CHC Corp. About this business →
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About Synergy CHC Corp.
Source: Item 1 (Business) from the 10-K filed April 1, 2026. Description as filed by the company with the SEC.
Item 1. Business
Unless the context otherwise
requires, for purposes of this section, the terms “we,” “us,” “the Company” or “Synergy”
refer to Synergy CHC Corp.
Our Company
We are a provider of consumer
health care, beauty, and lifestyle products. Our current brand portfolio consists of two marquee brands, FOCUSfactor, a clinically-tested brain
health supplement (this study was performed independently and is not related to any U.S. Food and Drug Administration (“FDA”)
-approved investigational new drug (IND) application) that has been shown to improve memory, concentration and focus, and Flat Tummy,
a lifestyle and wellness brand that provides a suite of nutritional products to help women achieve their nutrition and weight management
goals. Collectively, these brands are referred to as nutraceuticals. Our products are sold through some of the nation’s leading
club, mass drug, and other retailers such as Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe. Additionally,
we have expanded into Canada and Mexico.
We built our brand portfolio
through strategic acquisitions. We acquired the FOCUSfactor brand in January 2015 for cash consideration of $6.0 million, including
earnout. In November 2015, we acquired our second marquee brand, Flat Tummy, for AUD 10.0 million (approximately $7.0 million),
using a mix of cash and stock. Our capital structure following the acquisitions of our key brands in 2015 has been highly levered, and
our focus has been on paying our debt and, as a result, we do not have the resources to grow our business. We have grown our FOCUSfactor
brand from 3 SKUs at acquisition to over 34 SKUs, and our Flat Tummy Brand from 1 SKU to 13 SKUs. We use the term SKU, or stock-keeping
unit, to refer to a product with a unique UPC (Universal Product Code), which is the barcode used to identify products.
Read full description ↓
We intend to accelerate the
growth of both our FOCUSfactor supplements and FOCUSfactor energy Ready To Drink (RTD) products. Our asset-light business model, in which
we partner with third-party manufacturers to produce our brand offerings, allows us to scale quickly and profitably while satisfying growing
demand.
Our Brands
Our flagship brand, FOCUSfactor, is a brain health nutritional supplement
with over 25 years of history and a clinically-tested formula (this study was performed independently and is not related to
any FDA-approved IND application) comprised of a proprietary blend of key brain supporting ingredients along with vitamins, minerals,
and other nutrients. We believe FOCUSfactor is the only product in its category whose entire formula has been shown to support memory,
concentration and focus. Our FOCUSfactor brand consists of over 34 SKUs and is sold primarily through leading retailers in the United States,
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
SKU available at the beginning of our relationships in 2015 and 2016. In addition, we have increased our presence in retail locations
for these key partners, resulting in a significant increase in points of distribution, defined as the number of SKUs multiplied by the
number of retail locations for each retailer. We have also expanded the brand internationally into Canada (2020) and Mexico (2025).
FOCUSfactor has expanded
into the beverage market with its focus plus energy RTD. According to Zion Research in January 2024, the global beverage market is
large ($176 billion in 2022) and growing (projected 8.6% CAGR covering eight years from 2022 through 2030) with an expanding range
of functional benefits such as energy, hydration, cognition/focus, weight loss, gut health and immunity. Examples such as Celsius and
Beyond Raw offer dual-benefit products that deliver fat burning plus energy while C4 Smart Energy and FocusAid deliver focus plus
energy. Additionally, consumers are looking for not only refreshing drinks but health perks such as zero sugar and low-calorie drinks.
This consumer shift in preferences towards more functional benefits can be seen in the evolution of the energy RTD category where originally
competitors like Red Bull and Monster delivered conventional energy, then the category offered more performance energy products with added
vitamins and amino acids in products such as Reign and C4 Performance to products with more natural energy characteristics and then to
the dual-benefit energy products that we see today.
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FOCUSfactor is well-positioned to
capitalize on the evolving energy RTD category (U.S. sales of $19.2 billion in 2023 and a CAGR of 6.3% from 2018 to 2023, according
to Euromonitor in December 2023) with its new focus plus energy RTD. We believe this represents a major growth opportunity, with
our dual-benefit RTD formula offering both focus and energy behind a 24+ year brand with strong heritage and awareness in the area
of brain health. The FOCUSfactor brand name clearly communicates the differentiation benefit of adding focus to energy. The FOCUSfactor
formula does not have to rely as heavily on caffeine as other brands such as Celsius, Bang, Reign and C4, as its formula is a balanced
blend of vitamins, cognitive nutrients and caffeine all in a zero sugar, low calorie, great-tasting drink. The brand also delivers
a significant value relative to many competitors. Additionally, FOCUSfactor has long-term relationships with large retailers where
it has an established presence, which will assist in market penetration for its RTD products. FOCUSfactor is looking to attract both existing
consumers of supplement products (typically customers over age 50) to RTDs as well as a younger demographic (aged 18-49).
FOCUSfactor has successfully
demonstrated the ability to leverage its existing retailer relationships to expand its RTDs. From March 2023 through August 2023, FOCUSfactor
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. From April 2024 through July 2024, a second pilot was successfully completed at a
major Canadian club retailer throughout Canada with results ranging from C$378 per club per week to C$2,206 per club per week.
Our second marquee brand,
Flat Tummy, consists of a range of lifestyle and wellness products and accessories including tea, shakes, lollipops, supplements, apparel,
and exercise accessories. We also provide a Flat Tummy mobile app, which, as of December 31, 2025, had approximately 2.0 million
unique downloads and is intended as a tool to promote the Flat Tummy lifestyle centered around general wellness and health. Our Flat Tummy
brand consists of 13 SKUs and is sold direct to consumer through the Flat Tummy website and application, as well as through Amazon.com,
Target.com and iherb.com.
We also own six additional
non-core brands. While we may elect to promote these brands and commercialize their products in the future, we have prioritized our
key brands, FOCUSfactor and Flat Tummy, and management is focused on the growth of these core products.
Our Competitive Strengths
We believe that we have attributes
that differentiate us from our competitors and provide us with significant competitive advantages. Our key competitive strengths include:
Well-Positioned in Growing Categories
Driven by Favorable Consumer Trends
An increased focus on health,
beauty and wellness by consumers has served as a tailwind for our brands. The nutritional supplement market has experienced significant
growth across a range of areas including immune health, brain health, heart health, sleep/stress, and overall nutrition and wellness as
a result of an aging population, increased obesity, pandemic concerns and a desire for more natural solutions and treatments over prescription
medication. We believe that we are well positioned to benefit from these favorable trends. The brain health segment is slated to grow
at 8% per year in the United States and 13% per year globally through 2030, according to Grand View Research. We believe our focus
on lifestyle products has also benefited from the growth and prevalence of social media.
2
Results Backed by Independent Study for
FOCUSfactor
We believe the FOCUSfactor
brand is strengthened by an independent clinical study to support the product claims for improved memory, concentration, and focus. FOCUSfactor
has been tested in a single-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate its effect on memory,
concentration, and focus in healthy adults. The study was not a clinical trial conducted pursuant to an FDA-approved IND application,
and the FDA has not reviewed this study or evaluated these performance claims.
In this study, FOCUSfactor
was tested on its entire 52-ingredient formulation rather than testing one or two ingredients within a formulation. FOCUSfactor was
shown to provide a 44% increase in recall memory (an increase of 6.5 words compared to 4.5 words for the placebo group) after six weeks
of use versus placebo. This differentiates FOCUSfactor from other brain-health supplements and is a prime reason why FOCUSfactor
has been placed in premier retailers. This controlled study was conducted in healthy male and female subjects between the ages of 18 and
65 who were randomized in a control group and a placebo group. Subjects were compensated for their participation. See “ — FOCUSfactor
Study” for additional information.
Experienced Management Team with Proven
Track Record of Value Creation
Our executive team has a
combined 90 years of experience in consumer marketing and distribution and has been instrumental in acquiring and building our core
brands. Management has exercised strong financial discipline in its acquisition strategy, with a focus on acquiring brands at attractive
valuations. For example, we acquired FOCUSfactor for approximately 3x trailing EBITDA. Management’s philosophy is to acquire
promising brands that fit within our health, beauty and lifestyle offerings, and apply our marketing and distribution strategies to develop
brands to their full potential. We believe we are adept at identifying promising opportunities that build out and complement our core
brand portfolio.
Premier Retail Partners
Our premier retail partners
include Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe and others. We sell products to these partners
under their standard arrangements, which do not include a term or duration as sales under each vendor agreement are generally made on
a purchase order basis. Our partners provide a platform to expand the breadth of our current offerings through product line extensions
and new product innovation. We continue to introduce new SKUs to our current retail partners, such as the addition of FOCUSfactor RTDs
and vision products to these retail partners and other channels. Additionally, the international footprint of certain of our various retail
partners facilitates our geographic expansion plans.
Scalable and Flexible Asset-Light Model
to Support Growth
Our focus is on brand management,
marketing, product development and distribution, and we utilize contract manufacturing partners in order to produce our various brand
offerings. The use of third-party manufacturing partners allows us to scale quickly, as we ensure that our partners have sufficient
capacity to meet our demand needs. We also maintain multiple relationships with different contract manufacturers, ensuring diversification
of our manufacturing base and reducing the likelihood of supply bottlenecks or deficits that could potentially slow our growth.
Our Growth Strategy
We intend to drive growth
and increased profitability in our business through these key elements of our strategy:
Broaden Media Advertising Strategy
We have experienced significant
acceleration in sales growth for the FOCUSfactor brand as a result of our television advertising in prior years. We launched a national
advertising campaign in August 2020, which aired on major news and entertainment networks such as Fox News, CNN, MSNBC, TLC, and
TNT, targeting adults 45 years of age and older. We anticipate a coordinated expansion of our advertising strategy during 2026, as
we focus on pushing additional SKUs within our retail sales partner network to continue to build brand awareness and increase reach for
FOCUSfactor. We also plan to continue to invest in online marketing to promote all of our brands, including social media and influencer
driven marketing. We have also experienced significant growth through our increased distribution, which we continue to drive forward.
3
Acquire Brands which Complement Our Existing
Portfolio
We will continue to evaluate
acquisition opportunities that we believe fit well within our brand portfolio and create value for our stockholders, such as further retail
expansion in nutraceuticals and market expansion in health and beauty. In spite of historical capital constraints, our opportunistic approach
to acquisitions has resulted in a successful track record of identifying promising targets that align with our overall brand strategy
in the health, beauty and lifestyle segments.
Partner with Additional Leading Retailers
to Expand the Reach of Our Products
Based on the success of our
products with our established leading retail partners, we believe that we are well positioned to add new retailers that will enhance our
distribution footprint. We believe we have expansion opportunities with food retailers, including those focused on health foods.
Diversify Our Geographic Presence through
Entry into New Markets
We seek to accelerate our
sales growth by expanding and further diversifying our geographic footprint. For the year ended
December 31, 2025, substantially all of our revenue was generated within North America. Our goal is to increase our revenues
generated from new markets. As we target new international markets, our strategy is to develop highly competitive and differentiated products
that are produced in-country for ease of entry, with support from our regulatory group and an in-country regulatory consultant
to help expedite the approval process. We entered the Mexico market in the fourth quarter of 2025 and plan to enter Taiwan and Asia in
2026, initially with FOCUSfactor, followed by Flat Tummy. We then plan to expand our brands into Australia (where we have Therapeutic
Goods Administration (“TGA”) approval for our FOCUSfactor products). In addition, we are developing our marketing plans in
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
Engagement
We have made investments
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
with customers. Our brands appeal to both specific consumer needs as well as lifestyle choices and we seek to deepen our understanding
of our customers and boost recognition of our brands through increased engagement.
Continue to Develop and Expand Our Current
Brands
Our plan is to further develop
and expand our brands by reaching a broader set of customers through advertising and product expansion. More specifically, we look to
develop new products for our brands to satisfy the various customer segment opportunities (i.e., baby boomers, millennials, etc.) and
satisfy various consumer needs as they relate to new and improved formulations, expanded and improved product benefits, alternative delivery
formats and sizes. As we increase the product line-up behind our brands, we leverage our current retail distribution network by expanding
our presence as well as adding incremental distribution with new retail partners. With a broader brand presence, we believe our advertising
becomes even more efficient at driving sales velocity.
This is evidenced by our
expanded FOCUSfactor product line, including focus and energy RTD and liquid shots that are marketed to a younger adult audience. In 2023,
we successfully launched an RTD pilot program in the United States through a major retailer. Additionally, in the second quarter
of 2024, we launched three core FOCUSfactor focus and energy RTD products in Canada. In the first quarter of 2025, we introduced new complementary
products to the Flat Tummy line-up, including new protein shakes, GLP-1 support products and pre-workout powders. In the fourth quarter
of 2025, we introduced FOCUSfactor to Mexico.
4
Marketing and Sales
Our targeted, consumer-driven marketing
strategy has been key to building our brands and driving revenue growth. We manage dedicated marketing strategies for each of our brands
in order to build deep connections with our customers.
FOCUSfactor. Our
marketing strategy for FOCUSfactor is primarily focused on increased distribution and advertising campaigns that appeal to the demographics
of our wellness focused customer base.
We also utilize in-store promotions
along with online and social media advertising to promote our FOCUSfactor brand. We leverage the following online and social media assets
as part of our marketing strategy:
●
Website: Our FOCUSfactor website helps to educate and inform consumers on our line of products. The website also serves as a direct-to-consumer sales channel for most FOCUSfactor products.
●
Instagram: Our main social media platform is Instagram. As of December 31, 2025, we had approximately 332,000 followers.
●
FOCUSfactor — Brain Hub App: 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. 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.
Flat Tummy. We
employ a primarily online and social media driven strategy for our Flat Tummy brand. The brand is focused primarily on women. We employ
campaigns to reach our core target segments through a mix of traditional online advertising as well as influencer-based marketing.
●
Website: Our Flat Tummy website acts as a platform for engagement with our customers. 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.
●
Instagram: Our primary social media platform is Instagram. As of December 31, 2025, we had approximately 1.7 million followers. Our marketing strategy for Flat Tummy seeks to leverage our large online following to promote products from across the Flat Tummy brand. More recently we have engaged with social media influencers as a new strategy to promote our products.
●
Facebook: 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: Our Flat Tummy app had approximately 1.9 million unique downloads as of December 31, 2025, across both the Apple and Android platforms. The app provides customized workouts, nutrition information, and diet plans. The app is currently free to customers; however, we are exploring different strategies to monetize our large user base.
FOCUSfactor Study
FOCUSfactor has been tested
in a single-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate its effect on memory, concentration,
and focus in healthy adults. The controlled study was conducted in normal, healthy, male and female subjects between the ages of 18 and
65 who had responded to advertisements. A total of 96 subjects were enrolled and randomized to one of the two treatment groups (FOCUSfactor
and placebo). Subjects were compensated for their participation. The study was sponsored by Factor Nutrition Labs, LLC, the developer
of FOCUSfactor, and was conducted in 2011 at Cognitive Research Corporation (“CRC”) in Saint Petersburg, Florida. The sponsor,
in consultation with CRC, was responsible for study design including selection of dose, eligibility criteria, efficacy and safety assessments,
and vitamin/nutraceutical supply. CRC, a contract research organization, was responsible for data collection, database preparation, overall
project management, site monitoring, data management, statistical analyses, and preparation of the final study report.
5
The primary endpoint was
sum recall for five trials of the Rey Auditory Verbal Learning Test (RAVLT), a standardized neuropsychological test of memory. The RAVLT
is one of the most commonly used tests of memory in psychopharmacology research. The test was originally developed in the 1940s and has
proven useful in evaluating verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus
retrieval, and subjective organization. The standard RAVLT begins with a subject being read a list of 15 unrelated words at the rate of
one word per second. The examiner then asks the subject to recall as many words as possible. This procedure is then repeated four more
times with the same list of words and the number of correct responses is summed. This summed score was chosen as the primary outcome measure,
or endpoint, for the current study.
The study demonstrated that,
compared to placebo, FOCUSfactor improved abilities referred to as memory (i.e., short term memory), attention (e.g., focus), concentration
and working memory in healthy adults. Following six weeks of treatment, subjects who received FOCUSfactor had a mean increase in
recall of 6.5 words compared to 4.5 words for those who received placebo (t = -4.32, df = 87, p <0.001). The total words
recalled over the five trials following six weeks of treatment (corrected for baseline score) was 51.9 words for subjects receiving
FOCUSfactor compared to 49.7 words for subjects receiving placebo (t = -2.98, df = 87, p = 0.002). The significant effect on
the RAVLT summed score supports the hypothesis that FOCUSfactor improves memory, attention (e.g., focus), and concentration. In addition,
FOCUSfactor was found to be very well tolerated.
Our History
We were organized as a corporation
under the laws of the State of Nevada on December 29, 2010 under the name “Oro Capital Corporation.” In April 2014,
Synergy Strips Corp., a Delaware corporation, became our wholly-owned subsidiary, and we changed our name from “Oro Capital
Corporation” to “Synergy Strips Corp.” In August 2015, we changed our name to “Synergy CHC Corp.” In
January 2019, our other U.S. subsidiaries, Neuragen Corp., Sneaky Vaunt Corp., The Queen Pegasus Corp. and Breakthrough Products
Inc., merged with and into the Company. In July 2021, we acquired Hand MD Corp. as a wholly-owned subsidiary.
We were a public reporting company until July 17, 2020, the date
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
of 1934 (the “Exchange Act”). As a result of our public offering in October 2024, we became subject again to the information
and reporting requirements of the Exchange Act and we file periodic reports, proxy statements and other information with the SEC.
Our Industry
The global nutritional supplement
market is expected to grow at a compound annual growth rate (CAGR) of approximately 9.3% from 2018 to 2028 according to Inkwood Research.
One of the drivers of this growth is the increasing availability of over-the-counter products as an alternative to prescription medication.
FOCUSfactor competes in the
brain health supplement category. The global brain health supplements market was estimated to be $8.6 billion in 2022 and is expected
to grow at a compound annual growth rate of 13.3% from 2023 to 2030, according to Grand View Research. The industry is fragmented, with
both global and domestic competitors, which gives us an opportunity to scale and continue to take market share.
Our Flat Tummy brand competes
in the weight management and wellbeing market, which in 2022 was estimated to be a $11.3 billion global market, with forecasted growth
of 4.0% annually from 2023 to 2032, according to Business Research Insights.
Demographic trends and changing
consumer habits, including a focus on reducing obesity prevalence, have been drivers of this market. We expect these trends will benefit
the Flat Tummy brand and allow for new and innovative products to appeal to the changing market demographics.
6
Research and Development
The development of new products
is comprised of two distinct steps. First, our marketing team reviews new product opportunities by analyzing market data and consumer
trends in the market as well as products offered by our competition and then develops preliminary new product concepts which include claims/benefits,
delivery form, packaging, and pricing targets, among others. We then work with our third-party manufacturers and leverage their research
and development to finalize our new product initiative (including formula and specifications), as these partners are experienced in product
development and formulation. When we acquire a brand, we typically further expand the SKUs under that brand, through internal development
and with our existing partners. Generally, we take ownership of the formulas and related intellectual property, unless the products use
a generic formulation.
Manufacturing and Related Operations
Our company collaborates
with external manufacturers, known for their reliability, to produce our diverse range of products. We carefully select partners based
on their expertise and manufacturing capabilities, ensuring our products are of the highest quality. The FOCUSfactor line is produced
by several respected manufacturers, including Nutrition Formulators Inc., Vit-Best Nutrition, Multi-Pak Packaging, ProTab Laboratories
and Tailored Bottling Solutions to ensure supply continuity and support brand growth. For the Flat Tummy line, we work closely with manufacturers,
including Caraway Tea Company, Nutrition Formulators Inc., and Clever Foods.
Distribution
Most of our revenues are
generated through the retail channels, primarily due to our FOCUSfactor brand which is sold mainly through leading retailers. These retailers
include club, mass, drug and other retailers such as Costco, Amazon.com, Walmart, Walgreens, BJ’s, and The Vitamin Shoppe. All
of our brands are also sold directly to consumers through their respective brand websites.
Competition
The U.S. nutritional
supplements retail industry is a large and highly fragmented industry with few barriers to entry. We compete against other domestic and
international manufacturers, specialty retailers, mass merchants, multi-level marketing organizations, mail-order and direct-to-consumer companies,
and e-commerce companies. This market is highly sensitive to the introduction of new products, which may rapidly capture a significant
share of the market. Certain of our competitors may have significantly greater financial, technical and marketing resources than we do,
and may be able to adapt to changes in consumer preferences more quickly, devote greater resources to the marketing and sale of their
products, or generate greater brand recognition. In addition, our competitors may be more effective and efficient in introducing new products.
Although there are many competing
products on the market across our product categories, we believe that the FOCUSfactor brand is strengthened by an independent study to
support its claim of improving memory, concentration and focus. FOCUSfactor’s competitors include a wide range of products, from
targeted brain-enhancement supplements to indirect competitors such as energy drinks that claim to improve concentration. Our Flat
Tummy brand competes in well-established segments with a diverse range of competition both domestically and internationally.
Government Regulation
Domestic (United States) Overview
The processing, formulation,
safety, manufacturing, packaging, labeling, advertising and distribution of our products in the United States are subject to regulation
by several agencies, including the FDA, the Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission,
and by various agencies and programs of the states and localities in which our products are sold. The FDA, which exercises regulatory
authority over foods, dietary supplements (a subset of the foods category), and cosmetics, is the primary U.S. regulatory body for
the product categories in which we participate within the U.S. market. While the FDA doesn’t mandate pre-approval or registration
for dietary supplements or food products, it does stipulate that these items must adhere to current good manufacturing practices (“cGMPs”)
and be produced in FDA-registered and audited facilities. Additionally, the FDA exercises regulatory oversight of ingredients and
labeling of these products.
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All FOCUSfactor products
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. The FDA is not aware
of scientific evidence to support homeopathy as effective. UrgentRx is an over-the-counter (“OTC”) drug, which has specific
regulatory requirements, including ingredient and manufacturing requirements. Under the OTC monograph system, selected OTC drugs are generally
recognized as safe and effective and do not require the submission and approval of a new drug application. The FDA OTC monographs include
well-known ingredients and specific requirements for permitted indications, required warnings and precautions, allowable combinations
of ingredients and dosage levels. Products marketed under the OTC monograph system must conform to specific quality, formula and labeling
requirements. We do not currently sell UrgentRx.
The U.S. Food and Drug Administration
Dietary Supplements and Foods
The Dietary Supplement Health
and Education Act of 1994 (“DSHEA”) amended the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”)
to establish a new framework governing the composition, safety, labeling, manufacturing and marketing of dietary supplements. Generally,
under the FD&C Act, dietary ingredients (i.e., vitamins; minerals; herbs or other botanicals; amino acids; or dietary substances for
use by humans to supplement the diet by increasing total dietary intake; or any concentrate, metabolite, constituent, extract or combination
of any of the above) that were marketed in the United States prior to October 15, 1994 may be used in dietary supplements without
notifying the FDA. “New” dietary ingredients (i.e., dietary ingredients that were not marketed in the United States before
October 15, 1994) must be the subject of a new dietary ingredient notification submitted to the FDA unless the ingredient has been
“present in the food supply as an article used for food” without being “chemically altered.” A new dietary ingredient
notification must provide the FDA evidence of a “history of use or other evidence of safety” establishing that use of the
dietary ingredient “will reasonably be expected to be safe.” A new dietary ingredient notification must be submitted to the
FDA at least 75 days before the initial marketing of the new dietary ingredient. The FDA may determine that a new dietary ingredient
notification does not provide an adequate basis to conclude that a dietary ingredient is reasonably expected to be safe.
Such a determination could
prevent the marketing of such dietary ingredient. In 2011 and 2016, the FDA issued draft guidance setting forth recommendations for complying
with the new dietary ingredient notification requirement. In 2024, FDA has issued another guidance finalizing New Dietary Ingredient Notification
(“NDIN”) procedures and timeframes, noting that other parts of the 2016 draft guidance will be finalized in due time. Although
FDA guidance is non-binding and does not establish legally enforceable responsibilities, and companies are free to use an alternative
approach if the approach satisfies the requirements of applicable laws and regulations, FDA guidance is a strong indication of the FDA’s
view on the topic discussed in the guidance, including its position on enforcement. At this time, the NDIN draft guidance, and finalized
timelines and procedures guideline are not anticipated to have a material impact on our operations. As a part of our product development
process, ingredients in products are vetted for compliance with FDA’s regulations for dietary supplements. Any ingredient suspected
to fall under the NDIN classification is further vetted to confirm the ingredient is Generally Recognized As Safe (GRAS) or that the ingredient
manufacturer/distributor has submitted NDIN to the FDA.
The FDA or other agencies
could take actions against products or product ingredients that, in their determination, present an unreasonable health risk to consumers
that would make it illegal for us to sell such products. In addition, the FDA could issue consumer warnings with respect to the products
or ingredients in such products that we sell. Such actions or warnings could be based on information received through FD&C Act-mandated reporting
of serious adverse events.
The Bioterrorism Act, enacted
in 2002, is a U.S. federal law aimed at bolstering the nation’s ability to prevent, prepare for, and respond to bioterrorism
and other public health emergencies. Key provisions include mandatory registration of food facilities with the FDA, prior notification
of imported food shipments, recordkeeping requirements for food facilities, and the FDA’s authority to administratively detain food
products posing serious health risks. This legislation enhanced food safety by facilitating better monitoring of food facilities and imports,
improving traceability and recall efforts, and strengthening the FDA’s ability to respond swiftly to potential threats to public
health.
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In June 2007, pursuant
to the authority granted by the FD&C Act as amended by DSHEA, the FDA published detailed current Good Manufacturing Practice (“cGMP”)
regulations that govern the manufacturing, packaging, labeling, and holding operations of dietary supplement manufacturers. The cGMP regulations,
among other things, imposed significant recordkeeping requirements on manufacturers. The cGMP requirements are in effect for all dietary
supplement manufacturers, and the FDA conducts inspections of dietary supplement manufacturers pursuant to these requirements. The failure
of a manufacturing facility to comply with the cGMP regulations renders products manufactured in such facility “adulterated,”
and subjects such products and the manufacturer to a variety of potential FDA enforcement actions. In addition, the Food Safety Modernization
Act (“FSMA”), which was enacted in January 2011, aimed to modernize and strengthen the food safety system by shifting
the focus from responding to foodborne illness outbreaks to preventing them. The act granted the FDA new regulatory authority over the
way foods are grown, harvested, and processed. It also required food facilities to implement preventive controls to identify and address
potential hazards in their operations. FSMA represents a fundamental shift in food safety regulation, emphasizing prevention, risk-based approaches,
and enhanced collaboration throughout the food supply chain, which has increased the costs of dietary ingredients and has subjected the
suppliers of such ingredients to more rigorous inspections and enforcement. FSMA also requires importers of food, including dietary supplements
and dietary ingredients, to conduct verification activities to ensure that the food or ingredients they import meet applicable domestic
requirements.
We take several actions to
ensure manufacturers we engage comply with the Bioterrorism Act, have implemented FSMA procedures (as applies), and are operating under
cGMPs. As is common in our industry, we rely on our third-party suppliers and manufacturers to have policies and procedures that
ensure that the products they manufacture and sell to us comply with all applicable regulatory and legislative requirements. Internally,
we have a set of supplier onboarding procedures that ensure that the third-party facilities are registered with the FDA and are operating
a quality system up to cGMP standards for the respective product category. We make an intentional effort to engage manufacturers that
have additional quality certifications and third-party audits, such as food safety certifications under the Global Food Safety Initiative
(GFSI) or dietary supplement cGMP certifications audited by the National Sanitation Foundation (NSF), whenever possible. During this onboarding
process, the supplier’s history is also researched for any recent recalls, warning letters, or import alerts related to their facility
or products manufactured by the supplier. Additionally, each third-party manufacturer is required to enter into a quality agreement
with us. This document specifically outlines responsibilities and cGMP/documentation expectations for each party. In general, we also
seek representations and warranties, indemnification and/or insurance from our vendors. However, even with adequate insurance and indemnification,
any claims of non-compliance could significantly damage our reputation and consumer confidence in our products. In addition, the
failure of such products to comply with applicable regulatory and legislative requirements could prevent us from marketing the products
or require us to recall or remove such products from the market, which in certain cases could materially and adversely affect our business,
financial condition and results of operations. A removal or recall could also result in negative publicity and damage to our reputation
which could reduce future demand for our products. In such case, we may attempt to offset any losses related to recalls and removals with
reformulated or alternative products; however, there can be no assurance that we would be able to offset all or any portion of losses
related to any future removal or recall.
The FD&C Act permits
structure/function claims to be included in labels and labeling for dietary supplements without FDA pre-market approval. However,
companies must have substantiation that the claims are “truthful and not misleading,” and must submit a notification with
the text of the claims to the FDA no later than 30 days after marketing the dietary supplement with the claims. Permissible structure/function
claims may describe how a particular nutrient or dietary ingredient affects the structure, function, or general well-being of the
body, or characterize the documented mechanism of action by which a nutrient or dietary ingredient acts to maintain such structure or
function. The label or labeling of a product marketed as a dietary supplement may not expressly or implicitly represent that a dietary
supplement will diagnose, cure, mitigate, treat, or prevent a disease (i.e., a disease claim). If the FDA determines that a particular
structure/function claim is an unacceptable disease claim that causes the product to be regulated as a drug, a conventional food claim,
or an unauthorized version of a “health claim,” or, if the FDA determines that a particular claim is not adequately supported
by existing scientific 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 labels and labeling accordingly. We have an in-house regulatory team that reviews the scientific literature
and develops substantiation as part of the product development process to ensure the crafting of compliant structure-function claims
and product positioning. Our regulatory team engages in the review of web copy, e-commerce copy, and other marketing copy at the
request of the brand directors of each respective brand.
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In addition, DSHEA provides
that so-called “third-party literature,” e.g., “a publication, including an article, a chapter in a book,
or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the
editors of the publication” supplements, when reprinted in its entirety, may be used “in connection with the sale of a dietary
supplement to consumers” without the literature being subject to regulation as labeling. Such literature: (1) must not be false
or misleading; (2) may not “promote” a particular manufacturer or brand of dietary supplement; (3) must present
a balanced view or is displayed or presented with other such items on the same subject matter so as to present a balanced view of the
available scientific information; (4) if displayed in an establishment, must be physically separate from the dietary supplements;
and (5) should not have appended to it any information by sticker or any other method. If the literature fails to satisfy each of
these requirements, we may be prevented from disseminating such literature with our products, and any continued dissemination could subject
our product to regulatory action as an illegal drug.
The FDA has broad authority
to enforce the provisions of federal law applicable to dietary supplements, including powers to issue a public warning or notice of violation
letter to a company, publicize information about illegal products, detain products intended for import, require the reporting of serious
adverse events, require a recall of illegal or unsafe products from the market, and request the Department of Justice to initiate a seizure
action, an injunction action or a criminal prosecution in United States courts.
Federal Trade Commission
The FTC exercises jurisdiction
over the advertising of all products, including foods, dietary supplements and cosmetics, and requires that all advertising to consumers
be truthful and non-misleading. The FTC actively monitors the dietary supplement space and has instituted numerous enforcement actions
against dietary supplement companies for failure to have adequate substantiation for claims made in advertising or for the use of false
or misleading advertising claims or practices. These enforcement actions have resulted in consent decrees and significant monetary judgments
against the companies and/or individuals involved. Regulators require a company to convey product claims clearly and accurately and further
require marketers to maintain adequate substantiation for their claims. More specifically, the FTC requires such substantiation to be
based upon competent and reliable scientific evidence and requires a company to have a reasonable basis for the expressed and implied
product claim before it disseminates an advertisement. A reasonable basis is determined based on the claims made, how the claims are presented
in the context of the entire advertisement, and how the claims are qualified. The FTC’s standard for evaluating substantiation is
designed to ensure that consumers are protected from false and/or misleading claims by requiring scientific substantiation of product
claims at the time such claims are first made. The failure to have this substantiation violates the Federal Trade Commission Act.
Foreign
Our products sold in foreign
countries are also subject to regulation under various national, local, and international laws that include provisions governing, among
other things, the formulation, manufacturing, packaging, labeling, testing, advertising, and distribution of these products within their
respective categories. Some foreign entities categorize these products/formulations as “Medicines” or subsets of a medicinal
category instead of as “food supplements” or “dietary supplements”, based on the regionally-specific regulations
and the nature of the product. Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation,
of certain of our products.
In foreign markets, our regulatory
department works with an in-country regulatory consultant group to guide us through the regulatory process needed to launch our product
in a particular country such as Canada, the United Kingdom and Australia. For example, Canada and Australia require a product submission
packet and approval from Health Canada (“HC”) and the TGA, respectively, for products that would be considered “Natural
Health Products” (in Canada) or “Listed Medicines” (in Australia). In the United Kingdom, on the other hand, no formal
regulatory submission or pre-approval is needed for products within the food supplement category. Launch timing varies by country.
In the United States and United Kingdom, once a formula is established and labeling has been approved by our regulatory and legal
advisors, the product can be launched upon production. The Australian approval process generally takes four to eight weeks from the
time the packet is submitted, while in Canada the approval process can take from six to twelve months from submission.
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In Canada, HC has oversight
over our FOCUSfactor and Flat Tummy products. Our FOCUSfactor and Flat Tummy products are considered natural health products (“NHPs”)
by HC, and each has been issued, so they each have a natural product number (“NPN”) that was assigned by HC upon its review
and approval. This applies to all products currently marketed or licensed in Canada, except for the FOCUSfactor energy drinks, which are
considered supplemented foods and are not subject to pre-approval. Energy drinks are instead subject to supplemented foods regulations
and manufacturing standards.
In the United Kingdom, FOCUSfactor
products are considered food supplements that are regulated by the Food Standards Agency (“FSA”). There is no requirement
for licensing or registering food supplement products in the United Kingdom. Products must comply with relevant food law, which include
formulation/ingredient restrictions, specific labeling requirements, and other parameters. Brexit has introduced significant challenges
for the sale of food supplements from the UK into the EU. These challenges primarily stem from regulatory misalignment and new border
controls. Previously, products could be freely traded within the EU under harmonized regulations, but now, UK-based supplements must
adhere to separate EU regulations to be sold in the European market. This necessitates costly and time-consuming compliance efforts,
including product testing and re-labelling. Additionally, customs procedures and tariffs introduced post-Brexit have further impeded
the flow of goods, increasing costs for businesses and potentially limiting consumer access to certain products. Flat Tummy products are
not currently sold in the United Kingdom.
In Australia, FOCUSfactor
products are “Listed Medicines” that are regulated by the TGA and require an AUST L (Australia Listed Medicine) number. Listed
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”). Flat Tummy products are not currently sold in Australia.
New Legislation or Regulation
Legislation may be introduced
which, if passed, would impose substantial new regulatory requirements on dietary supplements. We cannot determine what effect additional
domestic or international governmental legislation, regulations, or administrative orders, when and if promulgated, would have on our
business in the future. New legislation or regulations may require the reformulation or revised labeling of certain products to meet new
standards, require the recall or discontinuance of certain products not capable of reformulation, or impose additional record keeping
or submission requirements. Moreover, emerging or future regulations might introduce additional challenges beyond those currently foreseen,
further affecting the industry landscape.
Fragmented state-level regulations
develop in the United States from time-to-time. 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. Among its provisions, it requires manufacturers to implement
age verification measures for the sale of consumers in the state of New York. Despite its passage, opposition from industry trade
groups persists, citing concerns over its impact on the dietary supplement industry. Another noteworthy and continuously-evolving state-level regulation
is Proposition 65, which is a California initiative that governs the presence of some chemicals and associated warnings and is managed
by the California Office of Environmental Health Hazard Assessment (OEHHA).
On a federal level in the
United States, repeated legislative attempts have been made within the last several years to introduce a mandatory product listing
(MPL) for the dietary supplement industry through the FDA, which would require notification to the FDA before bringing a product to the
market and for label information to be submitted to and maintained in a central database. While the most recent MPL attempt failed in
2022, the FDA’s outlined budget and legislative proposals for 2026 continue to include the modernization of DSHEA regulations and
the introduction of an MPL. Several trade association groups within the dietary supplement industry continue to express opposition
to the current proposal, citing a clear lack of scope and definition of what it ultimately may require.
In Canada, Health Canada is in the process of reviewing and updating
the database of ingredient and product monographs. While this effort is considerably focused on the clarification and harmonization of
existing monographs and resources, the changing of certain ingredient monographs may have the potential to impact formulation or labeling,
if any such ingredient is included in one of our licensed products. If this does occur, Health Canada is expected to provide phase-in and
guidance for any such changes. Health Canada has also provided updated labeling formatting for NHPs, with a compliance date for existing
products of 2028. Concurrently, Health Canada is in the consultation period for an updated fee schedule for Health Canada-related activities,
such as the review of product submission packets, site licensing, and other activities relevant to maintaining operations and regulatory
compliance in Canada. These discussions are still ongoing, but present potential additional future expenses to companies with natural
health product registrations in the Canadian regions, as well as manufacturers or importers of such products. The benefit of this proposed
pay scheme is that it may significantly reduce the number of product submissions from other companies in the Canadian market, which may
reduce competition in the Canadian market and perhaps reduce review timelines by Health Canada for new product registrations and other
such activities, therefore decreasing the time barrier to entry.
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Intellectual Property
We own 27 trademarks that
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. We own a number of trademark
registrations in countries outside the United States. Federally registered trademarks in the United States have a perpetual
life, as long as they are maintained and renewed on a timely basis and used properly as trademarks, subject to the rights of third parties
to seek cancellation of the trademarks if they claim priority or confusion of usage. Most foreign trademark offices use similar trademark
renewal processes. We regard our trademarks and other proprietary rights as valuable assets and believe they make a significant positive
contribution to the marketing of our products.
We protect our legal rights
concerning our trademarks by appropriate measures, which may include legal action. We possess a portfolio of both registered and unregistered
(i.e., common law) trademarks. In certain circumstances, we seek and obtain registrations for our trademarks, which may confer certain
advantages, and the decision to register a trademark is made on a case-by-case basis. We have registered and intend to register certain
trademarks in certain limited jurisdictions outside the United States where our products are sold, but we may not register all or
even some of our trademarks in every country in which we conduct business or intend to conduct business.
We owned U.S. Patent
8,329,227 covering FOCUSfactor’s proprietary formulation “for enhanced mental function.” This patent was issued by the
United States Patent and Trademark Office in December 2012 and expired in April 2025.
In addition to this intellectual
property, we also rely on our proprietary knowledge and ongoing technological innovation to develop a competitive position in the market
for our products. Each of our patents and know-how are integral to the conduct of our business and the loss of any could have a material
adverse effect on our business.
Human Capital Management
We recognize that attracting,
motivating and retaining passionate talent at all levels is vital to continuing our success. By improving employee retention and engagement,
we also improve our ability to support our customers and protect the long-term interests of our stakeholders and stockholders. We
invest in our employees through continuously improving benefits and various health and wellness initiatives, and offer competitive compensation
packages, working to continuously improve fairness in internal compensation practices.
As of December 31, 2025,
we had 28 full-time employees. We believe that the employer-employee relationships in our Company are positive. We have no labor
union contracts.