FDA rule offers only narrow field for blood sugar management claims, experts say

Gray area​

The central difficulty in crafting claims on dietary supplements aimed at the blood sugar management category is that there something of a gray area between “healthy” and “pre-diabetic.”  You can help healthy people stay healthy, but once they are sliding toward unhealthy blood sugar levels, once they have started to become somewhat insulin resistant, it’s mostly hands off, said two attorneys who advise dietary supplement companies on how to make health claims that comply with US Food and Drug Administration guidelines.

“The basic rules apply, and that is that when you characterize the relationship between a dietary supplement and a disease or a health condition that could lead to a disease, you are making a health claim,” ​Justin Prochnow, a shareholder in the firm Greenberg Traurig told NutraIngredients-USA.

“The practical line of what you can permissibly say tends to be something along the lines of supporting or maintaining blood sugar levels that are already in the healthy range. And you do need evidence to support that claim,”​ he said.

“You can talk about maintaining normal blood sugar levels. The key thing to make quite clear in your marketing is that you are starting from a basis of health,”​ said Jason Sapsin, an attorney in the firm Fox Rothschild.

FDA's final word​

Sapsin said the consumer’s health state is a key consideration, because of the aforementioned difficulty in defining exactly where disease occurs. Once a consumer has advanced to the point of needing insulin or some other form of drug therapy, marketing supplements to those individuals becomes increasingly problematic. FDA has weighed in on the potential pitfalls of marketing supplements to act as adjuncts to drug therapy in its final rule on structure function claims​, issued in 2000.

On claims relating to diabetes and blood sugar management the agency wrote: “One comment stated that as long as the statement makes it clear that the product is being recommended for its nutritional impact on structure or function ‘as part of the therapy and not as the therapy itself,’ FDA should permit the statement. According to the comment, ‘use as part of your diet when taking insulin to help maintain a healthy blood sugar level’ should be acceptable because the product is being recommended for its nutritional impact on structure or function as part of the therapy and not as the therapy itself. Another comment asked whether removing the words ‘when taking insulin’ from the statement would make it an acceptable structure/function claim.​

“The agency agrees that dietary supplements may be useful in providing nutritional support. Associating such a statement with an express or implied claim that the dietary supplement augments a therapy or drug action, however, implies that the dietary supplement has a role in treating or preventing the disease for which the drug or other therapy is used.”​

Implied claims​

Things left unsaid are also part of what makes a compliant claim in this sphere. Sapsin said the claims language and subsidiary marketing must be crafted with a eye toward what the average consumer might reasonably be expected to read between the lines.

“FDA has even objected to a basic claim like ‘maintains healthy blood sugar levels,’ ” ​Sapsin said. “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 serious illness that in FDA’s view is not amenable 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 compliant claim. Elevated blood sugar levels are a bad thing, but aren’t something that a dietary supplement can legally claim to help with, he said.

“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 said.

“It is a pretty narrow range of claims that FDA views as compliant,” ​he said.