Lysulin, Inc.
FDA and FTC jointly issued a warning letter to Lysulin, Inc. (San Diego, CA) in September 2021 regarding five dietary supplement products marketed for diabetes and prediabetes management. The regulators found that claims on the company's website, social media pages, and Amazon storefront established the products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease — specifically diabetes and prediabetes — without FDA approval. FDA cited violations for introducing unapproved new drugs and misbranded drugs into interstate commerce, while the FTC issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and consumer redress obligations.
Flagged claims (15)
CLINICALLY TESTED: "… Lysulin can help to lower blood glucose and A1c levels while improving the lipid profile in prediabetes and diabetes"
[D]aily serving of patented Lysulin ® to reduce blood glucose
Let Lysulin be your partner for better diabetes management
Our mission at Lysulin is to help people with Prediabetes or Type 2 Diabetes prevent, manage, or in some cases even completely reverse the disease.
Lysulin is an all natural supplement to lower blood sugar
Reduces Glucose in the blood stream
The Lysulin® Weight Loss Shake is the ONLY SHAKE with the patented Lysulin® ingredient to reduce Glucose from the blood stream …
The combination and high level of these active ingredients have been shown to help maintain healthy A1c blood sugar levels in diabetics and prediabetics.
What is Lysulin? Formulated by a renowned diabetes scientist, Lysulin … help maintain healthy A1c blood sugar levels in diabetics and pre-diabetics.
Lysulin Nutritional Support for People With Diabetes & Prediabetes
Lysulin…clinically shown to help people with diabetes or pre-diabetes…works like a sponge to remove Glucose from your bloodstream…#type2diabetic #diabetescare …#insulindependent #diabetes #insulinresistance…
Lysulin provides people with diabetes and pre-diabetes with the nutritional support they need to maintain healthy levels of Insulin Resistance and A1c.
BLOOD SUGAR CONTROL: Lysulin helps lower blood glucose, glycated proteins, and A1c levels for people with type 2 diabetes, prediabetes, and anyone at risk of developing diabetes and metabolic syndrome.
Lysulin… Natural Diabetic Formula to Lower Blood Glucose for Type 2 Diabetes Or Prediabetes…
Lysulin is patented and proven in a human clinical study to help people with diabetes and prediabetes maintain healthy levels of A1c blood sugar.
Required actions (5)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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.
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)
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