Multiple FDA offices involved in investigation after receiving complaints, according to agency documents obtained via FOIA

Based on Hunterbrook Media’s reporting, Hunterbrook Capital is short $SHOT  at the time of publication. Positions may change at any time after publication. This is not investment advice. See full disclaimer below.

The Food and Drug Administration has launched an investigation into Safety Shot (NASDAQ: $SHOT), according to complaints, emails, and other agency documents received via a Freedom of Information Act request. This news comes one day after Hunterbrook Media published a report about the beverage company that has claimed it can reduce blood alcohol content by up to 50% in 30 minutes.

According to the documents (which can be read in full here), at least two separate FDA field offices, one on each coast, have been involved to varying degrees in the Safety Shot investigation.

The FDA shared three partially redacted complaints it received about Safety Shot between September and November of last year. In response to what the agency learned, FDA investigator Sharon Giamberini shared a recommendation that the FDA “conduct an inspection” of Safety Shot’s manufacturing facility.

Safety Shot boasts that it is produced in an “FDA-approved facility” on its cans.

The company is headquartered in Jupiter, FL — but the exact location of Safety Shot’s manufacturing facility was not disclosed by the FDA.

One complaint notified the regulatory agency of Safety Shot’s assertion that “alcohol gets converted into sugar thus detoxing blood alcohol levels,” which the complainant said was “simply not possible.”

Another implored the FDA to “consider the risk to consumers if an intoxicated individual takes this product after consuming alcohol and drives a vehicle or operates machinery.” The complaint said the results could be “devastating.” 

A third complaint directed regulators to a promotional video that Safety Shot posted on social media, in which a drinker’s BAC purportedly declined from .40 (possibly lethal) to .12 in 30 minutes. “[REDACTED] indicated there are no clinical studies” this complaint said. 

“[REDACTED] indicated he did not want to be involved in the investigation but wanted to make FDA aware of the matter.” He also noted that the product is marketed with “several structure/function claims,” which can fall under the FDA’s jurisdiction. 

Earlier this year, Glynn Wilson, the sole doctor on Safety Shot’s board, resigned.

When asked about the FDA investigation, Safety Shot did not immediately respond for comment.

None of the material Hunterbrook Media received from the FDA suggests that it is investigating the allegations that consuming Safety Shot can make some people very sick. Tiena, a Safety Shot consumer and investor, told Hunterbrook Media that after drinking Safety Shot, she threw up for 12 hours straight and was “as sick as I have ever been.”

The FDA’s investigation appears to be in the very early stages. It said it was conducting surveillance and planning on inspecting Safety Shot’s manufacturing facility in “the approximate time frame” of January to February 2024. The agency appears to have conducted a “follow-up” operation as recently as April 16. 

The agency did not indicate how far along it was in completing its investigation. 

Eve Peyser writes about the weirdest, funniest, and most interesting aspects of modern life. Her work has been featured in The New York Times, Vanity Fair, GQ, and many other publications.

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