Jason Sapsin was quoted in the NutraIngredients-USA article, "FDA Rules Offers Only Narrow Field for Blood Sugar Management Claims." Full text can be found in the January 20, 2015, issue, but a synopsis is below.
As obesity rates continue to rise, diabetes rates increase as well. Companies marketing ingredients intended to help consumers with metabolic conditions must be extremely careful with how enthusiastically they push their benefits.
Jason Sapsin explains that "you can talk about maintaining normal blood sugar levels. The key thing is to make quite clear in your marketing is that you are starting from a basis of health."
Sapsin also notes that the consumer's health state is a key consideration due to the difficulty in defining exact where disease occurs.
The claims language and subsidiary marketing must be crafted with an eye towards what the average consumer might reasonably be expected to read between the lines.
Sapsin says that "FDA has even objected to a basic claim lie 'maintains healthy blood sugar levels.' The agency says it could be inferred by the consumer that this would apply to people whose blood sugar levels are already abnormal. Diabetes is a serious illness that in FDA's view is not amendable to self-diagnosis or treatment. The agency's concern is if a consumer is already experiencing symptoms related to abnormal swings in blood sugar levels and believes that those can be controlled by a dietary supplement, that person may not seek a medical diagnosis."
Sapsin emphasized that the verb "to maintain" is a key element of a complaint claim. Elevated blood sugar levels are a bad thing, but isn't something that a dietary supplement can legally claim to help with.
"Where the agency has objected to is situations in which companies talked about actually lowering blood sugar levels. It is such a widespread problem and one that is receiving increasing amounts of attention, but that is also exactly the reason you must be careful about unclear communications regarding the value or benefit of the product,"Sapsin noted.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
