Phytag Labs
FDA and FTC jointly issued a warning letter to Phytag Labs (George Rivera, Bee Cave, TX) regarding their 'GLUCOTYPE2' dietary supplement, which was marketed with claims that it could treat, prevent, or cure Type 2 diabetes and related conditions. The agencies determined the product constituted an unapproved new drug under the FD&C Act and was misbranded due to inadequate directions for use. The FTC simultaneously issued a cease-and-desist demand, warning that continued unsubstantiated disease claims could result in civil penalties of up to $43,792 per violation, injunctions, and consumer redress obligations.
Flagged claims (10)
[R]ich in corosolic acid (a substance found to possess blood-sugar-lowering…and anti- inflammatory properties)…
GlucoType 2 Blood Sugar Metabolism Supplement Stabilizer… Type 2 Diabetes Optimizer…
[J]ust one GlucoType 2™ capsule each day, for 30 days (90 days recommended), the anti-diabetic properties of the ingredients contained in GlucoType 2™ work their best to support the fight against Type 2 diabetes and a number of other possible health ailments, before their onset.
[L]owers elevated blood sugar levels and blood pressure in Type 2 Diabetes across the day…
GlucoType2™ is breakthrough, all natural blood sugar control support supplement that's not just helping support the fight against Type 2 diabetes, it help in reducing inflammation, lowering cholesterol, reducing nerve pain and even helps with various types of body fungus
[C]onquers insulin resistance and also shown to be useful in the treatment of certain classes of non-insulin-dependent diabetes
Bitter Melon [an ingredient in the product] lowers elevated blood sugar levels and blood pressure in Type 2 Diabetes
CONTROL YOUR BLOOD SUGAR NOW
Gymnema Sylvestre [an ingredient in the product] …useful in the treatment of certain classes of non-insulin-dependent diabetes
[R]egulates blood sugar levels, … and helps in the fight against diabetes & heart attacks
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 this matter may result in legal action including, without limitation, seizure and injunction.
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