On February 1, 2024, Safety Shot, Inc. received comments from the United States Securities and Exchange Commission (SEC) regarding Post-Effective Amendment No. 5 to their Form S-1 filed on January 23, 2024. The SEC's review highlighted discrepancies in Safety Shot's disclosures, particularly concerning the clinical trial status and FDA approval requirements for their product JW-500. The SEC requested clarification on whether JW-500 is a cosmetic product as stated on page 8 of the amendment or if it requires clinical trials as mentioned on page 4. Additionally, the SEC reissued a comment asking Safety Shot to revise their disclosure to discuss the commercialization status of their products, including Photocil, JW-700, and JW-500, and to clarify the regulatory categories under which their products fall, such as...Show More

On February 1, 2024, Safety Shot, Inc. received comments from the United States Securities and Exchange Commission (SEC) regarding Post-Effective Amendment No. 5 to their Form S-1 filed on January 23, 2024. The SEC's review highlighted discrepancies in Safety Shot's disclosures, particularly concerning the clinical trial status and FDA approval requirements for their product JW-500. The SEC requested clarification on whether JW-500 is a cosmetic product as stated on page 8 of the amendment or if it requires clinical trials as mentioned on page 4. Additionally, the SEC reissued a comment asking Safety Shot to revise their disclosure to discuss the commercialization status of their products, including Photocil, JW-700, and JW-500, and to clarify the regulatory categories under which their products fall, such as drug, medical device, or food additive. The SEC also noted that Safety Shot made safety and efficacy claims for products not approved by the FDA or similar foreign regulators and instructed the company to remove such statements. Furthermore, the SEC requested additional information on the company's relationship with GBB Labs, Inc., the nature of ongoing litigation involving GBB Labs, and the potential impact on Safety Shot's products and company. The SEC reminded Safety Shot of their responsibility for the accuracy and adequacy of their disclosures.