FDA Issues Warning About Unregulated Wellness Supplement Associated with Serious Health Hazards

The Food and Drug Administration (FDA) has recently issued a stark warning about a wellness supplement known as Neptune’s Fix, which has been colloquially dubbed ‘gas station heroin.’ This product, which claims to enhance brain function and alleviate symptoms of anxiety, depression, pain, and opioid use disorder, has been found to contain tianeptine, a substance not approved for use in the United States due to its high risk of addiction and potential for abuse.

Tianeptine, an opioid alternative, has been branded by some law enforcement officials as ‘worse than heroin’ because of its intense high and addictive properties. The FDA has cautioned that the drug can lead to severe health complications, including seizures and loss of consciousness. Alarmingly, poison control centers have reported a surge in poisonings related to tianeptine, with a significant increase from just 11 cases between 2000 and 2013 to 151 by 2020.

FDA warns against Neptune’s Fix products containing unapproved and risky substance, tianeptine. Severe adverse events reported, including seizures. Labels may not list all ingredients. Consumers urged to avoid & seek medical help for adverse reactions. #FDAWarning #TianeptineRisk pic.twitter.com/JFH3rGl0v1

— HFUX Research | Medical Human Factors (@HFUXresearch) November 21, 2023

Despite the dangers, Neptune’s Fix has been readily available for purchase in various retail outlets across at least ten states, including gas stations, delis, vape shops, tobacco shops, convenience stores, and online platforms. This widespread availability has made it alarmingly accessible to unsuspecting consumers seeking relief from various ailments.

In response to the growing threat, eight states have taken decisive action by banning the drug, and Florida has classified it as a Schedule 1 substance, equating it with drugs like heroin and LSD. These measures reflect the seriousness of the risks associated with tianeptine and the need for stringent regulation.

The fact tianeptine was once known as a “serotonin reuptake enhancer” and it was not even known that its actually an opioid kinda makes you wonder what else commonly known drugs do that we arent aware of.

— Sam Savson (@SSavson) November 21, 2023

The FDA’s warning comes after reports of individuals experiencing confusion, sweating, rapid heartbeat, spikes in blood pressure, nausea, vomiting, and agitation after taking the supplement. In more severe cases, users have suffered from slowed breathing, respiratory system shutdown, coma, and even death. At least four fatalities have been linked to the use of this so-called wellness supplement since its emergence in the mid-2010s.

Critics have pointed out that the FDA’s response to the dangers posed by Neptune’s Fix was less than timely. It took the agency nine months to issue a public warning after initially receiving reports of adverse reactions, according to emails released under the Freedom of Information Act. This delay has raised concerns about the effectiveness of the FDA’s monitoring and communication processes regarding unregulated substances.

The case of Neptune’s Fix underscores the importance of consumer vigilance and the need for comprehensive regulatory oversight of supplements and non-prescription drugs. While the pursuit of alternative treatments for common health issues is understandable, it is imperative that such products are safe, effective, and properly vetted by authorities to prevent harm to the public.

As the FDA continues to monitor and address the situation, it is crucial for individuals to heed the warnings and avoid products containing tianeptine. Healthcare professionals and lawmakers must also work together to ensure that dangerous substances like those found in Neptune’s Fix are kept off the market and out of the hands of vulnerable populations.

In conclusion, the saga of Neptune’s Fix serves as a cautionary tale about the potential dangers lurking within the unregulated supplement market. It is a reminder that, in the absence of FDA approval, consumers must approach wellness products with skepticism and prioritize their health and safety above all else.