The FDA warns that supplements claiming to provide a cure or quick fix for health issues are likely too good to be true.
Diabetes is a growing concern worldwide, with millions of new cases emerging annually. Dr. Mitchell Katz, CEO of New York City Health and Hospitals, highlighted the need for safe and effective treatments to prevent type 2 diabetes in high-risk individuals. A study from China investigated Jinlida granules, a traditional Chinese herbal medicine, and its potential to reduce diabetes risk. However, regulatory obstacles hinder the approval and availability of such treatments in the United States.
The research published in JAMA Internal Medicine revealed that Jinlida, made of 17 herbal ingredients and approved for type 2 diabetes in China, significantly lowered the risk of diabetes in individuals with impaired glucose tolerance. Participants taking Jinlida experienced a 41% reduced risk compared to those on a placebo.
The study involved 885 participants aged 18 to 70, monitored over two years. Both groups underwent lifestyle interventions, including physical activity sessions, dietary adjustments, and other modifications. The Jinlida group showed improvements in various health markers, including blood sugar levels, waist size, BMI, and cholesterol levels.
Although studies suggest Jinlida’s effectiveness in managing blood glucose, herbal treatments face different regulatory standards in the US than medications. Herbal supplements are considered foods by the FDA, and companies do not require premarket approval before marketing them. Herbal products cannot claim to cure diseases without meeting FDA drug approval guidelines.
The FDA’s strict regulations pose challenges for herbal treatments like Jinlida to gain recognition similar to pharmaceutical drugs. The approval process involves demonstrating consistent composition, efficacy, and safety, which can be costly and cumbersome for herbal companies. Despite promising results, herbal formulas like Jinlida may not be prescribed by licensed medical professionals due to lack of FDA approval.
The existing drug approval system in the US, while ensuring safety and efficacy, may hinder potentially beneficial treatments, especially those from traditional medicine, from entering the market. Dr. Katz emphasized the need to explore treatments beyond pharmaceuticals, acknowledging the barriers that herbal treatments face in gaining FDA approval.
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