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Helios, Sunbio Release Menopause Ingredient Guidelines
October 18, 2010
1 Min Read
LAS VEGASHelios Corp and Sunbio Corp will launch a new initiative at SupplySide West called Safety vs. Uncertainty for women (the "SVU Initiative"), which is their ground rules and a code of performance for ingredient suppliers within the menopausal category.
Helios Corp and Sunbio noted concerns about the risk of more burdensome restrictions and guidelines and said it hopes the guidelines will help ingredient suppliers become more proactive to avoid government intervention. SVU spells out a specific code and commitment to guidelines that accommodate the evolving standards as inserted in FTC/ FDA actions over the past several months. The
SVU Menopausal Ingredient Code is as follows:
Menopause active Ingredients will maintain at least two human clinical studies to prove safety, efficacy, and performance.
Each clinical will be conducted in a group with at least 40 women
The active ingredient seller will conduct a binding affinity study to show there is no binding on either the alpha or beta receptor sights which will then show no risk of cancer for women taking the ingredient.
The supplier will be able to demonstrate a full liver toxicity evaluation to prove the active ingredient is non-hepatotoxic.
The supplier will conduct MCF-7 studies to show no link of the menopausal active ingredient to breast cancer
The Ingredient supplier to the menopausal category will show its active component of the formula will pass a four-week and a 13-week toxicity study evaluation as well as genetic toxicology tests.
For more information, visit booth number 18091 during SupplySide West and ask for Michael Jeffers or Thomas Chang.
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