What changed in this filing

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Item 1. Business

2024-04-01 compared with 2023-04-03 · 319 added, 328 removed, 53 unchanged (92% of the section changed)

Wellness is committed to supporting health and wellness by developing innovative solutions to a range of conditions.

We take pride in

our research and development of over-the-counter (OTC) products and intellectual property, which aim to address some of the most prevalent

health and wellness concerns today.

Our product pipeline includes a diverse range of products, such as hair loss treatments, eczema creams,

vitiligo solutions, and sexual wellness products, that cater to different health and wellness needs.

We are dedicated to staying up-to-date

with the latest scientific research and technology, ensuring that our products are effective, safe, and meet the highest industry standards.

achieve our mission, we rely on a team of highly skilled and experienced professionals who are committed to advancing our vision of health

and wellness.

Our team includes scientists, researchers, product developers, and business experts who collaborate to create new products

and enhance existing ones.

We also partner with industry leaders and organizations to leverage the latest technologies and expand our

generate revenue through various channels, including the sales of our OTC and consumer products, as well as licensing royalties.

products are available through various retailers and e-commerce platforms, making them accessible to a broad customer base.

Additionally,

we collaborate with other companies to license our intellectual property, creating additional revenue streams and expanding our global

signed agreements to license JW-700 to Taisho, a $2.6 billion revenue company and Japan’s leading seller of minoxidil products.

Taisho plans on launching the product commercially in 2024.

In India, the Company signed an agreement with Cosmofix Technovation Pvt

Ltd and Sanpellegrino Cosmetics to license its JW-700 and Photocil products.

Additional licensing opportunities for these products are

being pursued primarily in overseas markets.

SHOT) was formerly known as Jupiter Wellness Inc.

In August 2023, the Company successfully completed the asset purchase

of the functional beverage Safety Shot from GBB Drink Lab, Inc.

(“GBB”), thereby gaining ownership of various assets, including

the intellectual property, trade secrets, and trademarks associated with its dietary supplement Safety Shot Beverage (the “Safety

Shot Beverage”).

Concurrently with the asset purchase, the Company changed its name to Safety Shot, Inc.

and changed its NASDAQ

trading symbol to SHOT.

The Company launched its e-commerce sale of the Safety Shot Beverage in December 2023.

Safety Shot Beverage has been formulated to reduce the accumulation of blood alcohol.

Noteworthy is the fact that the Safety Shot Beverage

comprises 28 active ingredients, all falling under the Generally Regarded As Safe (GRAS) category.

Under sections 201(s) and 409 of the

Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a dietary supplement, that is subject

to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately

shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition

of a dietary supplement.

crucial to note that the Safety Shot Beverage is currently manufactured in a facility adhering to Good Manufacturing Practices (GMP),

ensuring the highest standards of quality and safety throughout its production process.

The Company currently maintains a workforce comprising

eight full-time employees of its own.

in Consumer Packaged Goods, our focus centers on the commercialization of a 12-ounce beverage positioned as a dietary supplement.

our existing product, we are actively pursuing a future product line, including a convenient powdered stick pack version.

This strategic

expansion aligns with our corporate vision to address evolving consumer demands, positioning the Company in the market for dietary supplements.

We believe that this initiative not only enriches our product portfolio but also emphasizes our dedication to innovation and adaptability,

catering to the discerning preferences of health-conscious consumers.

The Company intends to continue its current product lines, except

for its products which contain CBD, which the Company no longer sells.

Our product pipeline also includes a diverse range of products,

such as hair loss treatments, vitiligo solutions, and sexual wellness products, that cater to different health and wellness needs and

our commitment to supporting health and wellness by developing innovative solutions to a range of conditions but will focus our efforts

on the commercialization of the Safety Shot Beverage.

Safety Shot Beverage has established a development infrastructure that the Company believes fits with its existing over-the-counter and

prescription-grade health and wellness products.

achieve our mission, we rely on our team of highly skilled and experienced professionals who are committed to advancing our vision of

health and wellness.

Our team includes individuals with scientific backgrounds, an experienced researcher, product developers, and business

experts who collaborate to create new products and enhance existing ones.

We also seek to partner with industry leaders and organizations

to gain access to the latest technologies and expand our reach.

generate revenue through various channels, our primary sales include our “nostingz” suncare products which are sold through

e-commerce platforms, licensing revenues from Photocil and sales of the Safety Shot Beverage.

Photocil is currently sold in India through

a licensing agreement.

We received FDA approval of our labelling and composition to sell Photocil as an OTC product in the US and plan

to relaunch the product in the US in the fourth quarter of 2024 through e-commerce channels.

Safety Shot Beverage is currently sold through

e-commerce and social media platforms.

Additionally, we are collaborating with other companies to license our intellectual property,

to create additional revenue streams and expand our global presence.

At present, we do not experience concentration risk or dependence

on major customers.

maintain a diverse network of raw material suppliers integral to our production processes.

Acquisition strategies encompass both direct

procurement and collaborative efforts with our co-packers.

The selection of suppliers is contingent upon various factors, including ingredient

specificity, availability, and other essential considerations.

Notably, these suppliers coincide with those currently providing materials

to other facilities engaged in the manufacturing of drinks, powders, tablets, and capsules.

Our roster of suppliers comprises reputable

entities such as Jiaherb, Compound Solutions, Kyowa-Hakko, Mitsubishi Ingredients, Nura, Sensapure Flavors, Brenntag, E3 Ingredients,

Ingredients Online, among others.

This strategic alliance with established industry players underscores our commitment to sourcing high-quality

raw materials essential for the production of our innovative product line.

Furthermore, our approach to supplier relationships reflects

a dedication to maintaining a seamless and reliable supply chain.

We believe that this not only ensures the consistency of our current

offerings but also positions us favorably for future developments.

The Management believes that as we continue to expand our product

portfolio, we believe that these partnerships with trusted suppliers play a pivotal role in upholding the standards that we expect of

a result of recent changes to the laws governing CBD products, as well as the declining popularity of CBD products, the Company no longer

markets or sells any CBD products.

The Company hopes to find a suitor or partner to dispose of its CBD related assets but has not entered

into any agreements to do so.

Safety Shot Beverage was launched on our own website and through Amazon in December 2023 and is currently speaking with Big Box stores

with the intention to launch by the end of the first quarter or early second quarter of 2024.

Company is advancing several formulations to address psoriasis and vitiligo (Photocil), increase the effectiveness of minoxidil to treat

hair loss (JW-700 “minoxidil booster”), women’s sexual wellness (JW-500), and jellyfish sting prevention sunscreen

(NoStingz), and atopic dermatitis/eczema (JW-110).

The Company halted testing related to its atopic dermatitis product and all other compounds and products containing CBD.

was launched commercially in India in Q3 2022 as a treatment for vitiligo and psoriasis.

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of therapeutic UV radiation from the sun.

The Company plans to re-launch Photocil in the US in the fourth quarter of 2024.

is an OTC cosmetic product using a USP monographed compound as a skin protectant.

The product labelling and ingredients were approved

provides an effective barrier against the stinging mechanism of jellyfish cnidocyte preventing the delivery of venom to the victim.

like other topical sun screen products, the product is clinically proven to protect users from jellyfish, sea lice, and UVA/UVB rays.

It is not intended to treat jellyfish or sea lice bites.

As the product contains ingredients with well-established safety profiles it

did not require pre-market FDA approval ahead of product launch.

Its manufacturing, labeling and components comply with FDA regulations

for sunscreens.

currently being licensed abroad and developed for US launch, the product has been clinically shown to increase the enzymes needed for

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and formulation work are ongoing.

The Company intends to launch JW-700 in the U.S in the fourth Quarter of 2024.

was born out of clinical trials designed to establish a topical treatment for the restoration of nipple sensitivity for breast augmentation

patients, in addition to patients who had undergone chemotherapy or lumpectomy surgery following a cancer diagnosis.

During early studies,

women reported not only increased sensitivity but also increased libido.

The Company plans to file for a pre-IND meeting with the US

FDA and seek Orphan Drug Designation.

An expedited 505(b)(2) regulatory pathway for development is being considered as the current formulation

contains an already approved drug.

The Company plans

to complete the formulation and test launch the product in Q4, 2024.

of SS-100 formulation will be completed after the reviewing the results of the on-going clinical trial of the Safety Shot Beverage.

the Company plans to set up a Pre-IND meeting with the FDA, unlike Safety Shot Beverage which does not require FDA approval on grounds

of being a dietary supplement product.

SS-100 will be classified as a drug as it will used to treat acute alcohol poisoning which the

Company believes meets the definition of a rare disease as described below, and will require filing an IND with the FDA and conducting

clinical trials to determine safety and efficacy.

The Company plans to seek Orphan Drug Designation for SS-100, a modified version of

Safety Shot Beverage.

Given that the FDA defines a drug as Orphan if it is used for the treatment, prevention or diagnosis of a rare

disease or condition, which is one that affects less than 200,000 persons in the US (which equates to approximately 6 cases per 10,000)

and that Acute Alcohol Poisoning (which has ~ 10% fatality rate and has ~20,000 cases in US) meets these criteria and therefor it meets

the criteria for Orphan Drug Designation.

Orphan Drug status provides certain benefits to the Company including exclusive marketing and

development rights, tax credits and fee waivers.

The development of the modified Safety Shot Beverage which we call SS-100 designed to

treat acute alcohol poisoning will require the filing of an IND and controlled clinical trials to establish safety and efficacy.

any other drug, the Company will be required to take the steps necessary to have any drug approved.

The main steps are (i) the request

for a pre-IND meeting with the FDA for feedback on clinical plans, (ii) based on the feedback from (i) to file an IND, (iii) subject

to IND acceptance by the FDA conduct Phase 1, phase 2 and Phase 3 clinical trials and then submit an NDA for product approval.

seeking orphan drug designation for a drug must submit a request for designation to the agency.

The company requesting designation of

the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to

support their designation request.

Orphan drug designation is a separate process from seeking approval or licensing.

Drugs for rare diseases

go through the same rigorous scientific review process as any other drug for approval or licensing.

Without receiving such product approval,

the drug product can’t be sold.

a detailed timeline of the products, please see “Our Business – Product Roadmap” section on page 43.

and Development

research and development team in continually looking to develop new therapeutic products, while continually improving and enhancing our

existing products and product candidates to address customer demands and emerging trends.

Our team is currently working to further improve

the protection provided by NoStingz and develop more effective formulas for our JW-700 product.

existing products and product candidates to address customer demands and emerging trends to develop more effective formulas for our JW-700

have conducted extensive research and experimentation involving a substantial number of volunteers under the influence of intoxicants.

Our findings indicate that the Safety Shot Beverage can reduce a person’s Blood Alcohol Content, as measured by the premier Breathalyzer

in the market.

The observable enhancements in cognitive abilities among the test subjects have been carefully documented.

See “Business-Research

and Development”

Company incurred research and development expenses of $100,591 and $1,637,117 for the years ended December 31, 2023 and 2022, respectively.

and Marketing

primarily sell our products through third-party physical retail stores and partners who license and distribute them to other markets.

Currently, our products are licensed for distribution in over 31 countries.

The majority of our sales occur via traditional physical

retailers, including their websites.

We also sell via online retailers, such as Amazon and Walmart.

To drive loyalty, word-of-mouth marketing,

and sustainable growth, we invest in customer experience and customer relationship management.

Our marketing investments are directed

towards driving profitable growth through advertising, public relations, and brand promotion activities, including digital platforms,

sponsorships, collaborations, brand activations, and channel marketing.

Additionally, we continue to invest in our marketing and brand

development efforts by investing capital expenditures on product displays to support our channel marketing via our retail partners.

primarily sell our products through e-commerce websites including Amazon.

To drive loyalty, word-of-mouth marketing, and sustainable

growth, we invest in customer experience and customer relationship management.

Our marketing investments are directed towards driving

profitable growth through advertising, public relations, and brand promotion activities, including digital platforms, sponsorships, collaborations,

brand activations, and channel marketing.

Additionally, we continue to invest in our marketing and brand development efforts by investing

capital expenditures on product displays to support our channel marketing via our retail partners.

We are currently speaking with Big

Box stores with the intention to launch end of the first quarter to early second quarter of 2024.

Manufacturing,

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Entertainment

November 30, 2020, we entered into and closed the Exchange Agreement with SRM, a Hong Kong Special Administrative Region of the People’s

Republic of China limited company and wholly owned subsidiary of Vinco, and SRM Shareholders, pursuant to which we acquired 100% of the

SRM Common Stock from the SRM Shareholders in exchange for 200,000 shares of the Company’s common stock, the resale of which is

subject to a leak out provision and escrow of 50,000 shares of the Company’s common stock.

Upon closing, and pursuant to the Exchange

Agreement, the Company delivered the 150,000 shares of its common stock to SRM and placed 50,000 shares in escrow (“Escrow Shares”).

Pursuant to the Exchange Agreement, the Company released the Escrow Shares in 2021.

Pursuant to the Exchange Agreement, the Company assumed

all of the financial obligations of SRM, as well as its employees and offices.

As a result of the Exchange Agreement, SRM became a wholly-owned

subsidiary of the Company.

has relationships with and supplies the amusement park industry with exclusive products such as toys, lights, fans and other items that

are sold in amusement parks.

SRM has developed, manufactured and supplied the amusement park industry with exclusive products that are

often only available to consumers inside the relevant amusement park, entertainment venues and theme hotels in Orlando Florida, Beijing

China, Japan and other places throughout the worldwide theme park industry.

SRM has developed unique products in conjunction with suppliers

of products for core licensed items for major well-known brands, themes, characters, and movies.

developed by SRM are generally shipped directly to the theme park without warehousing at the Company’s facilities.

have long-term agreements with its customers, and instead develops products on an item-by-item basis subject to purchase orders from

its customers.

SRM, the Company additionally intends to seek to sell its sun care products in amusement parks and related beach-adjacent properties

such as cruise lines and ocean resorts.

We are currently pursuing the sale of its jellyfish protection sun care products for sale in

these locations.

Company entered into a stock exchange agreement (the “Exchange Agreement”) with SRM Entertainment, Inc.

to govern the separation of SRM and the Company.

On May 26, 2023, we amended and restated the Exchange Agreement (the “Amended

and Restated Exchange Agreement”) to include additional information regarding the distribution and the separation of SRM and the

The separation as set forth in the Amended and Restated Exchange Agreement with the Company closed August 14, 2023.

to the Amended and Restated Exchange Agreement, on May 31, 2023, SRM issued to the Company 6,500,000 shares of SRM Common Stock (representing

79.3% of SRM’s outstanding shares of Common Stock) in exchange for 2 ordinary shares of SRM Ltd owned by the Company (representing

all of the issued and outstanding ordinary shares of SRM) (the “Share Exchange”).

On August 14, 2023, SRM consummated its

Initial Public Offering (“IPO”), pursuant to which it sold 1,250,000 shares of its common stock at a price of $5.00 per share.

In connection with the Share Exchange and SRM’s IPO, the Company distributed 2,000,000 shares of SRM’s common stock to the

Company’s stockholders and certain warrant holders (out of the 6.5 million shares issued in May 2023) which occurred on the effective

date of the Registration Statement but prior to the closing of the IPO.

Following such distribution, the Company owns 4.0 million of

the 9,450,000 shares of common stock outstanding and SRM is now a minority owned subsidiary of the Company.

Competitive Strengths

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to innovation has allowed us to create unique products that address unmet needs in the market, all backed by rigorous clinical research.

Our focus on research and development has enabled us to stay ahead of the curve and provide our customers with products that are not

only effective but also innovative.

We take pride in our patent portfolio and the continuous growth we have achieved, as it showcases

our dedication to creating new and unique solutions for our customers.

By staying committed to innovation, we are confident in our ability

to meet the ever-changing needs of the market and continue to be a leading player in the wellness industry.

Growth Strategies

elements of our growth strategy include:

To capitalize on our market opportunity, we have assembled an ambitious long-term roadmap to introduce products crafted to meet the

unique needs of each of our customers.

We plan to develop products across multiple categories, with a focus on continuously

improving the customer experience to increase sales to both new and existing customers alike.

We are highly focused on finding and growing potential customers through distribution channels such as retail stores, e-commerce

portals, and direct relationships with care providers such as dermatologists in the US, while expanding our direct-to-consumer

approach and leveraging current channel partnerships.

We intend to forge innovative, strategic partnerships with a variety of stakeholders, ranging from established industry leaders to

ambitious startups.

Our goal is not only to broaden our reach, but to maximize the potential of our existing solutions and to create

value-added opportunities across the entire partner ecosystem.

We intend to grow our brand equity by increasing brand awareness in existing geographic markets, diversifying our product offerings,

and developing our partner ecosystem.

Furthermore, we will look to expand our reach and drive higher household penetration rates in

our current markets.

Explore uncharted international markets, utilizing current licensees to tap into untested territories.

We will create tailored

strategies and resources to accommodate the unique requirements of each of these new markets, taking a proactive approach to reach

regions that have historically been difficult to breach and expand our global presence.

may include major pharmaceutical and biotechnology companies, as well as specialist consumer brands companies and public and private

research institutions.

We cannot be certain that we will be able to compete against current or future competitors, or that competitive

pressure will not seriously harm our business prospects.

These competitors may be able to react faster to market changes, respond more

rapidly to new regulations, or allocate greater resources to the development and promotion of their products than we can.

some of these competitors may make acquisitions or establish collaborative relationships among themselves to increase their ability to

rapidly gain market share.

Given the rapid changes affecting the global, national, and regional economies in general and cannabis-related

medical research and development in particular, we may not be able to create and maintain a competitive advantage in the marketplace.

Time-to-market is an important factor in our industry, and our success will depend on our ability to develop innovative products that

will be accepted by patients as efficient and helpful to use.

success will also depend on our ability to respond quickly to, among other things, changes in the economy, market conditions, and competitive

Any failure to adequately anticipate or respond to such changes could have a material effect on our financial condition, operating

results, liquidity, cash flow and our operational performance.

sets us apart in the marketplace is our clinical trials approach (double-blinded, placebo-controlled trials) that have demonstrated the

clinical efficacy of our topical products.

our intellectual property is a critical component of our business, and we take necessary measures to protect it.

We rely on a blend of

patent, trademark, copyright, and trade secret laws, as well as contractual obligations like confidentiality agreements, licenses, and

intellectual property assignment agreements to establish and defend our exclusive rights.

To control access to our proprietary information,

we enforce a policy that mandates our staff, contractors, consultants, and other third parties to sign confidentiality and proprietary

rights agreements.

Although these laws, procedures, and limitations offer some level of protection, they may not entirely shield our

intellectual property rights from being challenged, invalidated, infringed upon, or misused.

There is also no assurance that we will

succeed in any patent infringement claims made against third parties.

In addition, the laws of certain countries may not grant the same

level of protection to proprietary rights as the laws of the United States, which could limit our ability to safeguard our proprietary

technology in some jurisdictions.

We believe that our focus on research and development is designed to enable us to stay ahead of the curve and provide our customers with

products that are not only effective but also innovative.

We take pride in our patent portfolio and the continuous growth we have achieved,

as we believe that it showcases our dedication to creating new and unique solutions for our customers.

By staying committed to innovation,

we are confident in our ability to meet the ever-changing needs of the health and wellness market.

We believe that the Safety Shot Beverage

stands as a unique product in the dietary supplement beverage market.

Nevertheless, our competitive landscape includes many companies

involved in the production of health and welfare products, including beverages.

January 19, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Agreement”) with certain purchasers,

for the issuance of 8,631,574 common stock warrants (the “PIPE Offering”) at a price of $0.125 per warrant, comprised of

two common stock warrants (the “Common Warrants,”), each to purchase up to one share of Common Stock per Common Warrant with

an exercise price of $1.00 per share, with (a) 4,315,787 Common Warrants being immediately exercisable for three years following 6 months

from the closing of the PIPE Offering, and (b) 4,315,787 Common Warrants being immediately exercisable for five years following 6 months

from the closing of the PIPE Offering.

Concurrently to the PIPE Agreement, the Company entered into a Securities Purchase Agreement (the

“RD Agreement”) with certain purchasers, pursuant to which on January 23, 2023, 4,315,787 shares of common stock, par value

$0.001 (the “Common Stock”), at a price of $0.70 per share were issued to the purchasers (the “RD Offering”).

The Common Stock was issued pursuant to a Registration Statement on Form S-3 filed by the Company with the Securities and Exchange Commission

(the “Commission”) on September 28, 2022 (File No.

333-267644) and declared effective on November 9, 2022.

The aggregate

gross proceeds to the Company from both the PIPE Offering and the RD Offering were approximately $4.1 million, with the purchase price

of one share, one 3-year warrant and one 5-year warrant as $0.95.

The net proceeds were $3,450,675.

March 31, 2023 the Company entered into a Financial Advisory Agreement (“FSA”) with Greentree Financial Group, Inc.

certain professional services to the Company.

In connection with the FSA, the Company issued 500,000 restricted shares of its common

stock to Greentree.

July 10, 2023, the Company entered into an asset purchase agreement (the “Agreement”) with GBB Labs, Inc., a Delaware corporation

set up as an acquisition company (“Buyer”), GBB Drink Lab Inc., a Florida corporation (“Seller”), 2V Consulting

LLC, a Florida limited liability company, the Jarrett A Boon Revocable Trust Dated October 22, 2014, Gregory D.

Blackman, an individual

and Brothers Investment 7777, LLC.

Pursuant to the Agreement, the Buyer purchased certain assets relating to the Safety Shot Beverage

for a consideration comprising of:

(a) the sum of Two Hundred Thousand U.S.

Dollars (US $200,000) (the “Cash Purchase Price”);

and (b) 5,000,000 Common Shares (the “Consideration Shares” and together with the Cash Purchase Price, collectively, the

“Purchase Price”).

The asset purchase was closed on August 31, 2023.

filed Provisional Patent (CBD Formulations and Uses Thereof:

62/884,995) on a combination of CBD and Aspartame on August 8, 2019.

The patent is to cover any products that contain a combination of CBD and Aspartame.

This initially was intended to cover the products

under the CaniDermRX Brand.

The provisional patent application was converted into a full US patent application (No.:

16/987,941) and

PCT application (PCT/US2020/045408I) on August 9, 2020.

If issued, the patent will give patent protection until 2040.

The Company no

longer sells CaniDermRX products.

filed Provisional Patent (CBD Sunscreen Formulations and Uses Thereof:

63/005,854) on our CBD-infused sunscreen products on August

The patent is to cover any products under our CaniSun product line that contains CBD.

The priority date starts at the time the

provisional is converted into a full patent application, which occurred on April 6, 2021.

If issued, the patent will give patent protection

The Company no longer sells CaniSun products.

filed Provisional Patent (Oroanasal CBD formulations and uses thereof (No.:

63/042,458) on June 22, 2020.

This covers the use of CBD

products for the treatment of respiratory viruses.

We are not advancing these products as they contain CBD.

of the date hereof, the Company owns five patents, including the patent (US 9,186,350 B2) and patent (US 10,028,991 B2) for the composition

of the Safety Shot Beverage used for minimizing the harmful effects associated with alcohol consumption.

Safety Shot Beverage:

production, distribution and sale in the United States of the Safety Shot Beverage is subject to various U.S.

federal, state and local

regulations, including but not limited to:

the Federal Food, Drug and Cosmetic Act (“FD&C Act”);

the Occupational Safety

and Health Act and various state laws and regulations governing workplace health and safety;

various environmental statutes;

Drinking Water and Toxic Enforcement Act of 1986 (“California Proposition 65”);

data privacy and personal data protection

laws and regulations, including the California Consumer Privacy Act of 2018 (as modified by the California Privacy Rights Act) and a

number of other federal, state and local statutes and regulations applicable to the production, transportation, sale, safety, advertising,

marketing, labeling, packaging, and ingredients of the Safety Shot Beverage.

also may in the future be affected by other existing, proposed and potential future regulations or regulatory actions, including those

described below, any of which could adversely affect our business, financial condition and results of operations.

legislation and regulation may be introduced in the United States at the federal, state, municipal and supranational level in respect

of each of the subject areas discussed below.

Public health officials and health advocates are increasingly focused on the public health

consequences associated with obesity and alcohol consumption, especially as they may affect children, and are seeking legislative change

to reduce the consumption of sweetened and alcohol beverages.

are subject to a number of regulations applicable to the formulation, labeling, packaging, and advertising (including promotional campaigns)

of our products.

In California, we are subject to California Proposition 65, a law which requires that a specified warning be provided

before exposing California consumers to any product that contains in excess of threshold amounts of a substance listed by California

as having been found to cause cancer or reproductive toxicity.

California Proposition 65 does not require a warning if the manufacturer

of a product can demonstrate that the use of the product in question exposes consumers to an average daily quantity of a listed substance

that is below that threshold amount, which is determined either by scientific criteria set forth in applicable regulations or via a “safe

harbor” threshold that may be established by the state, or the substance is naturally occurring, or is subject to another applicable

As of the date of this registration statement, we are not required to put a warning label on our product and our products

are perfluoroalkyl and polyfluoroalkyl substances (“PFAS”) free.

We are unable to predict whether a component found in our

product might be added to the California list in the future.

Furthermore, we are also unable to predict when or whether the increasing

sensitivity of detection methodology may become applicable under this law and related regulations as they currently exist, or as they

may be amended.

If we are required to add warning labels to any of our products or place warnings in certain locations where our products

are sold, it will be difficult to predict whether, or to what extent, such a warning would have an adverse impact on sales of our products

in those locations or elsewhere.

In addition, there has been increasing regulatory activity globally regarding constituents in packaging

materials, including PFAS.

Regardless of whether perceived health consequences of these constituents are justified, such regulatory activity

could result in additional government regulations that impact the packaging of our beverages.

addition, the U.S.

Food and Drug Administration (the “FDA”) has regulations with respect to serving size information and

nutrition labeling on food and beverage products, including a requirement to disclose the amount of added sugars in such products.

Department of Agriculture promulgated regulations requiring that, by January 1, 2022, the labels of certain bioengineered foods

include a disclosure that the food is bioengineered.

These regulations may impact, reduce and/or otherwise affect the purchase and consumption

of our products by consumers.

ingredients in the Safety Shot Beverage are deemed Generally Recognized as Safe (GRAS) and align with FDA standards, permitting their

inclusion in supplements.

In the event that the FDA or any governmental agency identifies an ingredient or aspect of our product as unsafe,

we commit to promptly withdrawing that component in accordance with regulatory directives.

From a product and sales perspective, there

are no impediments or concerns raised by any governmental agency.

It is essential to note that the Safety Shot Beverage is classified

as a dietary supplement, exempt from the approval or filing requirements mandated for pharmaceutical drugs by the FDA or other regulatory

development of SS-100 concentrate for the treatment of acute alcohol poisoning will require filing an IND with the FDA for a clinical

program to demonstrate safety and efficacy, unlike Safety Shot Beverage which does not require FDA approval on grounds of being a dietary

supplement product.

process for obtaining Orphan Drug designation is to submit an application to the FDA that provides data (patient population;

of product) supporting the application.

The FDA will make a determination based on the data and whether it is unique against other drugs

in the same category already granted Orphan Drug status.

development and manufacturing of JW 500, JW 700, and Photocil are subject to various U.S.

federal, state and local regulations, including

but not limited to:

the Federal Food, Drug and Cosmetic Act (“FD&C Act”);

the Occupational Safety and Health Act and

various state laws and regulations governing workplace health and safety;

various environmental statutes.

JW 500, and JW700, are cosmetic

products and do not require pre-marketing approval but must follow the FDA guidelines on manufacturing.

We are fully compliant with these

Photocil is an OTC product and has received FDA approval for packaging and ingredients.

follows the FDA requirements, i.e.

manufacturing, labelling and components, for sunscreens.

laws related to CBD have undergone significant change.

From the passage of the Farm Bill to recent proclamations from the FDA the laws

and rules related to CBD procucts have changed.

As a result of the uncertainty regarding CBD rules, coupled with the reduced demand for

CBD products, the Company recently made a decision not to market or sell any further CBD products.

We had not generated any significant

revenues from the sale of CBD products.

we believe that our sunscreen products comply with the FDA Final Rule for sunscreen products under 21 CFR 352 Sunscreen products for

Over-the-Counter Human Use.

Therefore, we believe that our sunscreen products fall within the FDA monograph and that FDA premarket approval

and testing is not required.

Our products have been tested for SPF Evaluation (SPF rating), Critical Wave Length (Broad Spectrum claim)

and Water Resistance, each of which is defined within the monograph and labeled accordingly.

products are tested each time they are manufactured.

NoStingz is manufactured by DCR Labs and is compliant with the FDA’s Current

Good Manufacturing Practice (“CGMP”) regulations in accordance with 21 CFR 210/211 (required for Over-the-Counter drug products).

DCR Labs has self-imposed health and safety standards to ensure compliance with the FDA’s CGMPs.

as a result of uncertainty regarding government regulation, and a declining market for CBD products, the Company is no longer marketing

or selling any CBD related products, including our CaniSun sunscreen product.

are committed to producing exceptional therapeutic products for our customers, and our employees play a crucial role in realizing this

4 unchanged sentences

for our staff to contribute to their communities and make a positive social impact..

of December 31, 2022, we had ten full-time employees, including Chief Executive Officer Brian S.

John, Chairman and Chief Scientific

Glynn Wilson, and Chief Financial Officer, Douglas McKinnon.

of December 31, 2023, we had eight full-time employees.

We believe our relations with our employees to be good.

we do not own any real property.

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issuers that file electronically with the SEC.

and Development

primary objective of our research and development program is to advance the development of our existing and proposed products, to enhance

the commercial value of such products.

Company incurred research and development expenses of $1,637,117 and $1,079,362 for the years ended December 31, 2022 and 2021, respectively.

July 12, 2021, we entered into a clinical trial research agreement (the “Clinical Trial Research Agreement”) with Applied

Biology, Inc.

Under the Clinical Research Agreement, AB will design, manage and conduct a head-to-head study of JW-101

compared to EUCRISA (crisaborole ointment 2%) for the treatment of Eczema (the “Study”).

An interim analysis is expected.

previously reported in a Current Report on Form 8-K filed with the SEC on December 14, 2021, the Company, entered into a stock purchase

agreement (the “Original Purchase Agreement”), which was later amended and restated (the “Purchase Agreement”),

and reported in a Current Report on Form 8-K filed with the SEC on January 13, 2022 (the “January 13th Disclosure”), with

Next Frontier Pharmaceuticals, Inc.

(“Next Frontier Pharmaceuticals”), a Delaware corporation, and certain of its affiliates

(the “Next Frontier Affiliates”, and together with “Next Frontier Pharmaceuticals”, the “Next Frontier

Parties”), pursuant to which the Company planned to acquire Next Frontier Pharmaceuticals (the “Acquisition”).

Purchase Agreement contained conditions to close that were not met by the Next Frontier Parties, including delivery of financial statement.

As such, on February 17, 2022, without consummating the Acquisition, Next Frontier Pharmaceuticals delivered to the Company a letter

pursuant to which Next Frontier Pharmaceuticals terminated the Purchase Agreement (the “Termination Date”).

Considering the

aforementioned termination, the Company did not effectuate the Transactions, including the distribution of shares of SRM to the Company’s

stockholders, as was contemplated in the Purchase Agreement and previously disclosed in the January 13th Disclosure.

of the Termination Date, an indebtedness balance in an aggregate amount totaling $11.2 million, which was previously advanced by the

Company to the Next Frontier Parties under those certain Secured Promissory Note, dated December 8, 2021 (the “December 2021 Note”),

and Secured Promissory Note, dated January 7, 2022 (the “January 2022 Note,” collectively with the December 2021 Note as

the “NFP Notes”), is owed and outstanding.

The December 2021 Note has a maturity date of June 8, 2022, and the January 2022

Note has a maturity date of July 7, 2022, or otherwise when due.

In March 2022, the Company issued a Notice of Default on the NFP Notes.

As a result, the Company has determined that the NFP Notes have been impaired and has taken an impairment charge of $10,000,000 against

the 2021 earnings and $1,000,000 against the 2022 earnings.

1937, Cannabis sativa L.

has been a federally regulated Schedule I drug under the Controlled Substances Act, 21 U.S.C.

“CSA”), regulated by the Drug Enforcement Agency (the “DEA”).

was not until 2014 when a distinction between the use of Cannabis sativa L.

for medical, recreational, and industrial purposes was made

via Section 7606 of the Agricultural Act of 2014, which cleared a legal path for industrial hemp to be grown in three limited circumstances,

1) by researchers at an institute of higher education, 2) by state departments of agriculture, or 3) by farmers participating in a research

program permitted and overseen by a state department of agriculture.

2016, the DEA, U.S.

Department of Agriculture, and the FDA issued a joint statement detailing the guidelines for growth of industrial

hemp as part of state-sanctioned research programs.

Those guidelines state that hemp can only be sold in states with pilot programs,

plants and seeds can only cross state lines as part of permitted state research programs, and seeds can only be imported by individuals

registered with the DEA.

believe the passage of the Farm Bill will allow us to expand our marketplace opportunities.

On December 20, 2018, President Donald J.

Trump signed into law the Agriculture Improvement Act of 2018, otherwise known as the “Farm Bill”.

Prior to its passage,

hemp, a member of the cannabis family, and hemp-derived CBD were classified as a Schedule I controlled substances, and so were deemed

to be illegal under the CSA.

With the passage of the Farm Bill, hemp cultivation is broadly permitted.

The Farm Bill explicitly allows

the transfer of hemp-derived products across state lines for commercial or other purposes.

It also puts no restrictions on the sale,

transport, or possession of hemp-derived products, so long as those items are produced in a manner consistent with the law.

Section 10113 of the Farm Bill, hemp cannot contain more than 0.3 percent THC.

THC refers to the chemical compound found in cannabis

that produces the psychoactive “high” associated with cannabis.

Any cannabis plant that contains more than 0.3 percent THC

would be considered non-hemp cannabis—or marijuana—under federal law and would thus face no legal protection under this new

legislation and would be an illegal Schedule 1 drug under the CSA.

Additionally,

there will be significant, shared state-federal regulatory power over hemp cultivation and production.

Under Section 10113 of the Farm

Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan

that must be submitted to the Secretary of the United States Department of Agriculture or USDA.

A state’s plan to license and regulate

hemp can only commence once the Secretary of USDA approves that state’s plan.

In states opting not to devise a hemp regulatory

program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with

a federally run program.

This system of shared regulatory programming is similar to options states had in other policy areas such as

health insurance marketplaces under the Affordable Care Act, or workplace safety plans under Occupational Health and Safety Act—both

of which had federally-run systems for states opting not to set up their own systems.

Farm Bill outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license

or producing cannabis with more than 0.3% THC).

The Farm Bill details possible punishments for such violations, pathways for violators

to become compliant, and even which activities qualify as felonies under the law, such as repeat offenses.

of the goals of the Agricultural Act of 2014 was to generate and protect research into hemp.

The Farm Bill continues this effort.

7605 re-extends the protections for hemp research and the conditions under which such research can and should be conducted.

section 7501 of the Farm Bill extends hemp research by including hemp under the Critical Agricultural Materials Act.

This provision recognizes

the importance, diversity, and opportunity of the plant and the products that can be derived from it, but also recognizes that there

is still a lot to learn about hemp and its products from commercial and market perspectives.

products are tested each time they are manufactured.

All contracted labs used by the Company to manufacture our products are compliant

with the FDA’s Current Good Manufacturing Practice (“CGMP”) regulations in accordance with 21 CFR 210/211 (required

for Over-the-Counter drug products).

Each of the Company’s contracted Labs has self-imposed health and safety standards to ensure

compliance with the FDA’s CGMPs.

Regulation of Hemp Extracts

FDA is generally responsible for protecting the public health by ensuring the safety, efficacy, and security of (1) prescription and

over the counter drugs;

(2) biologics including vaccines, blood & blood products, and cellular and gene therapies;

(3) foodstuffs

including dietary supplements, bottled water, and baby formula;

and, (4) medical devices including heart pacemakers, surgical implants,

prosthetics, and dental devices.

its regulation of drugs, the FDA process requires a review that begins with the filing of an investigational new drug (IND) application,

with follow-on clinical studies and clinical trials that the FDA uses to determine whether a drug is safe and effective, and therefore

subject to approval for human use by the FDA.

from the FDA’s mandate to regulate drugs, the FDA also regulates dietary supplement products and dietary ingredients under the

Dietary Supplement Health and Education Act of 1994.

This law prohibits manufacturers and distributors of dietary supplements and dietary

ingredients from marketing products that are adulterated or misbranded.

This means that these firms are responsible for evaluating the

safety and labeling of their products before marketing to ensure that they meet all the requirements of the law and FDA regulations,

including, but not limited to the following labeling requirements:

(1) identifying the supplement;

(2) nutrition labeling;

(3) ingredient

and, (5) daily use information.

FDA has not approved cannabis, marijuana, hemp or derivatives as a safe and effective drug for any indication.

We may in the future file

an IND with the FDA for our JW-100 product in the event the pending provisional patent on an Aspartame/CBD combination is approved.

of the date hereof, our products containing CBD derived from industrial hemp are not marketed or sold using claims that their use is

a safe and effective treatment for any medical condition subject to the FDA’s jurisdiction.

FDA has concluded that products containing cannabis or industrial hemp derived CBD are excluded from the dietary supplement definition

under sections 201(ff)(3)(B)(i) and (ii) of the U.S.

Food, Drug & Cosmetic Act, respectively.

The FDA’s position is that products

containing cannabis, CBD or derivatives are Schedule 1 drugs under the Controlled Substances Act, and so are illegal.

Our products containing

CBD derived from industrial hemp are not marketed or sold as dietary supplements.

However, at some indeterminate future time, the FDA

may choose to generally change its position concerning products containing hemp derived CBD, and may choose to enact regulations that

are applicable to such products.

In this event, our industrial hemp based products containing CBD may be subject to regulation.

of our products contain controlled substances as defined in the Controlled Substances Act (CSA).

Controlled substances that are pharmaceutical

products are subject to a high degree of regulation under the CSA, which establishes, among other things, certain registration, manufacturing

quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA.

recent approvals by the FDA and DEA for a newly approved medication which contains cannabidiol (CBD), the scheduling of these substances,

many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market our products.

Any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects.

Regulation of CBD

June 25th, 2018 the US Federal Drug Administration (FDA) approved Epidiolex.

Epidiolex is the first and only FDA-approved prescription

cannabidiol (CBD).

It is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis

complex (TSC) in patients 1 year of age and older.

Accordingly, the FDA has designated CBD as a drug and the need for all marketed products

to follow FDA guidelines for safety and efficacy.

It is not yet clear how this will affect thousands of CBD products already on the market

given the multitude of state and local regulations that cover this field.

Recent Development

June 4, 2021, the Company filed a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21,

2021, for the sale or other disposition from time to time by the selling shareholders identified in the prospectus of up to 1,050,002

shares of Common Stock consisting of up to 525,001 Common Stock, at a $4.54 share price, which may be issued upon the conversion of convertible

promissory notes issued in May 2021, and up to 525,001 Common Stock, at a $6.00 share price, which may be issued upon the exercise of

outstanding warrants.

to a registration statement on Form S-1 (File No.

333- 258005) which was declared effective on June 21, 2021 (the “June Registration

Statement”) the Company undertook a firm commitment offering (the “Offering”) of shares of our common stock (“Common

Stock”), par value $0.001 per share.

With a combined public offering price of each share of Common Stock and Company Warrant (as

defined below) of $2.80, a total of 11,066,258 shares (the “Company Offering Shares”) and 11,607,142 warrants (the “Company

Warrants”) to purchase 11,607,142 shares were registered.

In addition a total of 540,884 shares were offered by the Company selling

As part of the compensation, the Company also issued 442,650 warrants to Aegis Capital Corp.

to purchase 442,650 shares.

January 20, 2022 the Company received a letter from Nasdaq stating that, because the Company made the Share Grants not pursuant to the

2021 Equity Plan despite them considered to be S-8 eligible, Nasdaq had determined that the Company did not comply with Listing Rule

It was brought to our attention that 180,000 shares of common stock, out of the total 1,020,000 shares of common stock to consultants

(the “Consulting Share Awards”) that were issued to three consultants, Greentree Financial (100,000 shares), Inc., L&H

(20,000 shares), and Tee 2 Green Enterprises, Ltd.

(60,000 shares), during the relevant period (the “Share Grants”),

should have been issued pursuant to the 2021 Equity Plan because the Share Grants were considered to be S-8 eligible.

As a result, the

inadvertent issuance of the Share Grants to the mentioned-above three consultants was not made in compliance with Listing Rule 5635(c).

The Company subsequently notified Nasdaq that the Board has approved the reallocation of the Share Grants to be accounted for as if they

were originally issued under the 2021 Equity Plan, and has made the corresponding change to the Company’s books and records.

since the 2021 Equity Plan has previously been exercised in full, to allow for the reallocation of the Share Grants under the 2021 Equity

Plan, on January 17, 2022, the Board determined that 100,000 options that have previously been issued under the 2021 Equity Plan to Brian

John, and 100,000 options issued to Dr.

Glynn Wilson be cancelled, a revocation to which Messrs.

John and Wilson have agreed.

the remedial measures, on January 20, 2022 , the Company was informed that the Company has regained compliance with the Rule and that

this matter is now closed.

January 19, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Agreement”) with certain purchasers,

for the issuance of 8,631,574 common stock warrants (the “PIPE Offering”) at a price of $0.125 per warrant, comprised of

two common stock warrants (the “Common Warrants,”), each to purchase up to one share of Common Stock per Common Warrant with

an exercise price of $1.00 per share , with (a) 4,315,787 Common Warrants being immediately exercisable for three years following 6 months

from the closing of the PIPE Offering, and (b) 4,315,787 Common Warrants being immediately exercisable for five years following 6 months

from the closing of the PIPE Offering.

Concurrently to the PIPE Agreement, the Company entered into ot a Securities Purchase Agreement

(the “RD Agreement”) with certain purchasers, pursuant to which on January 23, 2023, 4,315,787 shares of common stock, par

value $0.001 (the “Common Stock”), at a price of $0.70 per share were issued to the purchasers (the “RD Offering”).