Qualified health claims enable food marketers to talk about a relationship between a food substance and disease where there is supporting science, but where the evidence fails to meet the FDA’s ‘significant scientific agreement’ standard.
The problem, says Campbell Soup – in comments to the FDA on its nutrition innovation strategy – is that the wording of the approved claim is typically so qualified that no food marketer would want it anywhere near a food label.
“Plainly, manufacturers will not invest the time and resources necessary to develop and substantiate qualified health claims if the only return on investment is an approved claim that is so laden with disclaimers as to render the claim entirely unappealing to consumers and therefore not commercially viable.”
‘FDA should not go so far as require disclaimers that defeat the very purpose of the claim’
More efficient processes for the submission, review and approval of qualified health claims will encourage more manufacturers to invest in developing the scientific documentation and clinical evidence to substantiate and petition for their use, said the company, but if the wording isn’t looked at as well, nothing will change.
“We strongly suggest that FDA consider whether a significant liberalization of qualified health claim language would help drive innovation and be beneficial to consumers.
“In particular, many of the qualified health claims that have been approved to date contain mandatory disclaimers that undermine the intended benefit of the claim. While a degree of caution in approving qualified health claims is clearly appropriate, FDA should not go so far as require disclaimers that defeat the very purpose of the claim.
“When assessing which, if any, disclaimers should be required for a given claim, we respectfully suggest that FDA should carefully consider the First Amendment principles that underpin any such analysis.”
CRN: Why spend the money to secure claims that are ‘commercially unusable’?
The Grocery Manufacturers Association (GMA) – of which Campbell Soup is no longer a member – echoed many of the same points in its comments to the FDA, adding that, “GMA supports shorter, more succinct, consumer-friendly language…”
Indeed, noted the Council for Responsible Nutrition, the wording required by FDA is typically “lengthy and convoluted, making qualified health claims ineffective at communicating potential health benefits to consumers” and “commercially unusable by the food industry.”
The FDA should also respond more promptly to petitions, argued the CRN, which noted that the FDA has still not issued a response to its 2014 petition claiming long chain omega-3 fatty acids EPA and DHA can help lower blood pressure.
Nestlé: FDA should develop a framework for the appropriate labeling of products marketed to people managing diabetes or pre-diabetes
Nestlé, in turn, urged the FDA to develop a framework that would help the food industry formulate and market products for people trying to manage diabetes or prediabetes.
“Historically, it has been challenging to communicate how foods and beverages fit in the diet of individuals who are using nutrition to help manage diabetes. We would support FDA in developing a framework for the appropriate labeling of products specifically formulated for and / or marketed to individuals who are managing diabetes or pre-diabetes.”
- Read more stakeholder comments on the FDA's nutrition innovation strategy HERE.
Examples of qualified health claims reviewed by the FDA:
“Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps. FDA concludes that there is little scientific evidence to support this claim."
“High-amylose maize resistant starch may reduce the risk of type 2 diabetes, although the FDA has concluded that there is limited scientific evidence for this claim.”
"Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim."
“Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”