Joi and Blokes dba Joi + Blokes
FDA issued a warning letter to Joi and Blokes dba Joi + Blokes (Denver, CO), a telehealth company offering compounded semaglutide and tirzepatide products, for false or misleading marketing claims on their website. The company falsely implied their compounded products were FDA-approved by describing them as 'bioidentical' to brand-name drugs like Ozempic and Wegovy, and also misbranded products by displaying the 'Joi + Blokes' name on product labels when the company is not the actual compounder. FDA cited violations of FD&C Act sections 502(a) and 502(bb) for misbranding, and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (2)
At Blokes, we offer a cost-effective semaglutide option that is bioidentical with more expensive brands.
By utilizing the same bioidentical compound as Ozempic and Wegovy, Blokes can provide a cost-effective alternative.
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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