Aceva, LLC
FDA and FTC jointly issued a warning letter to Aceva, LLC (CEO Joseph Esposito) in September 2021 regarding their 'Sugar Balance' dietary supplement. The agencies found that website and social media claims — including assertions about improving insulin sensitivity, controlling blood glucose, and helping manage diabetes — caused the product to be classified as an unapproved new drug and a misbranded drug under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims could result in civil penalties of up to $43,792 per violation and consumer refund obligations. Aceva was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure, injunction, or FTC legal action.
Flagged claims (7)
Regulating Blood Sugar. . .
Sugar Balances helps improve insulin sensitivity and enhance blood sugar control.
Sugar Balance is a clinically‐effective formula containing powerful ingredients designed to improve insulin sensitivity and enhance blood glucose (sugar) control.
Help get your Diabetes under control. Sugar Balance is a clinically effective formula containing powerful ingredients designed to improve insulin sensitivity and enhance blood glucose (sugar) control.
If you need to decrease your body's need for insulin, use Sugar Balance
[F]or improved A1c levels and glycemic control.
If you need to decrease your body's need for #insulin, use Sugar Balance.
Required actions (6)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Notice is hereby given that you must cease and desist from making any claim that a product and prevent, treat, or cure diabetes without competent and reliable scientific evidence consisting of well‐controlled human clinical studies substantiating that the claims are true.
please notify Richard Cleland of the FTC via electronic mail at [email protected] within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC's concerns.
marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation pursuant to Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. § 45(m)(1)(B)
may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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