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Lysulin® Announces Lifting of FDA/FTC Warning Letter

·2 min read

SAN DIEGO, June 02, 2022--(BUSINESS WIRE)--Lysulin, Inc. announced today that is has received a close-out letter from the U.S. Food and Drug Administration lifting a 2021 warning letter relating to its promotion of Lysulin dietary supplements.

Dr. John F. Burd, Ph.D., CEO of Lysulin, said, "Lysulin is pleased to report that we have resolved the issues raised by the FDA and the FTC relating to the promotion and advertising of our dietary supplements. We held productive conversations with the FDA regarding our product claims, and we remain committed to bringing consumers a first-in-class nutritional supplement formulated to assist with glucose management in a responsible and transparent manner."

Lysulin provides a clinically studied approach for goal-oriented blood glucose management, available in over-the-counter dietary supplements.* Lysulin’s unique, patented formulation contains three carefully balanced essential nutrients: Lysine, Zinc and Vitamin C, which in over 20 years of independent research have been shown to help consumers maintain healthy blood glucose levels.*

Glucose in the blood attaches to proteins in the body, changing the protein’s structure and affecting how these proteins function. This destructive process is called protein glycation, which many experts believe is the main cause of unhealthy blood sugar levels and insulin resistance. Hemoglobin A1c (A1c) is a glycated protein, and because A1c levels measure the average blood glucose over the prior three months, physicians use the A1c test to measure blood glucose levels. Maintaining healthy A1c levels significantly reduces the risk of blood sugar complications.

"Lysulin is delivering remarkable results in nutritional support for people who want to maintain healthy glucose levels," said Burd. "Lysulin is committed to delivering its innovative formulation, backed by science, to help support a proactive approach to a healthy lifestyle. Nutrition and daily exercise are also critical components to maintaining healthy blood sugar levels."

With over 30 years of experience in glucose monitoring technology, Dr. Burd was founder and CEO of Dexcom and is renowned for his work in the medical and biotechnology field. He was inducted into the American Association of Clinical Chemistry (AACC) Hall of Fame in 2005 after winning the Ullman prize for innovation in clinical chemistry.

Lysulin’s supplements are easy-to-take, gluten free, vegetarian and vegan. Lysulin is available without a prescription and can be purchased at www.lysulin.com. For accompanying information for this press release and for further details about Lysulin, visit Lysulin.com.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220602006025/en/

Contacts

John Burd, PhD
Email: jburd@jfburd.com
Phone: 619-992-2873