What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-03-31 compared with 2021-04-12 · 457 added, 412 removed, 95 unchanged (90% of the section changed)

1 unchanged sentence

is a cutting-edge developer of cannabidiol (CBD) based medical therapeutics and wellness products.

Company’s clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns,

herpes cold sores, and skin cancer.

We are in the early stage of manufacturing, distributing, and marketing a diverse line of

consumer products infused with CBD.

The Company’s

clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores,

and skin cancer.

We are in the early stage of manufacturing, distributing, and marketing a diverse line of consumer products infused

We have a proprietary, line of products:

CaniSun, CaniSkin and CaniDermRX.

Under the CaniSun

brand, we are marketing patent pending CBD-infused sun care lotion formulas containing various sun protection factors, or

In addition, we are exploring the use of CBD with other prescription

and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically, we are exploring

the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis (JW-_100), a non-prescription

lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the treatment of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate and will be further tested

in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations of the United States Food and

Drug Administration (“FDA”) under an investigational new drug, or IND, application.

In February 2021, we

announced the results of our novel Cannabidiol-Aspartame combination treatment JW-100 clinical trial which has shown it significantly

Reduces ISGA Score in Eczema patients.

Under the CaniSun brand, we are marketing patent

pending CBD-infused sun care lotion formulas containing various sun protection factors, or SPFs.

In addition, we are exploring the use

of CBD with other prescription and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically, we are exploring the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis

(JW-_100), a non-prescription lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the

treatment of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate

and will be further tested in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations

of the United States Food and Drug Administration (“FDA”) under an investigational new drug, or IND, application.

February 2021, we announced the results of our novel Cannabidiol-Aspartame combination treatment JW-100 clinical trial which has shown

it significantly Reduces ISGA Score in Eczema patients.

A double blinded placebo controlled interventional study was conducted.

Subjects were assigned

to apply, at home, one of three treatments:

JW-100 (a CBD and aspartame combination topical formulation), a CBD only topical formulation,

or a placebo topical formulation.

After 14 days, the average reduction in the Investigators Static Global Assessment (ISGA) score was

calculated for each group.

Additionally, the proportion of subjects achieving (ISGA) score 0 (clear) or 1 (almost clear) with at least

2 grade improvement from baseline was recorded for each arm of the study.

50% of subjects in the JW-100 arm achieved ISGA clear or almost

clear (1 or 2) with at least a 2-grade improvement from baseline after treatment versus 20% and 15% in the CBD-only and placebo arms,

respectively.

The percentage of subjects achieving clear or almost clear with at least a 2-grade improvement from baseline was found to

be statistically significant (p=0.028).

JW-100, a novel topical formulation containing CBD and aspartame, was shown to significantly reduce

ISGA score in atopic dermatitis patients after two weeks of use.

The combination of CBD and aspartame was more effective at reducing ISGA

scores than CBD alone .

parallel, we plan to initiate the development of other products.

We originally anticipated developmental studies to be completed in 2020,

however, these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license products in the OTC skin care

market that can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

There can be no assurances that we will

acquire or enter into such partnership or licensing agreements .

The endocannabinoid

system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating pain sensation,

cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use of CBD containing

topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically with CBD.

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific indications.

On November30, 2020

the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People's Republic of China limited

company (“SRM”).

SRM has relationships with and supplies 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.

Organizational History

Jupiter Wellness, Inc.

was originally

incorporated in the State of Delaware on October 24, 2018.

Our principal business address is 725 N.

Hwy A1A, Suite C-106, Jupiter, FL

Description of Business

Company Overview

Jupiter Wellness,

were assigned to apply, at home, one of three treatments:

JW-100 (a CBD and aspartame combination topical formulation), a CBD only topical

formulation, or a placebo topical formulation.

After 14 days, the average reduction in the Investigators Static Global Assessment (ISGA)

score was calculated for each group.

Additionally, the proportion of subjects achieving (ISGA) score 0 (clear) or 1 (almost clear) with

at least 2 grade improvement from baseline was recorded for each arm of the study.

50% of subjects in the JW-100 arm achieved ISGA clear

or almost clear (1 or 2) with at least a 2-grade improvement from baseline after treatment versus 20% and 15% in the CBD-only and placebo

arms, respectively.

The percentage of subjects achieving clear or almost clear with at least a 2-grade improvement from baseline was

found to be statistically significant (p=0.028).

JW-100, a novel topical formulation containing CBD and aspartame, was shown to significantly

reduce ISGA score in atopic dermatitis patients after two weeks of use.

The combination of CBD and aspartame was more effective at reducing

ISGA scores than CBD alone.

In parallel, we plan to initiate the development of other products.

We originally anticipated developmental

studies to be completed in 2020, however, these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license

products in the OTC skin care market that can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

be no assurances that we will acquire or enter into such partnership or licensing agreements.

November 2021, Jupiter Wellness received an official written response from a Type B pre-Investigational New Drug (IND) meeting with the

Food and Drug Administration (FDA) for JW-100, a topical drug the treatment of eczema.

The main purpose of the pre-IND meeting was

to evaluate the drug development plan for JW-100.

Jupiter Wellness believes that the written response from the FDA supports the Company’s

approach and its overall drug development strategy to enable the filing of an IND for its clinical studies on JW-100.

November 16, 2021, Jupiter Wellness announced the results of a double-blinded placebo controlled clinical trial on JW-300 showing efficacy

for the treatment of developing burns (sunburn).

endocannabinoid system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating

pain sensation, cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use

of CBD containing topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific

November 30, 2020 the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People’s Republic

of China limited company (“SRM”).

SRM has relationships with and supplies 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.

Organizational

Wellness, Inc.

was originally incorporated in the State of Delaware on October 24, 2018.

Our principal business address is 1061 E.

110, Jupiter, FL 33477.

Wellness, Inc.

is a cutting-edge developer of cannabidiol (CBD) based medical therapeutics and wellness products.

The Company’s clinical

pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores, and skin

We are in the early stage of manufacturing, distributing, and marketing a diverse line of consumer products infused with CBD.

The Company’s

clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores,

and skin cancer.

We are in the early stage of manufacturing, distributing, and marketing a diverse line of consumer products infused

We have a proprietary, line of products:

CaniSun, CaniSkin and CaniDermRX.

Under the CaniSun brand, we are marketing patent pending CBD-infused

sun care lotion formulas containing various sun protection factors, or SPFs.

In addition, we are exploring the use of CBD with other

prescritption and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically,

we are exploring the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis (JW-100),

a non-prescription lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the treatment

of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate and

will be further tested in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations of

the United States Food and Drug Administration (“FDA”) under an investigational new drug, or IND, application.In February

Under the CaniSun brand, we are marketing patent

pending CBD-infused sun care lotion formulas containing various sun protection factors, or SPFs.

In addition, we are exploring the use

of CBD with other prescritption and/or over-the-counter, or OTC, consumer products that have potentially therapeutic and medical applications.

Specifically, we are exploring the use of such topical solutions for the treatment of eczema, dermatitis (JW-100), and actinic keratosis

(JW-100), a non-prescription lotion/lip balm (JW-200) for the treatment of symptoms of cold sores, and a prescription product for the

treatment of burns (JW-101).

The CaniDermRX (JW-100) topical solution for the treatment of eczema dermatitis is the lead product candidate

and will be further tested in humans as an investigational cosmetic ingredient followed by clinical trials subject to the regulations

of the United States Food and Drug Administration (“FDA”) under an investigational new drug, or IND, application.In February

2021, we announced the results of our novel Cannabidiol-Aspartame combination treatment JW-100 clinical trial which has shown it significantly

18 unchanged sentences

ISGA scores than CBD alone.

we plan to initiate the development of other products.

We originally anticipated developmental studies to be completed in 2020, however,

these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license products in the OTC skin care market that

can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

There can be no assurances that we will acquire or

enter into such partnership or licensing agreements.

The endocannabinoid

system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating pain sensation,

cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use of CBD containing

topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically with CBD.

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific indications.

30, 2020, the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People's Republic of China

limited company (“SRM”).

SRM has relationships with and supplies 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.

Under our CaniSun Brand, we

developed a patent pending CBD-infused sunscreen with broad-spectrum SPF protection.

We have completed lab testing for CBD

solubility–infusing clear, colorless, odorless, and 99.5% pure CBD isolate with three different sun care active ingredients,

parallel, we plan to initiate the development of other products.

We originally anticipated developmental studies to be completed in 2020,

however, these studies were delayed due to COVID-19.

We are also actively seeking to acquire or license products in the OTC skin care

market that can be infused with CBD and marketed under our CaniSkin and CaniDermRX brand names.

There can be no assurances that we will

acquire or enter into such partnership or licensing agreements.

endocannabinoid system, which is a body system affected by CBD, plays a pivotal role in maintaining a healthy skin through modulating

pain sensation, cell proliferation and inflammation.

Our strategy for treatment of skin indications is, therefore, to focus on the use

of CBD containing topical formulations and to explore potential combinations of CBD and other agents that may augment and act synergistically

We will explore this strategy by conducting controlled clinical trials to try to ultimately gain FDA approval for specific

November 30, 2020, the Company acquired SRM Entertainment, Limited, a Hong Kong Special Administrative Region of the People’s Republic

of China limited company (“SRM”).

SRM has relationships with and supplies 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.

our CaniSun Brand, we developed a patent pending CBD-infused sunscreen with broad-spectrum SPF protection.

We have completed lab testing

for CBD solubility–infusing clear, colorless, odorless, and 99.5% pure CBD isolate with three different sun care active ingredients,

homosalate, octisalate and octocrylene, which have already been approved by the FDA.

The CBD-infused sun care market is fairly

nascent in the United States;

The CBD-infused sun care market is fairly nascent

in the United States;

we believe that there are currently no major competitors in the category.

We see an opportunity to

become the leading manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive digital and

social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 55 and SPF 50 face lotion on

June 6, 2019.

We also sell our CBD-infused lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

have additional CaniSun products in various stages of development as follows:

CBD-infused SPF 30 Lip Balm, Peppermint and Acai Fragrance

We see an opportunity to become the leading

manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive digital and social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 55 and SPF 50 face lotion on June 6, 2019.

We also sell our CBD-infused

lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

currently have additional CaniSun products in various stages of development as follows:

SPF 30 Lip Balm, Peppermint and Acai Fragrance

SPF 15 sunscreen daily lotion;

1 unchanged sentence

sunscreen lotions (SPF 30 and 50).

products listed above are in the developmental stage, whereby we are finalizing the formula to be used in each product, respectively.

of the products listed above are in the developmental stage, whereby we are finalizing the formula to be used in each product, respectively.

For CBD-infused product candidates in development, such as our CBD-infused SPF 30 Lip Balm and CBD-infused SPF 15 sunscreen lotion, we

5 unchanged sentences

in sunscreen lotions.

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

we believe that our currently offered 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.

testing on these products is standard testing for suncare products.

Such testing protocols are not intended to test for any effects of

Therefore, we believe that our sunscreen products fall within the FDA monograph.

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.

of the testing on these products is standard testing for suncare products.

Such testing protocols are not intended to test for any effects

of adding CBD.

In addition to these tests that were conducted to support the claims on the package, each batch is also tested for appearance,

color, odor, pH, viscosity, specific gravity, analytical for the sunscreen active ingredients, and microbial content testing.

are tested each time they are manufactured.

DCR Labs manufactures our products and has represented to us that it is compliant with the

FDA’s Current Good Manufacturing Practice, or CGMP, regulations in accordance with 21 CFR 210/211 required for Over-the-Counter

products are tested each time they are manufactured.

DCR Labs manufactures our products and has represented to us that it is compliant

with the FDA’s Current Good Manufacturing Practice, or 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.

to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

JupiterWellness.com

is our primary corporate website, which will serve as the primary source of information about us for investors and contain press releases,

clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate that each brand will

have its own front-facing website dedicated to retail sales and brand specific information.

For example, our line of sun care products,

CaniSun, has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

As we expand our brands

(CaniSkin and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to each brand moving forward.

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

expect to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

JupiterWellness.com is our primary corporate website, which will serve as the primary source of information about us for investors and

contain press releases, clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate

that each brand will have its own front-facing website dedicated to retail sales and brand specific information.

For example, our line

of sun care products, CaniSun, has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

we expand our brands (CaniSkin and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to

each brand moving forward.

We are also building a website dedicated to servicing our wholesale and larger distributor clients.

This website will have more information

about each product and provide a central location for larger retailers to find more in-depth information about all of our brands in one

leverage our websites with a social media presence across multiple platforms designed to utilize product reviews to increase brand loyalty,

brand recognition and sales.

will have more information about each product and provide a central location for larger retailers to find more in-depth information about

all of our brands in one place.

plan to leverage our websites with a social media presence across multiple platforms designed to utilize product reviews to increase

brand loyalty, brand recognition and sales.

The references to our website in this prospectus are inactive textual references only.

The information on

our website is neither incorporated by reference into this prospectus nor intended to be used in connection with this offering.

see growth potential in developing retail locations.

We intend to utilize cross-promotion marketing campaigns with our products and product

category expansion that leverages our existing distribution channels.

We have built an e-commerce platform designed to connect us directly

to consumers.

information on our website is neither incorporated by reference into this prospectus nor intended to be used in connection with this

We also see growth potential in developing retail locations.

We intend to utilize cross-promotion marketing campaigns with

our products and product category expansion that leverages our existing distribution channels.

We have built an e-commerce platform designed

to connect us directly to consumers.

We use the platform to sell products, educate customers and build brand loyalty.

Brand and CaniDermRX Brand

We are currently

developing other products such as CBD-infused skin care lotion under the CaniSkin brand.

Specifically, a CBD-infused moisturizing face

serum is under development.

are currently developing other products such as CBD-infused skin care lotion under the CaniSkin brand.

Specifically, a CBD-infused moisturizing

face serum is under development.

We must first finalize the formula to be used in the face serum, and, once approved, the product candidate

9 unchanged sentences

safety and efficacy.

we plan to seek acquisition opportunities in the branded consumer products space, including but not limited to other OTC therapeutic brands

and skin care brands that can be developed, manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

We filed a provisional patent number 62/884,955 on 08/09/2019 on an Aspartame/CBD

combination and intend to develop products containing a combination of CBD and Aspartame under the CaniDermRX name for the treatment of

pain and inflammation.

On February 11, 2021, the US Patent Published our US Patent Application 20210038513 and on April 5, 2021 we filed

the International filing through PCT Application PCT/US 2020/045408.

We believe that our CaniDermRX product candidates have the potential

to treat many skin indications such as atopic dermatitis, pruritis-itch, non-atopic dermatitis/eczema, psoriasis, dermatomyositis, scleroderma,

seborrheic dermatitis, actinic keratosis, epidermolysis bullosa and cutaneous neoplasias.

addition, we plan to seek acquisition opportunities in the branded consumer products space, including but not limited to other OTC therapeutic

brands and skin care brands that can be developed, manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

filed a provisional patent number 62/884,955 on 08/09/2019 on an Aspartame/CBD combination and intend to develop products containing

a combination of CBD and Aspartame under the CaniDermRX name for the treatment of pain and inflammation.

On February 11, 2021, the US

Patent Published our US Patent Application 20210038513 and on April 5, 2021 we filed the International filing through PCT Application

PCT/US 2020/045408.

On April 6, 2021, we filed a PCT Application No.:

PCT/US2021/025947* on CBD sunscreens.

believe that our CaniDermRX product candidates have the potential to treat many skin indications such as atopic dermatitis, pruritis-itch,

non-atopic dermatitis/eczema, psoriasis, dermatomyositis, scleroderma, seborrheic dermatitis, actinic keratosis, epidermolysis bullosa

and cutaneous neoplasias.

Aspartame is a rigorously tested food ingredient.

Reviews by major governmental regulatory bodies have previously found the ingredient safe for consumption at higher levels than we contemplate

using in our CaniDermRX product candidates.

We believe that our formulations that include Aspartame, such as topical crème, lip

balm, powder and dog treats, are well-tolerated by, and safe for, users.

We believe that infusing CBD in our products may help alleviate

irritation that may be caused by applying sun care products and may lead to reduced inflammation.

In human skin, receptors of the endocannabinoid

system are found in differentiated keratinocytes, hair follicle cells, sebaceous glands, immune cells, and sensory neurons.

of cannabinoid receptor type 2, or CB2, for which CBD is a ligand receptor in these cells has been shown to reduce pain and itch sensation,

regulate keratinocyte differentiation and proliferation, decrease hair follicle growth, and modulate the release of damage-induced keratins

and inflammatory mediators to control the homeostasis of the skin environment.

Market Opportunity

for hemp, and for products based on extracts of hemp, is expected to grow substantially over the coming years.

It is estimated by BDS

Analytics and Arcview Market Research that the collective market for CBD sales in the U.S.

will surpass $20 billion by 2024 and that there

will be a compound annual growth rate of 49 percent by 2024 across all distribution channels.

We see great potential to grow and generate

revenues in this expanding market.

According to Grand View Research,

Reviews by major governmental regulatory bodies have previously

found the ingredient safe for consumption at higher levels than we contemplate using in our CaniDermRX product candidates.

that our formulations that include Aspartame, such as topical crème, lip balm, powder and dog treats, are well-tolerated by, and

safe for, users.

We believe that infusing CBD in our products may help alleviate irritation that may be caused by applying sun care products

and may lead to reduced inflammation.

In human skin, receptors of the endocannabinoid system are found in differentiated keratinocytes,

hair follicle cells, sebaceous glands, immune cells, and sensory neurons.

Activation of cannabinoid receptor type 2, or CB2, for which

CBD is a ligand receptor in these cells has been shown to reduce pain and itch sensation, regulate keratinocyte differentiation and proliferation,

decrease hair follicle growth, and modulate the release of damage-induced keratins and inflammatory mediators to control the homeostasis

of the skin environment.

market for hemp, and for products based on extracts of hemp, is expected to grow substantially over the coming years.

It is estimated

by BDS Analytics and Arcview Market Research that the collective market for CBD sales in the U.S.

will surpass $20 billion by 2024 and

that there will be a compound annual growth rate of 49 percent by 2024 across all distribution channels.

We see great potential to grow

and generate revenues in this expanding market.

to Grand View Research, the U.S.

sun care market size was estimated at $1.95 billion in 2016.

The growing consumer awareness regarding the ill-effects of over

exposure to ultraviolet, or UV, rays on the undefended skin is expected to propel growth.

The sun care market is a highly competitive

market and product differentiation in the sun care market is low.

Given the relatively low amount of product differentiation, we see an

opportunity to carve out a unique market share with our CBD-infused sun care products.

We cannot make any claims as to such benefits prior

to performing certain testing.

We see an opportunity, although there can be no assurance that we will be successful, to become the leading

manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive digital and social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 50 and SPF 55 face lotion on June 6, 2019.

We also sell our CBD-infused

lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

Market Strategy

to seek acquisition opportunities in the branded consumer products space, including but not limited to other non-CBD OTC therapeutic brands

and skin care brands that can be manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

We may market such

products as they are currently comprised or may seek to add CBD to the product.

In the event we decide to add CBD to such products, we

intend to first conduct FDA regulated clinical trials for safety and efficacy testing.

We have no definitive agreements in place to acquire

any other entities.

intend to sell the product online directly through our own website, and other third-party marketplaces as these sites permit.

The growing consumer awareness regarding

the ill-effects of over exposure to ultraviolet, or UV, rays on the undefended skin is expected to propel growth.

The sun care market

is a highly competitive market and product differentiation in the sun care market is low.

Given the relatively low amount of product

differentiation, we see an opportunity to carve out a unique market share with our CBD-infused sun care products.

We cannot make any

claims as to such benefits prior to performing certain testing.

We see an opportunity, although there can be no assurance that we will

be successful, to become the leading manufacturer of CBD-infused sun care products, marketing the CaniSun brand through an extensive

digital and social media awareness campaign.

We announced the launch of our CaniSun sun care line of SPF 30, SPF 50 and SPF 55 face lotion

on June 6, 2019.

We also sell our CBD-infused lip balm and CBD-infused SPF 30 sunscreen spray on our website Canisun.com.

plan to seek acquisition opportunities in the branded consumer products space, including but not limited to other non-CBD OTC therapeutic

brands and skin care brands that can be manufactured, marketed and distributed under our CaniSkin and CaniDermRX brand names.

market such products as they are currently comprised or may seek to add CBD to the product.

In the event we decide to add CBD to such

products, we intend to first conduct FDA regulated clinical trials for safety and efficacy testing.

We have no definitive agreements

in place to acquire any other entities.

also intend to sell the product online directly through our own website, and other third-party marketplaces as these sites permit.

Distribution Agreement

5, 2020, we entered into the Nidaria Distribution Agreement with Nidaria, Pursuant to which we purchase, market, promote, distribute and

sell Nidaria’s Safe Sea®

sunscreen that provides protection against jellyfish stings.

Pursuant to the Nidaria Distribution Agreement,

the Company shall serve as Nidaria’s exclusive distributor of Safe Sea in the state of Florida.

The Nidaria Distribution Agreement

shall have a term of two (2) years, commencing December 1, 2020, and may be renewed for one (1) additional year upon the mutual consent

of us and Nidaria.

We expect to continually update

and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

Jupiterwellness.com is our

primary corporate website, which will serve as the primary source of information about us for investors and contain press releases, clinical

trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate that each brand will have

its own front-facing website dedicated to retail sales and brand specific information.

For example, our line of sun care products, CaniSun,

has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

As we expand our brands (CaniSkin

and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to each brand moving forward.

also building a website dedicated to servicing our wholesale and larger distributor clients.

This website will have more information about

each product and provide a central location for larger retailers to find more in-depth information about all of our brands in one place.

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”).

November 5, 2020, we entered into the Nidaria Distribution Agreement with Nidaria, Pursuant to which we purchase, market, promote, distribute

and sell Nidaria’s Safe Sea® sunscreen that provides protection against jellyfish stings.

Pursuant to the Nidaria Distribution

Agreement, the Company shall serve as Nidaria’s exclusive distributor of Safe Sea in the state of Florida.

The Nidaria Distribution

Agreement shall have a term of two (2) years, commencing December 1, 2020, and may be renewed for one (1) additional year upon the mutual

consent of us and Nidaria.

This agreement was not renewed for 2022 by mutual consent.

expect to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis.

Jupiterwellness.com is our primary corporate website, which will serve as the primary source of information about us for investors and

contain press releases, clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands.

We anticipate

that each brand will have its own front-facing website dedicated to retail sales and brand specific information.

For example, our line

of sun care products, CaniSun, has its own website at CaniSun.com and allows for online retail purchase of the entire product line.

we expand our brands (CaniSkin and CaniDermRX), we anticipate utilizing the same strategy and dedicating a new e-commerce website to

each brand moving forward.

We are also building a website dedicated to servicing our wholesale and larger distributor clients.

will have more information about each product and provide a central location for larger retailers to find more in-depth information about

all of our brands in one place.

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 shall release the Escrow Shares upon SRM generating $200,000 in cash receipts and revenue

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a wholly-owned subsidiary of the Company.

SRM 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

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.

Products developed by

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

SRM does not have long-term

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

Through SRM, we additionally

intend to seek to sell our sun care products in the amusement parks.

We are currently developing a line of non-CBD infused sun care products

for sale in the amusement parks.

SRM has four full time employees.

There are several companies developing

cannabinoid therapeutics for a range of medical indications.

The cannabinoid therapeutic area currently includes formulated extracts of

the Cannabis plant and synthetic formulations.

These formulations include CBD and THC, or a combination of CBD/THC as the active pharmaceutical

Certain companies such as GW Pharmaceuticals, PLC have focused on hemp-based CBD formulations;

while other companies such

as Zynerba Pharmaceuticals Inc.

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, we additionally intend to seek to sell our sun care products in the amusement parks.

We are currently developing a line of non-CBD

infused sun care products for sale in the amusement parks.

has four full time employees.

are several companies developing cannabinoid therapeutics for a range of medical indications.

The cannabinoid therapeutic area currently

includes formulated extracts of the Cannabis plant and synthetic formulations.

These formulations include CBD and THC, or a combination

of CBD/THC as the active pharmaceutical ingredient.

Certain companies such as GW Pharmaceuticals, PLC have focused on hemp-based CBD

formulations;

while other companies such as Zynerba Pharmaceuticals Inc.

and Insys Therapeutics Inc.

have focused on synthetic CBD formulations.

The CBD-based consumer product

industry is highly fragmented with numerous companies, consisting of publicly- and privately-owned companies.

There are also large, well-funded

companies that have indicated their intention to compete in the hemp-based product category in the U.S.

We routinely evaluate internal

and external opportunities to optimize value for stockholders through new product development or by asset acquisitions or sales, and believe

we are well-positioned to capitalize in the growing CBD product category.

We face competition from larger companies that are, or may be,

in the process of offering similar products to ours.

Many of our current and potential competitors have longer operating histories, significantly

greater financial, marketing and other resources than we have or may be expected to have.

Competitors may include major

pharmaceutical and biotechnology companies and public and private research institutions.

Our management 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 to market changes, respond more rapidly to new regulations or allocate greater resources to the

development and promotion of their products than we can.

Furthermore, some of these competitors

may make acquisitions or establish collaborative relationships among themselves to increase their ability to rapidly gain market share.

CBD-based consumer product industry is highly fragmented with numerous companies, consisting of publicly- and privately-owned companies.

There are also large, well-funded companies that have indicated their intention to compete in the hemp-based product category in the

We routinely evaluate internal and external opportunities to optimize value for stockholders through new product development or

by asset acquisitions or sales, and believe we are well-positioned to capitalize in the growing CBD product category.

We face competition

from larger companies that are, or may be, in the process of offering similar products to ours.

Many of our current and potential competitors

have longer operating histories, significantly greater financial, marketing and other resources than we have or may be expected to have.

may include major pharmaceutical and biotechnology companies and public and private research institutions.

Our management 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

These competitors may be able to react 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.

Large pharmaceutical companies may eventually enter the market.

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.

Our success will also depend on our ability to respond

quickly to, among other things, changes in the economy, market conditions, and competitive pressures.

Any failure to anticipate or respond

adequately to such changes could have a material effect on our financial condition, operating results, liquidity, cash flow and our operational

Intellectual Property

Provisional Patent (CBD Formulations and Uses Thereof:

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

results, liquidity, cash flow and our operational performance.

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

the clinical efficacy of our topical products.

filed Provisional Patent (CBD Formulations and Uses Thereof:

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

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

This initially will cover the products under the CaniDermRX

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

This initially will 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.

16/987,941) and PCT application

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

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

Provisional Patent (CBD Sunscreen Formulations and Uses Thereof:

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 will occur on April 6, 2021.

If issued, the patent will give patent protection until

We filed Provisional Patent (Oroanasal

CBD formulations and uses thereof (No.:

The priority date starts at the time the

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

If issued, the patent will give patent protection

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

Research and Development

Our research and development programs

are generally pursued by engineers and scientists employed by us in on a full-time basis or hired as per diem consultants or through partnerships

with industry leaders in manufacturing and design and researchers and academia.

We are also working with subcontractors in developing

specific components of our technologies.

The 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.

This covers the use of CBD

products for the treatment of respiratory viruses.

and Development

research and development programs are generally pursued by engineers and scientists employed by us in on a full-time basis or hired as

per diem consultants or through partnerships with industry leaders in manufacturing and design and researchers and academia.

working with subcontractors in developing specific components of our technologies.

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 $1,079,362 and $308,367 for the years ended December 31, 2021 and 2020, respectively.

Government Regulation

Since 1937, Cannabis sativa L.

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

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”).

The Company will sponsor the Study and under the projected budget laid out

in the Clinical Trial Research Agreement will pay AB $1,088,010.00 for its research activities.

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 13 th 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”).

In light of 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 13 th 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”), 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.

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.

1937, Cannabis sativa L.

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

811 (the “CSA”), regulated

by the Drug Enforcement Agency (the “DEA”).

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

“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.

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

On December 20, 2018, President Donald J.

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.

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

On December 20, 2018, President Donald

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.

Under 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.

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,

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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

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.

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 repeated offenses.

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

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 repeated 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.

Further, section

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

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.

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

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.

are tested each time they are manufactured.

DCR Labs manufactures our products 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).

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

FDA Regulation of Hemp Extracts

The 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.

Regarding 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.

Aside 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:

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.

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.

DCR Labs manufactures our products 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.

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 labeling;

(5) daily use information.

The FDA has not approved cannabis,

marijuana, hemp or derivatives as a safe and effective drug for any indication.

We intend to file an IND with the FDA for our CaniDermRX

products in the event the pending provisional patent on an Aspartame/CBD combination is approved.

As 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.

The 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.

(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 intend to file an IND

with the FDA for our CaniDermRX products 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.

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.

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.

Despite 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.

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

As of December 31, 2020, we had five full-time employees, including Chief

Executive Officer Brian S.

John, Chief Financial Officer, Douglas McKinnon, and Chief Operating Officer, Richard Miller, and Rob White,

manager of shipping and receiving.

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 25 th , 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.

of December 31, 2021, we had twelve full-time employees , including Chief Executive Officer Brian S.

John, Chairman and Chief Science

Glynn Wilson, Chief Financial Officer, Douglas McKinnon, Chief Operating Officer, Ryan Allison and Chief Compliance Officer,

Richard Miller.

We believe our relations with our employees to be good.

Currently, we do not own any real

We rent an office space at 725 N.

Hwy A1A, Suite C-106, Jupiter, FL 33477 for $2,140 per month.

This office space is rented

on a month-to- month lease.

we do not own any real property.

We rent an office space at 1061 E.

Indiantown Rd., Ste.

110, Jupiter, FL 33477 for $15,038 per month.

The Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal

option for an additional three years..

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business