Research is revealing astounding links between diet and cognitive function, but a massive gulf still separates what happens to, for example, DHA-eating rats and what supplemental DHA will do in an unsuspecting, food-purchasing individual. That’s why Ram Chaudhari, Ph.D., senior vice president, R&D, Fortitech Inc., Schenectady, NY, is leery of promoting any one food or nutrient as a certifiable “brain food.”
“No single nutrient will have a full impact,” he says. “There are always other metabolic processes going on simultaneously, so you’ve got to have other nutrients carried along with them. We have different situations with different consumers, so we cannot apply the same components, at the same dosages, to every population. It’s just not going to work that way.”
Marketing meets FDA
Marketers, take note: Resist the temptation to tout your products as the greatest development since SAT cram courses. If Chaudhari’s advice isn’t enough, just consider FDA’s eagle-eyed oversight. For, while manufacturers can make three types of product claims, the government exercises some regulatory enforcement over each of them.
The toughest claim to earn is for disease-reduction, which requires scientific backing sufficient to warrant FDA approval. An example with respect to brain foods is the qualified health claim that FDA grants for phosphatidylserine: “Consumption of phosphatidylserine may reduce the risk of [dementia/cognitive dysfunction] in the elderly. Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of [dementia/cognitive function] in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”
As the language makes clear, it’s hardly a ringing endorsement. And yet, notes Jeff Bernfeld, executive director, marketing, Martek Biosciences Corporation, Colombia, MD, “it can take decades to get a health claim that’s not completely couched in language that makes you wonder, ‘Why even bother?’” So we move to the next category of claim: the nutrient content statement. “That’s when you see packages saying that a food is a good source or excellent source” of some nutrient, he says. While making such a statement entails less scrutiny, whether manufacturers go even that far often depends on how much value they think a nutrient content claim adds to the consumer’s perception of the product. After all, he notes, a nutrient content claim doesn’t tell the consumer what the nutrient does.
Considering structure-function
That’s what structure-function claims are for. These describe how a food affects the body’s normal structure or function. And pairing such a claim with a corresponding nutrient content claim may be the best route to grabbing consumers’ attention. As Bernfeld says, while no savvy marketer would rely solely on nutrient content claims alone, “if you had a nice line on your packages that says, ‘Contains DHA omega-3 fatty acid—an important component of brain health,’ and you said that the product was an excellent source of DHA omega-3, that could be compelling.”
Sometimes these claims seem to be an exercise in creative writing. FDA offers guidelines as to the appropriate type of language: “No specific adjectives constitute a disease claim. Therefore, words such as ‘restore,’ ‘support,’ ‘maintain,’ ‘raise,’ ‘lower,’ ‘promote,’ ‘regulate,’ or ‘stimulate’ might create an implied disease claim if, in the context they are used, they imply an effect on disease. Similarly, words like ‘prevent,’ ‘mitigate,’ ‘diagnose,’ ‘cure,’ or ‘treat’ would be disease claims if the context of their use implied an effect on a disease. “Supporting brain health” might pass muster, but “preventing the onset of Alzheimer’s” would likely raise the FDA’s ire.
Still, structure-function claims are the least-regulated of the bunch, so it’s ultimately up to the manufacturer to vet that they’re actually valid for the nutrient and structural/functional benefits in question. If you want to stay in FDA’s good graces, just remember to notify the agency within 30 days of using the claim; print the disclaimer, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease” on the package; and have plenty of data on hand to defend your claim should anyone challenge it.
Web Resources
Defending the Need for Omega-3 Claims
FDA Guidence for Industry: Structure-Function Claims
Excellent source claim allowed for EPA/DHA combo
Blueberry Extract Boosts Brain Function
Natural Supplements to Ward Off Alzheimer’s (Aging on the Brain: The Neurodegenerative Battle)
Setting a Daily Value for Omega-3s an Industry Priority (Changing Regulatory Landscape for LC-PUFAs)
Other Resources
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