Metabolic disease is a rising tide in the United States and western societies generally. Current trends indicate that one in three American adults will develop Type 2 diabetes by 2050. There is less agreement about why this is the case, and what to do about it. Obesity rates are rising in lockstep. Whether obesity causes diabetes, long taken as gospel, is now a subject of debate.
“The alarming thing if you take metabolic diseases, they are increasing in younger age individuals who previously were considered immune to these conditions,” said Dr Jeffrey Bland, PhD, president of the Personalized Lifestyle Medicine Institute at a recent industry event hosted by the United Natural Products Alliance.
“We have this belief that it is caused by obesity. I don’t think that it true. I think obesity in and of itself is not the cause of diabetes; there is an association but no direct causal link. There is something else going on,” he said.
In any case, diet changes and exercise are clearly part of the solution. And specific ingredients, such as chromium, phytonutrients from blueberries or other fruits, or whole grains or dietary fiber, can lay claim to some degree of scientific backing for their role in blood sugar management. But is it enough to back specific product claims? Not yet, according to FDA.
“IN FDA’s judgment the science isn’t there to justify making a claim,” said Marc Ullman, a principal in the firm Ullman, Shapiro & Ullman who counts a number of food companies among his clients. “This is a difficult course to navigate for industry at any level.”
Structure function fallback
So companies are left with structure function claims, said Jason Sapsin, an attorney with the firm Fox Rothschild. A food can claim to help maintain blood sugar levels within an already healthy range.
“In theory the structure function claim for a conventional food should be related to the food’s nutritive value,” Sapsin said. In other words, the food supplies the correct nutrients to support the healthy metabolism of glucose.
“The second principle that always applies is that any claim made needs to make it clear that it relates to already normal blood sugar levels,” he said.
Medical foods guidance
Medical foods, a specific regulatory category of foods formulated to meet specific nutrient deficiencies that arise form some diseases or from the treatment of those diseases, has long been a category in which foods addressing the needs of diabetics have been marketed. But FDA, in a recently updated draft guidance on medical foods, specifically omitted diabetes as a condition for which a medical food could be formulated. In the updated guidance the agency said: “Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by either type of (diabetes) . . . a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. Therefore, FDA generally would not consider a product labeled and marketed for DM to meet the regulatory criteria for a medical food.”
A[proved health claim
Qualified health claim
A highly qualified health claim for whole grain consumption and its effect on Type 2 diabetes was recently approved by FDA. The claim, which was submitted by food giant ConAgra, reads as follows: 'Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.'
Will such a claim be of use to formulators and marketers? Time will tell. But the need and the opportunity are evident. In a recent report Frost and Sullivan concluded thatthe marked for the diabetic management nutritional ingredients was $126 million in 2012 and will grow to grow to $240 million in 2019.
Tiptoeing through the claims
So how best to communicate the benefits certain foods or ingredients might to fit within the “diet therapy” that FDA talks about in the medical foods guidance? Sapsin said a company can still talk about the attributes of its food.
“You can still talk about the glycemic index of your food. You can still talk about sugar content,” he said.
“I think there is another way to look at it. I think it’s less about telling industry that it can’t help people manage their condition through their diet than it is telling industry there are limits to telling people what they can achieve through their diet,” Sapsin said.
And the wording marketers use to communicate the value of certain foods and ingredients in this area might help unlock some of that market that Frost and Sullivan is talking about. Consultant Jeff Hilton, speaking with FoodNavigator-USA last year, said maybe it’s time to shelve phrases such as “low GI,” and “metabolic syndrome” because they haven’t resonated with consumers.
"'Healthy blood sugar’ is a better way to communicate with consumers, although it will still take a lot of education. But I do think there is a huge potential in this market as so many people are pre-diabetic,” he said.