FDA Delays Decision on Resistant Starch Petition

FDA Delays Decision on Reversing Prediabetes with Resistant Starch
FDA Delays Resistant Starch Health Claim Decision

The U.S. Food and Drug Administration has been evaluating a health claim petition that resistant starch from high amylose corn may help to reduce the risk of Type 2 Diabetes for more than 19 months. According to information posted on the FDA’s website, the FDA has once again extended the deadline for a decision to November 15, 2016. This delay is regrettable.

To be clear, the FDA may delay releasing a decision on the resistant starch/Type 2 Diabetes petition for months, if not years. In the meantime, eighty six million Americans have Prediabetes and most of them do not know it. Without intervention, 15-30% of Prediabetics will progress to Type 2 Diabetes within 5 years. [1] In the long run, approximately 70% of Prediabetics eventually develop Type 2 Diabetes if they continue with their current lifestyle and diet. Individuals who are older, overweight and have other diabetes risk factors are more likely to develop Type 2 Diabetes than younger individuals of normal weight who regularly exercise and maintain a healthy diet. Of course, genetic risk can trump lifestyle factors.

Prediabetes is also expensive. A 2014 Diabetes Care study estimated that prediabetes costs $44 billion annually. [2] In fact, the economic burden associated with diabetes exceeded $433 billion in 2012, or more than $1,000 for each American in 2012. It is also 48% more than the cost of the economic burden in 2007. If you think health care is too expensive right now – just wait to see what your healthcare is going to cost after the incidence of diabetes doubles!

The Centers for Disease Control, and many other health-based organizations are diligently working to raise awareness of this condition. I wish the U.S. Food and Drug Administration was helping solve the problem instead of delaying access to nutritional tools like resistant starch.

[1] Centers for Disease Control and Prevention. http://www.cdc.gov/diabetes/prevention/prediabetes-type2/

[2] Dall TM et al., Diabetes Care, 2014; 37(12):3172-3179.