Industry Groups Suggest 'Healthy Eating' Approach On Label Enforcement

Supplement industry trade associations urge FDA to consider expanding the scope of products eligible to use “healthy” on product labels, though NPA says the issue could be on the backburner for the Trump administration.

Dietary supplement trade associations welcome FDA’s guidance of enforcement discretion for labeling food products “healthy” when the use is noncompliant with current labeling regulations, but urge the agency to broaden its scope on the issue.

FDA published guidance in September on use of “healthy” in food and dietary supplement labeling, in instances when the claims do not comply with the agency’s current regulations

In its guidance , the agency asked for industry comment on points including “what types of food, if any should be allowed to bear the term “healthy”, whether all food categories should be subject to the same criteria, whether the nutrients be introduced to foods or should they be provided in part, or in total by fortification.

Further, the agency asked, “if nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health?”

The labeling regulation updated with a May 2016 rule provides regulatory definitions for nutrient content claims including “healthy” or related terms such as “health,” “healthful,” “healthfully,” “healthfulness,” healthies,” and others. Those terms can be used if the food or supplement meets certain nutrient conditions and when used with an explicit or implicit claim or statement about a nutrient, such as “healthy, contains 2 grams of fat.”

The nutrient conditions for bearing a “healthy” nutrient content claim include specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, sodium and other requirements for nutrients to include in the diet, such as vitamin C, iron and protein.

In an April 20 blog post, FDA Center for Food Safety and Applied Nutrition Director Susan Mayne acknowledged that nutrition science has evolved. “Whereas in the past we placed greater emphasis on total fat, we now know that not all fats are alike, and some are better for health than others. And while the focus on ensuring that people are getting the right amounts of different nutrients still matters, other things matter as well, such as food groups or the combinations of different foods or beverages in the diet," Mayne said.

FDA’s guidance, which was effective immediately, communicates that it will exercise enforcement discretion for two product types that use the term healthy but do not comply with the rule. Products that:

• are “not low in total fat but have a fat profile makeup of predominately mono or polyunsaturated fats,” or;
• “contain at least ten percent of the Daily Value per reference amount customarily consumed of potassium or vitamin D.

Mayne noted a March meeting with food industry stakeholders brought to light many different opinions on defining “healthy” based solely on specific nutrients. “Some favored having the new definition continue to include certain beneficial nutrients, such as vitamins, minerals and fat,” she said. “Others suggested it be based instead on beneficial food groups too – such as whole grains, fruits and vegetables – while still others opted for a combination of the two.”

The American Herbal Products Association, the Council for Responsible Nutrition and the Natural Products Association submitted comments to FDA by the April 26 deadline, docket FDA–2016–D–2335. (Also see "NPA, Informed-Choice Pact: Health And Wellness Industry News Roundup" - HBW Insight, 20 Feb, 2017.)

In APHA's comments, President Michael McGuffin said it is reasonable for FDA to “craft a regulation that would allow, and in fact encourage, labeling of foods that are recommended to be included in a ‘healthy eating pattern’ as ‘healthy’ in food labeling,’ with such additional criteria as are needed to ensure that a ‘healthy’ claim for any specific food consisting of or containing the foods identified” is truthful and non-misleading.”

CRN's comments similarly state FDA should modify requirements of the regulation specific to “beneficial nutrients” to allow use of “healthy” for products beyond those contained in the rule. “The healthy nutrient content claim should be permitted for all foods that meet the nutrient contribution criterion whether the nutrients for which intake is encouraged are intrinsic to the foods or provided by fortification,” said Andrea Wong, CRN's vice president for scientific and regulatory affairs.

Dietary Research Emphasizes Healthy Patterns

In making his argument for foods that encourage healthy eating patterns, McGuffin noted that the Dietary Guidelines for Americans 2015-2020 support his position (Also see "Industry Roundup: Carlyle Backs Pharma Venture, Nutranomics CEO Returns" - HBW Insight, 11 Jan, 2016.), as do the February 2015 findings of the Scientific Report of the Dietary Guidelines Advisory Committee. (Also see "Industry Roundup: P&G Streamlining, Sunscreen TEA Challenges; Nutrient ‘Shortfalls’ On Dietary Guideline Report" - Pink Sheet, 23 Feb, 2015.)

“The report encourages the consumption of healthy dietary patterns that are low in saturated fat, added sugars, and sodium” he says, noting the report also says that rather than focusing purely on reduction, “emphasis should also be placed on replacement and shifts in food intake and eating patterns,” the AHPA

McGuffin points to an example in the scientific report that suggests emphasis on expanding industry efforts to reduce the sodium content of foods and help consumers understand how to flavor unsalted foods with spices and herbs. “Such healthy options to reduce sodium intake could allow herb and spice blends or prepared foods that substitute herbs and spices for salt to bear a claim such as ‘a healthy alternative to salt,” he says.

Likewise, “AHPA suggests that another legitimate option to sugar-sweetened beverages would be unsweetened teas, including black and green teas and herbal teas, and believes again that companies that market teas would be motivated to provide healthier options if regulations allowed a ‘healthy’ claim, such as ‘unsweetened tea is part of a healthy diet,’” he added.

CRN's Wong also pointed to DGA data, noting the data state that many consumers do not meet their needs for several important and essential nutrients, including potassium, dietary fiber, choline, magnesium, calcium and vitamins A, D, E and C.

“It is important to recognize that fortified foods contribute to raising intakes of nutrients that many Americans are consuming in amounts below the [estimated average requirement],” she said. “The ‘healthy’ nutrient content claim should be permitted for all foods that meet the nutrient contribution criterion whether the nutrients for which intake is encourages are intrinsic to the foods or provided by fortification. A variety of foods should be able to bear the ‘healthy’ nutrient content claim to give Americans options in constructing healthy diets.”

“Healthy” claims for foods and dietary supplements have been an issue for several years.

In March 2015, KIND LLC, marketers of KIND nutrition bars, received an FDA warning letter for numerous violations, including that its use of “healthy” on labeling was noncompliant with the requirements of the rule.

In December that year, KIND submitted a citizen petition asking FDA to update its existing requirements related to food labeling to become consistent with the DGAC report and consider allowing food labeling to bear the term “healthy” if a product contributes to dietary patterns of health, rather than on specific nutrients.

Could 'Healthy' Follow 'Natural' Arc?

NPA President Daniel Fabricant says to resolve “healthy” labeling, “there needs to be a clear tie to how the term ‘healthy’ on products and any sort of structure for it, really helps clarify things for industry and consumers, and there should be a cost benefit too."

Fabricant added there should be opportunities to include “healthy” labeling for products carrying nutrients such as fiber when they provide a consumer's total daily intake of the nutrient. “For those sort of areas, we think it makes sense to say ‘it’s healthy,’ in some form or another,” he said during an interview.

Additionally, FDA under the Trump administration may have bigger regulatory fish to fry, and the White House already has stalled federal agencies' publishing of regulations generated in new rulemakings. (Also see "Trump Order Reducing Regulation Might Imperil FDA Good Guidance Practices" - Pink Sheet, 30 Jan, 2017.)

“They’re not looking to add a bunch of new regs or new things like that that may or may not help businesses,” Fabricant said.

“What you saw in the last administration is, ‘let’s throw out as many regulations as we can and let’s see what sticks.’ This particular administration wants much more of an account of, ‘okay, what’s the actual effect on business? So, I hope as this conversation evolves, that there’s some discussion on what it means for the industry. There may have to be labeling changes. What does that entail dollar wise?”

However, Fabricant observed “there’s so much on the table that still needs to be worked out” before FDA defines types of products and situations that make products eligible to bear the term, and he noted the agency’s slow process on defining the term “natural” for use on supplement product labeling.

“The agency has been petitioned, and it’s been in regulations, and a statue for them to define natural,” Fabricant said. “They still haven’t done that, though they’re getting around to it, finally,” he said.

In November 2015, FDA requested comments on whether it should formally define “natural” for use in food products, including supplements, and whether protection of the public health compels the agency to conduct more rigorous oversight. (Also see "FDA Seeks Comment On 'Natural' Food Labeling; Cosmetics Not Mentioned" - HBW Insight, 11 Nov, 2015.)