United States securities and exchange commission logo
February 1, 2024
Brian S. John
Chief Executive Officer
Safety Shot, Inc.
1061 E. Indiantown Rd., Ste. 110
Jupiter, FL 33477
Re: Safety Shot, Inc.
Post-Effective
Amendment No. 5 on Form S-1
Filed January 23,
2024
File No. 333-258005
Dear Brian S. John:
We have conducted a limited review of the post-effective
amendment to your registration
statement and have the following comments.
Please respond to this letter by filing a post-effective
amendment and providing the
requested information. If you do not believe a comment applies to your
facts and circumstances
or do not believe an amendment is appropriate, please tell us why in
your response.
After reviewing any amendment and the information you provide
in response to this
letter, we may have additional comments.
Post-Effective Amendment No. 5 to Form S-1
Summary, page 3
1. We note your disclosure
on page 4 that JW-500 was born out of clinical trials and that you
have plans for
additional clinical trials of JW-500 in the second half of 2024. We also note
your disclosure on page
8 that "JW 500, JW700, and Photocil are cosmetic products and
do not require clinical
trials." Please revise your disclosure to reconcile this discrepancy
and to clarify whether
JW-500 requires FDA approval.
General
2. We note your revised
disclosure and response to comment 11 and reissue the
comment. Please revise
your disclosure to discuss the current status of commercialization
of each of your
products, in particular: Photocil, JW-700, and JW-500. For example,
please discuss each
country where Photocil and JW-700 are currently offered, and clarify
whether JW-500 is still
under development and is not being offered to consumers. In this
Brian S. John
FirstName
Safety Shot,LastNameBrian S. John
Inc.
Comapany1,NameSafety
February 2024 Shot, Inc.
February
Page 2 1, 2024 Page 2
FirstName LastName
regard, please also note:
Your disclosure still contains statements of safety and
efficacy for products that have
not been approved by the FDA or similar foreign regulators. For
example, on page 42
you state "[t]hese tests employed breathalyzers, providing
conclusive evidence of the
Safety Shot Beverage s effectiveness. While these endeavors
have demonstrated the
product s reliability, the Company is presently engaged in a
formal double-blinded
placebo-controlled clinical trial to further substantiate its
findings, exemplifying a
commitment to rigorous scientific validation." We remind you that
safety and
efficacy are determinations that are solely within the authority
of the FDA or similar
foreign regulators. As such, please revise your disclosure to
remove any statements of
safety and efficacy for any products that have not been approved
by the FDA or
similar foreign regulators.
3. We reissue comment 5 as it relates to the regulations applicable to
your products. For
Safety Shot and your other products, please further clarify the
government regulations,
and specifically identify the particular category you believe each
falls within under the
regulation of the FDA (drug, medical device, dietary supplement, food
additive, etc.),
revise the Government Regulation section to provide materially
complete discussions of
all regulations addressed on page 8, revise to eliminate disclosures
throughout the
document that are inconsistent with your position regarding the
applicable government
regulations, and disclose the regulatory category for each in your
product roadmap on
page 43 and in the Government Regulation section. We note the
following:
You take the position that Safety Shot is a food additive, but
continue to make
statements implying that Safety Shot is a drug (intended to
treat, diagnose, cure, or
prevent a disease) or a dietary supplement. We note, for example,
the disclosure on
page 42 that Safety Shot "is crafted to streamline the body s
detoxification process
from alcohol, employing a thoughtfully selected combination of
vitamins, minerals,
and nootropics to enhance rehydration and mental clarity.
Noteworthy is the fact that
the Safety Shot Beverage comprises 28 active ingredients, all
falling under the
Generally Regarded As Safe (GRAS) category." We also note the
statements made in
the backgrounds of Directors Boon and Gulyas, former executives
with GBB Drink
Lab.
You disclose on page 4 and elsewhere that NoStingz is an
"effective barrier" and "as
product contains ingredients with well established safety
profiles it does not require
FDA approval." You also describe it as a barrier to UVA/UVB and
include it within
the category of "sun screen products." On page 8 you state that
it falls within the
category of cosmetics. Clarify if the claims related to repelling
jellyfish venom and
protecting from sea lice also fall within the definition of
cosmetics.
Revise to further clarify how SS-100 would be characterized as
a drug in contrast to
Safety Shot, which you characterize as a food additive. In
addition, please
disclose additional information to clarify the basis for your
statement that SS-100
would qualify for Orphan Drug Designation to treat Acute Alcohol
Poisoning. For
Brian S. John
Safety Shot, Inc.
February 1, 2024
Page 3
example, clarify how Acute Alcohol Poisoning meets the FDA's
definition of a Rare
Disease. Also clarify the significance of Orphan Drug Designation.
Please also revise
the Government Regulation section to clarify the process for seeking
FDA approval
of a drug and for obtaining Orphan Drug Designation.
4. We note the recent filing pursuant to Item 7.01 of Form 8-K that included
your January
17, 2024 press release regarding the lawsuit between GBB Lab, Inc. and
FSD
Pharma. Please revise the document, including the disclosure in Recent
Developments, to
disclose your relationship to GBB Labs, Inc., which is your subsidiary,
as disclosed in
Recital B of the asset purchase agreement filed as Exhibit 10.26. Please
revise the
disclosure throughout this document to clarify the references to "GBB",
including
to which entity you refer. Please also revise the document to identify
the proceedings and
disclose the nature and stage of the proceedings and relief sought.
Clarify FSD Pharma's
relationship with GBB Labs, Inc. or FSD Pharma, as applicable, pursuant
to which the
NDA was executed. Clarify the potential impact on your product and
company if GBB
Labs is not successful in the litigation. In addition, please revise your
beneficial ownership
table to disclose the 5 million shares issued to GBB Drink Labs in
connection with the
asset purchase agreement, as disclosed on page 7, and clarify which, if
any, of your
directors beneficially own those shares.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date.
Please contact Juan Grana at 202-551-6034 or Abby Adams at 202-551-6902
with any
other questions.
Sincerely,
FirstName LastNameBrian S. John Division of
Corporation Finance
Office of
Industrial Applications and
Comapany NameSafety Shot, Inc.
Services
February 1, 2024 Page 3
cc: Arthur S. Marcus, Esq.
FirstName LastName