Cryotherapy, a treatment that involves exposing oneself to temperatures as low as -300 degrees Fahrenheit, grabbed headlines last fall after the tragic accidental death of a young woman who was using a whole-body cryotherapy machine. Proponents of cryotherapy claim that standing in the full-body machine for two to three minutes can relieve muscle soreness, combat fatigue, or even reduce wrinkles. However, the FDA recently released a consumer alert warning consumers that the FDA “does not have evidence” that cryotherapy effectively treats conditions including chronic pain, arthritis or migraines. Additionally, the alert emphasizes that the agency has never approved a whole-body cryotherapy machine for therapeutic use.
Interestingly, the FDA’s statement was based only on an “informal review” of literature. Despite its informal origins, one could easily envision this consumer alert becoming Plaintiffs’ Exhibit A in litigation against cryotherapy-machine manufacturers. Based on a search of the FDA’s website, it is not the agency’s standard practice to issue a consumer alert based on an informal review. But should such informal analyses become routine, defendant manufacturers will face an uphill battle in countering the persuasiveness that the agency’s endorsement imparts on this informal process.