FDA Sends Warning Letter to WHOOP, Inc. for Marketing Blood Pressure Insights Without Approval

Have you purchased any of WHOOP’s Blood Pressure Insight (“BPI”)? You may be using a misbranded device. If you or someone you know suffered harm as a result of the recent purchase of a Whoop’s Blood Pressure Insight, please click here, call us at 844-431-0695, or email us cis@fbfglaw.com to discuss your legal options.
The FDA’s reviewed WHOOP’s BPI and determined that it’s company has violated the Federal Food Drug and Cosmetic Act. WHOOP’s product fits the definition of a device because “it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” It’s also related to the diagnosis of hypo and hypertension. The FDA analysis is substantiated by WHOOP firm’s statement that BPI is intended to identify “higher blood pressure.”
The FDA also found that WHOOP’s BPI is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o) for failure to notify FDA of its intent to introduce a device into commercial distribution. Also, it is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B) for failure to obtain premarket approval.
WHOOP argued that it’s BPI is not a device because it’s meant to “encourage and maintain a healthy lifestyle.” The FDA analyzed whether WHOOP’s product fits this definition and determined that it did not. WHOOP’s product cannot be considered a low-risk product because it can reassure users that they have normal blood pressure when they do not. A person reliance could result in stroke, heart attack, heart failure, kidney failure, cognitive decline, and premature death. The FDA further notes that WHOOP’s product does fit the definition of a low-risk product because the FDA actively regulates similar products that are used to determine a user’s blood pressure.
The FDA concluded that WHOOP needs to take corrective measures to be in compliance or risk monetary or injunctive penalties.
Attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully recovered millions of dollars on behalf of consumers aggrieved by such misbranded products.  We are currently investigating this matter. If you or someone you know purchased WHOOP’s BPI, please contact us to discuss your legal options.